Pregnancy & Lactation : הריון/הנקה

4.6         Fertility, pregnancy and lactation

All the measures listed below should be considered in relationship to the severity of the disease and the urgency of the treatment.

Fertility

There are no data available in humans.
Women of childbearing potential / Contraception in females

Therapy with tretinoin should only be started in a female patient of childbearing age if each of the following conditions is met:

•      The patient is informed by the physician of the risks concerning pregnancy during and for one month after treatment with tretinoin.
•      The patient is willing to comply with the mandatory contraception measures. It is absolutely essential that every woman of childbearing potential who is to undergo treatment with tretinoin uses a reliable contraception method without interruption during and for one month after discontinuation of treatment with tretinoin (see section 4.4).
•     Pregnancy tests must be performed at monthly intervals during therapy.

Pregnancy

Tretinoin is teratogenic (see sections 4.3 and 5.3). Tretinoin is a retinoid and teratogenic effects have been seen in humans exposed to retinoid drugs.

In humans, there is a limited amount of data from the use of tretinoin in pregnant women but there is a high risk of severe malformation of the foetus, particularly when tretinoin is given during the first trimester.

Vesanoid/Tretinoin must not be used during pregnancy, especially during the first trimester, or in women of childbearing potential not using contraception, unless the clinical condition of the woman (severity of the patient’s condition, urgency of the treatment) requires treatment with tretinoin.

If Vesanoid/Tretinoin is administered in early pregnancy, the patient must be warned of the teratogenic risk of Vesanoid/Tretinoin and of the risk of severe malformation of the foetus.

Breastfeeding

Breastfeeding must be discontinued if therapy with tretinoin is initiated (see section   4.3).