Lemtrada

Lemtrada™ (alemtuzumab)
Drug identification number (DIN): 02418320
Genzyme Canada

Lemtrada™ is a monotherapy delivered by intravenous infusion for the management of relapsing-remitting multiple sclerosis in adults with active disease defined by clinical and imaging features, to reduce the frequency of clinical exacerbations (relapses) and to delay the progression of physical disability.

Indication and use

Lemtrada (alemtuzumab) is indicated for the management of adults with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

Lemtrada treatment should be initiated and supervised by neurologists experienced in the treatment of people with MS and who have fully familiarized themselves with the efficacy and safety profile of Lemtrada™.

It is not known if Lemtrada is safe and effective in children under age 18 or adults over 65.

Lemtrada is not recommended in pregnant or nursing women. Women who could become pregnant should use effective contraceptive methods during treatment with Lemtrada and for four months after each course of treatment. It is unknown if Lemtrada can be transferred to a baby through breast milk, but there could be a risk.

Lemtrada is contraindicated in people: who are hypersensitive to alemtuzumab or to any ingredient in the formulation or component of the container; who are infected with Human Immunodeficiency Virus (HIV); who have active or latent tuberculosis; who have severe active infections; with active malignancies; on antineoplastic or immunosuppressive therapies; with a history of progressive multifocal leukoencephalopathy (PML).

Lemtrada is not approved for people with CIS or progressive MS. For information on CIS approved treatment options and treatments for progressive MS, please speak with your physician or contact the MS Society of Canada at 1-800-268-7582.

Administration and dose

Lemtrada is given as an infusion into a vein. Each infusion takes approximately four hours. For the first treatment course, individuals receive one infusion per day for five days. One year later, individuals receive one infusion per day for three days.

Each infusion delivers 12 mg of Lemtrada. There is no Lemtrada treatment between the two courses.

Mechanism of action (MOA)

Monoclonal antibodies are proteins which bind to a unique site (called an antigen) on cells. Lemtrada binds to an antigen, called CD52, which is present at high levels on certain cells of the immune system. The mechanism by which alemtuzumab exerts its therapeutic effects in MS is not fully understood, but may involve immunomodulation through the depletion and repopulation of lymphocytes (white blood cells).

Side effects*

The most common side effects of Lemtrada are infusion-associated reactions (headache, rash, fever, nausea, hives, itching, insomnia, chills and flushing) and infections (nasopharyngitis, urinary tract and upper respiratory tract).

Other very common side effects may include: back pain, joint pain, pain in arms or legs, upper respiratory tract infection/cough, cold, urinary tract infection, chills, sore throat or mouth pain, feeling tired, bruising, tingling sensation and diarrhea.

This is not a comprehensive list of all possible side effects of Lemtrada. Please see the Lemtrada product monograph for a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Lemtrada.)

Cost reimbursement

The price of Lemtrada is $11,964 per vial for a treatment course of 5 vials over one week in year one of treatment, and 3-vials over one week in year two of treatment. Much of the cost may be reimbursed through private and group health plans for people who meet the prescribing criteria and through provincial drug programs for individuals who meet the prescribing criteria. For more information, speak to your healthcare provider.

Clinical trials

CARE MS I
Findings from a phase III study assessing the safety and efficacy of alemtuzumab (a lymphocyte-depleting humanized monoclonal antibody) compared with interferon beta 1a as a first line therapy in previously untreated people with relapsing-remitting MS demonstrated treatment with alemtuzumab to be more effective at the end of the study period than treatment with interferon beta 1a.

CARE MS II
Findings from a separate phase III study assessing the safety and efficacy of alemtuzumab compared with interferon beta 1a in people with relapsing-remitting MS who have relapsed despite first-line treatment (interferon beta or glatiramer acetate) suggest that alemtuzumab was more effective in reducing relapse rate and disability progression compared with interferon beta 1a.

Drug support program

MS One to One™, at 1-855-MS1-2ONE (1-855-671-2663). Please discuss any other questions about treatment options with your physician.

References

Jeffrey A Cohen*, Alasdair J Coles*, Douglas L Arnold, Christian Confavreux, Edward J Fox, Hans-Peter Hartung, Eva Havrdova, Krzysztof W Selmaj,Howard L Weiner, Elizabeth Fisher, Vesna V Brinar, Gavin Giovannoni, Miroslav Stojanovic, Bella I Ertik, Stephen L Lake, David H Margolin,Michael A Panzara, D Alastair S Compston, for the CARE-MS I investigators. The Lancet, Early Online Publication, 1 November 2012 doi.org/10.1016/ S0140-6736(12)61769-3

Alasdair J Coles, Cary L Twyman, Douglas L Arnold, Jeff rey A Cohen, Christian Confavreux, Edward J Fox, Hans-Peter Hartung, Eva Havrdova, Krzysztof W Selmaj, Howard L Weiner, Tamara Miller, Elizabeth Fisher, Rupert Sandbrink, Stephen L Lake, David H Margolin, Pedro Oyuela, Michael A Panzara, D Alastair S Compston, for the CARE-MS II investigators* The Lancet, Early Online Publication, 1 November 2012 doi:10.1016/S0140-6736(12)61768-1

Lemtrada™ is a registered trademark of Genzyme Canada.