CAMPATH
Clinical safety rating
cautionComprehensive clinical and safety monograph for CAMPATH (CAMPATH).
Comprehensive clinical and safety monograph for CAMPATH (CAMPATH).
Treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapyOff-label: Multiple sclerosis (relapsing forms), Conditioning regimen for hematopoietic stem cell transplantation, Prevention of graft-versus-host disease, Treatment of solid organ transplant rejection
Alemtuzumab is a recombinant humanized monoclonal antibody that binds to CD52, a cell surface antigen expressed on B and T lymphocytes, NK cells, monocytes, and macrophages. Binding induces antibody-dependent cell-mediated cytotoxicity and complement-mediated lysis, resulting in prolonged lymphocyte depletion.
| Metabolism | Metabolism of alemtuzumab is not well defined; as a monoclonal antibody, it is expected to be catabolized into amino acids via general protein degradation pathways. |
| Excretion | Clearance via opsonization and degradation in reticuloendothelial system; negligible renal or biliary excretion (<1% unchanged). |
| Half-life | Terminal half-life approximately 12 days (range 6-21 days) after repeated doses, supporting weekly dosing in CLL. |
| Protein binding | Not extensively characterized; negligible albumin binding due to monoclonal antibody structure. |
| Volume of Distribution | Approximately 0.2-0.5 L/kg, indicating distribution primarily within vascular and interstitial spaces. |
| Bioavailability | Intravenous only; bioavailability 100% by IV route; no oral or IM formulation. |
| Onset of Action | Rapid depletion of circulating lymphocytes begins within hours after first IV infusion. |
| Duration of Action | Lymphocyte depletion persists for several weeks to months post-treatment; recovery may take up to 12 months. |
| Molecular Weight | 150000 |
12 mg/day intravenously over 2 hours, administered for 5 consecutive days (total 60 mg). For patients with relapsed/refractory chronic lymphocytic leukemia (CLL), the recommended dose is 3 mg/day intravenously on day 1, 10 mg/day on day 2, and 30 mg/day on day 3 (dose escalation), followed by 30 mg/day three times per week on alternate days for up to 11 weeks (total cumulative dose up to 640 mg).
| Dosage form | VIAL |
| Renal impairment | No dose adjustment required for creatinine clearance (CrCl) ≥10 mL/min. Use with caution in severe renal impairment (CrCl <10 mL/min) or end-stage renal disease; no specific dose recommendations available. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). For severe hepatic impairment (Child-Pugh C), use caution; no specific dose recommendations available, and safety has not been established. |
| Pediatric use | Not approved for use in pediatric patients. Safety and effectiveness in children under 18 years have not been established. No standard dosing guidelines. |
| Geriatric use | No dose adjustment required based solely on age. However, elderly patients (≥65 years) may have higher incidence of infusion-related reactions, immunosuppression, and infections; monitor closely. Use same dosing as adults with attention to renal function. |
| 1st trimester | Avoid. Alemtuzumab is a humanized monoclonal antibody (IgG1) that crosses the placenta. First-trimester exposure carries risk of fetal B-cell depletion and other hematologic abnormalities based on known effects of immune suppression. |
| 2nd trimester | Avoid. In second trimester, placental transfer of IgG increases. There is a risk of fetal lymphopenia and increased susceptibility to infections. |
| 3rd trimester | Avoid. Third-trimester exposure can cause neonatal lymphopenia, cytopenias, and increased infection risk due to active transplacental IgG transfer. |
Clinical note
Comprehensive clinical and safety monograph for CAMPATH (CAMPATH).
| Placental transfer | Alemtuzumab is an IgG1 monoclonal antibody that crosses the placenta via FcRn-mediated transport. Transfer increases as gestation progresses; fetal levels may approach maternal levels in the third trimester. |
| Breastfeeding | Alemtuzumab is likely present in human milk based on excretion of other monoclonal antibodies. Due to high molecular weight, transfer into milk is expected to be low; however, there is potential for immunosuppression and adverse effects in the breastfed infant. Caution is advised; consider waiting at least 4-6 half-lives (approximately 4 weeks after last dose) before breastfeeding. |
| Lactation Rating | L5 (Contraindicated) |
| Teratogenic Risk | Pregnancy category C. First trimester: Anticipated risk of embryolethality and teratogenicity based on animal studies showing fetal loss and malformations. Second and third trimesters: Risk of hematologic toxicity and immunosuppression in the fetus. Alemtuzumab is an IgG1 monoclonal antibody that crosses the placenta, with increasing transfer as gestation advances. |
| Fetal Monitoring | Monitor CBC with differential and platelets weekly during therapy and for at least 6 weeks after discontinuation. Monitor for signs of infection, infusion reactions, and autoimmune adverse events. Thyroid function tests are recommended before and periodically during treatment due to risk of thyroid disorders. Monitor for cytopenias, including pancytopenia. |
| Fertility Effects | No formal fertility studies conducted. Animal studies showed no impairment of fertility. However, immunosuppression may affect reproductive health, and patients should discuss fertility preservation options before treatment. |
■ FDA Black Box Warning
WARNING: CYTOPENIAS, INFUSION REACTIONS, AND INFECTIONS. Cytopenias: Serious, including prolonged pancytopenia and autoimmune cytopenias (hemolytic anemia, thrombocytopenia). Infusion reactions: Severe including hypotension, rigors, fever, and dyspnea; premedicate and monitor. Infections: Serious including CMV, EBV, and other opportunistic infections; monitor for reactivation.
| Serious Effects |
Hypersensitivity to alemtuzumab or any excipientsActive systemic infectionsHIV infectionUncontrolled infections requiring antimicrobial therapyCurrent malignancy (except basal cell carcinoma)History of progressive multifocal leukoencephalopathy (PML)
| Precautions | Cytopenias (including autoimmune hemolytic anemia, aplastic anemia), infusion reactions, serious infections (including CMV, EBV, and other opportunistic infections), immunization with live viral vaccines not recommended, thyroid disorders, autoimmune hepatitis, and progressive multifocal leukoencephalopathy (PML). |
| Food/Dietary | No known food interactions. No restriction on dietary intake. |
| Clinical Pearls | Premedicate with acetaminophen and antihistamine before infusion to reduce infusion reactions. Monitor for cytopenias; growth factor support may be needed. High risk of CMV reactivation; consider prophylaxis. Lymphocyte depletion is prolonged; live vaccines contraindicated for at least 12 months after therapy. |
| Patient Advice | You will receive premedication before each infusion to help prevent infusion-related side effects like fever, chills, or rash. · This medication lowers your white blood cell counts significantly, increasing your risk for infections. Report any fever, sore throat, or cough immediately. · You may experience low red blood cell counts (anemia) and low platelet counts, leading to fatigue or easy bruising/bleeding. · Avoid live vaccines (e.g., MMR, flu nasal spray, shingles vaccine) during treatment and for at least 12 months after. · Use effective contraception during and for 6 months after treatment; this drug can harm a fetus. · Do not receive any immunizations without consulting your doctor first. · Report any signs of infusion reaction during the infusion (e.g., chest tightness, shortness of breath, hives) to your healthcare provider immediately. |
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