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Leflunomide Pregnancy and Breastfeeding Warnings

Leflunomide is also known as: Arava

Leflunomide Pregnancy Warnings

The manufacturer states that women of childbearing potential must be advised that if there is any delay in the onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing. If the results are positive, the physician and patient must discuss the risk to the pregnancy. Rapidly lowering the blood level of the active metabolite (by instituting the drug elimination procedure below), at the first delay of menses may decrease the risk to the fetus. Following discontinuation of leflunomide, all women of childbearing potential should undergo the following drug elimination procedure (below): 1) Administer cholestyramine 8 grams, 3 times daily for 11 days. (The 11 days only need to be consecutive when there is a need (such as pregnancy) to lower the cholesterol levels rapidly.) 2) Verify plasma levels less than 0.02 mg/L by 2 separate tests at least 14 days apart. If plasma levels are higher than 0.02 mg/L, additional cholestyramine treatment should be considered. Human plasma levels less than 0.02 mg/L are expected to have minimal risk based on available animal data. Without the drug elimination procedure, it may take up to 2 years to reach plasma M1 metabolite levels less than 0.02 mg/L due to individual variation in drug clearance.

Leflunomide has been assigned to category X by the FDA. Animal studies have revealed signs of teratogenicity and embryolethality. There are no controlled data in human pregnancy. Women of childbearing potential must not be started on leflunomide until pregnancy is excluded and it has been established that they are using reliable contraception. Use of leflunomide is considered contraindicated in women who are or may become pregnant, or prior to the completion of the drug elimination procedure after treatment. Before starting treatment with leflunomide, the patient should be cautioned of the potential for serious risk to a fetus. There are no data that suggest leflunomide is associated with an increased risk of male-mediated fetal toxicity. Animal studies to evaluate this risk have not been conducted. However, to minimize any possible risk, the manufacturer recommends that men wishing to father a child should consider discontinuing use of leflunomide and take cholestyramine 8 grams, 3 times a day for 11 days.

Leflunomide Breastfeeding Warnings

There are no data on the excretion of leflunomide into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Leflunomide is not recommended for use by nursing mothers.

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