Teriflunomide
Teriflunomide is an immunomodulator with anti-inflammatory properties. It is a once-daily oral medication for the treatment of relapsing-remitting multiple sclerosis (RRMS). In large clinical trials teriflunomide was shown to decrease the number of MS relapses that occur and helped to slow the accumulation of physical disability caused by MS.
Indications and use
Teriflunomide is indicated as a monotherapy for the treatment of people with relapsing-remitting MS (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Teriflunomide should only be prescribed by clinicians who are experienced in the diagnosis and management of MS.
The safety and efficacy of teriflunomide in children with MS below the age of 18 years have not yet been evaluated and should be used with caution in people aged 65 years and over.
Teriflunomide is contraindicated in women who are pregnant or women of childbearing potential not using reliable contraception. Teriflunomide may cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before the start of treatment.
Teriflunomide is also contraindicated in people: with known hypersensitivity to teriflunomide, leflunomide or any of the non-medicinal ingredients in the formulation; who are currently treated with leflunomide; and with severe hepatic impairment.
Teriflunomide 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 MS Canada at 1-800-268-7582.
Administration and dose
Teriflunomide is a 14mg film-coated tablet taken once a day, with or without food.
Mechanism of action (MOA)
Although the exact mechanism of action for teriflunomide is not fully understood, it may involve a reduction in the number of activated lymphocytes (T- and B-cells) in the CNS that may cause MS inflammation.
Side effects*
Side effects may include: diarrhea, nausea, flu or sinus infection, upset stomach, abdominal pain, rash, abnormal liver tests, hair thinning or loss. Teriflunomide can cause abnormal blood test results.
This is not a comprehensive list of all possible side effects of teriflunomide. Please review the teriflunomide 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.
Clinical trials
In clinical trials, teriflunomide significantly reduced the annualized relapse rate and slowed disability progression at two years versus placebo.
In the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial, teriflunomide 14 mg significantly reduced the annualized relapse rate and slowed disability progression at two years versus placebo in people with RRMS.
In the TOWER (Teriflunomide Oral in people With relapsing remitting multiplE sclerosis) trial, teriflunomide 14 mg significantly reduced the annualized relapse rate and slowed disability progression sustained for 12 weeks was statistically significantly reduced versus placebo in people with RRMS.
Cost reimbursement
Much of the cost of generic teriflunomide can 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.