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Link to original content: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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The effects of various covariates \(e.g., )]TJ 0.0002 Tc -0.0002 Tw -18.55 -1.335 Td (body size [weight, height, body surface area], age,)Tj 0.0006 Tc -0.0016 Tw 20.135 0 Td [( gender, baseline creatin)6 (ine clearan)6 (ce\) on )]TJ -0.0022 Tw -20.135 -1.33 Td [(ofatum)8 (umab pharm)8 (acokinetics were assessed )]TJ 0.0002 Tc -0.0027 Tw [(in a population pharm)8 (acokinetic analysis. )]TJ EMC /P <>BDC 0 Tc 0 Tw T* ( )Tj EMC /Span <>BDC /TT2 1 Tf 0.0022 Tw T* (Body Weight:)Tj EMC /P <>BDC /TT0 1 Tf 0.0005 Tc 0.0007 Tw 5.945 0 Td [( Volum)8 (e)-1 ( of distribution a)]TJ 0.0004 Tc -0.0004 Tw 10.115 0 Td [(nd clearance increas)5 (ed with )]TJ -0.0001 Tc 0.0001 Tw 11.33 0 Td (body weight. However, this )Tj -27.39 -1.33 Td (increase was not clinically significant. No )Tj 0.0003 Tc -0.0003 Tw 17.02 0 Td [(dosage adjustm)8 (e)-1 (nt is recomm)8 (ended based on body )]TJ 0 Tw -17.02 -1.335 Td (weight. )Tj EMC /P <>BDC 0 Tc T* ( )Tj EMC /Span <>BDC /TT2 1 Tf -0.0014 Tc 0 -1.33 TD (Age:)Tj EMC /P <>BDC /TT0 1 Tf 0.0001 Tc -0.0011 Tw 2.055 0 Td ( Age did not significantly infl)Tj 0.0004 Tc -0.0004 Tw 11.865 0 Td [(uence ofatum)8 (um)8 (ab phar)-7 (m)8 (a)-6 (c)-1 (okineti)]TJ -0.0002 Tc -0.001 Tw 14.105 0 Td [(cs in patients ranging from)8 ( )]TJ 0.0003 Tc -0.0003 Tw -28.025 -1.335 Td [(21 to 86 years of age. No pharm)8 (acokinetic da)]TJ -0.0024 Tw 18.19 0 Td [(ta are availab)5 (l)-2 (e in pediatric patien)5 (t)-2 (s. )]TJ EMC /P <>BDC 0 Tc 0 Tw -18.19 -1.335 Td ( )Tj EMC /Span <>BDC /TT2 1 Tf -0.0001 Tc T* (Gender:)Tj EMC /P <>BDC /TT0 1 Tf 0.0004 Tc -0.0011 Tw 3.615 0 Td ( Gender had a modest effect on ofatumum)Tj -0.0013 Tw 16.85 0 Td (ab pharmacokinetics \(14% to 25% lower )Tj 0.0008 Tw -20.465 -1.335 Td [(clearance and volum)8 (e of distribut)]TJ 0.001 Tc -0.0026 Tw 13.385 0 Td [(ion in f)4 (em)9 (ale patien)6 (t)-1 (s com)9 (p)1 (ared to m)9 (ale patien)6 (t)-1 (s\) in a )]TJ 0.0001 Tc -0.0034 Tw -13.385 -1.335 Td (cross-study population analysis \(41% )Tj -0.0021 Tw 15.22 0 Td (of the patients in this anal)Tj 0.0002 Tc -0.0002 Tw 10.305 0 Td [(ysis were m)8 (a)-1 (le and 59% were )]TJ 0.0007 Tc -0.0007 Tw -25.525 -1.33 Td [(fem)9 (ale\). These effects are not cons)5 (id)6 (ered clin)]TJ 0.0004 Tc -0.0004 Tw 18.19 0 Td [(ically im)8 (portant, and no dosage adjustment is )]TJ 0.0005 Tc 0 Tw -18.19 -1.335 Td [(recomm)8 (ended. )]TJ EMC /P <>BDC 0 Tc 0 -1.335 TD ( )Tj EMC /Span <>BDC /TT2 1 Tf 0.0003 Tc 0.0019 Tw 0 -1.33 TD [(Renal Im)8 (pair)-7 (m)8 (ent:)]TJ EMC /P <>BDC /TT0 1 Tf 0.0007 Tc -0.0007 Tw 8.17 0 Td [( Creatin)6 (ine clearance at b)6 (aseline did no)6 (t )]TJ 0.0002 Tc -0.0002 Tw 16.25 0 Td [(have a clinically im)8 (portant effect on )]TJ 0.0007 Tc -0.0007 Tw -24.42 -1.335 Td [(ofatum)9 (umab pharm)9 (acokinetics in pa)]TJ 0.0002 Tc -0.0018 Tw 14.58 0 Td [(tients with calculated cre)4 (a)-1 (ti)]TJ 0.0001 Tc -0.0001 Tw 10.97 0 Td (nine clearance values ranging )Tj 0.0007 Tc 0.0005 Tw -25.55 -1.335 Td [(from)9 ( 33 to 287 m)9 (L)2 (/)-6 (m)9 (in. )]TJ EMC /P <>BDC /TT3 1 Tf -0.0004 Tc 1.6126 Tw 0 -2.34 TD [(13 NONCLINI)-8 (CAL )1610 (TOXICOLOGY )]TJ EMC /P <>BDC 0.7775 Tw 0 -1.335 TD [(13.1 Carcinogenesis, )775 (Mutagenesi)]TJ 0.0003 Tc 0.0019 Tw 16.5 0 Td [(s, Impairment of Fertility)7 ( )]TJ EMC /P <>BDC /TT0 1 Tf -0.0015 Tw -16.5 -1.325 Td [(No carcinogenicity or m)8 (utagenicity studies )]TJ -0.0011 Tw 17.47 0 Td [(of ofatum)8 (um)8 (ab ha)-6 (ve been conducted. In a )]TJ -0.0015 Tw -17.47 -1.33 Td (repeat-dose toxicity study, no tu)Tj -0.0004 Tw 12.86 0 Td [(m)8 (origenic or unexpected m)8 (itogenic responses were noted in )]TJ -12.86 -1.335 Td [(cynom)8 (olgus)-5 ( m)8 (onkeys treated for 7 months with )5 (up to 3.5 tim)8 (e)-1 (s the human dose of ofatum)8 (umab. )]TJ 0 Tc 0.0008 Tw T* [(Effects on male and fem)8 (a)-6 (le fertility have)]TJ 0.0004 Tc -0.0004 Tw 16.33 0 Td [( not been evaluated in anim)8 (al studies. )]TJ EMC /P <>BDC 0 Tc 0 Tw -16.33 -1.33 Td ( )Tj EMC /P <>BDC /TT3 1 Tf -0.0006 Tc 0.0028 Tw 0 -1.345 TD [(13.3 )-775 (Reproduct)-8 (i)-3 (ve and Developmental Toxicolog)-5 (y)6 ( )]TJ EMC /P <>BDC /TT0 1 Tf 0.0002 Tc -0.0002 Tw 0 -1.325 TD [(Pregnant cynom)8 (olgus monkeys dosed with 0.7 )]TJ 0.0008 Tc -0.0008 Tw [(or 3.5 tim)9 (es the hum)9 (an dos)-5 (e of ofatum)9 (um)9 (ab )]TJ 0.0002 Tc -0.001 Tw 0 -1.33 TD (weekly during the period of organogenesis \(gestation )Tj -0.0002 Tw 21.525 0 Td [(days 20 to 50\) had no m)8 (a)-1 (ternal toxicity or )]TJ 0.0004 Tc -0.0004 Tw -21.525 -1.335 Td [(teratogenicity. Both dose levels of ofatum)8 (um)8 (ab )8 (depleted circulating B cel)]TJ 0.0008 Tc 0.0004 Tw 29.49 0 Td [(ls in th)6 (e da)5 (m)9 (s, with )]TJ 0.0002 Tc -0.0002 Tw -29.49 -1.335 Td (signs of initial B cell recovery 50 days after )Tj 0.0001 Tc -0.0001 Tw 17.75 0 Td (the final dose. Following Caesarean section at )Tj 0.0005 Tc -0.0005 Tw -17.75 -1.33 Td [(gestational day 100, fetuses from)8 ( ofa)-6 (t)-2 (um)8 (um)8 (ab-t)7 (reated dam)8 (s exhibited decreases in m)8 (ean )]TJ EMC ET /Artifact <>BDC BT /OC /MC0 BDC 0 Tc 0 Tw 12 0 0 12 64.4328 18.9482 Tm ( )Tj EMC ET EMC /Artifact <>BDC Q q 1 0 0 1 120.6970062 785.2004395 cm /GS1 gs /Fm0 Do Q EMC /Artifact <>BDC q 1 0 0 1 612 773.2004395 cm /GS1 gs /Fm1 Do Q EMC endstream endobj 1711 0 obj <>>>/Resources 1716 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 65.791 -7.9 Td (This ) Tj 22.92 0 Td (label ) Tj 26.055 0 Td (may ) Tj 22.71 0 Td (not ) Tj 18.12 0 Td (be ) Tj 14.692 0 Td (the ) Tj 18.023 0 Td (latest ) Tj 29.595 0 Td (approved ) Tj 48.974 0 Td (by ) Tj 14.17 0 Td (FDA. ) Tj -281.05 -12 Td (For ) Tj 18.96 0 Td (current ) Tj 38.765 0 Td (labeling ) Tj 41.055 0 Td (information, ) Tj 61.25 0 Td (please ) Tj 34.707 0 Td (visit ) Tj 22.299 0 Td (https://www.fda.gov/drugsatfda) Tj ET endstream endobj 1712 0 obj <>>>/Resources 1713 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 0 -7.9 Td ( ) Tj ET endstream endobj 1713 0 obj <> endobj 1714 0 obj <> endobj 1715 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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The antibody was gene)]TJ 0.0005 Tc -0.0005 Tw 19.195 0 Td [(rated via transgenic m)8 (ouse and hybridom)8 (a )]TJ 0.0004 Tc -0.0018 Tw -19.195 -1.335 Td [(technology and is produced in a recombinant m)8 (u)]TJ 0.0001 Tc -0.0009 Tw 19.525 0 Td [(rine cell line \(NS0\) using standard m)8 (a)-1 (mmalian )]TJ 0.0004 Tc -0.002 Tw -19.525 -1.335 Td (cell cultivation and pur)Tj 0.0002 Tc -0.0002 Tw 9.25 0 Td (ification technologies. )Tj EMC /P <>BDC 0 Tc 0 Tw -9.25 -1.33 Td ( )Tj EMC /P <>BDC 0.0001 Tc 0.0009 Tw 0 -1.335 TD (ARZERRA is a sterile, colorless, preservati)Tj 0.0002 Tc -0.0002 Tw 17.475 0 Td (ve-free liquid concentrate for intravenous )Tj -17.475 -1.335 Td [(adm)8 (i)-2 (nistration. ARZERRA is supplied at a concentr)]TJ -0.0003 Tc 0.0003 Tw 20.86 0 Td [(ation of 20 m)8 (g/)-7 (m)8 (L in 10 )]TJ 0.0002 Tc -0.0002 Tw 10.05 0 Td [(m)8 (L)1 ( single-use vials. )]TJ 0.0004 Tc -0.0004 Tw -30.91 -1.33 Td [(Each single-use vial contains 100 m)8 (g)-5 ( ofatum)8 (um)]TJ 0.001 Tc -0.001 Tw 19.27 0 Td [(a)-5 (b)1 ( in 5 m)9 (L)2 ( of soluti)]TJ 0.0001 Tc -0.0026 Tw 7.93 0 Td (on. Inactive ingredients )Tj 0.0005 Tc -0.0005 Tw -27.2 -1.335 Td [(include: 8.55 m)8 (g)1 (/)-7 (m)8 (L sodium)8 ( citrate and 0.195 )]TJ 0.0006 Tc -0.0022 Tw [(mg/m)8 (L citric acid m)]TJ 0.0004 Tc -0.0029 Tw 26.99 0 Td (onohydrate as buffering )Tj 0.0005 Tc -0.0019 Tw -26.99 -1.335 Td [(agents, 5.85 mg/)-7 (m)8 (L sodium)8 ( chloride as an isotoni)]TJ 0.0003 Tc -0.0009 Tw 19.97 0 Td (c agent, and Water for Injection, USP as the )Tj -0.0001 Tc 0.0001 Tw -19.97 -1.33 Td (solvent. The pH is 6.5. )Tj EMC /P <>BDC /TT0 1 Tf 0 Tc 1.6122 Tw 0 -2.345 TD [(12 CLINICAL )1605 (PHARMACOLOGY )]TJ EMC /P <>BDC -0.0002 Tc 0.0024 Tw 0 -1.335 TD [(12.1 )-775 (Mechanism of Action )]TJ EMC /P <>BDC /TT1 1 Tf 0.0008 Tc -0.0008 Tw 0 -1.32 TD [(Ofatum)9 (um)9 (a)-5 (b)1 ( binds specifically )]TJ 0.001 Tc -0.002 Tw 12.805 0 Td [(to bo)6 (th the sm)9 (all and larg)6 (e ex)6 (trac)5 (ellu)6 (lar lo)6 (ops of)4 ( the CD20 )]TJ 0.0003 Tc 0.0005 Tw -12.805 -1.335 Td [(molecule. T)6 (he CD20 m)8 (o)-5 (lecule is expressed on )]TJ 0.001 Tc -0.001 Tw 18.89 0 Td [(no)6 (rm)9 (al B lym)9 (p)-4 (hocytes \(p)6 (re)5 (-B- to m)9 (ature )]TJ 0.0003 Tc 0.0004 Tw -18.89 -1.335 Td [(B-lym)8 (phocyte\) and on B)7 (-)-2 (cell CLL. The CD20 m)8 (o)-5 (lecule)]TJ -0.0014 Tw 22.44 0 Td [( is not shed from)8 ( th)]TJ 0.0005 Tc -0.0005 Tw 7.745 0 Td (e cell surface and is )Tj 0.0001 Tc -0.0001 Tw -30.185 -1.33 Td (not internalized following antibody binding. )Tj EMC /P <>BDC 0 Tc 0 Tw 0 -1.335 TD ( )Tj EMC /P <>BDC 0.0009 Tc -0.0009 Tw T* [(The Fab dom)9 (ain of ofatum)9 (um)9 (ab binds to the )]TJ 0.0004 Tc -0.0004 Tw 18.11 0 Td [(CD20 m)8 (olecule and the Fc dom)8 (a)-1 (in m)8 (e)-1 (diates )]TJ -0.0004 Tc 0.0004 Tw -18.11 -1.33 Td [(immune effe)-7 (ctor functions )]TJ 0.0008 Tc -0.0033 Tw 10.855 0 Td [(to resu)6 (lt in B-cell lysis )]TJ /TT2 1 Tf 0.0005 Tc -0.0005 Tw 9.305 0 Td (in vitro)Tj /TT1 1 Tf 0.0002 Tc -0.0002 Tw 2.92 0 Td (. Data suggest that possible )Tj 0.0006 Tc -0.0026 Tw -23.08 -1.335 Td [(m)8 (echanis)-5 (m)8 (s)-5 ( of cell lysis include complem)8 (e)-1 (nt-d)]TJ 0.0002 Tc -0.0002 Tw 19.025 0 Td (ependent cytotoxicity )Tj -0.0052 Tw 8.89 0 Td (and antibody-dependent, )Tj 0.0003 Tc -0.0003 Tw -27.915 -1.335 Td [(cell-m)8 (e)-1 (diated cytotox)5 (i)-2 (city. )]TJ EMC /P <>BDC 0 Tc 0 Tw 0 -1.33 TD ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0002 Tc 0.7774 Tw 0 -1.345 TD [(12.2 Pharmaco)-4 (d)-4 (y)6 (namics )]TJ EMC /P <>BDC /TT1 1 Tf 0.0003 Tc -0.0019 Tw 0 -1.325 TD (In patients with CLL refractory to fludarabi)Tj 0.0006 Tc 0.0002 Tw 17.45 0 Td [(n)6 (e)-1 ( and alem)8 (tuzum)8 (a)-1 (b, the m)8 (e)-6 (dian decreas)5 (e in )]TJ 0.0003 Tc -0.0019 Tw -17.45 -1.33 Td (circulating CD19-positive B cells )Tj 0.0005 Tc 13.67 0 Td [(w)8 (a)-1 (s 91% \(n = 50\) with the 8)]TJ EMC /Span <>BDC 0.0004 Tc 0 Tw 7.98 0 0 7.98 363.9388 264.6188 Tm (th)Tj EMC /P <>BDC 0.0003 Tc -0.0017 Tw 12 0 0 12 370.1788 259.0988 Tm ( infusion and 85% \(n = 32\) with )Tj 0.0008 Tc -0.0008 Tw -25.55 -1.335 Td (the 12)Tj EMC /Span <>BDC 0.0004 Tc 0 Tw 7.98 0 0 7.98 93.2188 248.5988 Tm (th)Tj EMC /P <>BDC 0.0002 Tc -0.0002 Tw 12 0 0 12 99.4588 243.0788 Tm [( infusion. The tim)8 (e to recovery of lym)8 (p)]TJ 0.0003 Tc -0.0023 Tw 15.77 0 Td (hocytes, including CD19-positive B cells, to )Tj 0.0006 Tc -0.0006 Tw -18.76 -1.335 Td [(norm)8 (a)-1 (l levels has not been determ)8 (ined. )]TJ EMC /P <>BDC 0 Tc 0 Tw 0 -1.33 TD ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0004 Tc 0.7776 Tw 0 -1.345 TD [(12.3 Pharmaco)-5 (kinetics )]TJ EMC /P <>BDC /TT1 1 Tf 0.0004 Tc -0.0004 Tw 0 -1.325 TD [(Pharm)8 (acokinetic data w)8 (e)-1 (re obtained from)8 ( 146 )]TJ -0.0012 Tw (patients with refractory CLL who received a )Tj -0.0003 Tw 0 -1.33 TD [(300-m)8 (g initial dose followed by 7 weekly a)]TJ 0.0001 Tc -0.0001 Tw 17.415 0 Td [(nd 4 monthly infusions of 2,000 m)8 (g. The C)]TJ EMC /Span <>BDC -0.0109 Tc 0 Tw 7.98 0 0 7.98 481.1188 161.5988 Tm [(ma)-11 (x)]TJ EMC /P <>BDC 0.0002 Tc -0.0002 Tw 12 0 0 12 495.3987 163.0988 Tm ( and )Tj -0.0022 Tc 0 Tw -35.985 -1.335 Td (AUC)Tj EMC /Span <>BDC 7.98 0 0 7.98 89.4988 145.5788 Tm [(\(0)-6 (-)]TJ /C2_0 1 Tf 0 Tc <0066>Tj /TT1 1 Tf 1.88 0 Td (\))Tj EMC /P <>BDC 0.0008 Tc -0.0008 Tw 12 0 0 12 107.7388 147.0788 Tm [( aft)-6 (er the 8)]TJ EMC /Span <>BDC 0.0004 Tc 0 Tw 7.98 0 0 7.98 159.4588 152.5988 Tm (th)Tj EMC /P <>BDC -0.0004 Tw 12 0 0 12 165.6388 147.0788 Tm [( infusion in Study 1 were approxim)8 (a)-1 (te)]TJ 0 Tc -0.0007 Tw 15.335 0 Td (ly 40% and 60% higher than after the )Tj 0 Tw -23.84 -1.335 Td (4)Tj EMC /Span <>BDC 0.0004 Tc 7.98 0 0 7.98 69.5788 136.5788 Tm (th)Tj EMC /P <>BDC 0.0005 Tc -0.0005 Tw 12 0 0 12 75.8188 131.0587 Tm [( infusion in Study 2. The m)8 (ean volum)8 (e )]TJ 0.0004 Tc -0.0016 Tw 15.855 0 Td (of distribution at steady-state \(V)Tj EMC /Span <>BDC 0.0018 Tc 0 Tw 7.98 0 0 7.98 422.0188 129.5587 Tm (ss)Tj EMC /P <>BDC 0.0006 Tc -0.0006 Tw 12 0 0 12 428.8588 131.0587 Tm [(\) values ranged from)8 ( )]TJ 0.0009 Tc -0.0009 Tw -30.44 -1.33 Td [(1.7 to 5.1 L. Ofatum)9 (um)9 (a)-5 (b)1 ( is elim)9 (inated th)]TJ 0.0002 Tc -0.0018 Tw 16.835 0 Td (rough both a target-independent route and a )Tj 0.0007 Tc -0.0027 Tw -16.835 -1.335 Td [(B cell-m)9 (ediated route. Ofatum)9 (um)9 (a)-5 (b)1 ( exhibited dos)]TJ 0.0003 Tc -0.0003 Tw (e-dependent clearance in)Tj -0.0001 Tc 0.0001 Tw 29.99 0 Td ( the dose range of 100 )Tj 0.0006 Tc -0.0011 Tw -29.99 -1.335 Td [(to 2,000 m)8 (g)1 (. Due to the depletion of B cells)]TJ 0.0002 Tc -0.0039 Tw 17.53 0 Td (, the clearance of of)Tj 0.0008 Tc -0.0008 Tw 7.9 0 Td [(atum)9 (umab decreased )]TJ 0.0003 Tc -0.0003 Tw -25.43 -1.33 Td (substantially after subs)Tj 0.0002 Tc 0.0003 Tw 9.17 0 Td [(equent infusions com)8 (pared to the first infusion. The m)8 (ean clearance )]TJ EMC ET /Artifact <>BDC BT /OC /MC0 BDC 0 Tc 0 Tw 12 0 0 12 63.5788 19.0987 Tm ( )Tj EMC ET EMC /Artifact <>BDC Q q 1 0 0 1 120.6970062 785.2004395 cm /GS1 gs /Fm0 Do Q EMC /Artifact <>BDC q 1 0 0 1 612 773.2004395 cm /GS1 gs /Fm1 Do Q EMC endstream endobj 1721 0 obj <>>>/Resources 1726 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 65.791 -7.9 Td (This ) Tj 22.92 0 Td (label ) Tj 26.055 0 Td (may ) Tj 22.71 0 Td (not ) Tj 18.12 0 Td (be ) Tj 14.692 0 Td (the ) Tj 18.023 0 Td (latest ) Tj 29.595 0 Td (approved ) Tj 48.974 0 Td (by ) Tj 14.17 0 Td (FDA. ) Tj -281.05 -12 Td (For ) Tj 18.96 0 Td (current ) Tj 38.765 0 Td (labeling ) Tj 41.055 0 Td (information, ) Tj 61.25 0 Td (please ) Tj 34.707 0 Td (visit ) Tj 22.299 0 Td (https://www.fda.gov/drugsatfda) Tj ET endstream endobj 1722 0 obj <>>>/Resources 1723 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 0 -7.9 Td ( ) Tj ET endstream endobj 1723 0 obj <> endobj 1724 0 obj <> endobj 1725 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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A reproductive study in pre)]TJ 0.0002 Tc -0.0002 Tw [(gnant cynom)8 (olgus m)8 (onkeys that received )]TJ 0.0007 Tc -0.0013 Tw 0 -1.335 TD [(ofatum)9 (umab at doses up to 3.5 tim)9 (es the reco)]TJ -0.0007 Tw [(mmended hum)9 (a)-5 (n)1 ( dose of ofatum)9 (um)9 (ab did not )]TJ 0.0005 Tc -0.0005 Tw 0 -1.33 TD [(dem)8 (onstrate m)8 (a)-1 (ternal to)6 (xicity or teratogenic)]TJ 0.0013 Tc -0.0029 Tw 17.715 0 Td [(ity. Ofatum)9 (um)9 (ab crossed th)6 (e placen)6 (tal b)6 (arrier, and )]TJ 0.0003 Tc -0.0003 Tw -17.715 -1.335 Td (fetuses exhibited depletion of peripheral B cells)Tj 0.0005 Tc -0.0021 Tw 19.115 0 Td [( and decreas)5 (e)-1 (d spleen )]TJ 0.0004 Tc -0.0029 Tw 8.935 0 Td (and placental weights. )Tj 0.0001 Tc 0.0009 Tw -28.05 -1.335 Td (ARZERRA should be used during pr)Tj 0.0003 Tc -0.0003 Tw 14.805 0 Td (egnancy only if the potential bene)Tj 0.0008 Tc -0.002 Tw 13.585 0 Td [(fit to the m)9 (o)1 (ther justifies )]TJ 0.0009 Tc -0.0019 Tw -28.39 -1.33 Td [(the poten)6 (tia)5 (l risk to the f)9 (etus. )]TJ EMC /P <>BDC 0 Tc 0 Tw 0 -1.335 TD ( )Tj EMC /P <>BDC 0.0005 Tc -0.0005 Tw T* [(There are no hum)8 (a)-1 (n or anim)8 (al data on the potential)]TJ 0.0001 Tc -0.0001 Tw 20.47 0 Td ( short-term and long-term)Tj 0.0006 Tc -0.0006 Tw 10.295 0 Td ( effects of perinatal )Tj 0.0003 Tc -0.0003 Tw -30.765 -1.33 Td (B-cell depletion in offspring following in-utero)Tj 0.0006 Tc 0.0002 Tw 18.92 0 Td [( exposure to ofatum)8 (umab. Ofatum)8 (um)8 (a)-6 (b)1 ( does not )]TJ 0.0009 Tc -0.0019 Tw -18.92 -1.335 Td [(bind norm)9 (al hum)9 (an tissues other th)]TJ 0.0002 Tc -0.0002 Tw 14.085 0 Td [(an B lym)8 (phocytes. It is not know)]TJ 0.0001 Tc -0.0001 Tw 13.245 0 Td (n if binding occurs to unique )Tj 0.0005 Tc -0.0021 Tw -27.33 -1.335 Td [(em)8 (bryonic or fetal tissu)6 (e targets. In addition, )]TJ 0.0004 Tc -0.0014 Tw 18.185 0 Td [(the kinetics of B-lym)8 (phocyte recovery are )]TJ 0.0001 Tc -0.0001 Tw -18.185 -1.33 Td (unknown in offspring with B-cell depletion )Tj /TT3 1 Tf 0.0004 Tc -0.002 Tw 17.61 0 Td [([see Nonclinical Toxicology \()8 (13.3\))18 (])]TJ /TT2 1 Tf -0.005 Tc 0 Tw 14.335 0 Td (. )Tj EMC /P <>BDC 0 Tc -31.945 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0003 Tc 1.3325 Tw 0 -1.345 TD [(8.3 Nursing )1330 (Mothers )]TJ EMC /P <>BDC /TT2 1 Tf 0.0005 Tc -0.0005 Tw 0 -1.32 TD [(It is not known whether ofatum)8 (um)]TJ 0.0007 Tc 0.0003 Tw 13.855 0 Td [(ab is secreted in hum)9 (an m)9 (ilk; )]TJ 0.0003 Tc -0.0015 Tw [(however hum)8 (a)-1 (n IgG is secreted )]TJ 0.0004 Tw -13.855 -1.335 Td [(in hum)8 (an m)8 (i)-7 (lk. Published data suggest that neona)]TJ 0.0007 Tc -0.0021 Tw 19.83 0 Td [(tal and infant consum)9 (ption of breast m)9 (ilk does )]TJ -0.0032 Tw -19.83 -1.335 Td [(not resu)6 (lt in substantial absorp)]TJ 0.0005 Tc -0.0017 Tw 12.22 0 Td [(tion of these m)8 (a)-1 (tern)6 (al antibodies)]TJ 0.0003 Tc -0.0003 Tw 13.045 0 Td [( into circu)5 (l)-2 (ation. Because the )]TJ 0.0001 Tc -0.0001 Tw -25.265 -1.33 Td (effects of local gastrointes)Tj 0.0004 Tc -0.0016 Tw 10.525 0 Td [(tinal and lim)8 (ited system)8 (ic e)]TJ 0.0006 Tc -0.0006 Tw 10.99 0 Td [(xposure to ofatum)8 (um)8 (ab are unknown, )]TJ 0.0002 Tc -0.0012 Tw -21.515 -1.335 Td (caution should be exercised when ARZERRA)Tj 0.0006 Tc -0.0006 Tw 18.41 0 Td [( is adm)8 (i)-2 (nistered )]TJ 0.0004 Tc -0.002 Tw [(to a nursing wom)8 (a)-1 (n. )]TJ EMC /P <>BDC 0 Tc 0 Tw -18.41 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0004 Tc 1.3326 Tw 0 -1.34 TD [(8.4 Pediatric )1335 (Use )]TJ EMC /P <>BDC /TT2 1 Tf 0.0001 Tc -0.0011 Tw 0 -1.325 TD (Safety and effectiveness of ARZERRA ha)Tj 0.0002 Tc -0.0002 Tw 16.91 0 Td (ve not been established in children. )Tj EMC /P <>BDC 0 Tc 0 Tw -16.91 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0004 Tc 1.3326 Tw 0 -1.34 TD [(8.5 Geriatric )1330 (Use )]TJ EMC /P <>BDC /TT2 1 Tf 0 Tc 0 Tw 0 -1.325 TD (Clinical studies of ARZERRA did )Tj 0.0004 Tc -0.0009 Tw 13.97 0 Td [(not include sufficient num)8 (bers of subjects aged 65 and over to )]TJ 0.0005 Tc -0.0005 Tw -13.97 -1.335 Td [(determ)8 (ine whether they respond differently from)8 ( younger subjects )]TJ /TT3 1 Tf 0 Tc 0 Tw 26.77 0 Td ([see Clinical Pharmacology )Tj 0.0004 Tc -26.77 -1.33 Td [(\(12.3\))18 (])]TJ /TT2 1 Tf 0 Tc 2.81 0 Td (. )Tj EMC /P <>BDC -2.81 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf 0.0001 Tc 1.3321 Tw 0 -1.345 TD [(8.6 Renal )1330 (Impairment )]TJ EMC /P <>BDC /TT2 1 Tf 0.0002 Tc -0.0002 Tw 0 -1.32 TD [(No for)-7 (m)8 (al studies of ARZERRA in patients )]TJ 0.0006 Tc -0.0026 Tw 17.81 0 Td [(with renal im)8 (pairm)8 (e)-1 (nt have been conducted )]TJ /TT3 1 Tf -0.0017 Tc 0 Tw 17.77 0 Td [([se)-3 (e)-3 ( )]TJ 0.0003 Tc -0.0003 Tw -35.58 -1.335 Td [(Clinical Pharmacology \(12.3\))18 (])]TJ /TT2 1 Tf -0.005 Tc 0 Tw 12.425 0 Td (. )Tj EMC /P <>BDC 0 Tc -12.425 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0002 Tc 1.3324 Tw 0 -1.34 TD [(8.7 Hepatic )1330 (Impairment )]TJ EMC /P <>BDC /TT2 1 Tf 0.0002 Tc -0.0002 Tw 0 -1.325 TD [(No for)-7 (m)8 (al studies of ARZERRA in patients w)]TJ 0.0006 Tc -0.0016 Tw 18.53 0 Td [(ith hepatic im)8 (pairm)8 (e)-1 (nt have been conducted. )]TJ EMC /P <>BDC /TT0 1 Tf -0.0005 Tc 1.6127 Tw -18.53 -2.345 Td (10 OVERDOSAGE )Tj EMC /P <>BDC /TT2 1 Tf 0.0007 Tc -0.0032 Tw 0 -1.32 TD (No data are available regard)Tj 0 Tc -0.0016 Tw 11.275 0 Td (ing overdosage with ARZERRA. )Tj EMC ET /Artifact <>BDC BT /OC /MC0 BDC 0 Tw 12 0 0 12 64.5803 19.0987 Tm ( )Tj EMC ET EMC /Artifact <>BDC Q q 1 0 0 1 120.6970062 785.2004395 cm /GS1 gs /Fm0 Do Q EMC /Artifact <>BDC q 1 0 0 1 612 773.2004395 cm /GS1 gs /Fm1 Do Q EMC endstream endobj 1731 0 obj <>>>/Resources 1736 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 65.791 -7.9 Td (This ) Tj 22.92 0 Td (label ) Tj 26.055 0 Td (may ) Tj 22.71 0 Td (not ) Tj 18.12 0 Td (be ) Tj 14.692 0 Td (the ) Tj 18.023 0 Td (latest ) Tj 29.595 0 Td (approved ) Tj 48.974 0 Td (by ) Tj 14.17 0 Td (FDA. ) Tj -281.05 -12 Td (For ) Tj 18.96 0 Td (current ) Tj 38.765 0 Td (labeling ) Tj 41.055 0 Td (information, ) Tj 61.25 0 Td (please ) Tj 34.707 0 Td (visit ) Tj 22.299 0 Td (https://www.fda.gov/drugsatfda) Tj ET endstream endobj 1732 0 obj <>>>/Resources 1733 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 0 -7.9 Td ( ) Tj ET endstream endobj 1733 0 obj <> endobj 1734 0 obj <> endobj 1735 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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q 1 0 0 1 -6.735626 -31.997314 cm 71.76 705.72 456.48 0.48 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 71.76 678.12 0.48 27.6 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 678.12 0.48 27.6 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 678.12 0.48 27.6 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 678.12 0.48 27.6 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 678.12 0.48 27.6 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 678.12 0.48 27.6 re f Q BT /P <>BDC 0.0002 Tc 4.9998 Tw 12 0 0 12 92.2644 635.0828 Tm [(Back )5000 (pain )]TJ EMC /P <>BDC 14.249 0 Td (8 )Tj EMC /P <>BDC 6 0 Td (1 )Tj EMC /P <>BDC (12 )Tj EMC /P <>BDC (2 )Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 71.76 664.32 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 664.32 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 664.32 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 664.32 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 664.32 0.48 13.8 re f Q q 1 0 0 1 -6.735626 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cm 71.76 622.38 0.48 27.66 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 622.38 0.48 27.66 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 622.38 0.48 27.66 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 622.38 0.48 27.66 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 622.38 0.48 27.66 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 622.38 0.48 27.66 re f Q BT /P <>BDC 0.0004 Tc 4.9996 Tw 12 0 0 12 92.2644 