Silkay 125 Use In Pregnancy & Lactation

Pregnancy: There are no reliable data on the use of Bosentan in pregnant women. The potential risk for humans is still unknown. Bosentan is contraindicated in pregnancy.
Women of childbearing potential: Before the initiation of Bosentan 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, Bosentan may render hormonal contraceptives ineffective. 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 gynecologist is recommended. Because of possible hormonal contraception failure during Bosentan treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Bosentan are recommended to allow early detection of pregnancy.
Breastfeeding: It is not known whether Bosentan is excreted into human breast milk. Breastfeeding is not recommended during treatment with Bosentan.
Fertility: 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.