From the FDA Drug Label
The recommended dose of teriflunomide tablets is 7mg or 14 mg orally once daily Teriflunomide tablets can be taken with or without food. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablet therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets
The recommended treatment protocol for Teriflunomide (Aubagio) in patients with relapsing forms of multiple sclerosis (MS) is to take 7mg or 14mg orally once daily, with or without food.
- Key monitoring parameters include:
- Transaminase and bilirubin levels within 6 months before initiation of therapy
- ALT levels at least monthly for six months after starting teriflunomide tablets
- Contraindications include severe hepatic impairment, pregnancy, hypersensitivity, and current leflunomide treatment 1, 1
From the Research
Teriflunomide (Aubagio) is recommended as a first-line treatment for relapsing forms of multiple sclerosis, with the 14 mg dose generally preferred due to greater efficacy, as evidenced by the TOWER trial 2. The treatment protocol for Teriflunomide involves administering a once-daily oral tablet of 7 mg or 14 mg, with the 14 mg dose being more effective in reducing relapse rates and disability progression. Before initiating treatment, patients should undergo:
- Baseline liver function tests
- Complete blood count
- Tuberculosis screening
- Blood pressure measurement
- Pregnancy testing for women of childbearing potential Contraception is mandatory during treatment as teriflunomide is teratogenic. Ongoing monitoring includes:
- Liver function tests monthly for the first 6 months then every 6-8 weeks thereafter
- Complete blood counts as needed for symptoms
- Blood pressure checks at regular intervals The medication works by inhibiting dihydroorotate dehydrogenase, reducing proliferation of activated T and B lymphocytes that contribute to MS pathology. Common side effects include:
- Headache
- Diarrhea
- Nausea
- Hair thinning
- Elevated liver enzymes If rapid elimination is needed (e.g., pregnancy planning), an accelerated elimination procedure using cholestyramine or activated charcoal can be implemented. Teriflunomide should be avoided in patients with severe liver disease, pregnant women, and those with immunodeficiency conditions, as supported by studies such as the TEMSO trial 3 and reviews like the Cochrane database of systematic reviews 4. Key considerations for the use of teriflunomide are also discussed in other studies, including its potential benefits and safety profile 5, 6.