This summary has been prepared by the Multiple Sclerosis Society
of Canada and reviewed for accuracy by the national medical
Gilenya is the first in a new class of compounds called sphingosine
1-phosphate receptor (S1PR) modulators. Gilenya, also known as
fingolimod, provides selective and reversible
retention of lymphocytes in lymph nodes, and it is thought to preserve
key immune functions. It is taken as a daily pill.
Gilenya has been approved for use in people who have tried one
or more MS therapies, but are unresponsive or intolerant to them. It
is indicated for use as a monotherapy for the treatment of people
with the relapsing-remitting form of MS to reduce the frequency
of clinical exacerbations (relapses) and to delay the progression
of physical disability. Health Canada’s approval is
based on results from two large-scale placebo-controlled clinical
trials, each with over 1,200 participants.
INDICATIONS AND USE
Gilenya is indicated for the relapsing forms of multiple
sclerosis (MS) to reduce the frequency of clinical exacerbations
and to delay the accumulation of physical disability in people
who have tried one or more MS therapies, but are unresponsive
or intolerant to them.
It is not known if Gilenya is safe and effective in children
under age 18 or adults over 65.
The safety of Gilenya during pregnancy is uncertain but the
drug could potentially cause birth defects.
The recommended dose of Gilenya is 0.5 mg taken orally, once a day. The first dose of Gilenya must be taken under observation at a doctor’s office or clinic to monitor for signs and symptoms of bradycardia (decreased heart rate). In case of serious heart side effects at the end of the 6-hour observation period, you will need to be observed longer, possibly overnight, in a health care facility.
Fingolimod doses higher than 0.5 mg are associated with a higher risk of adverse reactions without additional benefit and are not approved for use.
Gilenya comes in capsules. It is taken orally once a day with or without food.
The most common side effects of Gilenya include; headache, flu, diarrhea, back pain, abnormal liver tests and cough.
GILENYA CAN CAUSE SERIOUS SIDE EFFECTS INCLUDING:
The label also carries warnings about other potential serious risks, including decreased heart rate and/or other heart effects after the first dose; increased risk of infections (in clinical trials, a small number of serious herpes infections occurred, including two deaths from herpes infections that occurred in people taking a dose higher than the approved dose of fingolimod); risk of macular edema (swelling of the center of the retina inside the eye); decrease in lung function; slight increase in blood pressure; increases of liver enzymes (which could indicate liver malfunction), and risk of harm to fetus (Category C, based on animal studies).
Baseline (pre-treatment) blood tests and an electrocardiogram (ECG) test are required before starting treatment and 6 hours after the first dose of Gilenya is administered. Blood tests will assess your haemoglobin and white blood count, liver function and whether or not you have had chicken-pox. To go on the drug you must be immune to the chicken-pox virus.
Within a few months of going on the drug you will also have to have an eye assessment of your retina as the drug can occasionally cause swelling with visual blurring (macular edema).
Gilenya should not be used in patients with certain heart-related conditions. Therefore, before you use Gilenya, talk to your doctor or pharmacist if you have current or past heart problems, if you are taking medicines for cardiac problems or high blood pressure, or you have a history of sudden loss of consciousness.
This is not a comprehensive list of all possible side effects of Gilenya. For more information, ask your physician or pharmacist.
DRUG IDENTIFICATION (DIN)
Gilenya is covered by most private insurance plans in the country. In November 2011 the Common Drug Review issued a positive recommendation for Gilenya. The Common Drug Review advises whether or not a drug is cost effective and should be covered by public drug programs. Provincial drug programs then use this information in making their decisions. It should be noted that Quebec conducts its own review, independent of the CDR. Please call 1-800-268-7582 for additional information on reimbursement in your province.
CLINICAL TRIAL RESULTS
FREEDOMS Study Group1
A Placebo-Controlled Trial of Oral Fingolimod in Relapsing
Oral fingolimod, a sphingosine-1-phosphate–receptor modulator
improved relapse rates and end points measured on magnetic
resonance imaging (MRI), as compared with either placebo or
intramuscular interferon beta-1a, in phase 2 and 3 studies
of multiple sclerosis.
