Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

Pregnancy

Epiduo is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.
There are no or limited amount of data from the use of adapalene topically in pregnant women.
Animal studies by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3).
Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited.
If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.

Breastfeeding
No study on animal or human milk transfer was conducted after cutaneous application of Epiduo (adapalene / benzoyl peroxide) gel.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to Epiduo is negligible. Epiduo can be used during breast-feeding.
To avoid contact exposure of the infant, application of Epiduo to the chest should be avoided when used during breast-feeding.
Fertility
No human fertility studies were conducted with Epiduo gel.
However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies (see section 5.3).