Drug Identification Number (DIN): 02416328
Aubagio, also known as 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 Aubagio 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
Aubagio (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.
Aubagio should only be prescribed by clinicians who are experienced in the diagnosis and management of MS.
The safety and efficacy of Aubagio 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.
Aubagio is contraindicated in women who are pregnant or women of childbearing potential not using reliable contraception. Aubagio may cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before start of treatment.
Aubagio is also contraindicated in people: with known hypersensitivity to teriflunomide, leflunomide or to any of the non-medicinal ingredients in the formulation; who are currently treated with leflunomide; and with severe hepatic impairment.
Aubagio 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
Aubagio is a 14mg film-coated tablet taken once a daily, with or without food.
Mechanism of action (MOA)
Although the exact mechanism of action for Aubagio 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 may include: diarrhea, nausea, flu or sinus infection, upset stomach, abdominal pain, rash, abnormal liver tests, hair thinning or loss. Aubagio can cause abnormal blood test results.
This is not a comprehensive list of all possible side effects of Aubagio. Please see the Aubagio 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 Aubagio.)
In clinical trials, Aubagio significantly reduced the annualized relapse rate and slowed disability progression at two years versus placebo.
In the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial, Aubagio 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, Aubagio 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.
TOPIC - Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
The 24-month, double-blind, multi-centre trial enrolled 618 patients who had experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of MS symptoms within 90 days of randomization, and MRI scan showing two or more lesions characteristic of MS. The two-year study was designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack.
Aubagio 14 mg significantly reduced the risk of a new clinical relapse. There was a 35 per cent reduction among patients who received Aubagio 14 mg compared to placebo (p=0.0374). As measured by MRI over the two-year period, there was a five per cent increase in total lesion volume among patients treated with Aubagio 14 mg compared to a 28 per cent increase among patients treated with placebo (p=0.0374). In addition, there was a 59 per cent reduction in gadolinium-enhancing T1 lesions among patients treated with Aubagio 14 mg compared to placebo (p=0.0008).
A 28-day blister pack of Aubagio (once daily oral tablets) is $1,515,30. Aubagio is available to all Canadians living with relapsing-remitting MS through Genzyme's MS One to One™ program and is covered by many public and private drug plans. For more information, speak to your healthcare provider and have them contact the program for enrolment instructions by calling 1-855-671-2663.
To date, the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia, Newfoundland and Labrador, New Brunswick, Prince Edward Island and Yukon Territory have added Aubagio to their drug plan benefits.
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.
TEMSO (TEriflunomide Multiple Sclerosis Oral). N Engl J Med 2011; 365:1293-1303
TOWER (Teriflunomide Oral in people With relapsing remitting multiplE sclerosis). 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
TOPIC Main Outcomes: Efficacy and Safety of Once-Daily Oral Teriflunomide in Patients with Clinically Isolated Syndrome. 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS).
Genzyme® and Aubagio® are registered trademarks. All rights reserved.