Arava Pregnancy Warnings
-Animal studies have revealed signs of teratogenicity and embryolethality. There are no controlled data in human pregnancy.
-The active metabolite of this drug, A771726 is suspected to cause serious birth defects when administered during pregnancy.
-Women should wait to become pregnant for at least 2 years after discontinuation of treatment and plasma levels of A771726 should be less than 0.02 mg/L. If this is not feasible, the manufacturer suggests a washout. Following discontinuation of leflunomide, all women of childbearing potential should undergo the following drug elimination procedure:
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.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
US: To monitor fetal outcomes of pregnant women exposed to leflunomide, health care providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: X
Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Pregnancy should be excluded before starting therapy.
-This drug should not be used in women who are or may become pregnant, or prior to the completion of the drug elimination procedure after treatment.
-Patients should be notified to contact their doctor immediately if they suspect they may be pregnant.
See references