This 24-month, double-blind, randomized study, enrolled participants
who had relapsing–remitting multiple sclerosis, who were
18 to 55 years of age, had a score of 0 to 5.5 on the Expanded
Disability Status Scale (which ranges from 0 to 10, with higher
scores indicating greater disability), and had had one or more
relapses in the previous year or two or more in the previous
2 years. A total of 1033 of the 1272 patients completed the
study. As compared with placebo, both doses of oral fingolimod
improved the relapse rate, the risk of disability progression,
and end points on MRI. These
benefits will need to be weighed against possible long-term
risks. (New England Journal of Medicine, 2010; 362:
TRANSFORMS Study Group2
Oral Fingolimod or Intramuscular Interferon for Relapsing
In this 12-month, double-blind, double-dummy study, 1292 participants
with relapsing– remitting multiple sclerosis who had
a recent history of at least one relapse were randomly assigned
to receive either oral fingolimod at a daily dose of either
1.25 or 0.5 mg or intramuscular interferon beta-1a (an established
therapy for multiple sclerosis) at a weekly dose of 30 μg.
The primary end point was the annualized relapse rate. Key
secondary end points were the number of new or enlarged lesions
on T2-weighted magnetic resonance imaging (MRI) scans at 12
months and progression of disability that was sustained for
at least 3 months. A total of 1153 people completed the study.
The annualized relapse rate was significantly lower in both
groups receiving fingolimod than in the interferon group. MRI
findings supported the primary results. No significant differences
were seen among the study groups with respect to progression
of disability. Two fatal infections occurred in the group that
received the 1.25-mg dose of fingolimod: disseminated primary
varicella zoster and herpes simplex encephalitis. This trial
showed the superior efficacy of oral fingolimod with respect
to relapse rates
and MRI outcomes in patients with multiple sclerosis, as compared
with intramuscular interferon beta-1a. Longer studies are needed
to assess the safety and efficacy of treatment beyond 1 year.
(New England Journal of Medicine, 2010; 362:402-415)
There are a number of current clinical trials investigating
the long-term efficacy and safety of fingolimod in people with
relapsing-remitting MS, as well as trials investigating the
efficacy and safety of fingolimod compared to other Health
Canada approved disease modifying therapies on the market.
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
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- FREEDOMS Study Group. A Placebo-Controlled
Trial of Oral Fingolimod in Relapsing Multiple Sclerosis. N
Engl J Med 2010; 362: 387-401
- TRANSFORMS Study Group. Oral Fingolimod
or Intramuscular Interferon for Relapsing Multiple Sclerosis.
N Engl J Med 2010; 362:402-415
The drug information contained in this publication
has been obtained from the manufacturers’ product monographs.
Consult the package insert for more
detailed information about the product’s indications, contraindications,
medical use and side effects. If you are taking any of the medications
listed above, do not change the dose or stop taking your medication
without consulting your physician first.
Avonex® is a registered trademark of Biogen Idec Canada Inc.
Betaplus® is a registered trademark of Bayer HealthCare Pharmaceuticals
Betaseron® is a registered trademark of Bayer HealthCare Pharmaceuticals
Copaxone® is a registered trademark of Teva Neuroscience
Extavia® is a registered trademark of Novartis Pharmaceuticals
Gilenya® is a registered trademark of Novartis Pharmaceuticals
Gilenya GO Program® is a registered trademark of Novartis Pharmaceuticals
MS Alliance® is a registered trademark Biogen IDEC Canada
Rebif® is a registered trademark of EMD Serono Canada Inc.
Multiple Support Program® is a registered trademark of EMD Serono
Shared Solutions® is a registered trademark of Teva Neuroscience
Tysabri® is a registered trademark of Biogen Idec Canada Inc.
and Elan Pharmaceuticals
Tysabri Care Program® is a registered trademark of Biogen Idec
Canada Inc. and Elan Pharmaceuticals
© 2010, National Multiple Sclerosis Society
This resource has been adapted by the Multiple Sclerosis Society of Canada with
permission of the National Multiple Sclerosis Society (USA).
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