Arzerra (ofatumumab) is indicated for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive Chronic Lymphocytic Leukemia (CLL)

INN:

Subtype:

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

License:

FDA

Class:

CD20 MAb

R/R

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

1. Approved Labelling

Arzerra (ofatumumab) is indicated for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive Chronic Lymphocytic Leukemia (CLL).

2. Treatment Regimen

Dilute and administer as an intravenous infusion. Do not administer as an intravenous push or bolus.

The recommended dosage and schedule as single-agent extended treatment in CLL is:

  • 300 mg on Day 1, followed by
  • 1,000 mg 1 week later on Day 8, followed by
  • 1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years.

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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