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.
