Drug Action
Teriflunomide is a metabolite of leflunomide which has immunomodulating and anti- inflammatory properties.
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Drug reference
Teriflunomide is a metabolite of leflunomide which has immunomodulating and anti- inflammatory properties.
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Treatment of relapsing-remitting multiple sclerosis (initiated under specialist supervision) ▶BY MOUTH ▶Adult: 14 mg once daily
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Anaemia. leucopenia. neutropenia . serious infection. severe hypoproteinaemia. severe immunodeficiency. significantly impaired bone-marrow function. thrombocytopenia
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Adult over 65 years. anaemia. dyspnoea— assess for interstitial lung disease and consider suspending treatment. hypoproteinaemia (avoid if severe). impaired bone-marrow function (avoid if severe). latent tuberculosis. leucopenia. persistent cough—assess for interstitial lung disease and consider suspending treatment. severe infection—delay or suspend treatment until resolved. significant alcohol consumption. signs or symptoms of serious skin reactions (including ulcerative stomatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)—discontinue treatment. switching between other immunomodulating drugs. thrombocytopenia
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NICE decisions ▶Teriflunomide for treating relapsing-remitting multiple sclerosis (January 2014) NICE TA303 Teriflunomide is recommended for the treatment of adults with active relapsing-remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years), in adults who: . do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and . the manufacturer provides teriflunomide with the discount agreed in the patient access scheme www.nice.org.uk/guidance/ta303 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (March 2014) that the use of teriflunomide (Aubagio) ® in NHS Scotland is restricted to use in patients with relapsing- remitting multiple sclerosis who do not have highly active disease, and only as an alternative to treatment with interferon beta or glatiramer acetate.
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→Appendix 1: teriflunomide
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▶Common or very common Abdominal pain upper. alopecia. anaemia. anxiety. arthralgia. cystitis. diarrhoea. headache. hypersensitivity. hypertension. increased risk of infection. menorrhagia. myalgia. nausea. nerve disorders. neutropenia. oral disorders. pain. palpitations . sensation abnormal. skin reactions. urinary frequency increased. vomiting. weight decreased ▶Uncommon Thrombocytopenia ▶Frequency not known Asthenia. hepatitis acute. interstitial lung disease. nail disorder. pancreatitis. sepsis SIDE-EFFECTS, FURTHER INFORMATION Hepatic injury Discontinue treatment if signs or symptoms of hepatic injury, or if liver enzymes exceed 3 times the upper limit of reference range. Important: accelerated elimination procedure recommended following discontinuation due to serious adverse effects (consult product literature).
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Effective contraception essential for women of child-bearing potential during treatment and for up to 2 years after treatment. In patients undergoing treatment with teriflunomide that are planning to conceive, the accelerated elimination procedure should be used prior to conception. Use of non-oral contraception is recommended during the accelerated elimination procedure—consult product literature.
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Avoid—toxicity in animal studies.
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Present in milk in animal studies— manufacturer advises avoid.
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Manufacturer advises avoid in severe impairment.
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▶Monitor full blood count (including differential white cell count and platelet count) before treatment and as clinically indicated during treatment. ▶Monitor blood pressure before treatment and periodically thereafter. ▶Hepatic monitoring Monitor liver function before treatment and every 2 weeks for first 6 months then every 8 weeks thereafter or as clinically indicated (pre-existing liver disease may increase risk). Increase to weekly monitoring if alanine aminotransferase (ALT) is 2–3 times the upper limit of reference range; discontinue treatment if signs or symptoms of hepatic injury, or if liver enzymes exceed 3 times the upper limit of reference range.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Aubagio (Genzyme Therapeutics Ltd) Teriflunomide 14 mg Aubagio 14mg tablets | 28 tablet P £1,037.84 Malignant disease Antibody responsive malignancy ANTINEOPLASTIC DRUGS › MONOCLONAL ANTIBODIES
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Accelerated elimination procedures To aid drug elimination in case of serious adverse effect or before conception, stop treatment and give either colestyramine p. 210 or charcoal, activated p. 1438. After the accelerated elimination procedure a plasma concentration of less than 20 micrograms/litre (measured on 2 occasions at least 14 days apart) and a waiting period of one and a half months are necessary before conception.
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14 mg once daily
First-line fragment. Read the complete Indications and Dose section above.
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