Generic Name and Formulations:
Alemtuzumab 30mg/mL; soln for IV infusion after dilution; preservative-free.
Sanofi Genzyme Company
Indications for CAMPATH:
B-cell chronic lymphocytic leukemia (B-CLL).
Premedicate with antihistamine and acetaminophen before 1st dose, and at dose escalations. Give by IV infusion over 2hrs. Initially 3mg daily until infusion reactions are ≤ grade 2, then increase to 10mg daily until infusion reactions are ≤ grade 2, then to maintenance 30mg/day three times per week (on alternate days); duration of therapy (including escalation): 12 weeks. Do not exceed max single dose 30mg/dose or 90mg/week. Give PCP and herpes viral prophylaxis during treatment and for at least 2 months after completion or until CD4+ count ≥200cells/µL, whichever occurs later. Dose adjustments for neutropenia and thrombocytopenia: see full labeling. Retitrate if therapy interrupted for ≥7 days.
Withhold dose for severe cytopenias (except lymphopenia); discontinue if autoimmune or recurrent/persistent severe cytopenias (except lymphopenia) develop. Monitor for infusion reactions; withhold dose if grade 3 or 4. Monitor for CMV infection during and for at least 2 months after completion. Withhold dose for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Obtain CBCs, platelet counts weekly, assess CD4+ counts after treatment until recovery to ≥200cells/µL. Pregnancy (Cat.C). Nursing mothers: not recommended.
Avoid live virus vaccines (after recent alemtuzumab therapy). May interfere with tests using antibodies. Irradiate any blood products given (GVHD may occur).
Monoclonal antibody, CD52 (recombinant, humanized).
Infusion reactions, cytopenias (eg, neutropenia, lymphopenia, thrombocytopenia, anemia), infections (eg, CMV), nausea, emesis, diarrhea, insomnia, anxiety.
Single-use vial—1, 3