Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females
Women of childbearing potential should avoid becoming pregnant while receiving BESPONSA.

Women should use effective contraception during treatment with BESPONSA and for at least 8 months after the last final dose. Men with female partners of childbearing potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last final dose.

Pregnancy

There are no data in pregnant women using inotuzumab ozogamicin. Based on non-clinical safety findings, inotuzumab ozogamicin can cause embryo-foetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity (see section 5.3).


BESPONSA must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus. Pregnant women, or patients becoming pregnant while receiving inotuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the fetus.

Breast-feeding

There are no data on the presence of inotuzumab ozogamicin or its metabolites in human milk, the effects on the breast-fed child, or the effects on milk production. Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with BESPONSA and for at least 2 months after the final dose (see section 5.3).

Fertility

Based on non-clinical findings, male and female fertility may be compromised by treatment with inotuzumab ozogamicin (see section 5.3). There is no information on fertility in patients. Both men and women must seek advice for fertility preservation before treatment.