Arava contraindications and warnings


Following is information on contraindications to the use of leflunomide in general, pregnancy & breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).

When should Leflunomide not be used?

The active substance should not be used at:

  • Hypersensitivity to the active substance
  • severe immunodeficiencies (for example, AIDS)
  • severe bone marrow disease
  • Diseases of the hematopoietic system (such as the bone marrow)
  • serious infectious diseases
  • moderate and severe kidney damage, liver damage and severe protein loss (for example kidney damage).

What should you watch out for during pregnancy and lactation?

Leflunomide must not be taken during pregnancy and lactation. Women who want to become pregnant must be made aware by the doctor that they can only become pregnant for two years after taking the medication. Only then is the active ingredient in the body degraded so much that the possibly still present amount of leflunomide and its metabolite malonnitrilamide are no longer harmful to the unborn child. Especially Malonnitrilamid causes serious damage to the unborn child. Therefore, the levels of this metabolite must be below 0.02 milligrams per deciliter of blood plasma.

Men should stop taking Leflunomide before procreation as a precautionary measure. It is possible that the seed thus loaded leads to damage to the child thus conceived.

If pregnancy occurs while taking leflunomide, the following procedure may reduce the risk to the unborn child:

Either eight grams of cholestyramine (normally used to treat fat metabolism disorders) can be given three times a day or 50 grams of activated carbon powder four times a day for eleven days each. Both active ingredients bind leflunomide and its metabolite, which are harmful to the child and ensure a faster excretion of both from the body.

What should be considered in children?

In children, the drug must not be used because sufficient knowledge about effects and side effects are only available from the age of 18.

Warnings and Precautions

  • In case of shortness of breath and coughing during treatment seek medical advice.
  • The concomitant administration of drugs that may damage the liver or bone marrow (such as methotrexate, which is also antirheumatic) must be avoided.
  • During treatment with the drug, the blood count and liver enzymes must be checked regularly.
  • In case of severe skin or mucosal reactions to treatment discontinue therapy with the drug.
  • Blood pressure must be before and during
    the therapy with the drug in regular
    Intervals are checked.
  • Pregnancy must be excluded by medical treatment before using the medicine.
  • Treatment should only be started and supervised by medical specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
  • The drug can cause dizziness that makes driving and using machines dangerous.

Sometimes medications release allergic reactions.
If you notice any signs of allergic reaction, tell your doctor or pharmacist immediately.