Table 2.

Practical advice on use of alemtuzumab for multiple sclerosis

Before administering alemtuzumab	Check FBC, creatinine electrolytes, TSH, HIV, HepB and C, varicella immunity (and consider vaccination is not immune), and—in TB endemic areas—CXR.
Premedication	1 g methylprednisolone i.v. immediately before alemtuzumab on days 1 to 3 of each treatment course; antihistamines and antipyretics are advised.
Alemtuzumab dosing	12 mg/day administered by intravenous infusion (over approximately 4 h) for two treatment courses: (1) baseline course: 12 mg/day for 5 consecutive days (60 mg total dose), and (2) second course (12 months after the initial course): 12 mg/day for 3 days (36 mg total dose).
Infection prophylaxis	Acyclovir 200 mg twice a day (against herpes simplex) starting on the first day of each course and continuing for 28 days; cotrimoxazole three times weekly (against Listeria), starting on the first day of each course until 28 days after the last infusion (see text for alternatives).
Posttreatment monitoring	To monitor for idiopathic thrombocytopenic purpura (ITP) (and other cytopenias), full blood counts should be obtained at monthly intervals until 48 months after the last infusion. During and after this time, if ITP is suspected clinically, an urgent full blood count should be obtained. The SmPc also recommends monthly creatinine and urinalysis with microscopy until 48 months after the last infusion. A clinically significant change from baseline in serum creatinine, hematuria (not explained by menstruation), and/or proteinuria should prompt further evaluation for nephropathies, including a referral to a specialist. (But please see text where we argue that this monitoring may be unhelpful.) Thyroid function should be monitored for 3 months after treatment, until 48 months following the last infusion. After this period, testing should be performed based on clinical findings suggestive of thyroid dysfunction.
Pregnancy and breastfeeding	Pregnancy: according to the Summary of Product Characteristics (SmPC), serum concentrations of alemtuzumab are low or undetectable within 30 days of each treatment course. Therefore, women of childbearing potential should use effective contraception when receiving a course of alemtuzumab, and for 4 months following each course of treatment. Breastfeeding: it is unknown whether alemtuzumab is excreted in human breast milk, but it has been detected in the milk of lactating mice. Therefore, women should be advised to discontinue breastfeeding during each course of treatment with alemtuzumab, and for 4 months following each course of treatment.
Vaccinations	Patients must not receive live vaccinations after alemtuzumab. It is not known definitively whether alemtuzumab affects response to vaccination, but in a pilot study of 24 patients, the response appeared normal (apart, perhaps, during the first few months following treatment). The SmPC suggests that vaccination before alemtuzumab should be considered in patients who have not completed standard required vaccines, and for those who have no immunity to chickenpox. Required vaccinations should be given at least 6 weeks before treatment.