Lemtrada (alemtuzumab) 12 mg concentrate for solution for infusion indicated for treatment of adults with remitting-relapsing multiple sclerosis (MS) and active disease. Lemtrada, a monoclonal antibody that binds to CD52.
An urgent EU-wide review for safety of alemtuzumab has begun after reports of immune-mediated reactions and serious cardiovascular (CV) events, particularly within 3 days of dosing. There have been some life-threatening and fatal cases. While the review is ongoing, use of alemtuzumab has been restricted and new monitoring requirements introduced. Worldwide, >34,000 people with MS have been treated with Lemtrada in clinical trials and post-marketing in clinical practice. Since alemtuzumab (Lemtrada) was marketed in the UK in 2014, an estimated 9371 patient-courses have been administered.
Cases of CV reactions:
- Pulmonary haemorrhage: 5 patients,
- Myocardial infarction: 10 post-marketing cases,
- Arterial dissection: 6 post-marketing cases, and
- Stroke: 13 patients.
Cases of immune-mediated disorders:
- Autoimmune hepatitis: several post-marketing cases (2 deaths).
- Haemophagocytic lymphohistiocytosis: 7 cases.
Restricted indication for new patients:
- alemtuzumab for MS should only be started in adults with either:
- relapsing-remitting MS that is highly active despite adequate course of treatment with ≥2 other disease-modifying therapies or if all other disease-modifying therapies are contraindicated/unsuitable
- patients already on alemtuzumab may continue treatment if it is beneficial and they have discussed additional monitoring requirements and new risks
New monitoring requirements and precautions:
- monitor vital signs, including BP, before and periodically during alemtuzumab infusion-consider stopping infusion and conducting additional monitoring, including electrocardiography (ECG), if any clinically significant changes in vital signs occur
- monitor liver function tests before and during treatment
- discontinue treatment in patients who develop hepatic injury or serious immune-mediated reactions
- evaluate immediately any patients who develop early manifestations of pathologic immune activation, and consider a diagnosis of haemophagocytic lymphohistiocytosis
Advice for patients:
- Alert patients to symptoms of:
- pulmonary haemorrhage, myocardial infarction, stroke, and arterial dissection within days of infusion,
- hepatic injury,
- haemophagocytic lymphohistiocytosis.
Healthcare professionals and patients should continue to report any suspected adverse drug reactions to alemtuzumab via the Yellow Card Scheme.