579.3427 Tm (Pyrexia )Tj EMC /P <>BDC 13.998 0 Td (20 )Tj EMC /P <>BDC (3 )Tj EMC /P <>BDC (25 )Tj EMC /P <>BDC (5 )Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 71.76 608.58 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 608.58 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 608.58 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 608.58 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 608.58 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 608.58 0.48 13.8 re f Q BT /P <>BDC 4.9997 Tw 12 0 0 12 92.2644 565.5427 Tm (Fatigue )Tj EMC /P <>BDC 13.998 0 Td (15 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (15 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 71.76 594.84 0.48 13.74 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 594.84 0.48 13.74 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 594.84 0.48 13.74 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 594.84 0.48 13.74 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 594.84 0.48 13.74 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 594.84 0.48 13.74 re f Q BT /P <>BDC 0.0008 Tc -0.0008 Tw 12 0 0 12 92.2644 551.8027 Tm [(Edem)9 (a peripheral )]TJ EMC /P <>BDC 14.249 0 Td (9 )Tj EMC /P <>BDC 5.716 0 Td (<1 )Tj EMC /P <>BDC 6.286 0 Td (8 )Tj EMC /P <>BDC 6.001 0 Td (2 )Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 71.76 581.04 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 581.04 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 581.04 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 581.04 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 581.04 0.48 13.8 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 581.04 0.48 13.8 re f Q BT /P <>BDC 0.0004 Tc 4.9996 Tw 12 0 0 12 92.2644 538.0027 Tm (Chills )Tj EMC /P <>BDC 14.247 0 Td (8 )Tj EMC /P <>BDC 6 0 Td (0 )Tj EMC /P <>BDC (10 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 71.76 566.7 0.48 14.34 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 71.76 566.7 168 0.48 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 239.76 566.7 0.48 14.34 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 240.24 566.7 65.52 0.48 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 305.76 566.7 0.48 14.34 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 306.24 566.7 77.52 0.48 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 383.76 566.7 0.48 14.34 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 384.24 566.7 65.52 0.48 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 449.76 566.7 0.48 14.34 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 450.24 566.7 77.52 0.48 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 566.7 0.48 14.34 re f Q q 1 0 0 1 -6.735626 -31.997314 cm 527.76 566.7 0.48 0.48 re f Q BT /Span <>BDC 0 Tc 0 Tw 7.98 0 0 7.98 65.2644 526.9627 Tm (a)Tj EMC /P <>BDC 0.0005 Tc -0.0005 Tw 12 0 0 12 68.8044 521.4427 Tm [( )-595 (Pneum)8 (onia includes pneum)8 (onia, lung inf)]TJ 0.0003 Tc -0.0015 Tw 17.255 0 Td (ection, lobar pneumonia, and bronchopneumonia. )Tj EMC /Span <>BDC 0 Tc 0 Tw 7.98 0 0 7.98 65.2644 511.0027 Tm (b)Tj EMC /P <>BDC 0.0001 Tc -0.0001 Tw 12 0 0 12 69.2844 505.4827 Tm [( )-555 (Sepsis includes sepsis, neutropenic )2 (sepsis, bacterem)8 (ia, and septic shock. )]TJ EMC /Span <>BDC 0 Tc 0 Tw 7.98 0 0 7.98 65.2644 494.9827 Tm (c)Tj EMC /P <>BDC 0.0004 Tc -0.0004 Tw 12 0 0 12 68.8044 489.4627 Tm [( )-595 (Rash includes rash, rash m)12 (acular, and rash vesicular. )]TJ EMC /P <>BDC 0 Tc 0 Tw -0.295 -1.335 Td ( )Tj EMC /Span <>BDC /TT1 1 Tf -0.0003 Tc 0.0025 Tw 0 -1.33 TD (Infusion Reactions:)Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 72 487.32 102.06 0.9 re f Q BT /P <>BDC /TT0 1 Tf 0.0002 Tc -0.0002 Tw 12 0 0 12 167.3244 457.4827 Tm ( Infusion reactions occurred in 44% of patients on the day of the first \ )Tj 0.0003 Tc 0.0002 Tw -8.505 -1.335 Td [(infusion \(300 m)8 (g\), 29% on the day of the second )]TJ 0.0002 Tc 0.0006 Tw 19.8 0 Td [(infusion \(2,000 m)8 (g\), and less frequently during )]TJ 0 Tc -0.005 Tw -19.8 -1.335 Td (subsequent infusions. )Tj EMC /P <>BDC 0 Tw T* ( )Tj EMC /Span <>BDC /TT1 1 Tf 0 -1.335 TD (Infections:)Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 72 423.3 54.72 0.9 re f Q BT /P <>BDC /TT0 1 Tf 0.0001 Tc -0.0001 Tw 12 0 0 12 119.9844 393.4627 Tm ( A total of 108 patients \(70%\) experienced )Tj -0.0001 Tc 0.0001 Tw 17.275 0 Td (bacterial, viral, or fungal infections. A )Tj 0.0001 Tc -0.0001 Tw -21.835 -1.335 Td (total of 45 patients \(29%\) experienced )Tj /C2_0 1 Tf 0 Tc 0 Tw 15.55 0 Td <0074>Tj /TT0 1 Tf 0.0002 Tc -0.0002 Tw 0.55 0 Td (Grade 3 infections, of which 19 \(12%\) were fatal. The )Tj 0.0001 Tc -0.0001 Tw -16.1 -1.33 Td (proportion of fatal infections in the fludara)Tj 0.0005 Tc -0.0005 Tw 17.105 0 Td [(bine- and alem)8 (tuzum)8 (a)-1 (b-refractory group was 17%. )]TJ EMC /P <>BDC 0 Tc 0 Tw -17.105 -1.335 Td ( )Tj EMC /Span <>BDC /TT1 1 Tf -0.0004 Tc T* (Neutropenia:)Tj EMC ET q 1 0 0 1 -6.735626 -31.997314 cm 72 359.28 68.7 0.9 re f Q BT /P <>BDC /TT0 1 Tf 0.0003 Tc -0.0003 Tw 12 0 0 12 133.9644 329.4427 Tm [( Of 108 pa)-6 (tients with norm)8 (al neutrophil )]TJ 0.0001 Tc -0.0001 Tw 16.14 0 Td (counts at baseline,)Tj 0.0002 Tc -0.0018 Tw 7.36 0 Td ( 45 \(42%\) developed )Tj /C2_0 1 Tf 0 Tc 0 Tw -29.225 -1.33 Td <0074>Tj /TT0 1 Tf 0.0002 Tc -0.0002 Tw 0.55 0 Td (Grade 3 neutropenia. Nineteen \(18%\) deve)Tj 0.0003 Tc -0.0003 Tw 17.16 0 Td (loped Grade 4 neutrope)Tj -0.0036 Tc 0.0011 Tw [(ni)-6 (a)-5 (.)-4 ( So)-9 (me)-5 ( pa)-5 (t)-6 (i)-6 (e)-5 (nt)-6 (s)-4 ( )]TJ 0.0002 Tc -0.0007 Tw -17.71 -1.335 Td [(experienced new onset Grade 4 neutropenia >2 w)7 (eeks in duration. )]TJ EMC /P <>BDC 0 Tc 0 Tw T* ( )Tj EMC /P <>BDC /TT2 1 Tf 0.0002 Tc 1.332 Tw 0 -1.34 TD [(6.2 Immunogenicity)11 ( )]TJ EMC /P <>BDC /TT0 1 Tf 0 Tc -0.0007 Tw 0 -1.325 TD (There is a potential for immunogenicity with ther)Tj 0.0002 Tc -0.0012 Tw 19.745 0 Td [(apeutic proteins such as ofatum)8 (umab. Serum)8 ( )]TJ 0.0006 Tc -0.0006 Tw -19.745 -1.335 Td [(sam)8 (p)1 (les from patients w)8 (ith CLL in Study 1 were)]TJ 0.0002 Tc -0.0012 Tw [( tested by enzym)8 (e)-1 (-linked immunosorbent assay )]TJ 0.0007 Tc -0.0017 Tw 0 -1.33 TD [(\(ELISA\) f)4 (o)1 (r anti-of)4 (atumum)9 (ab antibo)6 (d)1 (ies dur)4 (ing a)]TJ 0.001 Tc -0.001 Tw [(nd af)4 (ter th)6 (e)5 ( 24-week tr)4 (e)5 (atm)9 (ent perio)6 (d. Results )]TJ 0.0001 Tc -0.0001 Tw 0 -1.335 TD (were negative in 46 patients after the 8)Tj EMC /Span <>BDC 0.0004 Tc 0 Tw 7.98 0 0 7.98 251.5044 206.9828 Tm (th)Tj EMC /P <>BDC -0.001 Tw 12 0 0 12 257.6844 201.4628 Tm ( infusion and in 33 patients after the 12)Tj EMC /Span <>BDC 0 Tw 7.98 0 0 7.98 445.6644 206.9828 Tm (th)Tj EMC /P <>BDC 0.0002 Tc -0.0002 Tw 12 0 0 12 451.9044 201.4628 Tm ( infusion. )Tj EMC /P <>BDC 0 Tc 0 Tw -32.22 -1.335 Td ( )Tj EMC /P <>BDC -0.0001 Tc 0.0001 Tw 0 -1.33 TD (Immunogenicity assay results are highly dependent)Tj 0.0001 Tc -0.0009 Tw ( on several factors including assay sensitivity )Tj 0.0004 Tc -0.0004 Tw 0 -1.335 TD [(and specificity, assay m)8 (e)-1 (thodology, sam)8 (ple handli)]TJ 0.0006 Tc -0.0006 Tw 20.135 0 Td [(ng, tim)8 (ing of sa)-5 (m)8 (p)1 (le collection, concom)8 (itant )]TJ 0.0002 Tc -0.0002 Tw -20.135 -1.335 Td [(m)8 (e)-1 (dications, and underlying disease.)]TJ 0.0004 Tc -0.0024 Tw 14.75 0 Td [( For these reasons, com)8 (p)-5 (arison of)]TJ 0.0002 Tc -0.0002 Tw ( incidence of antibodies to )Tj 0.0003 Tc 0.0022 Tw -14.75 -1.33 Td [(ARZERRA with the )8 (inciden)]TJ 0.0002 Tc -0.0014 Tw 11.36 0 Td (ce of antibodies to other )Tj 0.0006 Tc 0.0027 Tw 9.915 0 Td [(products m)8 (ay be m)8 (i)-2 (sleading. )]TJ EMC /P <>BDC /TT2 1 Tf -0.0005 Tc 2.1677 Tw -21.275 -2.345 Td (7)Tj EMC /P <>BDC [( DRUG )2165 (INT)-5 (E)2 (RACTIONS )]TJ EMC /P <>BDC /TT0 1 Tf 0.0003 Tc -0.0015 Tw 0 -1.325 TD [(No for)-7 (m)8 (al drug-drug interaction studie)]TJ -0.0002 Tc 0.0002 Tw 15.555 0 Td (s have been conducted with ARZERRA. )Tj EMC ET /Artifact <>BDC BT /OC /MC0 BDC 0 Tc 0 Tw 12 0 0 12 65.2644 6.7627 Tm ( )Tj EMC ET EMC /Artifact <>BDC Q q 1 0 0 1 120.6970062 785.2004395 cm /GS1 gs /Fm0 Do Q EMC /Artifact <>BDC q 1 0 0 1 612 773.2004395 cm /GS1 gs /Fm1 Do Q EMC endstream endobj 1741 0 obj <>>>/Resources 1746 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 65.791 -7.9 Td (This ) Tj 22.92 0 Td (label ) Tj 26.055 0 Td (may ) Tj 22.71 0 Td (not ) Tj 18.12 0 Td (be ) Tj 14.692 0 Td (the ) Tj 18.023 0 Td (latest ) Tj 29.595 0 Td (approved ) Tj 48.974 0 Td (by ) Tj 14.17 0 Td (FDA. ) Tj -281.05 -12 Td (For ) Tj 18.96 0 Td (current ) Tj 38.765 0 Td (labeling ) Tj 41.055 0 Td (information, ) Tj 61.25 0 Td (please ) Tj 34.707 0 Td (visit ) Tj 22.299 0 Td (https://www.fda.gov/drugsatfda) Tj ET endstream endobj 1742 0 obj <>>>/Resources 1743 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 0 -7.9 Td ( ) Tj ET endstream endobj 1743 0 obj <> endobj 1744 0 obj <> endobj 1745 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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The m)8 (e)-6 (dian age )]TJ 0 Tc -0.0006 Tw -25.21 -1.335 Td (was 63 years \(range: 41 to 86 years\), 72%)Tj 0.0003 Tc -0.0011 Tw 16.8 0 Td [( were m)8 (a)-1 (le, and 97% were White. )]TJ EMC /P <>BDC 0 Tc 0 Tw -16.8 -1.33 Td ( )Tj EMC /P <>BDC /TT1 1 Tf 0.0002 Tc -0.0002 Tw 0 -1.34 TD (Table 2. Incidence of All Adv)Tj 0.0005 Tc -0.0021 Tw 12.445 0 Td (erse Reactions Occurring in )Tj 0.24 w 1 M /C2_0 1 Tf 0 Tc 0 Tw 2 Tr 12.165 0 Td <0074>Tj /TT1 1 Tf 0.0005 Tc -0.0005 Tw 0 Tr 0.55 0 Td [(5%)11 ( of Patients in Study 1 and in )]TJ 0.0004 Tc -0.0004 Tw -25.16 -1.34 Td [(the Fludarabine- and Alemtuz)9 (u)2 (mab-Refr)]TJ -0.0003 Tc -0.0005 Tw 17.64 0 Td [(actory Subset of Study 1 \(MedDRA 9.0\))-7 ( )]TJ EMC /P <>BDC /TT0 1 Tf 0 Tc 0 Tw 2.36 -1.385 Td ( )Tj EMC /P <>BDC 0.0005 Tc -0.0005 Tw -3.35 -1.335 Td (Total Population )Tj EMC /P <>BDC 0.0007 Tc -0.0007 Tw 1.48 -1.335 Td (\(n = 154\) )Tj EMC /P <>BDC -0.0001 Tc 0.0001 Tw 10.465 2.67 Td (Fludarabine- and )Tj 0.0007 Tc 0 Tw -1.73 -1.335 Td [(Alem)9 (tuzumab-Refracto)6 (r)4 (y )]TJ EMC /P <>BDC 0.0008 Tc -0.0008 Tw 3.515 -1.335 Td (\(n = 59\) )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 591.24 0.48 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 72.24 591.3 167.4 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.64 591.24 0.72 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 240.36 591.3 143.28 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.64 591.24 0.72 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 384.36 591.3 143.4 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 591.24 0.48 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 543.24 0.48 48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.64 543.24 0.72 48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.64 543.24 0.72 48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 543.24 0.48 48 re f Q BT /P <>BDC 0 Tc 0 Tw 12 0 0 12 147.6439 573.2228 Tm ( )Tj EMC /P <>BDC 0 -1.15 TD ( )Tj EMC /P <>BDC T* ( )Tj EMC /P <>BDC T* ( )Tj EMC /P <>BDC T* ( )Tj EMC /P <>BDC 0.0006 