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Teriflunomide oral

Updated 2 Feb 2023 | Leflunomide and derivatives


Oral formulations of teriflunomide.

Drugs List

  • AUBAGIO 14mg film coated tablets
  • AUBAGIO 7mg film coated tablets
  • teriflunomide 14mg film coated tablets
  • teriflunomide 7mg film coated tablets
  • Therapeutic Indications


    Treatment of relapsing-remitting multiple sclerosis



    14mg once daily.


    Children aged 10 years and older weighing over 40kg
    14mg once daily.

    Children aged 10 years and older weighing 40kg and less
    7mg once daily.

    Patients that reach a stable body weight above 40kg should be switched to 14mg once daily.


    Children under 10 years
    Severe infection
    Bone marrow aplasia
    Immunodeficiency syndromes
    Renal dialysis
    Severe anaemia
    Severe hepatic impairment
    Severe leucopenia
    Severe neutropenia
    Severe thrombocytopenia

    Precautions and Warnings

    Females of childbearing potential
    High alcohol intake
    Patients over 65 years
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Interstitial lung disease
    Lactose intolerance
    Latent or healed tuberculosis

    Administration of live vaccines is not recommended
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Exclude pregnancy prior to initiation of treatment
    Monitor blood pressure pre-treatment and periodically thereafter
    Monitor serum transaminases (including ALT) before and during therapy
    Perform full blood count before treatment
    ALT (SGPT) between 2-3 x ULN: monitor LFT weekly
    Monitor differential blood count
    Advise patient to report any symptoms of interstitial lung disease
    Advise patient to report symptoms of infection immediately
    Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
    May give falsely decreased values of ionised calcium
    Consider accelerated elimination if discontinued due to adverse effects
    Advise patient to seek advice at first indications of pregnancy
    Consider withdrawal if psoriasis occurs/worsens
    Discontinue if ALT level exceeds 3 times the upper limit of normal
    Discontinue if evidence of interstitial lung disease
    Discontinue if pancreatitis occurs
    Discontinue if peripheral neuropathy occurs
    Discontinue if severe haematological reactions including pancytopenia occur
    Discontinue if severe skin reaction occurs
    Discontinue if signs or symptoms of hepatic injury occur
    Discontinue if ulcerative stomatitis occurs
    Advise patient not to take St John's wort concurrently
    Female: Ensure adequate contraception during treatment

    For patients who do not have pre-existing or suspected liver disorders, hepatic enzymes should be assessed at least every 4 weeks during the first 6 months of treatment and regularly thereafter. In patients with pre-existing liver disorders or have clinical signs and symptoms of hepatic dysfunction, hepatic enzymes should be assessed every 2 weeks during the first 6 months of treatment, and at least every 8 weeks thereafter for at least 2 years from initiation of treatment.

    For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with teriflunomide.

    No waiting period is required when initiating teriflunomide after interferon beta or glatiramer acetate or when starting interferon beta or glatiramer acetate, after teriflunomide.

    Caution is required when switching patients from natalizumab to teriflunomide. Due to the long half-life of natalizumab, concomitant exposure could occur for up to 2 to 3 months following discontinuation of natalizumab if teriflunomide was immediately started.

    Based on the half-life of fingolimod, a 6 week interval without therapy is needed for clearance from the circulation and a 1 to 2 month period is needed for lymphocytes to return to normal range following discontinuation of fingolimod. Starting teriflunomide during this period may lead to an additive effect on the immune system.

    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.

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

    Ionised calcium levels may appear falsely decreased. Consider determining the total albumin adjusted serum calcium concentration.

    Pregnancy and Lactation


    Teriflunomide is contraindicated during pregnancy.

    Use of teriflunomide during pregnancy is contraindicated by the manufacturer. Teriflunomide may cause serious birth defects when administered during pregnancy. If pregnancy occurs despite using contraception, consider accelerated elimination process. There are limited amount of data from the use of teriflunomide in pregnant women. Studies in animals have shown reproductive toxicity.


    Teriflunomide is contraindicated during breastfeeding.

    Use of teriflunomide during breastfeeding is contraindicated by the manufacturer. Animal studies have shown excretion of teriflunomide in breast milk.

    Side Effects

    Allergic reaction
    Carpal tunnel syndrome
    Creatine phosphokinase increased
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Drug-induced liver injury
    Gamma glutamyl transferase (GGT) increased
    Hypersensitivity reactions
    Increase in serum ALT/AST
    Interstitial lung disease
    Musculoskeletal pain
    Nail disorders
    Opportunistic infections
    Oral herpes
    Peripheral neuropathy
    Pulmonary hypertension
    Reduced neutrophil count
    Severe skin reactions
    Stevens-Johnson syndrome
    Tinea pedis
    Tooth ache
    Tooth infection
    Toxic epidermal necrolysis
    Upper abdominal pain
    Upper respiratory tract infection
    Urinary tract infections
    Weight loss
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2022

    Reference Sources

    Summary of Product Characteristics: Aubagio 7mg film-coated tablets. Sanofi Genzyme. Revised December 2021.
    Summary of Product Characteristics: Aubagio 14mg film-coated tablets. Sanofi Genzyme. Revised December 2021.

    NICE Evidence Services Available at: Last accessed: 07 April 2022

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