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Ofatumumab Dosage

Applies to the following strength(s): 20 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Lymphocytic Leukemia

RECOMMENDED DOSAGE REGIMEN:
-PREVIOUSLY UNTREATED CLL: This drug, in combination with chlorambucil, is indicated for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate:
300 mg IV on Day 1, followed by:
1000 mg IV one week later on Day 8 (Cycle 1) followed by:
1000 mg IV on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles
-EXTENDED TREATMENT IN CLL: As a single agent, this drug is indicated for extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL:
300 mg on Day 1, followed by:
1000 mg 1 week later on Day 8, followed by:
1000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years
-REFRACTORY CLL: For the treatment of patients with CLL refractory to fludarabine and alemtuzumab. The recommended dosage and schedule is 12 doses administered as follows:
300 mg initial dose on Day 1, followed 1 week later by:
2000 mg weekly for 7 doses (Infusions 2 through 8), followed 4 weeks later by:
2000 mg every 4 weeks for 4 doses (Infusions 9 through 12)

PRIOR TO ADMINISTRATION FOR ALL PATIENTS:
-This drug should be administered under the supervision of a physician experienced in cancer therapy and in an environment where full resuscitation facilities are immediately available.
-Patients should be premedicated before each infusion.
-Patients should be closely monitored during administration for the onset of infusion reactions, including cytokine release syndrome, particularly during the first infusion.
-This drug should not be administered as an IV push or bolus or as a subcutaneous injection.

PREMEDICATION:
PATIENTS SHOULD RECEIVE ALL OF THE FOLLOWING PREMEDICATION AGENTS 30 MINUTES TO 2 HOURS PRIOR TO EACH INFUSION:
PREVIOUSLY UNTREATED CLL OR EXTENDED TREATMENT IN CLL:
-Infusions 1 and 2: IV corticosteroid (prednisolone or equivalent) 50 mg AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
Infusions 3 and beyond (up to 13 infusions in previously untreated CLL; up to 14 infusions in extended treatment in CLL): IV corticosteroid (prednisolone or equivalent) 0 to 50 mg (the corticosteroid may be reduced or omitted for subsequent infusions if a Grade 3 or greater infusion related adverse event did not occur with the preceding infusion) AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
REFRACTORY CLL:
-Infusions 1, 2, and 9: IV corticosteroid (prednisolone or equivalent) 100 mg AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
-Infusions 3 to 8: IV corticosteroid (prednisolone or equivalent) 0 to 100 mg (the corticosteroid may be reduced or omitted for subsequent infusions if a Grade 3 or greater infusion related adverse event did not occur with the preceding infusion) AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
-Infusions 10 to 12: IV corticosteroid (prednisolone or equivalent) 50 to 100 mg (the corticosteroid may be given at a reduced dose of 50 mg to 100 mg if a Grade 3 or greater infusion related adverse event did not occur with Infusion 9) AND oral acetaminophen 1000 mg AND oral or IV antihistamine (diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)

ADMINISTRATION:
PREVIOUSLY UNTREATED CLL AND EXTENDED TREATMENT IN CLL:
-Cycle 1, Day 1: Initiate the first dose (300 mg) at 12 mL/hr for 30 minutes; if tolerated, increase to 25 mL/hr for 30 minutes; if tolerated increase to 50 mL/hr for 30 minutes; if tolerated increase to 100 mL/hr for 30 minutes; if tolerated increase to 200 mL/hr for 30 minutes; if tolerated increase to 300 mL/hr for 30 minutes; if tolerated increase to 400 mL/hr for remainder of the infusion. The median duration of infusion is 4.8 to 5.2 hours.
-Cycle 1, day 8 and cycles 2 to 12 (if no reaction to previous infusion): Initiate infusion at 25 mL/hr for 30 minutes, if tolerated increase to 50 mL/hr for 30 minutes, if tolerated increase to 100 mL/hr for 30 minutes, if tolerated increase to 200 mL/hr for 30 minutes, if tolerated increase to 400 mL/hr for remainder of infusion. The median duration of infusion is 4.2 to 4.4 hours.
REFRACTORY CLL: The recommended dosage and schedule is 12 doses administered as follows:
-Doses 1 and 2: Initiate infusion at 12 mL/hr for 30 minutes, if tolerated, increase to 25 mL/hr for 30 minutes, if tolerated increase to 50 mL/hr for 30 minutes, if tolerated increase to 100 mL/hr for 30 minutes, if tolerated increase to 200 mL/hr for remainder of infusion. The median duration of infusion is 6.8 hours.
-Doses 3 to 12: Initiate infusion at 25 mL/hr for 30 minutes, if tolerated, increase to 50 mL/hr for 30 minutes, if tolerated, increase to 100 mL/hr for 30 minutes, if tolerated, increase to 200 mL/hr for 30 minutes, if tolerated, increase to 400 mL/hr for remainder of infusion. The median duration of infusion is 4.2 to 4.4 hours.

Renal Dose Adjustments

No formal studies of this drug in patients with renal impairment have been performed. No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance greater than 30 mL/min).

Liver Dose Adjustments

No formal studies of this drug in patients with renal impairment have been performed.

Dose Adjustments

INFUSION RATE DOSE MODIFICATION FOR INFUSION REACTIONS:
Interrupt infusion for infusion reactions of any severity. Treatment can be resumed at the discretion of the treating physician. The following infusion rate modifications can be used as a guide:
If the infusion reaction resolves or remains less than or equal to Grade 2, resume infusion with the following modifications according to the initial Grade of the infusion reaction:
-Grade 1 or 2: Infuse at one-half of the previous infusion rate.
-Grade 3 or 4: Infuse at a rate of 12 mL/hour.
-After resuming the infusion, the infusion rate may be increased according to the standard schedule, based on patient tolerance.
-Consider permanent discontinuation of therapy if the severity of the infusion reaction does not resolve to less than or equal to Grade 2 despite adequate clinical intervention.
-Permanently discontinue therapy for patients who develop an anaphylactic reaction.

Precautions

US BOXED WARNINGS:
-HEPATITIS B VIRUS REACTIVATION: Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including this drug, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
-PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY: Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including this drug.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Do not administer as an IV push or bolus.
-The infusion should be carried out in an environment equipped to monitor for and manage infusion reactions.
-Administer with infusion pump and administration set.
-Recommended infusion rates should not be exceeded.

Storage requirements:
-Refer to manufacturer product information.

Reconstitution/preparation techniques:
-Refer to manufacturer product information.

IV compatibility:
-Refer to manufacturer product information.

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