Aubagio

Teriflunomide

THERAPY

Protocols

Before Starting Therapy :

Monitoring During Therapy :

Stopping Therapy :

Product Monograph

Specific Concerns

Pharmacodynamics :

Hepatotoxicity :

Severe liver injury including fatal liver failure occurred rarely in the post marketing setting. Concomitant use of Aubagio with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Liver enzyme elevations tend to occur, but are limited to the first year of treatment. 90% of cases were reversible with normalization within 40 days of washout.

Monitor the following :

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 arenot using reliable contraception. Pregnancy must be avoided during Aubagio treatment or prior to the completion of an accelerated elimination procedure after Aubagio treatment.

Teriflunomide has been found in the following :

Peripheral Neuropathy :

In the pivotal, placebo-controlled studies, the incidence of peripheral neuropathy confirmed by nerve conduction studies was 2.2% (15 patients out of 685) on 14 mg of teriflunomide, compared with 0.6% (4 patients out of 708) on placebo.

Most Common Adverse Reactions :

The following most common adverse reactions were reported with a frequency ≥10% in the 14 mg teriflunomide group and a difference of ≥1% as compared to placebo: alopecia, diarrhea, ALT increased, and nausea.

Teriflunomide is the main metabolite of leflunomide. The safety profile of in patients suffering from rheumatoid arthritis may be pertinent when prescribing teriflunomide in MS patients.

Long Term Studies :

The 9 year follow-up of the TEMSO study showed showed a 63% retention from extension study onset(7yrs) or a 43% retention from randomization in TEMSO(9yrs). The most common reason for discontinuation was withdrawal of consent. 11% discontinued because of adverse events mostly ALT elevations. There was no apparent increased risk for malignancies and no unexpected adverse event. De novo hypertension was noted in 6-10% and neutropenia in 2-5%.

Mean increases in EDSS scores varied between 0.22 to 0.46 over 348 weeks of follow-up from core study baseline

Post-Market
Adverse Events :

In post-marketing experience with AUBAGIO, the following adverse reactions have been identified: