Adult Dosing
Chronic lymphocytic leukemia (CLL)
- Dose 1: 300 mg IV x 1 wk; infusion rate should be 3.6 mg/hour (12 mL/hour)
- Dose 2: 2000 mg IV weekly for 7 doses (doses 2-8) x 4 wks; infusion rate should be 24 mg/hour (12 mL/hour)
- Dose 9: 2000 mg q4wk for 4 doses (doses 9-12), infusion rate up to 12 should be 50 mg/hour (25 mL/hour)
Notes:- Do not administer as an intravenous push or bolus
- Premedicate before each infusion
- Administer with in-line filter supplied with product
Pediatric Dosing
- Safety and effectiveness in pediatric population have not been established
[Outline]
- Serious infusion reactions may occur. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Interrupt infusion for infusion reactions of any severity and institute medical management as needed
- Prolonged severe neutropenia and thrombocytopenia may occur. Monitor CBC and platelet counts periodically during therapy
- Progressive multifocal leukoencephalopathy (PML) may occur. Monitor for new onset of or changes in neurological signs or symptoms. Discontinue ofatumumab if PML is suspected and initiate evaluation for PML
- Hepatitis B reactivation, including fulminant hepatitis and death may occur. Screen the patient before initiation of therapy and closely monitor carriers of hepatitis B virus (HBV) for clinical and laboratory signs of active HBV infection during and for 6 to 12 months following the last infusion
- Intestinal obstruction may occur. Perform a diagnostic evaluation if obstruction is suspected
- Do not immunize patients who recently received ofatumumab with live viral vaccines
Cautions: Use cautiously in
- Hepatitis B virus carrier
Pregnancy Category:C
Breastfeeding: Safety unknown. It is not known whether the drug is secreted in human milk, but IgG is secreted in human milk. Caution should be exercised while administering to a nursing woman.
