Lemtrada Adverse Reactions





Full Prescribing Info
Adverse Reactions
Summary of the safety profile in clinical studies: A total of 1,486 patients treated with LEMTRADA (12 mg or 24 mg) constituted the safety population in a pooled analysis of MS clinical studies with a median follow-up of 6.1 years (maximum 12 years), resulting in 8,635 patient-years of safety follow-up.
The most important adverse reactions are autoimmunity (ITP, thyroid disorders, nephropathies, cytopenias), IARs, and infections. These are described in Precautions.
The most common adverse reactions with LEMTRADA (in ≥20% of patients) were rash, headache, pyrexia, and respiratory tract infections.
Tabulated list of adverse reactions: The table as follows is based on the pooled safety data on all LEMTRADA 12 mg-treated patients during all available follow up in clinical trials.
Adverse reactions are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT). Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness. (See Table 3.)

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Description of selected adverse reactions: Terms marked with asterisk (*) in Table 3 include adverse reactions reported as Infusion Associated Reactions.
Terms marked with two asterisks (**) in Table 3 include adverse reactions observed in the post marketing setting which have occurred in the majority of cases with time to onset within 1-3 days of LEMTRADA infusion, following any of the doses during the treatment course.
Neutropenia: Cases of severe (including fatal) neutropenia have been reported within 2 months of LEMTRADA infusion.
Safety profile in long-term follow-up: The type of adverse reactions including seriousness and severity observed in LEMTRADA treatment groups through all available follow-up including patients who received additional treatment courses were similar to those in the active-controlled studies. The incidence of IARs was higher in course 1 than in subsequent courses.
In patients continuing from controlled clinical studies and who did not receive any additional LEMTRADA after the initial 2 treatment courses, the rate (events per person-year) of most adverse reactions was comparable to or reduced in years 3-6 as compared to years 1 and 2. The rate of thyroid adverse reactions was highest in year three and declined thereafter.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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