Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
Cerazette is not indicated during pregnancy. If pregnancy occurs during treatment with Cerazette, further intake should be stopped.

Animal studies have shown that very high doses of progestogenic substances may cause masculinisation of female foetuses.

Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. Pharmacovigilance data collected with various desogestrel- containing COCs also do not indicate an increased risk.

Breastfeeding

Based on clinical study data, Cerazette does not appear to influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, there have been infrequent postmarketing reports of a decrease in breast milk production while using Cerazette. Ssmall amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 - 0.05 microgram etonogestrel per kg body weight per day may be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day). Like other progestogen-only pills, Cerazette can be used during breastfeeding.

Limited long-term follow-up data are available on children, whose mothers started using Cerazette during the 4th to 8th week post-partum. They were breast-fed for 7 months and followed up to 1.5 years (n=32) or to 2.5 years (n=14) of age. Evaluation of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants, whose mother used a 
copper-IUD. Based on the available data Cerazette may be used during lactation. The development and growth of a nursing infant, whose mother uses Cerazette, should, however, be carefully observed.

Fertility

Cerazette is indicated for the prevention of pregnancy. For information on return to fertility (ovulation), see section 5.1.