Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Women of childbearing potential
Due to the risk of embryofoetal death or severe birth defects caused by sonidegib, women taking Odomzo must not be pregnant or become pregnant during treatment and for 20 months 
after ending treatment (see section 4.4).

Odomzo is contraindicated in woman of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (see section 4.3).

In case of pregnancy or missed menstrual periods
If the patient does become pregnant, misses a menstrual period, or suspects for any reason that she may be pregnant, she must notify her treating physician immediately.

Persistent lack of menses during treatment with Odomzo should be assumed to indicate pregnancy until medical evaluation and confirmation.

Contraception in males and females

Women of childbearing potential
Women of childbearing potential must be able to comply with effective contraceptive measures. They must use two methods of recommended contraception, including one highly effective method and a barrier method, during Odomzo therapy and for 20 months after the final dose. Women of childbearing potential whose periods are irregular or have stopped must follow all the advice on effective contraception.

Men
It is unknown whether sonidegib is contained in semen. Men should not father a child or donate semen while taking Odomzo and for at least 6 months after ending treatment. To avoid potential foetal exposure during pregnancy, male patients, even those who have had a vasectomy, must always use a condom (with spermicide, if available) when having sex with a female partner while taking Odomzo and for 6 months after the final dose.

The following are recommended forms of highly effective methods
•     Tubal sterilisation
•     Vasectomy
•     Intrauterine device (IUD) 
The following are recommended barrier methods
•     Any male condom (with spermicide, if available)
•     Diaphragm (with spermicide, if available) 
Pregnancy

There are no data on the use of sonidegib in pregnant women. Studies in animals have shown teratogenicity and foetotoxicity (see section 5.3). Odomzo is contraindicated during pregnancy.

Breast-feeding

It is unknown whether sonidegib is excreted in human milk. Because of the potential for serious adverse drug reactions, such as serious developmental defects in breast-fed newborns/infants from sonidegib, women must not breast-feed while taking Odomzo or for 20 months after ending treatment (see section 5.3).


Fertility
Data from studies in rats and dogs indicate that male and female fertility may be irreversibly compromised by treatment with Odomzo (see section 5.3). Additionally, amenorrhoea has been observed in clinical studies in women of childbearing potential (see section 4.8). Fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with Odomzo.