Tc -0.0006 Tw -5.78 -1.15 Td [(Body System)8 (/)-7 (A)3 (dverse Event )]TJ EMC /P <>BDC 13.345 1.5 Td (All Grades )Tj EMC /P <>BDC 0.002 Tc 0 Tw 1.765 -1.335 Td (% )Tj EMC /P <>BDC 0.0006 Tc 4.545 1.335 Td (Grade )Tj /C2_0 1 Tf 0 Tc 2.695 0 Td <0074>Tj /TT0 1 Tf 0.55 0 Td (3 )Tj EMC /P <>BDC 0.002 Tc -1.79 -1.335 Td (% )Tj EMC /P <>BDC 0.0007 Tc -0.0007 Tw 4.235 1.335 Td (All Grades )Tj EMC /P <>BDC 0.002 Tc 0 Tw 1.765 -1.335 Td (% )Tj EMC /P <>BDC 0.0006 Tc 4.545 1.335 Td (Grade )Tj /C2_0 1 Tf 0 Tc 2.695 0 Td <0074>Tj /TT0 1 Tf 0.55 0 Td (3 )Tj EMC /P <>BDC 0.002 Tc -1.79 -1.335 Td (% )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 542.46 0.48 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.64 542.46 0.72 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 240.36 542.52 65.28 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.64 542.46 0.72 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 306.36 542.52 77.28 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.64 542.46 0.72 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 384.36 542.52 65.28 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.64 542.46 0.72 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 450.36 542.52 77.4 0.72 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 542.46 0.48 0.78 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 508.44 0.48 34.02 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.64 508.44 0.72 34.02 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.64 508.44 0.72 34.02 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.64 508.44 0.72 34.02 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.64 508.44 0.72 34.02 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 508.44 0.48 34.02 re f Q BT /P <>BDC -0.0001 Tc 5.7501 Tw 12 0 0 12 69.0439 489.9428 Tm (Infections )Tj 4.243 0 Td (and )Tj 1.694 0 Td (infestations )Tj EMC /P <>BDC 10.36 0 Td ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 507.96 456.48 0.48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 494.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 494.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 494.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 494.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 494.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 494.16 0.48 13.8 re f Q BT /P <>BDC 0.001 Tc 0 Tw 12 0 0 12 90.6439 476.1428 Tm [(Pneum)9 (onia)]TJ EMC /Span <>BDC 0 Tc 7.98 0 0 7.98 144.6439 481.6628 Tm (a)Tj 4.75 Tw 12 0 0 12 148.1839 476.1428 Tm ( )Tj EMC /P <>BDC 9.205 0 Td (23 )Tj EMC /P <>BDC (14 )Tj EMC /P <>BDC (25 )Tj EMC /P <>BDC (15 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 480.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 480.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 480.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 480.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 480.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 480.36 0.48 13.8 re f Q BT /P <>BDC 0.0005 Tc -0.003 Tw 12 0 0 12 90.6439 462.3428 Tm (Upper respiratory tract )Tj 0.001 Tc 0 Tw T* [(inf)4 (ection )]TJ EMC /P <>BDC 0 Tc 5.25 Tw 14 1.15 Td (11 )Tj EMC /P <>BDC 6.25 0 Td (0 )Tj EMC /P <>BDC (3 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 452.76 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 452.76 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 452.76 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 452.76 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 452.76 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 452.76 0.48 27.6 re f Q BT /P <>BDC 0.0003 Tc 9.5797 Tw 12 0 0 12 90.6439 434.7428 Tm (Bronchitis )Tj EMC /P <>BDC (11 )Tj EMC /P <>BDC 19.966 0 Td (<1 )Tj EMC /P <>BDC 6.035 0 Td (19 )Tj EMC /P <>BDC 6.251 0 Td (2 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 438.96 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 438.96 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 438.96 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 438.96 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 438.96 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 438.96 0.48 13.8 re f Q BT /P <>BDC 0.0009 Tc 0 Tw 12 0 0 12 90.6439 420.9428 Tm (Sepsis)Tj EMC /Span <>BDC 0 Tc 7.98 0 0 7.98 121.3039 426.4628 Tm (b)Tj 11.11 Tw 12 0 0 12 125.3239 420.9428 Tm ( )Tj EMC /P <>BDC (8 )Tj EMC /P <>BDC 17.36 0 Td (8 )Tj EMC /P <>BDC 5.75 0 Td (10 )Tj EMC /P <>BDC 6 0 Td (10 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 425.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 425.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 425.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 425.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 425.16 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 425.16 0.48 13.8 re f Q BT /P <>BDC 0.0005 Tc 5.2495 Tw 12 0 0 12 90.6439 407.1428 Tm [(Nasopharyn)6 (g)1 (itis )]TJ EMC /P <>BDC 14.247 0 Td (8 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (8 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 411.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 411.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 411.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 411.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 411.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 411.36 0.48 13.8 re f Q BT /P <>BDC 0.0003 Tc 5.2497 Tw 12 0 0 12 90.6439 393.3428 Tm (Herpes )Tj 3.084 0 Td (zoster )Tj EMC /P <>BDC 11.165 0 Td (6 )Tj EMC /P <>BDC (1 )Tj EMC /P <>BDC (7 )Tj EMC /P <>BDC (2 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 397.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 397.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 397.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 397.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 397.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 397.56 0.48 13.8 re f Q BT /P <>BDC 0.0002 Tc 5.2498 Tw 12 0 0 12 90.6439 379.5428 Tm (Sinusitis )Tj EMC /P <>BDC 14.248 0 Td (5 )Tj EMC /P <>BDC (2 )Tj EMC /P <>BDC (3 )Tj EMC /P <>BDC (2 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 383.76 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 383.76 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 383.76 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 383.76 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 383.76 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 383.76 0.48 13.8 re f Q BT /P <>BDC 0.0005 Tc -0.0005 Tw 12 0 0 12 69.0439 365.2628 Tm [(Blood and lym)8 (phatic system)8 ( )]TJ 0 Tw T* (disorders )Tj EMC /P <>BDC 5.75 Tc 16.3 1.15 Td ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 383.28 456.48 0.48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 355.68 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 355.68 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 355.68 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 355.68 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 355.68 0.48 27.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 355.68 0.48 27.6 re f Q BT /P <>BDC 0.0001 Tc 4.9999 Tw 12 0 0 12 90.6439 337.6628 Tm [(Ane)-6 (m)8 (ia )]TJ EMC /P <>BDC 14 0 Td (16 )Tj EMC /P <>BDC (5 )Tj EMC /P <>BDC (17 )Tj EMC /P <>BDC (8 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 341.88 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 341.88 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 341.88 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 341.88 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 341.88 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 341.88 0.48 13.8 re f Q BT /P <>BDC 0.0006 Tc 5.7494 Tw 12 0 0 12 69.0439 323.3828 Tm (Psychiatric )Tj 4.696 0 Td (disorders )Tj EMC /P <>BDC 11.606 0 Td ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 341.4 456.48 0.48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 327.6 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 327.6 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 327.6 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 327.6 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 327.6 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 327.6 0.48 13.8 re f Q BT /P <>BDC 0.0004 Tc 4.9996 Tw 12 0 0 12 90.6439 309.5828 Tm [(Insom)8 (nia )]TJ EMC /P <>BDC 14.247 0 Td (7 )Tj EMC /P <>BDC 6 0 Td (0 )Tj EMC /P <>BDC (10 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 313.8 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 313.8 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 313.8 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 313.8 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 313.8 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 313.8 0.48 13.8 re f Q BT /P <>BDC 5.7497 Tw 12 0 0 12 69.0439 295.3028 Tm (Nervous )Tj 3.641 0 Td [(system)8 ( )]TJ 3.022 0 Td (disorders )Tj EMC /P <>BDC 9.64 0 Td ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 313.32 456.48 0.48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 299.46 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 299.46 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 299.46 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 299.46 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 299.46 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 299.46 0.48 13.86 re f Q BT /P <>BDC 5.2497 Tw 12 0 0 12 90.6439 281.4428 Tm (Headache )Tj EMC /P <>BDC 14.25 0 Td (6 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (7 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 285.66 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 285.66 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 285.66 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 285.66 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 285.66 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 285.66 0.48 13.8 re f Q BT /P <>BDC -0.0001 Tc 5.7501 Tw 12 0 0 12 69.0439 267.1628 Tm (Cardiovascular )Tj 6.303 0 Td (disorders )Tj EMC /P <>BDC 9.995 0 Td ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 285.18 456.48 0.48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 271.38 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 271.38 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 271.38 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 271.38 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 271.38 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 271.38 0.48 13.8 re f Q BT /P <>BDC 0.0001 Tc 5.2499 Tw 12 0 0 12 90.6439 253.3629 Tm (Hypertension )Tj EMC /P <>BDC 14.249 0 Td (5 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (8 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 255.78 0.48 15.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 255.78 0.48 15.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 255.78 0.48 15.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 255.78 0.48 15.