OFATUMUMAB IS INDICATED FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) REFRACTORY TO FLUDARABINE AND ALEMTUZUMAB.
THE RECOMMENDED DOSAGE AND SCHEDULE IS 12 DOSES ADMINISTERED AS FOLLOWS:
300 MG INITIAL DOSE (DOSE 1), FOLLOWED 1 WEEK LATER BY
2,000 MG WEEKLY FOR 7 DOSES (DOSES 2 THROUGH 8), FOLLOWED 4 WEEKS LATER BY
2,000 MG EVERY 4 WEEKS FOR 4 DOSES (DOSES 9 THROUGH 12)
ADMINISTRATION:
PREPARE ALL DOSES IN 1,000 ML OF 0.9% SODIUM CHLORIDE INJECTION, USP.
DOSE 1: INITIATE INFUSION AT A RATE OF 3.6 MG/HOUR (12 ML/HOUR).
DOSE 2: INITIATE INFUSION AT A RATE OF 24 MG/HOUR (12 ML/HOUR).
DOSES 3 THROUGH 12: INITIATE INFUSION AT A RATE OF 50 MG/HOUR (25 ML/HOUR).
PREMEDICATE 30 MINUTES TO 2 HOURS PRIOR TO EACH DOSE WITH ORAL ACETAMINOPHEN 1,000 MG (OR EQUIVALENT), ORAL OR INTRAVENOUS ANTIHISTAMINE (CETIRIZINE 10 MG OR EQUIVALENT), AND INTRAVENOUS CORTICOSTEROID (PREDNISOLONE 100 MG OR EQUIVALENT).
FOR MORE DETAILS, SEE DRUG MONOGRAPH.