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Teriflunomide

Therapeutic Indications

Teriflunomide is indicated for:

Relapsing remitting multiple sclerosis (MS)

Irrespective of gender only Adults (18 years old or older)

Teriflunomide is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS).

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 14 mg once daily

Contraindications

Active ingredient Teriflunomide is contraindicated in the following cases:

Severe hepatic impairment

No gender/age discrimination

Patients with severe hepatic impairment (Child-Pugh class C).

Lactation

No gender/age discrimination

Animal studies have shown excretion of teriflunomide in milk. Teriflunomide is contraindicated during breast-feeding.

Pregnancy

No gender/age discrimination

There are limited amount of data from the use of teriflunomide in pregnant women. Studies in animals have shown reproductive toxicity.

Teriflunomide may cause serious birth defects when administered during pregnancy. Teriflunomide is contraindicated in pregnancy.

Women of childbearing potential have to use effective contraception during treatment and after treatment as long as teriflunomide plasma concentration is above 0.02 mg/l. During this period women should discuss any plans to stop or change contraception with the treating physician.

The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy. It is possible that rapidly lowering the blood level of teriflunomide, by instituting the accelerated elimination procedure described below, at the first delay of menses, may decrease the risk to the foetus.

For women receiving teriflunomide treatment, who wish to become pregnant, the medicinal product should be stopped and an accelerated elimination procedure is recommended in order to more rapidly achieve concentration below 0.02 mg/l (see below).

If an accelerated elimination procedure is not used, teriflunomide plasma levels can be expected to be above 0.02 mg/l for an average of 8 months, however, in some patients it may take up to 2 years to reach plasma concentration below 0.02 mg/l. Therefore, teriflunomide plasma concentrations should be measured before a woman begins to attempt to become pregnant. Once the teriflunomide plasma concentration is determined to be below 0.02 mg/l, the plasma concentration must be determined again after an interval of at least 14 days. If both plasma concentrations are below 0.02 mg/l, no risk to the foetus is to be expected. For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative.

Accelerated elimination procedure

After stopping treatment with teriflunomide:

  • cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated,
  • alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of 11 days.

However, also following either of the accelerated elimination procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.

Both cholestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the accelerated elimination procedure with cholestyramine or activated powdered charcoal. Use of alternative contraceptive methods is recommended.

Impaired bone marrow function, significant anaemia, leucopenia, neutropenia, thrombocytopenia

No gender/age discrimination

Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia.

Severe immunodeficiency states

No gender/age discrimination

Patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS).

Renal dialysis

No gender/age discrimination

Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group.

Severe active infection

No gender/age discrimination

Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until resolution.

In placebo-controlled studies, no increase in serious infections was observed with teriflunomide. However, based on the immunomodulatory effect of teriflunomide, if a patient develops a serious infection, suspending treatment with teriflunomide should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy. Due to the prolonged half-life, accelerated elimination with cholestyramine or charcoal may be considered.

Patients receiving teriflunomide should be instructed to report symptoms of infections to a physician. Patients with active acute or chronic infections should not start treatment with teriflunomide until the infection(s) is resolved.

The safety of teriflunomide in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies. For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with teriflunomide.

Hypoproteinemia, nephrotic syndrome

No gender/age discrimination