Ambrisentan Pregnancy and Breastfeeding Warnings
Ambrisentan is also known as: Letairis
Ambrisentan Pregnancy Warnings
Use is contraindicated. AU TGA pregnancy category: X US FDA pregnancy category: X Comments: -Pregnancy testing should be performed before the initiation of treatment, monthly while on treatment, and for 1 month after stopping treatment. -Acceptable methods of contraception should be used during treatment and for 1 month after stopping treatment. -Acceptable methods of contraception include 1 highly effective form (intrauterine device (IUD), contraceptive implant, or tubal sterilization) or a combination of methods (hormone method with a barrier method or 2 barrier methods); if a partner's vasectomy is decided as 1 method of contraception, a hormone or barrier method should also be used. -Counsel patients on pregnancy planning and prevention, including emergency contraception. -Women should not become pregnant for at least 3 months after stopping treatment (AU).
Drug is expected to cause fetal harm if administered to pregnant women. Animal data have revealed teratogenicity in rats and rabbits. In both species, there were abnormalities of the lower jaw and hard and soft palate, malformation of the heart and great vessels, and failure of formation of the thymus and thyroid. Teratogenicity is a class effect of endothelin receptor antagonists. There are no data on the use of ambrisentan in human pregnancy. Use is considered contraindicated in pregnancy. The effect of ambrisentan on male human fertility is unknown, but it appears endothelin receptor antagonists may have an adverse effect on spermatogenesis. In a 6-month clinical trial with bosentan, another endothelin receptor antagonist, a decline in sperm count of at least 50% was observed in at least 25% of patients after 3 to 6 months; however in 22 of 25 patients who completed 6 months of treatment, sperm count remained within normal limits with no changes in sperm morphology, sperm motility, or hormone levels. 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.
Ambrisentan Breastfeeding Warnings
(UK) Use is contraindicated. (AU, US) A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.