Lemtrada®
Quick Facts
Lemtrada®, a monotherapy disease-modifying therapy, is a chemotherapy drug used to treat MS.
In-clinic intravenous infusion
5-day infusion followed by a second 3-day infusion the following year
Relapsing forms of multiple sclerosis in adults including relapsing-remitting MS and active secondary-progressive MS. Not recommended for clinically isolated syndrome
Potential Benefit:
Lemtrada® was studied vs active comparator over 2 years:
- 49% reduction in annual relapses
- Reduction in T2 lesion volume was not significantly different; both showed reduction.
- 42% relative reduction in 6-month confirmed disability progression
Common Potential Side Effects
Infusion site reactions, increased risk of infection, over-or-underactive thyroid.
Prescription Assistance:
For assistance finding additional resources that might help cover the costs of your prescription, contact MSAA.
DRUGMAKER
Sanofi
HOW Lemtrada® WORKS
Lemtrada® binds to white blood cells, immune cells called lymphocytes. Lemtrada® kills these white blood cells, reducing the immune system’s ability to attack myelin. The immune cells that grow back after treatment are not believed to damage nerves.
FDA-Approved
Lemtrada® was FDA approved in 2014 to treat relapsing forms of MS, including relapsing-remitting disease and active secondary-progressive disease, in adults. Lemtrada® is not recommended for use in people with clinically isolated syndrome.
Because of risk profile, Lemtrada® is generally prescribed only for people who have had an inadequate response to at least 2 other treatments.
Potential Side Effects
Common side effects include rash, itching, headache, pyrexia (increase in temperature), nasopharyngitis (inflammation of the nose and throat), nausea, diarrhea and vomiting, insomnia, numbness/tingling, dizziness, pain, flushing, and infection.
Adverse events from Lemtrada® can include infusion reactions to the medication, an increased risk of infection, emergent autoimmune diseases, a potentially severe bleeding disorder called immune thrombocytopenic purpura (ITP), and an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. For early detection and management of these risks, Lemtrada® is only available through a restricted distribution program, the Lemtrada® REMS (Risk Evaluation and Mitigation Strategy).
OTHER KEY INFORMATION
Testing completed prior to starting Lemtrada® includes:
- The following labs should be done prior to first dose: Complete Blood Count, Comprehensive Metabolic Panel, urinalysis, thyroid testing, liver function tests (aspartate aminotransferase/AST, alanine aminotransferase/ALT, bilirubin), serum creatinine, urinalysis with cell counts, varicella antibody testing, Tuberculosis screening. People should be immunized at least 6 weeks prior for any needed immunizations. It would be wise to have a dermatological screening and for women to have an annual HPV screening. It is also routine practice to check an individual’s Hepatitis Panel along with HIV testing.
Annual testing completed after starting Lemtrada® includes:
- Yearly skin exam
Regular testing completed after starting Lemtrada® includes:
- People taking Lemtrada® should have the following labs drawn monthly until 48 months since their last dose of medication: Complete Blood Count, serum creatinine, urinalysis with cell counts, liver function tests (aspartate aminotransferase/AST, alanine aminotransferase/ALT, bilirubin); and thyroid testing every 3 months until 48 months since the last dose of medication. People should become familiar with the most common symptoms of adverse events in order to monitor themselves regularly. These can be found in the prescribing information for Lemtrada®.