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Lemtrada
alemtuzumab
Black Box Warnings .
Appropriate Use
restricted distribution under a REMS program due to risk of autoimmunity, infusion reactions, and malignancies; prescribers, patients, pharmacies, and healthcare facilities must enroll at 1-855-676-6326 or www.lemtradarems.com
Autoimmunity
causes serious, sometimes fatal autoimmune conditions such as immune thrombocytopenia, anti-glomerular basement membrane disease; monitor CBC with diff, Cr, urinalysis with urine cell counts at baseline, then qmo during tx and x48mo after D/C
Infusion Reactions
causes serious, life threatening infusion reactions; must administer in certified healthcare setting with appropriate equipment and trained healthcare professionals to manage anaphylaxis or serious infusion reactions; monitor patients for 2h after each infusion; inform patients that serious infusion reactions can occur after the 2h monitoring period
Stroke Risk
serious and life-threatening stroke, including ischemic and hemorrhagic stroke reported within 3 days of administration; instruct patients to seek immediate medical attention if symptoms of stroke occur
Malignancies
may cause incr. risk of malignancies, including thyroid CA, melanoma, and lymphoproliferative disorders; perform baseline dermatologic exam, then q12mo
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-855-676-6326 or www.lemtradarems.com for more info]
multiple sclerosis, relapsing forms
- [1st course]
- Dose: 12 mg IV qd x5 days; Info: for patients with relapsing-remitting disease or active secondary progressive disease; not recommended for patients with clinically isolated syndrome; see pkg insert for premeds and prophylaxis
- [2nd course]
- Dose: 12 mg IV qd x3 days; Start: 12mo after 1st course; Info: for patients with relapsing-remitting disease or active secondary progressive disease; not recommended for patients with clinically isolated syndrome; see pkg insert for premeds and prophylaxis
- [subsequent courses]
- Dose: 12 mg IV qd x3 days; Start: as needed at least 12mo after last course; Info: for patients with relapsing-remitting disease or active secondary progressive disease; not recommended for patients with clinically isolated syndrome; see pkg insert for premeds and prophylaxis
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.