奥法木单抗注射溶液ARZERRA solution infusion 1000mg/50ml




所属类别: 1000毫克/50毫升/瓶

包装规格: 1000毫克/50毫升/瓶



生产厂家英文名:Novartis Ltd

原产地英文商品名:Arzerra infusion 1000mg/50ml/vial


中文参考商品译名:Arzerra注射溶液 1000毫克/50毫升/瓶







第1天300毫克,接着:第1天1 周后1000毫克,随后:7周后1000毫克,此后每8周较多2年药品副作用:见说明书ARZERRA(ofatumumab)用于治疗难治型慢性淋巴细胞性白血病(CLL)难治型慢性淋巴细胞性白血病患者


concentrate for solution for infusionINDICATIONS for ARZERRA® (ofatumumab)In combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriateIn combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLLFor extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLLFor the treatment of patients with CLL refractory to fludarabine and alemtuzumabIMPORTANT SAFETY INFORMATION for ARZERRA® (ofatumumab)WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHYHepatitis B virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA, in some cases resulting in fulminant hepatitis, hepatic failure, and deathProgressive multifocal leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRAInfusion ReactionsARZERRA can cause serious, including fatal, infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac events, back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactic reactionsAdminister ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Infusion reactions may occur despite premedicationInterrupt ARZERRA for infusion reactions of any severity and initiate appropriate medical treatment. If an anaphylactic reaction occurs, immediately and permanently discontinue ARZERRAHepatitis B Virus ReactivationHepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ARZERRAScreen all patients for HBV infection before initiating ARZERRAMonitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with ARZERRA. HBV reactivation has been reported for at least 12 months following completion of therapyIn ARZERRA-treated patients who develop reactivation of HBV, immediately discontinue ARZERRA and any concomitant chemotherapy, and institute appropriate treatmentHBV InfectionFatal infection due to hepatitis B in patients who have not been previously infected has been observed with ARZERRA. Monitor patients for clinical and laboratory signs of hepatitisProgressive Multifocal LeukoencephalopathyProgressive multifocal leukoencephalopathy (PML) resulting in death has occurred with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptomsIf PML is suspected, discontinue ARZERRA and initiate eva luation for PML, including neurology consultationTumor Lysis SyndromeTumor lysis syndrome (TLS), including the need for hospitalization, has occurred in patients treated with ARZERRA. Patients with high tumor burden and/or high circulating lymphocyte counts (>25 x 109/L) are at greater riskConsider TLS prophylaxis with antihyperuricemics and hydration prior to infusion of ARZERRAFor treatment of TLS, administer aggressive intravenous hydration and antihyperuricemic agents, correct electrolyte abnormalities, and monitor renal functionCytopeniasSevere cytopenias, including neutropenia, thrombocytopenia, and anemia, can occur with ARZERRA. Pancytopenia, agranulocytosis, and fatal neutropenic sepsis have occurred in patients who received ARZERRA in combination with chlorambucil. Grade 3/4 late-onset neutropenia and/or prolonged neutropenia were reported in ARZERRA-treated patientsMonitor complete blood counts at regular intervals during and after conclusion of therapy, and increase the frequency of monitoring in patients who develop grade 3/4 cytopeniasImmunizationsDo not administer live viral vaccines to patients who have recently received ARZERRAMost Common Adverse ReactionsPreviously untreated CLL: (≥10%, all grades) were infusion reactions (67% for ARZERRA plus chlorambucil vs 0% for chlorambucil) and neutropenia (27% vs 18%)Extended treatment therapy in CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, and upper respiratory infectionRelapsed CLL: Common adverse reactions (≥10%) were infusion reactions, neutropenia, febrile neutropenia, and leukopeniaIn the single-arm refractory CLL clinical trial, the most common adverse reactions (≥10%, all grades) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexiaLaboratory AbnormalitiesIn the previously untreated CLL clinical trial, postbaseline hematologic laboratory abnormalities (all grades) occurring with ≥5% incidence in patients receiving ARZERRA plus chlorambucil, and also ≥2% more than patients receiving chlorambucil, were leukopenia (67% for ARZERRA plus chlorambucil vs 28% for chlorambucil), neutropenia (66% vs 56%), and lymphopenia (52% vs 20%)

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