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 255.78 0.48 15.6 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 255.78 0.48 15.6 re f Q BT /P <>BDC 0 Tc 5.25 Tw 12 0 0 12 90.6439 237.7629 Tm (Hypotension )Tj EMC /P <>BDC 14.251 0 Td (5 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (3 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 241.98 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 241.98 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 241.98 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 241.98 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 241.98 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 241.98 0.48 13.8 re f Q BT /P <>BDC -0.0002 Tc 9.0602 Tw 12 0 0 12 90.6439 223.9628 Tm (Tachycardia )Tj EMC /P <>BDC (5 )Tj EMC /P <>BDC 19.965 0 Td (<1 )Tj EMC /P <>BDC 6.284 0 Td (7 )Tj EMC /P <>BDC 6 0 Td (2 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 228.18 0.48 13.8 re f Q q 1 0 0 1 -8.356079 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<>BDC -0.0001 Tc 5.0001 Tw 12 0 0 12 90.6439 182.0828 Tm (Cough )Tj EMC /P <>BDC 14.001 0 Td (19 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (19 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 186.3 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 186.3 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 186.3 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 186.3 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 186.3 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 186.3 0.48 13.8 re f Q BT /P <>BDC 0.0001 Tc 4.9999 Tw 12 0 0 12 90.6439 168.2829 Tm (Dyspnea )Tj EMC /P <>BDC 14 0 Td (14 )Tj EMC /P <>BDC (2 )Tj EMC /P <>BDC (19 )Tj EMC /P <>BDC (5 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 172.5 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 172.5 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 172.5 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 172.5 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 172.5 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 172.5 0.48 13.8 re f Q BT /P <>BDC 0.0006 Tc 5.7494 Tw 12 0 0 12 69.0439 154.0029 Tm [(Gastroin)6 (testinal )]TJ 6.587 0 Td [(diso)6 (rders )]TJ EMC /P <>BDC 9.716 0 Td ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC /P <>BDC ( )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 172.02 456.48 0.48 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 71.76 158.16 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 158.16 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 158.16 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 158.16 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 158.16 0.48 13.86 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 158.16 0.48 13.86 re f Q BT /P <>BDC 0.0001 Tc 4.9999 Tw 12 0 0 12 90.6439 140.1429 Tm (Diarrhea )Tj EMC /P <>BDC 13.999 0 Td (18 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (19 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 144.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 144.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 144.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 144.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 144.36 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 144.36 0.48 13.8 re f Q BT /P <>BDC 0.0002 Tc 12 0 0 12 90.6439 126.3428 Tm (Nausea )Tj EMC /P <>BDC 13.999 0 Td (11 )Tj EMC /P <>BDC (0 )Tj EMC /P <>BDC (12 )Tj EMC /P <>BDC (0 )Tj EMC ET q 1 0 0 1 -8.356079 -6.977234 cm 71.76 130.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 239.76 130.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 305.76 130.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 383.76 130.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 449.76 130.56 0.48 13.8 re f Q q 1 0 0 1 -8.356079 -6.977234 cm 527.76 130.56 0.48 13.8 re f Q BT /P <>BDC 0.0001 Tc -0.0017 Tw 12 0 0 12 69.0439 112.0628 Tm (Skin and subcutaneous tissue )Tj 0.0005 Tc 0 Tw T* (disorders 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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
 endstream endobj 1779 0 obj <> endobj 1780 0 obj <>stream q 1 0 0 1 -7.542999 -25.547241 cm 0 0 612 792 re W n 1 0 0 1 7.542999 25.547241 cm BT /P <>BDC /GS0 gs /TT0 1 Tf 0.0005 Tc -0.0011 Tw 12 0 0 12 64.457 681.1928 Tm [( )-2751 (Grade 3: Inf)9 (u)1 (se at a rate of 12 m)8 (L)1 (/hour. )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw 0 -1.335 TD <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0003 Tc -0.0003 Tw 1.5 0 Td [(After resum)8 (i)-2 (ng the infusion, the infusion rate )]TJ 0.0006 Tc -0.0013 Tw 18.33 0 Td [(m)8 (a)-1 (y be increased accord)6 (ing to Table 1 above, )]TJ 0.0004 Tc -0.002 Tw -18.33 -1.33 Td (based on patient tolerance. )Tj EMC /P <>BDC 0 Tc 0 Tw -1.5 -1.335 Td ( )Tj EMC /P <>BDC /TT2 1 Tf 0.0001 Tc 1.3321 Tw 0 -1.345 TD (2.4 Premedication )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw 0 -1.32 TD <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0005 Tc -0.0005 Tw 1.5 0 Td [(Prem)8 (edicate 30 m)8 (i)-2 (nutes to 2 hours prior to )]TJ 0.0003 Tc -0.0003 Tw 17.33 0 Td [(each d)5 (ose with oral acetam)8 (i)-2 (nophen 1,000 mg \(or )]TJ 0.0002 Tc -0.0027 Tw -17.33 -1.335 Td (equivalent\), oral or )Tj 0.0004 Tc -0.0004 Tw 7.89 0 Td [(intravenous antihistam)8 (ine \(cetiriz)]TJ 0.0001 Tc -0.0001 Tw 13.385 0 Td (ine 10 mg or equivalent\), and )Tj 0.0002 Tc -0.0027 Tw -21.275 -1.335 Td (intravenous corticosteroid \(predni)Tj 0.0003 Tc 0.0009 Tw 13.555 0 Td [(solone 100 m)8 (g or equivalent\). )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -15.055 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 1.5 0 Td (Do not reduce corticosteroid dose for Doses 1, 2, and 9. )Tj EMC /P <>BDC /C2_0 1 Tf -1.5 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0001 Tc -0.0004 Tw 1.5 0 Td [(Corticosteroid dose m)8 (a)-1 (y be reduced as follows for Doses 3 through 8 and 10 through 12: )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw 0 -1.335 TD <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0004 Tc -0.0008 Tw 1.5 0 Td [(Doses 3 thro)5 (ugh 8: Grad)5 (ually reduce corticostero)5 (id dose with)5 ( successive infusions if a )]TJ -0.0011 Tw 0 -1.33 TD [(Grade 3 or g)5 (r)-2 (eater infusion reaction di)]TJ 0.0006 Tc -0.0006 Tw 15.33 0 Td [(d not occu)6 (r with th)6 (e preceding dos)5 (e. )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -16.83 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0003 Tc -0.0003 Tw 1.5 0 Td [(Doses 10 through 12: Adm)8 (i)-2 (nister prednisolone)]TJ 0.0001 Tc -0.0001 Tw [( 50 m)8 (g to 100 mg or equivalent if a )]TJ 0.0004 Tc -0.0004 Tw 0 -1.335 TD [(Grade 3 or g)5 (r)-2 (eater infusion reac)]TJ 0.0002 Tc -0.0018 Tw 12.745 0 Td (tion did not occur with Dose 9. )Tj EMC /P <>BDC 0 Tc 0 Tw -15.745 -1.33 Td ( )Tj EMC /P <>BDC /TT2 1 Tf -0.0003 Tc 1.3325 Tw 0 -1.345 TD [(2.5 Preparation )1330 (a)]TJ -0.0005 Tc 0.0027 Tw 9.39 0 Td (nd Administration )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -9.39 -1.325 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0005 Tc -0.0005 Tw 1.5 0 Td (Do not shake product. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0002 Tc -0.0002 Tw 1.5 0 Td [(Inspect parenteral drug products visually for )4 (particulate m)8 (a)-1 (tter and discoloration prior to )]TJ -0.0001 Tc 0.0001 Tw 0 -1.335 TD [(adm)8 (i)-2 (nistration. ARZERRA should be a colorless )]TJ 0.0002 Tc -0.0002 Tw 19.8 0 Td [(solution and m)8 (a)-1 (y contain a sm)8 (all amount of )]TJ 0.0003 Tc -0.0003 Tw -19.8 -1.335 Td [(visible translucent-to-white, am)8 (orphous, ofatum)]TJ 0.0005 Tc -0.0005 Tw 19.24 0 Td [(um)8 (ab particles. The solution should not be )]TJ 0.0001 Tc -0.0009 Tw -19.24 -1.33 Td (used if discolored or cloudy, or if )Tj 0.0005 Tc -0.0017 Tw 13.61 0 Td [(foreign particulate m)8 (a)-1 (tter is present. )]TJ EMC /P <>BDC 0 Tc 0 Tw -15.11 -1.335 Td ( )Tj EMC /Span <>BDC /TT1 1 Tf -0.0001 Tc 0.0023 Tw 0 -1.34 TD (Preparation of Solution:)Tj EMC ET q 1 0 0 1 -7.542999 -25.547241 cm 72 352.5 125.46 0.9 re f Q BT /Span <>BDC /TT0 1 Tf 0 Tc 0 Tw 12 0 0 12 189.917 329.1128 Tm ( )Tj EMC /P <>BDC /C2_0 1 Tf -10.455 -1.325 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0002 Tc -0.0002 Tw 1.5 0 Td [(300-m)8 (g dos)-6 (e: W)9 (ithdraw and discard 15 m)8 (L)1 ( fr)]TJ 0.0006 Tc 0.0008 Tw 18.35 0 Td [(om)8 ( a 1,000-m)8 (L)1 ( polyolefin bag of 0.9% Sodium)8 ( )]TJ 0.0005 Tc 0.0003 Tw -18.35 -1.335 Td [(Chloride Injection, USP. W)9 (ithdraw 5 m)8 (L)1 ( from)8 ( )]TJ 0 Tc 0 Tw 18.965 0 Td [(ea)-6 (ch of 3 vials of ARZERRA and add to the )]TJ 0.0001 Tc -0.0009 Tw -18.965 -1.335 Td (bag. Mix diluted solution by gentle inversion. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0005 Tc 0.0003 Tw 1.5 0 Td [(2,000-m)8 (g)1 ( dose: W)9 (ithdraw and discard 100 m)8 (L)]TJ 0.0002 Tc -0.0002 Tw 18.685 0 Td [( fr)-7 (om)8 ( a 1,000-mL bag of 0.9% Sodium )]TJ 0.0005 Tc 0.0003 Tw -18.685 -1.335 Td [(Chloride Injection, USP. W)9 (ithdraw 5 m)8 (L)1 ( from)8 ( )]TJ 0.0001 Tc -0.0001 Tw 18.965 0 Td [(ea)-6 (ch of 20 vials of ARZERRA and add to the )]TJ -0.0009 Tw -18.965 -1.335 Td (bag. Mix diluted solution by gentle inversion. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0007 Tc -0.0007 Tw 1.5 0 Td [(Store dilute)5 (d solution)6 ( b)6 (etween 2)]TJ /C2_0 1 Tf 0 Tc 0 Tw 12.945 0 Td <0071>Tj /TT0 1 Tf -0.0007 Tc 0.0007 Tw ( to 8)Tj /C2_0 1 Tf 0 Tc 0 Tw 2.175 0 Td <0071>Tj /TT0 1 Tf -0.0005 Tc 0.0005 Tw (C \(36)Tj /C2_0 1 Tf 0 Tc 0 Tw 2.65 0 Td <0071>Tj /TT0 1 Tf 0.0004 Tc -0.0004 Tw ( to 46)Tj /C2_0 1 Tf 0 Tc 0 Tw <0071>Tj /TT0 1 Tf 0.0002 Tc (F\). )Tj EMC /P <>BDC 0 Tc -19.27 -1.335 Td ( )Tj EMC /Span <>BDC /TT1 1 Tf -0.0002 Tc 0.0024 Tw T* (Administration Instructions:)Tj EMC ET q 1 0 0 1 -7.542999 -25.547241 cm 72 208.5 144.06 0.9 re f Q BT /Span <>BDC 0 Tc 0 Tw 12 0 0 12 208.517 185.1128 Tm ( )Tj EMC /P <>BDC /C2_0 1 Tf -12.005 -1.325 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0003 Tc 0.0017 Tw 1.5 0 Td [(Do not m)8 (i)-2 (x ARZERRA with, or )]TJ -0.0002 Tc -0.001 Tw 13.085 0 Td [(adm)8 (i)-2 (nister as an infusion wi)]TJ 0.0004 Tc -0.0004 Tw 11.27 0 Td [(th, other m)8 (e)-1 (dicinal products. )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -25.855 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0006 Tc -0.0022 Tw 1.5 0 Td [(Adm)8 (i)-2 (nister using an inf)9 (u)1 (sion )]TJ 0.0005 Tc -0.0005 Tw 11.89 0 Td [(pum)8 (p, the in-line filter prov)]TJ 0.0001 Tc -0.0001 Tw 11.135 0 Td (ided with the product, and )Tj -0.0001 Tc -0.0024 Tw -23.025 -1.335 Td (polyvinyl chloride \(PVC)Tj 0.0006 Tc -0.0006 Tw 9.885 0 Td [(\) adm)8 (i)-2 (nistration sets. )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -11.385 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0004 Tc -0.0016 Tw 1.5 0 Td (Flush the intravenous line with)Tj 0.0002 Tc -0.0002 Tw 12.39 0 Td [( 0.9% Sodium)8 ( Chloride Injecti)]TJ -0.0001 Tc 0.0001 Tw 12.245 0 Td (on, USP before and after each )Tj 0.0004 Tc 0 Tw -24.635 -1.335 Td (dose. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc -1.5 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0003 Tc -0.0019 Tw 1.5 0 Td (Start infusion within 12 hours of preparation. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT0 1 Tf 0.0001 Tc -0.0001 Tw 1.5 0 Td (Discard prepared solution after 24 hours. )Tj EMC ET /Artifact <>BDC BT /OC /MC0 BDC 0 Tc 0 Tw 12 0 0 12 64.457 13.2128 Tm ( )Tj EMC ET EMC /Artifact <>BDC Q q 1 0 0 1 120.6970062 785.2004395 cm /GS1 gs /Fm0 Do Q EMC /Artifact <>BDC q 1 0 0 1 612 773.2004395 cm /GS1 gs /Fm1 Do Q EMC endstream endobj 1781 0 obj <>>>/Resources 1786 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 65.791 -7.9 Td (This ) Tj 22.92 0 Td (label ) Tj 26.055 0 Td (may ) Tj 22.71 0 Td (not ) Tj 18.12 0 Td (be ) Tj 14.692 0 Td (the ) Tj 18.023 0 Td (latest ) Tj 29.595 0 Td (approved ) Tj 48.974 0 Td (by ) Tj 14.17 0 Td (FDA. ) Tj -281.05 -12 Td (For ) Tj 18.96 0 Td (current ) Tj 38.765 0 Td (labeling ) Tj 41.055 0 Td (information, ) Tj 61.25 0 Td (please ) Tj 34.707 0 Td (visit ) Tj 22.299 0 Td (https://www.fda.gov/drugsatfda) Tj ET endstream endobj 1782 0 obj <>>>/Resources 1783 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 0 -7.9 Td ( ) Tj ET endstream endobj 1783 0 obj <> endobj 1784 0 obj <> endobj 1785 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
