Ofatumumab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Lymphocytic Leukemia

Patients should be premedicated before each infusion.

Total of 12 doses:
Initial dose (Dose 1): 300 mg
Doses 2 through 8: 1 week after initial dose, begin 2,000 mg weekly for 7 doses
Doses 9 through 12: 4 weeks after dose 8, begin 2,000 mg every 4 weeks for 4 doses

Each dose diluted in 1000 mL of 0.9% sodium chloride and given by slow intravenous infusion

Renal Dose Adjustments

Data not available

Creatinine clearance at baseline did not have a clinically important effect on ofatumumab pharmacokinetics in patients with calculated creatinine clearance values ranging from 33 to 287 mL/min.

Liver Dose Adjustments

Data not available

Dose Adjustments

Infusions should be interrupted for infusion reactions of any severity.
For grade 4 infusion reactions, the infusion should not be resumed.
For a grade 1, 2, or 3 infusion reaction, if the infusion reaction resolves or remains less than or equal to grade 2, the infusion may be resumed with the following modifications based on the initial grade of the infusion reaction:
Grade 1 or 2: Infuse at one-half of the previous infusion rate.
Grade 3: Infuse at a rate of 12 mL/hour.

After resuming the infusion, the infusion rate may be increased, based on patient tolerance.

No dosage adjustment is recommended based on body weight or gender.

Precautions

Do not administer as an intravenous push or bolus.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Premedication:
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).

Do not reduce corticosteroid dose for doses 1, 2, or 9.

Corticosteroid dose may be reduced as follows for doses 3 through 8 and 10 through 12:
Doses 3 through 8: Gradually reduce corticosteroid dose with successive infusions if a grade 3 or greater infusion reaction did not occur with the preceding dose.
Doses 10 through 12: Administer prednisolone 50 mg to 100 mg or equivalent if a grade 3 or greater infusion reaction did not occur with dose 9.

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