Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy

There are no data from the use of riociguat in pregnant women. Studies in animals have shown reproductive toxicity and placental transfer (see section 5.3). Therefore, Adempas is contraindicated during pregnancy (see section 4.3).

Women of childbearing potential must have a negative pregnancy test before starting treatment and each month during Adempas treatment and 1 month after the ending of the treatment.

The prescriber should document a negative urine or serum pregnancy test performed during the first 5 days of a normal menstrual period and at least 11 days after the last unprotected act of sexual intercourse.

Advise patients to contact their healthcare provider if they become pregnant or suspect they may be pregnant.
Perform a pregnancy test if pregnancy is suspected for any reason. For positive pregnancy tests, counsel patient on the potential risk to the foetus and patient options.


Women of childbearing potential
Women patients should not take this medication if they are planning a pregnancy.

Women of childbearing potential must use effective contraception during treatment with Adempas. month after ending treatment.

The prescriber must guide patients to choose one highly effective form of contraception (intrauterine device (IUD) or tubal sterilisation) or a combination of methods (hormone method with a barrier method or two barrier methods). If a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. Counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling.

Breast-feeding

No data on the use of riociguat in breast-feeding women are available. Data from animals indicate that riociguat is excreted into milk. Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment with this medicinal product. .

Fertility

No specific studies with riociguat in humans have been conducted to evaluate effects on fertility. In a reproduction toxicity study in rats, decreased testes weights were seen, but there were no effects on fertility (see section 5.3). The relevance of this finding for humans is unknown.