Generic Name and Formulations:
Alemtuzumab 12mg/1.2mL (10mg/mL); per vial; soln for IV infusion after dilution; preservative-free.
Sanofi Genzyme Company
Indications for LEMTRADA:
Treatment of relapsing forms of multiple sclerosis.
Premedicate with high-dose corticosteroids (eg, methylprednisolone 1000mg or equivalent) immediately prior to infusion and for the first 3 days of each treatment course; may consider antihistamines and/or antipyretics. Administer antivirals for herpetic prophylaxis on 1st day of each treatment course and for ≥2 months following treatment or until CD4+ lymphocyte count ≥200cells/μL, whichever occurs later. Give by IV infusion over 4 hours. ≥17yrs: First course: 12mg daily for 5 consecutive days; Second course: 12mg daily for 3 consecutive days given 12 months after first course.
<17yrs: not recommended.
Autoimmunity. Infusion reactions. Malignancies.
Risk of serious autoimmune conditions (eg, immune thrombocytopenia, anti-glomerular basement membrane disease). Obtain CBCs (w. differential), serum creatinine, and urinalysis with urine cell counts prior to initiation and at monthly intervals, and thyroid function tests (at baseline then every 3 months) for 48 months after last dose. Monitor for infusion reactions during and for ≥2 hours after each dose; discontinue immediately if severe reactions occur. Have equipment and personnel available to manage anaphylaxis. Increased risk of malignancies (eg, thyroid cancer, melanoma, lymphoproliferative disorders); monitor. Perform baseline and yearly skin exams. Preexisting or ongoing malignancies; monitor. Cardiovascular or pulmonary function compromised: monitor more frequently. Active infection: consider delaying treatment until controlled. Perform annual HPV screening in female patients. Screen for TB and treat if positive prior to initiation. Avoid potential sources of Listeria monocytogenes (eg, deli or undercooked meat, soft cheeses, unpasteurized milk); monitor for symptoms. HBV/HCV carriers. Increased risk of acute acalculous cholecystitis; if suspected, evaluate and treat promptly. Monitor for other autoimmune cytopenias. Complete necessary immunizations ≥6 weeks prior to treatment initiation. Pregnancy (Cat.C). Use effective contraception during and for 4 months after treatment completion. Nursing mothers: not recommended.
Monoclonal antibody, CD52 (recombinant, humanized).
Avoid live virus vaccines (after recent alemtuzumab therapy). Delay therapy for 6 weeks after varicella zoster vaccination. Increased risk of immunosuppression with concomitant antineoplastics or immunosuppressants. Additive effects following other previously received alemtuzumab-containing therapy (eg, Campath); caution.
Rash, headache, pyrexia, nasopharyngitis, nausea, UTI, fatigue, insomnia, URTI, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, vomiting; infusion reactions, thyroid disorders, autoimmune disorders, malignancies, cytopenias, pneumonitis (monitor).