Not reported in available sources.

No sex- or gender-specific efficacy analyses are reported; no sex-related differences in treatment effect have been described.

Recommended dose is 12 mg alemtuzumab IV once daily for 5 consecutive days, followed 12 months later by 12 mg IV once daily for 3 consecutive days; additional 3-day courses of 12 mg/day may be given at least 12 months apart if needed. Patients should receive corticosteroid premedication for the first 3 days of each course and oral anti-herpes prophylaxis starting on day 1 of each course and continuing for at least 1 month.

No sex- or gender-specific dose adjustments are recommended; the same adult dosing regimen is used for all patients.

Female patients have a specific identified risk of cervical human papillomavirus infection, cervical dysplasia and anogenital warts, for which annual HPV screening is recommended; superficial fungal infections, including vulvovaginal candidiasis, occurred more commonly with the medication than with interferon beta-1a, but comparative frequencies by sex were not reported.

Across pooled MS clinical studies (1,486 LEMTRADA‑treated patients; median follow‑up 6.1 years), the most important adverse reactions were autoimmune events (immune thrombocytopenic purpura [ITP], thyroid disorders, nephropathies, and cytopenias), infusion‑associated reactions (IARs), and infections. Very common adverse reactions (≥1/10) included rash, headache, pyrexia, upper respiratory tract infection, urinary tract infection, herpes virus infections, lymphopenia, leukopenia (including neutropenia), Basedow’s disease/hyperthyroidism/hypothyroidism, infusion‑associated reactions such as cytokine release syndrome, hypersensitivity, urticaria, pruritus, generalised rash, dyspnoea, nausea, flushing, fatigue, chills, insomnia, and MS relapse. The most common adverse reactions occurring in ≥20% of patients were rash, headache, pyrexia, and respiratory tract infections. Serious adverse reactions included serious ITP, nephropathies including anti‑GBM disease, autoimmune hepatitis and hepatic injury, HLH, acquired haemophilia A, thrombotic thrombocytopenic purpura, sarcoidosis, autoimmune encephalitis, serious infections (e.g. appendicitis, gastroenteritis, pneumonia, herpes zoster, tooth infection), listeriosis/listeria meningitis, EBV infection including severe hepatitis, haemorrhagic stroke, myocardial ischaemia and myocardial infarction, cervicocephalic arterial dissection, pulmonary alveolar haemorrhage, pneumonitis, acute acalculous cholecystitis, and severe infusion‑associated reactions such as tachycardia, atrial fibrillation, hypotension, and chest discomfort. Serious infections occurred in 2.7% of Lemtrada‑treated patients versus 1% with interferon beta‑1a, and serious IARs occurred in about 3% of Lemtrada‑treated patients. Neutropenia, including severe and fatal cases, has been reported within 2 months of infusion. The type and severity of adverse reactions were generally similar in long‑term follow‑up, with IAR incidence higher in Course 1 than in subsequent courses.

Women of childbearing potential should use effective contraception during each treatment course and for 4 months afterwards. Use during pregnancy is only recommended if the potential maternal benefit justifies fetal risk, as alemtuzumab may cross the placenta and untreated thyroid dysfunction can adversely affect pregnancy outcomes. Because excretion in human milk is unknown but was seen in animal studies, breastfeeding should be stopped during treatment and for 4 months after each course, although in some cases the benefits of breastfeeding may outweigh the theoretical risk of exposure; effects on human fertility during exposure are uncertain.

In a small clinical substudy of 13 treated men, no major abnormalities in sperm count, motility or morphology were observed. In huCD52 transgenic mice, high-dose alemtuzumab reduced normal sperm and increased abnormal sperm in males without impairing fertility, and in females reduced numbers of corpora lutea and implantation sites and decreased gestational weight gain, so a potential impact on human fertility during exposure cannot be excluded.