Arzerra (ofatumumab) is indicated in combination with chlorambucil, for the treatment of previously untreated patients with Chronic Lymphocytic Leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

INN:

Subtype:

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

License:

FDA

Class:

CD20 MAb

Newly Diagnosed

PIhttps://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/arzerra.pdf 

1. Approved Labelling 

Arzerra (ofatumumab) is indicated in combination with chlorambucil, for the treatment of previously untreated patients with Chronic Lymphocytic Leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

2. Treatment Regimen

Dilute and administer as an intravenous infusion. Do not administer as an intravenous push or bolus. Pre-medicate before each infusion.

The recommended dosage and schedule in combination with chlorambucil 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 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles.

For initial 300-mg dose: Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour).

For subsequent infusions of 1,000 mg: Initiate infusion at a rate of 25 mg/hour (25 mL/hour). Initiate infusion at a rate of 12 mg/hour if a Grade 3 or greater infusion-related adverse event was experienced during the previous infusion.

Pre-medicate with oral acetaminophen, oral or intravenous antihistamine, and intravenous corticosteroid.

3. AE/Warnings

Please see section 5 of the PI.

 

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