Silkay Use In Pregnancy & Lactation

Use in Pregnancy: May cause birth defects (based on animal data); use in pregnancy is contraindicated. Exclude pregnancy prior to initiation of therapy and obtain pregnancy tests monthly during treatment. Reliable contraception must be used during therapy and for 1 month after stopping treatment. Hormonal contraceptives (oral, injectable, transdermal, or implantable) should not be used as the sole means of contraception because they may not be effective in patients receiving bosentan. Patients with an intrauterine device (IUD) or tubal ligation do not need additional contraceptive measures. When a hormonal or barrier contraceptive is used, one additional method of contraception is still needed if a male partner has had a vasectomy. When initiating treatment for women of reproductive potential, a negative pregnancy test should be documented within the first 5 days of a normal menstrual period and ≥11 days after the last unprotected intercourse. A missed menses or suspected pregnancy should be reported to a healthcare provider and prompt immediate pregnancy testing. Sperm counts may be reduced in men during treatment. Women with pulmonary arterial hypertension (PAH) are encouraged to avoid pregnancy.
Use in Lactation: It is not known if bosentan is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.