Volibris Use In Pregnancy & Lactation

Women of childbearing potential: Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced. Monthly pregnancy tests during treatment with ambrisentan are recommended.
Pregnancy: Ambrisentan is contraindicated in pregnancy (see Contraindications). Animal studies have shown that ambrisentan is teratogenic. There is no experience in humans.
Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see Contraindications, Precautions and Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: It is not known whether ambrisentan is excreted in human breast milk. The excretion of ambrisentan in milk has not been studied in animals. Therefore breast-feeding is contraindicated in patients taking ambrisentan (see Contraindications).
Male fertility: The development of testicular tubular atrophy in male animals has been linked to the chronic administration of ERAs, including ambrisentan (see Pharmacology: Toxicology: Preclinical safety data under Actions). Although no clear evidence of a detrimental effect of ambrisentan long-term exposure on sperm count was found in ARIES-E study, chronic administration of ambrisentan was associated with changes in markers of spermatogenesis. A decrease in plasma inhibin-B concentration and an increase in plasma FSH concentration were observed. The effect on male human fertility is not known but a deterioration of spermatogenesis cannot be excluded. Chronic administration of ambrisentan was not associated with a change in plasma testosterone in clinical studies.