 endstream endobj 1786 0 obj <> endobj 1787 0 obj <> endobj 1788 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
 endstream endobj 1789 0 obj <> endobj 1790 0 obj <>stream q 1 0 0 1 -7.494751 -15.911316 cm 0 0 612 792 re W n 1 0 0 1 7.494751 15.911316 cm BT /P <>BDC /GS0 gs /TT0 1 Tf -0.0003 Tc 0.0025 Tw 12 0 0 12 64.5052 690.7087 Tm [(2 )-2165 (DOSAGE AND ADMINISTRATION )]TJ EMC /P <>BDC 0 -1.335 TD [(2.1 )-1330 (Recommended Dosage Regimen )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw 0 -1.32 TD <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0001 Tc -0.0001 Tw 1.5 0 Td [(Do not adm)8 (i)-7 (nister as an )]TJ 0 Tc -0.0016 Tw (intravenous push or bolus. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tw -1.5 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0004 Tc -0.0004 Tw 1.5 0 Td [(Prem)8 (edicate before each)5 ( infusion )]TJ /TT3 1 Tf 0 Tc 0 Tw [([see Dosage and Administration \(2.4\))18 (])]TJ /TT2 1 Tf -0.005 Tc 29.135 0 Td (. )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc -30.635 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0007 Tc -0.004 Tw 1.5 0 Td [(Adm)9 (i)-1 (nister with in-line f)]TJ 0.0005 Tc -0.0021 Tw [(ilter supplied with produ)6 (ct. )]TJ EMC /P <>BDC 0 Tc 0 Tw -1.5 -1.33 Td ( )Tj EMC /P <>BDC 0.0004 Tc -0.0014 Tw 0 -1.335 TD (The recommended dose and schedule is )Tj 0 Tc 0 Tw 16.165 0 Td [(12 doses adm)8 (i)-2 (nistered as follows: )]TJ EMC /P <>BDC /C2_0 1 Tf -16.165 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0003 Tc 0.0007 Tw 1.5 0 Td [(300 m)8 (g initial dose \(Dose 1\))]TJ 0.0001 Tc -0.0001 Tw (, followed 1 week later by )Tj EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0002 Tc -0.0005 Tw 1.5 0 Td [(2,000 m)8 (g weekly for 7 doses \(Doses 2 through 8\), followed 4 weeks later by )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0002 Tc -0.0002 Tw 1.5 0 Td [(2,000 m)8 (g every 4 weeks for 4 doses \(Doses 9 through 12\) )]TJ EMC /P <>BDC 0 Tc 0 Tw -1.5 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0001 Tc 1.3323 Tw 0 -1.34 TD (2.2 Administration )Tj EMC /P <>BDC /TT2 1 Tf 0.0002 Tc -0.0002 Tw 0 -1.325 TD [(Prepare all doses in 1,000 m)8 (L)1 ( of 0.9)-2 (% Sodium)8 ( Chloride Injection, USP )]TJ /TT3 1 Tf -0.0003 Tc 0.0003 Tw 28.855 0 Td [([s)-6 (ee Dosage and )]TJ 0.0001 Tc -0.0001 Tw -28.855 -1.335 Td [(Administration \(2.5\))18 (])]TJ /TT2 1 Tf 0 Tc 0 Tw 8.56 0 Td (. )Tj EMC /P <>BDC /C2_0 1 Tf -8.56 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0002 Tc -0.001 Tw 1.5 0 Td (Dose 1: Initiate infusion at a ra)Tj -0.0001 Tc 0.0021 Tw 12.39 0 Td [(te of 3.6 m)8 (g/hour \(12 m)8 (L)1 (/hour\). )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -13.89 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0002 Tc -0.001 Tw 1.5 0 Td (Dose 2: Initiate infusion at a ra)Tj 0.0001 Tc 0.0019 Tw 12.39 0 Td [(te of 24 m)8 (g/hour \(12 m)8 (L)1 (/hour\). )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -13.89 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0003 Tc -0.0011 Tw 1.5 0 Td (Doses 3 through 12: Initiate infusion at )Tj 0.0001 Tc 0.0015 Tw 15.92 0 Td [(a rate of 50 m)8 (g/hour \(25 m)8 (L)1 (/hour\). )]TJ EMC /P <>BDC 0.0009 Tc -0.0016 Tw -17.42 -1.33 Td [(In the abs)5 (en)6 (ce of)4 ( inf)4 (u)1 (sional tox)6 (i)-1 (city, the ra)5 (te )]TJ 0 Tc 0.0012 Tw [(of infusion m)8 (a)-1 (y be increas)]TJ 0.0003 Tc -0.0003 Tw 28.685 0 Td [(ed every 30 m)8 (i)-2 (nutes as )]TJ 0.0006 Tc -0.0014 Tw -28.685 -1.335 Td [(describ)6 (e)-1 (d in Table 1. Do not exceed)]TJ 0.0001 Tc -0.0017 Tw ( the infusion rates in Table 1. )Tj EMC /P <>BDC 0 Tc 0 Tw 0 -1.335 TD ( )Tj EMC /P <>BDC /TT4 1 Tf -0.0006 Tc 0.0006 Tw 0 -1.34 TD [(Table 1. Infusion Rates for ARZE)-4 (RRA )]TJ EMC /P <>BDC /TT2 1 Tf 0.0007 Tc -0.0007 Tw 0.69 -1.365 Td [(Interv)6 (al After )]TJ 0.0004 Tc -0.0004 Tw -0.545 -1.335 Td (Start of Infusion )Tj 0.0017 Tc 0 Tw 2.17 -1.33 Td [(\(m)10 (in\) )]TJ EMC /P <>BDC 0 Tc 10.57 2.665 Td ( )Tj EMC /P <>BDC -1.55 -1.335 Td (Dose 1)Tj EMC /Span <>BDC 7.98 0 0 7.98 234.1852 343.8487 Tm (a)Tj 12 0 0 12 237.7252 338.3287 Tm ( )Tj EMC /P <>BDC 0.0011 Tc -3.635 -1.33 Td [(\(m)9 (L/hour\) )]TJ EMC /P <>BDC 0 Tc 12.79 2.665 Td ( )Tj EMC /P <>BDC -1.57 -1.335 Td (Dose 2)Tj EMC /Span <>BDC 7.98 0 0 7.98 362.4052 343.8487 Tm (b)Tj 12 0 0 12 366.4252 338.3287 Tm ( )Tj EMC /P <>BDC 0.0011 Tc -3.65 -1.33 Td [(\(m)9 (L/hour\) )]TJ EMC /P <>BDC 0 Tc 12.57 2.665 Td ( )Tj EMC /P <>BDC 0.0004 Tc -0.0004 Tw -2.68 -1.335 Td (Doses 3 - 12)Tj EMC /Span <>BDC 0 Tc 0 Tw 7.98 0 0 7.98 501.6051 343.8487 Tm (b)Tj 12 0 0 12 505.6251 338.3287 Tm ( )Tj EMC /P <>BDC 0.0011 Tc -4.76 -1.33 Td [(\(m)9 (L/hour\) )]TJ EMC ET q 1 0 0 1 -7.494751 -15.911316 cm 66.36 383.52 0.48 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 383.52 479.28 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 383.52 0.48 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 335.52 0.48 48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.36 335.52 0.48 48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.4 335.52 0.48 48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.34 335.52 0.48 48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 335.52 0.48 48 re f Q BT /P <>BDC 0.0003 Tc -0.0003 Tw 12 0 0 12 91.5652 305.8687 Tm (0 - 30 )Tj EMC /P <>BDC 10.129 0 Td (12 )Tj EMC /P <>BDC 10.706 0 Td (12 )Tj EMC /P <>BDC 10.491 0 Td (25 )Tj EMC ET q 1 0 0 1 -7.494751 -15.911316 cm 66.36 335.04 479.28 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 319.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.36 319.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.4 319.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.34 319.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 319.02 0.48 16.02 re f Q BT /P <>BDC 0.0002 Tc -0.0002 Tw 12 0 0 12 88.5652 289.3687 Tm (31 - 60 )Tj EMC /P <>BDC 10.379 0 Td (25 )Tj EMC /P <>BDC 10.705 0 Td (25 )Tj EMC /P <>BDC 10.49 0 Td (50 )Tj EMC ET q 1 0 0 1 -7.494751 -15.911316 cm 66.36 318.54 479.28 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 302.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.36 302.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.4 302.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.34 302.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 302.52 0.48 16.02 re f Q BT /P <>BDC 12 0 0 12 88.5652 272.8688 Tm (61 - 90 )Tj EMC /P <>BDC 10.379 0 Td (50 )Tj EMC /P <>BDC 10.705 0 Td (50 )Tj EMC /P <>BDC 10.24 0 Td (100 )Tj EMC ET q 1 0 0 1 -7.494751 -15.911316 cm 66.36 302.04 479.28 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 286.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.36 286.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.4 286.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.34 286.02 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 286.02 0.48 16.02 re f Q BT /P <>BDC 12 0 0 12 85.5652 256.3688 Tm (91 - 120 )Tj EMC /P <>BDC 10.379 0 Td (100 )Tj EMC /P <>BDC 10.706 0 Td (100 )Tj EMC /P <>BDC 10.491 0 Td (200 )Tj EMC ET q 1 0 0 1 -7.494751 -15.911316 cm 66.36 285.54 479.28 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 269.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.36 269.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.4 269.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.34 269.52 0.48 16.02 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 269.52 0.48 16.02 re f Q BT /P <>BDC 0.0001 Tc 7.4299 Tw 12 0 0 12 93.1852 239.8688 Tm (>120 )Tj EMC /P <>BDC (200 )Tj EMC /P <>BDC 20.45 0 Td (200 )Tj EMC /P <>BDC 10.49 0 Td (400 )Tj EMC ET q 1 0 0 1 -7.494751 -15.911316 cm 66.36 269.04 479.28 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 252.48 0.48 16.56 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 66.36 252.48 93 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.36 252.48 0.48 16.56 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 159.84 252.48 133.56 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.4 252.48 0.48 16.56 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 293.88 252.48 122.46 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.34 252.48 0.48 16.56 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 416.82 252.48 128.34 0.48 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 252.48 0.48 16.56 re f Q q 1 0 0 1 -7.494751 -15.911316 cm 545.16 252.48 0.48 0.48 re f Q BT /Span <>BDC 0 Tc 0 Tw 7.98 0 0 7.98 64.5052 228.8288 Tm (a)Tj EMC /P <>BDC 0.0003 Tc 0.0013 Tw 12 0 0 12 68.0452 223.3087 Tm [( )-593 (Dose 1 = 300 m)8 (g \(0.3 mg/m)8 (L\) )]TJ EMC /Span <>BDC 0 Tc 0 Tw 7.98 0 0 7.98 64.5052 212.8687 Tm (b)Tj EMC /P <>BDC 0.0004 Tc 0.0006 Tw 12 0 0 12 68.5252 207.3488 Tm [( )-554 (Doses 2 and 3 - 12 = 2,000 m)8 (g \(2 mg/m)8 (L\) )]TJ EMC /P <>BDC 0 Tc 0 Tw -0.335 -1.335 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0001 Tc 1.3323 Tw 0 -1.345 TD [(2.3 Dose )1330 (Modification )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw 0 -1.32 TD <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0001 Tc -0.0008 Tw 1.5 0 Td (Interrupt infusion for infusion reactions of any severity )Tj /TT3 1 Tf -0.0017 Tw 22.275 0 Td ([see Warnings and Precautions )Tj 0.0005 Tc 0 Tw -22.275 -1.335 Td [(\(5.1\))19 (])]TJ /TT2 1 Tf 0 Tc 2.31 0 Td (. )Tj EMC /P <>BDC /C2_0 1 Tf -3.81 -1.335 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0004 Tc -0.0009 Tw 1.5 0 Td [(For Grade 4 infusion reactions, do not resum)8 (e)-1 ( the infusion. )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.5 -1.33 Td <0078>Tj EMC /P <>BDC /TT1 1 Tf ( )Tj /TT2 1 Tf 0.0003 Tc -0.0003 Tw 1.5 0 Td (For Grade 1, 2, or 3 infusion reaction, if the in)Tj 0.0002 Tc -0.0002 Tw 18.53 0 Td [(fusion reaction resolves or rem)8 (a)-1 (ins less than or )]TJ 0.0001 Tc -0.0001 Tw -18.53 -1.335 Td [(equal to Grade 2, resum)8 (e)-1 ( infusion with the fo)]TJ 0.0003 Tc 0.0022 Tw 18.13 0 Td [(llowing m)8 (odifications acco)]TJ 0.0007 Tc -0.0023 Tw 10.885 0 Td (rding to the initial )Tj 0.0001 Tc -0.0001 Tw -29.015 -1.335 Td (Grade of the infusion reaction. )Tj EMC /P <>BDC 0.0002 Tc -0.0002 Tw -1.5 -1.33 Td [( )-2750 (Grade 1 or 2: Infuse at one-ha)]TJ -0.0003 Tc -0.0007 Tw 15 0 Td (lf of the previous infusion rate. )Tj EMC ET /Artifact <>BDC BT /OC /MC0 BDC 0 Tc 0 Tw 12 0 0 12 64.5052 22.8487 Tm ( )Tj EMC ET EMC /Artifact <>BDC Q q 1 0 0 1 120.6970062 785.2004395 cm /GS1 gs /Fm0 Do Q EMC /Artifact <>BDC q 1 0 0 1 612 773.2004395 cm /GS1 gs /Fm1 Do Q EMC endstream endobj 1791 0 obj <>>>/Resources 1796 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 65.791 -7.9 Td (This ) Tj 22.92 0 Td (label ) Tj 26.055 0 Td (may ) Tj 22.71 0 Td (not ) Tj 18.12 0 Td (be ) Tj 14.692 0 Td (the ) Tj 18.023 0 Td (latest ) Tj 29.595 0 Td (approved ) Tj 48.974 0 Td (by ) Tj 14.17 0 Td (FDA. ) Tj -281.05 -12 Td (For ) Tj 18.96 0 Td (current ) Tj 38.765 0 Td (labeling ) Tj 41.055 0 Td (information, ) Tj 61.25 0 Td (please ) Tj 34.707 0 Td (visit ) Tj 22.299 0 Td (https://www.fda.gov/drugsatfda) Tj ET endstream endobj 1792 0 obj <>>>/Resources 1793 0 R/Subtype/Form>>stream 0 g 0 G 0 i 0 J []0 d 0 j 1 w 10 M 0 Tc 0 Tw 100 Tz 0 TL 0 Tr 0 Ts BT /ArialRoundedMTBold 10 Tf 0 0 1 rg 0 -7.9 Td ( ) Tj ET endstream endobj 1793 0 obj <> endobj 1794 0 obj <> endobj 1795 0 obj <>stream /
