Adult Dosing
B-Cell Chronic Lymphocytic Leukemia
- Initial dose: 3 mg/day IV until tolerated (usually 3-7 days)
- Titrate: 10 mg/day IV until tolerated; then 30 mg IV three times per week
- Max: 30 mg/dose; 90 mg/wk
- Total duration of therapy: 12 weeks
Dose modification for Neutropenia or Thrombocytopenia
With a baseline absolute neutrophil count [ANC] < 250/mcL and/or a platelet count 25,000/mcL
- For first occurrence: withhold alemtuzumab therapy; resume at 30 mg/day IV when ANC is at least 500/mcL and platelet count is at least 50,000/mcL
- Second occurrence: withhold alemtuzumab; resume at 10 mg/day IV when ANC is at least 500/mcL and platelet count is at least 50,000/mcL
- Third occurrence: discontinue alemtuzumab therapy
50% decrease from baseline in patients initiating therapy with a baseline ANC 250/mcL and/or a baseline platelet count 25,000/mcL:
- First occurrence: Withhold alemtuzumab therapy; resume at 30 mg/day IV upon return to baseline values
- Second occurrence: Withhold alemtuzumab; resume at 10 mg/day IV upon return to baseline values
- Third occurrence: Discontinue alemtuzumab therapy
Note: - Dose modification for Neutropenia or Thrombocytopenia: If the delay between dosing <7 days, resume therapy at same dose. If delay 7 days or more, resume therapy at 3 mg/day IV , increasing to 10 mg/day IV and then 30 mg/day IV as tolerated
- Premedicate with diphenhydramine 50 mg and acetaminophen 500 to 1,000 mg 30 minutes prior to first infusion and each dose escalation
Pediatric Dosing
- Safety and effectiveness in pediatric population have not been established
[Outline]
- Severe, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and prolonged myelosuppression have occurred; do not exceed 30 mg/day or 90 mg/wk [Refer Black Box warning]
- Risk of profound immunosuppression and increased risk of infection during treatment and up to 12 mo afterwards; patients with lymphopenia are at risk for graft-vs-host disease when nonirradiated blood products are given, use of irradiated blood products is recommended
- Risks of serious opportunistic infections, give anti-infective prophylaxis during and for 2 months after completion of therapy, or until CD4 count is at least 200 cells/mcL, whichever occurs later
- Discontinue further therapy if the patient experiences anaphylaxis. Patients who are hypersensitive to alemtuzumab may react to other monoclonal antibodies
- Do not administer live viral vaccines
- Administer as an IV infusion over 2 hours; not for IV push or bolus
- Women and men with reproduction potential should use contraception during treatment and for 6 months after therapy
- Monitor patients routinely for CMV infection during treatment and for at least 2 months following completion of treatment
- Monitor CBC and platelet counts qwk and more frequently if worsening anemia, neutropenia, or thrombocytopenia
Cautions: Use cautiously in
- Ischemic heart disease
- Concurrent antihypertensives
- Use cautiously in multiple sclerosis patients
Pregnancy Category:C
Breastfeeding: Unsafe, use not recommended.