Arzerra is indicated for the treatment of Chronic Lymphocytic Leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab
Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)
1. Approved Labelling
Arzerra is indicated for the treatment of Chronic Lymphocytic Leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.
2. Treatment Regimen
Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Patients should be closely monitored during administration of ofatumumab for the onset of infusion reactions, including cytokine release syndrome, particularly during the first infusion.
Patients should always be pre-medicated 30 minutes to 2 hours prior to Arzerra infusion according to the following dosing schedules:
- oral paracetamol (acetaminophen) 1,000 mg (or equivalent), plus
- oral or intravenous antihistamine (diphenhydramine 50 mg or cetirizine 10 mg or equivalent), plus
- intravenous corticosteroid (prednisolone 100 mg or equivalent).
If the second weekly infusion is completed without a severe ADR, the dose of the corticosteroid may be reduced for infusion numbers 3 through 8, at the discretion of the physician.
Prior to the ninth infusion (first monthly infusion), patients should receive the full dose of premedication agents described above. If the ninth infusion is completed without a severe ADR, the dose may be reduced to the equivalent of 50 mg prednisolone for subsequent infusions at the discretion of the physician.
The recommended dose is 300 mg for the first infusion and 2,000 mg for all subsequent infusions. The infusion schedule is 8 consecutive weekly infusions, followed 4-5 weeks later by 4 consecutive monthly (i.e. every 4 weeks) infusions.
First and second infusions
The initial rate of the first and second infusion of Arzerra should be 12 ml/hour. During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour.
If the second infusion has been completed without severe infusion related ADRs, the remaining infusions can start at a rate of 25 ml/hour and should be increased every 30 minutes up to a maximum of 400 ml/hour.
Method of administration
Arzerra is for intravenous infusion and must be diluted prior to administration. For instructions on dilution of the medicinal product before administration.
Please see section 4.4 of the SmPC.
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