Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females
Men and women should use effective contraception during treatment and for at least 6 months after Oncaspar discontinuation. Since an indirect interaction between oral contraceptives and pegaspargase cannot be ruled out , oral contraceptives are not considered sufficiently safe in such clinical situation.
A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5).

Pregnancy
There are limited data on the use of L-asparaginase and no data on the use of Oncaspar in pregnant women. No reproduction studies in animals with pegaspargase were performed but studies in animals with L-asparaginase have shown teratogenicity (see section 5.3). Therefore and due to its pharmacological properties, Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase.

Breast-feeding
It is not known whether pegaspargase is excreted into breast milk. Based on its pharmacological properties, any risk to the breast-fed newborns/infants cannot be excluded. As a precautionary measure, breast-feeding should be discontinued during treatment with Oncaspar and should not be restarted until after discontinuation of Oncaspar.

Fertility
No studies investigating the effect of pegaspargase on fertility have been performed.