Tracleer Use In Pregnancy & Lactation

Pregnancy: Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity; see Pharmacology: Toxicology: Preclinical Safety Data under Actions). There are no reliable data on the use of Tracleer in pregnant women. The potential risk for humans is still unknown. Tracleer is contraindicated in pregnancy (see Contraindications).
Women of childbearing potential: Before the initiation of Tracleer treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated. Patients and prescribers must be aware that due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see Interactions). Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal or implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception. If there is any doubt about what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended. Because of possible hormonal contraception failure during Tracleer treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Breast-feeding: It is not known whether bosentan is excreted into human breast milk. Breast-feeding is not recommended during treatment with Tracleer.
Fertility: Animal studies showed testicular effects (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). In a clinical study investigating the effects of bosentan on testicular function in male PAH patients, six of the 24 subjects (25%) had a decreased sperm concentration of at least 50% from baseline at 6 months of treatment with bosentan. Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men. In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.