Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

EMA

Class:

CD20 MAb

Newly Diagnosed

SmPC: http://www.arzerra.com/globalassets/arzerra/assets/ema-combined-en.pdf 

1. Approved Labelling

Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

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.

Monitoring

Patients should be closely monitored during administration of ofatumumab for the onset of infusion reactions, including cytokine release syndrome, particularly during the first infusion.

Pre-medication

Patients should always be pre-medicated 30 minutes to 2 hours prior to Arzerra infusion according to the following dosing schedules:

Previously untreated CLL:

  •  Oral paracetamol (acetaminophen) 1,000 mg (or equivalent, plus
  • Oral or intravenous antihistamine (diphenhydramine 50 mg or certirizine 10 mg or equivalent), plus
  • Intravenous corticosteroid (prednisolone 50 mg or equivalent)

Following the first and second infusion, if the patient does not experience a severe adverse drug reaction (ADR), pre-medication with a corticosteroid for subsequent infusions may either be reduced or omitted, at the discretion of the physician.

The recommended dose and schedule is 300 mg on day 1 followed 1 week later by 1,000 mg on day 8 (cycle 1), followed by 1,000 mg on day 1 of subsequent cycles, for a minimum of 3 cycles, until best response or a maximum of 12 cycles (every 28 days).

Best response is a clinical response that did not improve with 3 additional cycles of treatment.

First infusion

The initial rate of the first infusion of Arzerra should be 12 ml/h. During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h.

Subsequent infusions

If the first infusion has been completed without severe infusion-related ADRs, the subsequent infusions can start at a rate of 25 ml/h and should be increased every 30 minutes up to a maximum of 400 ml/h.

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.

3. AE/Warnings

Please see section 4.4 of the SmPC

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