Brief Succinct Statement of Safety Information1
Important note: Before prescribing, consult full prescribing information.
Presentation: Concentrate for solution for infusion. Each mL of concentrate contains 20 mg of ofatumumab. Vials containing 100 mg/5 mL or 1,000 mg/50 mL ofatumumab.
♦Previously untreated Chronic Lymphocytic Leukemia (CLL): ofatumumab is indicated, in combination with an alkylator-based regimen, for the treatment of patients with CLL who have not received prior therapy and are inappropriate for fludarabine-based therapy. ♦Relapsed CLL: Ofatumumab is indicated in combination with fludarabine and cyclophosphamide or in combination with bendamustine for the treatment of patients with relapsed CLL. ♦Refractory CLL: ofatumumab is indicated for the treatment of patients with CLL who have received prior therapy.
Dosage and administration:
Method of administration
♦Intravenous infusion. ♦Must be diluted prior to administration. ♦All of the premedication agents to be given 30 minutes to 2 hours prior to each infusion. For complete premedication schedule, refer to the full prescribing information. ♦To be administered under the supervision of a physician experienced in the use of cancer therapy. ♦Administration of therapy in an environment where full resuscitation facilities are immediately available. ♦Patients to be closely monitored for onset of infusion-related reactions, including cytokine release syndrome, particularly during the first infusion.
Important note: If an infusion-related ADR is observed, see the full prescribing information for Dose Modification and reinitiation of therapy after infusion related ADR.
Adults: ♦Previously untreated CLL: Recommended dose for cycle one is 300 mg on day 1, followed by 1,000 mg on day 8. Subsequent infusions of 1,000 mg are given on day 1 of every cycle up to a maximum of twelve cycles. Each cycle lasts 28 days and is counted from day 1 of the cycle. ♦Relapsed CLL: Recommended dose is 300 mg on day 1 followed by 1,000 mg on day 8. Subsequent infusions of 1,000 mg are given on day 1 of every cycle for up to a maximum of 6 cycles. Each cycle lasts 28 days and is counted from day 1 of the cycle. ♦Refractory CLL: Recommended dose for the first infusion is 300 mg, followed by weekly 2000 mg infusions in a total of 8 consecutive weeks. 4 to 5 weeks Arzerra untreated period follows. Resume treatment with further 4 consecutive monthly infusions (i.e. every 28 days). Special populations: ♦Pediatric age group: safety and efficacy not established. ♦Elderly patients and/or patients with renal and/or hepatic impairment: dose modifications unlikely.
Warnings and precautions: : ♦Infusion reactions: Arzerra has been associated with infusion reactions (more frequently on the first day of infusion) that can cause interruption or withdrawal of treatment or death. Use of pre-medication helps attenuate infusion reactions, but they may still occur. In case of severe infusion reactions, the treatment must be interrupted immediately and appropriate therapy initiated. Therapy should be permanently discontinued in patients who develop an anaphylactic reaction to Arzerra. In patients with history of decreased pulmonary function close monitoring is required. ♦CLL patients: risk of Tumor Lysis Syndrome (TLS). Monitoring of renal function, correction of electrolyte abnormalities, maintenance of fluid balance and supportive care is recommended. ♦Progressive Multifocal Leukoencephalopathy (PML) (including fatal cases) has been reported in CLL patients receiving cytotoxic therapy, including ofatumumab. Physicians should be alert for neuropsychiatric symptoms suggestive of PML. Discontinue treatment if PML is diagnosed and neurologist referral should be considered. ♦Immunizations: risk and benefits of live or inactive vaccines should be considered. ♦Hepatitis B infection and/or reactivation: cases of hepatitis B infection and/or reactivation have been reported during treatment with Arzerra. All patients should be screened for HBV infection prior to initiation of treatment with Arzerra. HBV antiviral therapy should be considered before initiation of Arzerra in patients with evidence of former hepatitis B. Treatment should not be initiated in patients with current hepatitis B infection until the infection resolves. HBV reactivation has been reported up to 12 months after last Arzerra infusion. Arzerra and any concomitant chemotherapy treatment must be interrupted immediately and appropriate therapy initiated if reactivation of HBV occurs. Treatment resumption after HBV reaction should be discussed with experts in hepatitis B. ♦Cardiovascular: in patients with history of cardiac disease close monitoring is recommended. Treatment should be discontinued if serious or life-threatening cardiac arrhythmias have been experienced. ♦Bowel obstruction: cases of bowel obstruction have been reported. Physicians should be alert for patients presenting with abdominal pain. Appropriate therapy should be initiated when required. ♦Laboratory monitoring: cases of cytopenias, including late-onset neutropenia have been reported. Monitoring of complete blood counts is recommended during treatment with Arzerra. Appropriate treatment should be initiated if cytopenias occur.
Women of child-bearing potential, pregnancy: ♦ Women of child-bearing potential should use adequate contraception during treatment and for at least 6 months after last treatment. ♦Arzerra should be used during pregnancy only if the benefits clearly outweigh the potential risks.
Breast-feeding: Caution should be exercised when Arzerra is administered to a woman who is breastfeeding.
Adverse drug reactions:
♦Very common (≥10%): lower respiratory tract infection (including pneumonia), upper respiratory tract infection, neutropenia, dyspnoea, cough, nausea, diarrhoea, rash, pyrexia, fatigue.
♦Common (1 to 10%): Herpes viral infection, sepsis (including neutropenic sepsis and septic shock), urinary tract infection, febrile neutropenia, hypersensitivity, infusion-related reaction, headache, tachycardia, hypertension, hypotension, oropharyngeal pain, bronchospasm, chest discomfort, nasal congestion, pruritus, urticaria, flushing, back pain, chills (including rigors), hyperhidrosis, cytokine release syndrome.
♦Uncommon (0.1 to 1%): hepatitis B infection and reactivation, progressive multifocal leukoencephalopathy, anaphylactic reactions including anaphylactic shock, tumour lysis syndrome, bradycardia, pulmonary oedema, hypoxia, small intestinal obstruction.
Interactions: No clinically relevant pharmacokinetic interactions were observed between ofatumumab and fludarabine, cyclophosphamide, bendamustine, chlorambucil, or its active metabolite, phenylacetic acid mustard.
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Legal classification: Country-specific.