WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY
Hepatotoxicity
Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO [see Warnings and Precautions]. If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions]. AUBAGIO is contraindicated in patients with severe hepatic impairment [see Contraindications]. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO.
Risk of Teratogenicity
Based on animal data, AUBAGIO may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting AUBAGIO. AUBAGIO is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during AUBAGIO treatment or prior to the completion of an accelerated elimination procedure after AUBAGIO treatment [see Contraindications, Warnings and Precautions, and Use in Specific Populations].
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NEWS HIGHLIGHTS
Published Studies Related to Aubagio (Teriflunomide)
Teriflunomide, an inhibitor of dihydroorotate dehydrogenase for the potential
oral treatment of multiple sclerosis. [2010] Teriflunomide, being developed as a potential oral treatment for multiple
sclerosis (MS) by sanofi-aventis, is the active metabolite of the rheumatoid
arthritis drug leflunomide. Both teriflunomide and leflunomide are inhibitors of
the mitochondrial enzyme dihydroorotate dehydrogenase, which is critically
involved in pyrimidine synthesis.
A Phase II study of the safety and efficacy of teriflunomide in multiple
sclerosis with relapses. [2006] multiple sclerosis (MS) with relapses... CONCLUSION: Oral teriflunomide was effective in reducing MRI lesions and was well
Pharmacokinetic evaluation of teriflunomide for the treatment of multiple
sclerosis. [2013] INTRODUCTION: Teriflunomide is an immunomodulatory drug that received FDA
approval for the treatment of relapsing forms of multiple sclerosis (MS) in
September 2012. Its primary mode of action is inhibition of dihydroorotate
dehydrogenase which inhibits the proliferation of activated T cells, but it also
has a number of other actions that may be important contributors to its efficacy
in MS...
Clinical Trials Related to Aubagio (Teriflunomide)
Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride [Recruiting]
Primary Objective To determine if colestipol hydrochloride tablets can accelerate the
elimination of teriflunomide. Teriflunomide will be administered for 14 days followed by
colestipol dosing of 11 days. Total duration of the study is 40 days.
Secondary Objectives To collect information on the pattern of side effects with use of
colestipol hydrochloride after teriflunomide administration and to determine the best
duration of therapy needed for adequate elimination
Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months [Recruiting]
This study will evaluate the effects of Aubagio on changes in the brain using MRI.
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis [Completed]
The primary objective was to estimate the tolerability and safety of 2 doses of
Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with
multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].
The secondary objectives were:
- to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in
combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,
relapse rate and patient-reported fatigue;
- to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with
a stable dose of GA.
Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients [Active, not recruiting]
Safety and Effectiveness of Switching Relapsing MS Patients Treated With Natalizumab at Risk for PML to Teriflunomide [Recruiting]
The purpose of this study is to determine if teriflunomide will be safe and effective to
prevent relapses in patients with relapsing types of MS when switching from natalizumab to
teriflunomide in patients at risk for PML. This is a two center interventional study of
patients who have had 12 or more continuous infusions of natalizumab , who are anti-JCV-ab
positive, and who had been free of clinical relapses during prior 12 months of natalizumab
therapy who will be switching to teriflunomide.
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