Alemtuzumab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Lymphocytic Leukemia

Initial dose: 3 mg daily IV over 2 hours.
Maintenance dose: Increase to 10 mg daily over 2 hours when tolerated by patient (infusion-related toxicity NCI-CTC Grade 2 or less). When 10 mg dose is tolerated, increase to maintenance level of 30 mg 3 times weekly (Monday, Wednesday, Friday) IV over 2 hours for up to 12 weeks.
Maximum dose: To decrease incidence of pancytopenia, single doses should not be greater than 30 mg and cumulative weekly doses should not be greater than 90 mg.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Dose Adjustments

If serious infections, serious hematologic toxicity, or other serious toxicities occur, alemtuzumab should be discontinued until resolution. It should be permanently discontinued if autoimmune anemia or thrombocytopenia occurs. If severe neutropenia (ANC<250/mcL) or thrombocytopenia (platelet count 25,000/mcL or less) occur, the following dose modifications are recommended:

First occurrence:
Discontinue alemtuzumab until ANC is at least 500/mcL and platelet count is at least 50,000/mcL, then restart therapy at the same dose. If the interruption is for 7 or more days, restart therapy at 3 mg and increase to 10 mg and then to 30 mg as tolerated.

Second occurrence:
Discontinue alemtuzumab until ANC is at least 500/mcL and platelet count is at least 50,000/mcL, then restart therapy at 10 mg. If interruption is for 7 or more days, restart therapy at 3 mg and increase to 10 mg only.

Third occurrence:
Discontinue alemtuzumab therapy permanently.

If ANC and/or platelet count decrease to 50% or less of the baseline value in patients with a baseline ANC of 500/mcL or less and/or a baseline platelet count 25,000/mcL or less: Discontinue alemtuzumab therapy and restart when ANC and/or platelet count return to baseline values. If the interruption is for 7 or more days, restart therapy at 3 mg and increase to 10 mg and then to 30 mg as tolerated.

Precautions

Complete blood counts and platelet counts should be monitored weekly during therapy and more often if anemia, neutropenia, or thrombocytopenia occurs. CD4+ counts should be monitored after treatment until recovery to greater than or equal to 200 cells/mcL.

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

Dialysis

Data not available.

Other Comments

Patients should be premedicated with an oral antihistamine and acetaminophen. In clinical trials, patients received diphenhydramine 50 mg and acetaminophen 650 mg 30 minutes before the infusion. Hydrocortisone 200 mg was used to treat severe infusion-related effects.

Patients should also receive concurrent anti-infective prophylaxis to minimize risk of opportunistic infections. One study used double strength trimethoprim/sulfamethoxazole twice daily for three days a week and famciclovir (or equivalent) 250 mg twice daily. Prophylaxis should be continued until 2 months after alemtuzumab discontinuation or until the CD4+ count is greater than or equal to 200 cells/mcL.

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