This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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(m)6 (a)-4 (b)-8 (\))2 ( )]TJ EMC /Span <>BDC -0.0004 Tc -0.0015 Tw 0 -1.15 TD [(Injectio)-4 (n,)-6 ( fo)-4 (r in)-8 (tr)-8 (a)-4 (v)-4 (eno)-4 (us infusio)-4 (n)]TJ /TT2 1 Tf 0 Tc 0 Tw 14.647 0 Td ( )Tj EMC /P <>BDC /TT1 1 Tf 0.0024 Tc -0.0043 Tw -14.647 -1.15 Td [(Init)5 (ial U.)4 (S.)4 ( Approval:)5 ( 2009 )]TJ EMC /P <>BDC /TT2 1 Tf 0 Tc 0 Tw 0 -1.383 TD ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0018 Tc 0.0172 Tw 0.12 -1.413 Td [(----------------------------INDIC)-16 (A)14 (T)-7 (I)-2 (O)-6 (N)-1 (S A)6 (ND )15 (US)-19 (A)14 (G)-6 (E)-102 (---------------------)-90 ( )]TJ EMC /P <>BDC /TT2 1 Tf 0.0007 Tc 0 Tw -0.12 -1.143 Td (ARZERRA)Tj EMC /Span <>BDC 0.0157 Tc 4.98 0 0 4.98 67.8157 632.0324 Tm (TM)Tj EMC /P <>BDC 0.0021 Tc -0.004 Tw 7.98 0 0 7.98 75.3757 628.5525 Tm [( \()4 (o)-2 (fatu)-9 (m)21 (u)-17 (m)13 (a)2 (b\))4 ( is)-7 ( a CD20-)4 (dir)4 (ected cy)6 (toly)6 (tic )-7 (m)13 (onoclonal )]TJ 0.0018 Tc -0.0037 Tw -5.616 -1.15 Td [(antibody)6 ( indicated for)4 ( the tr)4 (eat)-14 (m)13 (e)2 (nt of patients with chr)4 (onic lym)13 (phocy)6 (tic )]TJ 0.0006 Tc -0.0025 Tw 0 -1.158 TD [(leuke)-7 (m)19 (i)-7 (a \(C)-9 (LL)-5 (\) r)-5 (e)-7 (f)-5 (r)3 (actory to f)-5 (ludara)-7 (bine and ale)-7 (m)12 (tuzum)12 (a)-7 (b. )-7 (The ef)-5 (f)-5 (ectiveness )]TJ 0.0021 Tc -0.004 Tw 0 -1.15 TD [(of ARZ)4 (E)4 (RRA is b)-9 (a)2 (sed on the dem)21 (o)-2 (n)-9 (str)4 (ation of dur)4 (able objective r)4 (e)2 (sponses.)4 ( )]TJ 0.0026 Tc -0.0045 Tw T* [(No data dem)14 (onstr)5 (ate an im)14 (p)-9 (r)5 (ovem)14 (e)3 (nt in disease r)5 (e)3 (lated )-7 (sym)14 (p)-1 (to)-9 (m)14 (s)-7 ( or)5 ( )]TJ 0.0008 Tc -0.0027 Tw T* [(increased survival )-7 (w)]TJ -0.0006 Tc -0.0013 Tw 8.241 0 Td [(ith)-4 ( ARZERR)-10 (A. )-7 (\()-6 (1)-4 (, 1)-4 (4)-4 (\))2 ( )]TJ EMC /P <>BDC 0 Tc 0 Tw -8.241 -1.158 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.002 Tc 0.0174 Tw 0.12 -1.413 Td [(-----------------------)-180 (DOS)-19 (A)13 (G)-6 (E)-4 ( A)21 (N)-9 (D)-9 ( )8 (A)13 (D)-9 (M)-11 (I)-2 (NIST)-8 (R)-17 (A)21 (T)-8 (I)-10 (ON)-280 (----------------)-90 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -0.12 -1.21 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0019 Tc -0.0038 Tw 1.346 0 Td [(Dilute and ad)-9 (m)13 (i)2 (nis)-7 (t)2 (er)4 ( as )-7 (an intr)4 (avenous infusi)9 (on.)4 ( Do not)9 ( ad)-9 (m)13 (i)2 (nister)4 ( )-7 (as an )]TJ 0.0026 Tc -0.0045 Tw 0.075 -1.158 Td [(intr)5 (avenous pus)8 (h o)6 (r)5 ( bolus.)5 ( \()5 (2)-1 (.)5 (1)-1 (\))5 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.88 -1.218 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0018 Tc -0.0037 Tw 1.346 0 Td [(Reco)-9 (m)5 (m)13 (ended dose and schedule is 12 doses ad)-9 (m)20 (i)1 (nistered as follows: )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw 0.451 -1.226 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0017 Tc -0.0036 Tw 1.797 0 Td [(300 )-7 (m)20 (g)-2 ( initial dos)-8 (e, followed 1 week later by)6 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -2.256 -1.226 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0024 Tc -0.0043 Tw 1.797 0 Td [(2,)4 (000 )-7 (m)21 (g)-1 ( weekly)6 ( f)-10 (o)-1 (r)5 ( 7 doses,)4 ( followed 4 weeks later by )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -2.256 -1.226 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0027 Tc -0.0046 Tw 1.797 0 Td [(2,)5 (000 )-7 (m)21 (g)-1 ( every)7 ( 4 )-7 (weeks for)5 ( 4 doses.)5 ( \()5 (2)-1 (.)5 (1)-1 (\))5 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -4.511 -1.226 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0008 Tc 0.0048 Tw 1.346 0 Td [(Pre)-6 (m)12 (edic)-6 (ate with oral )8 (aceta)-14 (m)12 (inophen, )]TJ 0.0012 Tc -0.0031 Tw 15.617 0 Td [(oral or intravenous antihista)-6 (m)20 (i)1 (ne)-6 (, )]TJ 0.0017 Tc -0.0036 Tw -15.541 -1.15 Td [(and intr)4 (avenous co)6 (r)4 (ticoster)4 (o)-2 (id.)4 ( \()4 (2)-2 (.)4 (4)-2 (\))4 ( )]TJ EMC /P <>BDC 0 Tc 0 Tw -1.88 -1.158 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0014 Tc 0.0018 Tw 0.12 -1.286 Td [(---------------------)-150 (DOS)-19 (A)14 (G)-5 (E)-4 ( F)-7 (O)2 (RM)-10 (S )-15 (A)22 (N)-9 (D ST)-7 (RENG)-5 (THS)-244 (--------------)-89 ( )]TJ EMC /P <>BDC /TT2 1 Tf 0.0024 Tc 0.0032 Tw -0.12 -1.143 Td [(100 m)21 (g)-1 (/5 m)13 (L)-3 ( )8 (single-)5 (use )8 (vial.)4 ( \()5 (3)-1 (\))5 ( )]TJ EMC /P <>BDC 0 Tc 0 Tw T* ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0021 Tc 0.12 -1.293 Td [(-------------------------------)-15 (CON)-9 (TR)-17 (A)21 (I)-10 (N)-9 (DIC)-9 (A)13 (T)-8 (I)-10 (O)-6 (N)-2 (S)-109 (------------------------)-90 ( )]TJ EMC /P <>BDC /TT2 1 Tf -0.0019 Tc -0.12 -1.143 Td [(No)-6 (n)-6 (e)-2 (. \(4)-6 (\) )]TJ EMC /P <>BDC 0 Tc 36.09 37.173 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0017 Tc 0.0171 Tw 0.09 -1.413 Td [(-----------------------)-293 (W)-20 (A)21 (R)-9 (N)-1 (IN)-9 (GS A)21 (N)-16 (D )15 (PREC)-16 (A)21 (U)-9 (T)-7 (I)-10 (ON)-9 (S)-327 (----------------)-120 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -0.09 -1.21 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0016 Tc -0.0035 Tw 1.346 0 Td [(I)4 (n)-2 (fusio)5 (n)-2 ( Reactions)7 (: Pr)4 (e)-13 (m)13 (edicate with)-10 ( an intr)4 (avenous cor)4 (ticoster)4 (o)-2 (id \()4 (a)2 (s )]TJ 0.0018 Tc -0.0037 Tw 0.075 -1.158 Td [(appr)4 (opr)4 (iate\))4 (,)4 ( an oral analgesic,)4 ( and )]TJ 0.0008 Tc -0.0027 Tw 14.323 0 Td [(a)-6 (n)-3 ( oral or intraveno)-10 (u)-3 (s antihista)-6 (m)19 (ine)-6 (. )]TJ 0.0025 Tc -0.0044 Tw -14.323 -1.15 Td [(M)4 (onitor)5 ( patients closely)6 ( dur)5 (ing infusi)10 (ons.)4 ( I)5 (n)-1 (ter)5 (r)5 (upt infus)8 (i)2 (on if inf)5 (u)-1 (sion )]TJ 0.0027 Tc -0.0046 Tw 0 -1.158 TD [(r)5 (eactions occur)5 (.)5 ( )-7 (\()5 (2)-1 (.3,)5 ( 2.)5 (4,)5 ( 5.)5 (1\))5 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.88 -1.218 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0021 Tc -0.004 Tw 1.346 0 Td [(Cy)6 (topenias: M)4 (onitor)4 ( blood counts at )8 (r)4 (e)]TJ 0.0018 Tc -0.0037 Tw 15.722 0 Td [(gular)4 ( inter)4 (v)-2 (als for)4 ( neutr)4 (openia and )]TJ 0.0025 Tc -0.0044 Tw -15.647 -1.158 Td [(thr)5 (o)-9 (m)21 (bocy)6 (t)2 (openia.)4 ( \()5 (5)-1 (.)4 (2)-1 (\))5 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.88 -1.218 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0011 Tc -0.003 Tw 1.346 0 Td (Progressive Multifocal Leukoencephal)Tj -0.0029 Tw 15.534 0 Td [(opathy)5 ( \(P)-7 (ML\):)-7 ( )-7 (Monitor neurologi)8 (c )]TJ 0.0019 Tc -0.0038 Tw -15.459 -1.158 Td [(functio)6 (n and disco)6 (n)-2 (tinue ARZ)4 (E)4 (RRA )-7 (if PM)4 (L)4 ( is)-7 ( suspected.)4 ( \()4 (5)-2 (.)4 (3)-2 (\))4 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -1.88 -1.218 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0009 Tc -0.0028 Tw 1.346 0 Td [(Hepatitis B React)-7 (i)-7 (v)-3 (ation: Screen high-risk patients. Dis)-8 (c)1 (ontinue )]TJ 0.0012 Tc -0.0031 Tw 0.075 -1.158 Td [(ARZERRA)-6 ( in pati)-7 (ents who develop )8 (vira)]TJ 0.0009 Tc -0.0028 Tw 16.286 0 Td [(l hepatitis or )-7 (re)-6 (activation of viral )]TJ 0.0003 Tc -0.0022 Tw -16.286 -1.15 Td (hepatitis. \(5.4\) )Tj EMC /P <>BDC 0 Tc 0 Tw -1.88 -1.158 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0017 Tc 0.0021 Tw 0.09 -1.413 Td [(------------------------------)-263 (A)14 (D)-9 (VE)-11 (RSE RE)-19 (A)6 (C)-1 (TIO)-6 (N)-1 (S)-297 (-----------------------)-120 ( )]TJ EMC /P <>BDC /TT2 1 Tf 0.0016 Tc -0.0035 Tw -0.09 -1.218 Td [(M)4 (o)-2 (st co)-10 (m)5 (m)13 (on )-7 (adver)4 (se reactions \()]TJ /C2_0 1 Tf 0 Tc 0 Tw 13.579 0 Td <0074>Tj /TT2 1 Tf 0.0027 Tc -0.0046 Tw [(10%\))5 ( wer)5 (e)3 ( neutr)5 (openia,)5 ( pneu)-9 (m)21 (onia,)5 ( )]TJ 0.001 Tc 0.0046 Tw -13.579 -1.15 Td [(py)5 (rexia, cough, )8 (diarrhea, ane)-6 (m)12 (ia)-6 (, )8 (fati)]TJ 0.0012 Tc -0.0031 Tw [(gue, dy)5 (spnea, rash, nausea, bronchitis, )]TJ 0.0026 Tc -0.0045 Tw 0 -1.15 TD [(and upper)5 ( r)5 (e)3 (spir)5 (ator)5 (y)6 ( tr)5 (act infections.)5 ( \()5 (6)-1 (\))5 ( )]TJ EMC /P <>BDC 0 Tc 0 Tw 0.451 -1.158 Td ( )Tj EMC /P <>BDC /TT1 1 Tf 0.0003 Tc -0.0022 Tw -0.451 -1.173 Td [(To report SU)-7 (SPE)-9 (C)1 (TED AD)-7 (VERS)-7 (E REACTI)-9 (O)4 (NS,)-5 ( )-7 (contact )]TJ 0.004 Tc -0.0059 Tw T* [(G)7 (l)4 (axoSm)18 (i)4 (thK)7 (line at)6 ( 1-)6 (888-)6 (825-)6 (524)8 (9 or F)6 (D)4 (A at)6 ( 1-)6 (800-)6 (F)6 (D)4 (A-)6 (1088 or )]TJ EMC /Span <>BDC /CS0 cs 0 0 1 scn 0 Tw 0 -1.158 TD [(www.)6 (f)6 (d)4 (a.)6 (gov/m)18 (e)4 (dwat)6 (ch.)]TJ EMC ET q 1 0 0 1 -5.444336 -24.187622 cm 324 546.84 83.76 0.78 re f Q BT /Span <>BDC 0 g 0 Tc 7.98 0 0 7.98 402.3157 524.2724 Tm ( )Tj EMC /P <>BDC /TT2 1 Tf -10.496 -1.128 Td ( )Tj EMC /P <>BDC /TT0 1 Tf -0.0015 Tc 0.0019 Tw 0.09 -1.413 Td [(-----------------------)-210 (USE IN )]TJ -0.0012 Tc 0.0016 Tw 11.436 0 Td [(SPECIFI)-9 (C)-1 ( POPU)-8 (L)-14 (A)22 (T)-7 (I)-9 (ON)-8 (S)-244 (----------------)-119 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -11.526 -1.21 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0024 Tc -0.0043 Tw 1.346 0 Td [(Pr)5 (egnancy)6 (:)2 ( Based )-7 (on anim)21 (al data)]TJ 0.005 Tc -0.0069 Tw 13.353 0 Td [(, )-7 (m)16 (a)-2 (y)9 ( c)5 (a)5 (u)1 (se)5 ( fe)5 (t)5 (a)5 (l ha)5 (r)-8 (m)16 (. \()7 (8)1 (.)7 (1)1 (\))7 ( )]TJ EMC /P <>BDC /C2_0 1 Tf 0 Tc 0 Tw -15.158 -1.226 Td <0078>Tj EMC /P <>BDC /TT3 1 Tf 0.459 0 Td ( )Tj /TT2 1 Tf 0.0025 Tc 0.0031 Tw 1.346 0 Td [(Nur)5 (s)1 (ing m)21 (o)-1 (ther)5 (s: Published )8 (data )8 (sug)6 (g)]TJ 0.0021 Tc -0.004 Tw 15.263 0 Td [(est that consu)-9 (m)21 (ption of br)4 (east )-7 (m)13 (ilk )]TJ 0.0018 Tc -0.0037 Tw -15.188 -1.158 Td [(does not r)4 (e)2 (sult in substantial absor)4 (p)]TJ 0.0026 Tc -0.0045 Tw 14.346 0 Td [(ti)10 (on of )-7 (m)21 (a)3 (ter)5 (n)-1 (al antibodies into )]TJ -0.0012 Tc -0.0007 Tw -14.346 -1.15 Td [(circu)-5 (l)-2 (atio)-5 (n)-5 (.)1 ( \(8)-5 (.3)-5 (\) )]TJ EMC /P <>BDC 0 Tc 0 Tw -1.88 -1.15 Td ( )Tj EMC /P <>BDC /TT1 1 Tf 0.0009 Tc -0.0028 Tw 0 -1.181 TD [(See 17 for )-7 (PATIE)-9 (N)1 (T C)-6 (O)4 (UNSELIN)-6 (G)4 ( IN)-6 (FORMATI)-8 (O)4 (N )]TJ EMC /P <>BDC 0.0021 Tc 0.0035 Tw 21.88 -1.15 Td [(Revised:)4 ( O)6 (c)2 (t)4 (o)-2 (ber 2009 )]TJ EMC /P <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 26.0557 412.6724 Tm ( )Tj EMC ET q 1 0 0 1 -5.444336 -24.187622 cm 30 430.68 549 1.5 re f Q BT /P <>BDC /TT0 1 Tf 0.0002 Tc 0.0002 Tw 7.98 0 0 7.98 30.5557 389.3324 Tm [(FUL)-5 (L)2 ( PRESCRI)-8 (BING I)-8 (N)1 (F)-5 (O)4 (RM)-16 (A)-601 (ION)-7 (:)2 ( C)-7 (O)4 (N)-7 (T)2 (EN)-7 (TS* )]TJ EMC /Span <>BDC 14.756 0 Td (T)Tj 0.0005 Tc 0.0149 Tw -12.951 -1.158 Td [(INDIC)-14 (A)16 (T)-5 (IONS A)8 (ND )15 (US)-17 (A)16 (G)-4 (E)]TJ EMC /Span <>BDC 0 Tc 0 Tw -1.805 0 Td (1)Tj /TT2 1 Tf 12 0 0 12 34.9957 380.0924 Tm ( )Tj EMC /Span <>BDC 9.345 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 7.98 0 0 7.98 30.5557 370.9124 Tm (2)Tj 0.0154 Tw 1.805 0 Td [(DOS)-17 (A)15 (GE A)23 (N)-7 (D)-7 ( )8 (A)15 (D)-7 (M)-9 (INIST)-6 (R)-15 (A)23 (T)-6 (I)-8 (ON)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tw 12 0 0 12 34.9957 370.9124 Tm ( )Tj 11.305 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 44.9557 361.7324 Tm (2.1)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 361.7324 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0008 Tc 0.0071 Tw 7.98 0 0 7.98 66.5557 361.7324 Tm [(Recommended Dosage )8 (Regime)-7 (n)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 184.8157 361.7324 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 44.9557 352.4924 Tm (2.2)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 352.4924 Tm [( )-4850 ( )]TJ EMC /Span <>BDC /TT3 1 Tf 0.0012 Tc 7.98 0 0 7.98 66.5557 352.4924 Tm (Administration)Tj EMC /Span <>BDC 0.0003 Tc -2.707 -1.15 Td (2.3)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 343.3124 Tm ( )Tj 6.175 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0013 Tc -0.0009 Tw 7.98 0 0 7.98 66.5557 343.3124 Tm (Dose Modification)Tj EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 -1.15 Td (2.4)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 334.1324 Tm [( )-4885 ( )]TJ EMC /Span <>BDC /TT3 1 Tf 0.0011 Tc 7.98 0 0 7.98 66.5557 334.1324 Tm (Premedication)Tj EMC /Span <>BDC 0.0003 Tc -2.707 -1.158 Td (2.5)Tj 0.0007 Tc -0.0003 Tw 2.707 0 Td [(Preparation a)-7 (nd )-7 (Administration)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 56.0557 324.8924 Tm ( )Tj 10.03 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 7.98 0 0 7.98 30.5557 315.7124 Tm (3)Tj /TT2 1 Tf 12 0 0 12 34.9957 315.7124 Tm ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0007 Tc -0.0003 Tw 7.98 0 0 7.98 44.9557 315.7124 Tm [(DOS)-16 (A)16 (GE F)-5 (O)4 (RM)-8 (S )-15 (A)24 (N)-6 (D ST)-5 (RENGTHS)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 181.7557 315.7124 Tm ( )Tj EMC /Span <>BDC /TT0 1 Tf 7.98 0 0 7.98 30.5557 306.5324 Tm (4)Tj /TT2 1 Tf 12 0 0 12 34.9957 306.5324 Tm ( )Tj 8.01 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 7.98 0 0 7.98 44.9557 306.5324 Tm [(CON)-7 (T)2 (R)-15 (A)23 (I)-8 (N)-7 (DIC)-7 (A)15 (T)-6 (I)-8 (ONS)]TJ EMC /Span <>BDC -1.805 -1.158 Td (5)Tj 0.0026 Tc 0.0128 Tw 1.805 0 Td [(W)-16 (A)-3203 (S A)26 (N)-12 (D )15 (PREC)-711 (U)-5 (TI)-5 (O)6 (N)-5 (S)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 34.9957 297.2924 Tm ( )Tj 11.2 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0026 Tc 0.0128 Tw 7.98 0 0 7.98 58.216 297.2924 Tm (RNING)Tj 9.431 0 Td (A)Tj /TT3 1 Tf 0.001 Tc -0.0006 Tw -8.386 -1.15 Td (Infusion Reactions)Tj EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 0 Td (5.1)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 288.1124 Tm ( )Tj EMC /Span <>BDC 6.36 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 44.9557 278.9324 Tm (5.2)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 278.9324 Tm [( )-3960 ( )]TJ EMC /Span <>BDC /TT3 1 Tf 0.0006 Tc 7.98 0 0 7.98 66.5557 278.9324 Tm [(C)-7 (y)12 (tope)-7 (nias)]TJ EMC /Span <>BDC 0.0003 Tc -2.707 -1.158 Td (5.3)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 269.6925 Tm ( )Tj 14.095 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0009 Tc -0.0005 Tw 7.98 0 0 7.98 66.5557 269.6925 Tm [(Progressive Multifocal Leukoencephalopath)-7 (y)]TJ EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 -1.15 Td (5.4)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 260.5125 Tm ( )Tj 7.95 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0013 Tc -0.0009 Tw 7.98 0 0 7.98 66.5557 260.5125 Tm (Hepatitis B Reactivation)Tj EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 -1.15 Td (5.5)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 251.3325 Tm ( )Tj 7.14 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0015 Tc -0.0011 Tw 7.98 0 0 7.98 66.5557 251.3325 Tm [(Intestinal O)5 (b)1 (st)-895 (ction)]TJ EMC /Span <>BDC 6.407 0 Td [(r)4 (u)]TJ EMC /Span <>BDC 0.0003 Tc 0 Tw -9.114 -1.15 Td (5.6)Tj 0.0012 Tc 2.707 0 Td (Immunizations)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 242.1525 Tm [( )-4925 ( )]TJ EMC /Span <>BDC /TT0 1 Tf 7.98 0 0 7.98 30.5557 232.9124 Tm (6)Tj EMC /Span <>BDC /TT2 1 Tf 12 0 0 12 34.9957 232.9124 Tm ( )Tj 8.16 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.001 Tc -0.0006 Tw 7.98 0 0 7.98 45.0757 232.9124 Tm [(A)24 (D)-667 (E)-9 (RSE RE)-16 (A)9 (C)1 (TIONS)]TJ EMC /Span <>BDC 1.421 0 Td (V)Tj /TT3 1 Tf 0.0018 Tc -0.0014 Tw 1.271 -1.15 Td [(Clinical T)4 (r)4 (ials E)-489 (per)4 (ience)]TJ EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 0 Td (6.1)Tj /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 223.7325 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0018 Tc -0.0014 Tw 7.98 0 0 7.98 121.6911 223.7325 Tm (x)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 156.3157 223.7325 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 44.9557 214.5525 Tm (6.2)Tj 0.0013 Tc 2.707 0 Td [(Immunogenicit)-7 (y)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 12 0 0 12 56.0557 214.5525 Tm ( )Tj 5.545 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 7.98 0 0 7.98 30.5557 205.3124 Tm (7)Tj EMC /Span <>BDC /TT2 1 Tf 12 0 0 12 34.9957 205.3124 Tm ( )Tj 7.97 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf -0.0012 Tc 0.0016 Tw 7.98 0 0 7.98 44.9557 205.3124 Tm [(DRU)-8 (G INTE)-11 (R)-16 (A)22 (C)-16 (T)1 (IONS)]TJ EMC /Span <>BDC 0 Tc 0 Tw 34.286 24.286 Td (8)Tj EMC /Span <>BDC /TT2 1 Tf 12 0 0 12 322.9957 399.1124 Tm ( )Tj 11.31 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0019 Tc -0.0015 Tw 7.98 0 0 7.98 332.9557 399.1124 Tm [(USE IN SPECIFI)-728 ( PO)5 (PUL)-11 (A)25 (TI)-6 (O)5 (N)-5 (S)]TJ EMC /Span <>BDC 7.532 0 Td (C)Tj /TT3 1 Tf 0.0002 Tc 0 Tw -4.825 -1.15 Td [(Pregnanc)-11 (y)]TJ EMC /Span <>BDC 0.0003 Tc -2.707 0 Td (8.1)Tj /TT2 1 Tf 0 Tc 12 0 0 12 344.0557 389.9324 Tm ( )Tj EMC /Span <>BDC 4.055 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 332.9557 380.6924 Tm (8.3)Tj /TT2 1 Tf 0 Tc 12 0 0 12 344.0557 380.6924 Tm ( )Tj 5.765 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0004 Tc 7.98 0 0 7.98 354.5557 380.6924 Tm (Nursing Mothers)Tj EMC /Span <>BDC 0.0003 Tc -2.707 -1.15 Td (8.4)Tj /TT2 1 Tf 0 Tc 12 0 0 12 344.0557 371.5124 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0016 Tc -0.0012 Tw 7.98 0 0 7.98 354.5557 371.5124 Tm (Pediatric Use)Tj /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 402.1357 371.5124 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 332.9557 362.3324 Tm (8.5)Tj /TT2 1 Tf 0 Tc 12 0 0 12 344.0557 362.3324 Tm [( )-4510 ( )]TJ EMC /Span <>BDC /TT3 1 Tf -0.0012 Tc 0.0016 Tw 7.98 0 0 7.98 354.5557 362.3324 Tm [(Geri)-5 (atri)-5 (c)-5 ( Us)-5 (e)]TJ EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 -1.158 Td (8.6)Tj /TT2 1 Tf 0 Tc 12 0 0 12 344.0557 353.0924 Tm ( )Tj 6.135 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0006 Tc -0.0002 Tw 7.98 0 0 7.98 354.5557 353.0924 Tm [(Renal Impairmen)-7 (t)]TJ EMC /Span <>BDC 0.0003 Tc 0 Tw -2.707 -1.15 Td (8.7)Tj 0.0006 Tc -0.0002 Tw 2.707 0 Td [(Hepatic Impairm)-8 (ent)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 344.0557 343.9124 Tm ( )Tj 6.655 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0002 Tc 7.98 0 0 7.98 318.5557 334.7324 Tm (10)Tj /TT2 1 Tf 0 Tc 12 0 0 12 327.4357 334.7324 Tm ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0038 Tc 7.98 0 0 7.98 332.9557 334.7324 Tm [(O)7 (VERDO)7 (S)-13 (A)19 (GE)]TJ /TT2 1 Tf 0 Tc 12 0 0 12 390.3157 334.7324 Tm ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0002 Tc 7.98 0 0 7.98 318.5557 325.4924 Tm (11)Tj /TT2 1 Tf 0 Tc 12 0 0 12 327.4357 325.4924 Tm [( )-4760 ( )]TJ EMC /Span <>BDC /TT0 1 Tf 0.0005 Tc 7.98 0 0 7.98 332.9557 325.4924 Tm [(DESCRIPTI)-7 (O)4 (N)]TJ EMC /Span <>BDC 0.0002 Tc -1.805 -1.15 Td (12)Tj -0.0006 Tc 0.001 Tw 1.805 0 Td [(CLINIC)-23 (A)22 (L)-6 ( PH)-23 (A)7 (RM)-17 (A)22 (C)-8 (O)-5 (L)-6 (OGY)]TJ EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 327.4357 316.3124 Tm ( )Tj 9.565 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 332.9557 307.1324 Tm (12.1)Tj /TT2 1 Tf 0 Tc 12 0 0 12 348.4957 307.1324 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0014 Tc -0.001 Tw 7.98 0 0 7.98 354.5557 307.1324 Tm (Mechanism of Actio)Tj EMC /Span <>BDC (n)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 0 Tw 12 0 0 12 428.8357 307.1324 Tm ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 7.98 0 0 7.98 332.9557 297.8924 Tm (12.2)Tj /TT2 1 Tf 0 Tc 12 0 0 12 348.4957 297.8924 Tm ( )Tj 6.36 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0011 Tc 7.98 0 0 7.98 354.5557 297.8924 Tm [(Pharmacod)-7 (y)5 (nam)-8 (ics)]TJ EMC /Span <>BDC 0.0003 Tc -2.707 -1.15 Td (12.3)Tj 0.0014 Tc 2.707 0 Td (Pharmacokinetics)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 12 0 0 12 348.4957 288.7124 Tm ( )Tj 5.77 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf 0.0002 Tc 7.98 0 0 7.98 318.5557 279.5324 Tm (13)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 12 0 0 12 327.4357 279.5324 Tm ( )Tj 9.675 0 Td ( )Tj EMC /Span <>BDC /TT0 1 Tf -0.0014 Tc 0.0093 Tw 7.98 0 0 7.98 332.9557 279.5324 Tm [(NON)-9 (C)-1 (LINI)-9 (C)-16 (A)22 (L)-7 ( TOXIC)-9 (O)-5 (LO)-5 (GY)]TJ EMC /Span <>BDC /TT3 1 Tf 0.0003 Tc 0 Tw 0 -1.15 TD (13.1)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 12 0 0 12 348.4957 270.3524 Tm ( )Tj 2.65 -0.77 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0008 Tc -0.0004 Tw 7.98 0 0 7.98 354.5557 270.3524 Tm (Carcinogenesis, Mutagenes)Tj 0.0009 Tc -0.0005 Tw 12.421 0 Td (is, Impairment of )Tj 0.0045 Tc 0 Tw -12.421 -1.158 Td [(F)6 (e)4 (r)7 (t)4 (ility)]TJ EMC /Span <>BDC 0.0003 Tc -2.707 -1.15 Td (13.3)Tj EMC /Span <>BDC /TT2 1 Tf 0 Tc 12 0 0 12 348.4957 251.9325 Tm ( )Tj 13.73 0 Td ( )Tj EMC /Span <>BDC /TT3 1 Tf 0.0007 Tc -0.0003 Tw 7.98 0 0 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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda
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