Pregnancy & Lactation : הריון/הנקה

USE IN SPECIFIC POPULATIONS
Pregnancy

Risk Summary

Based on findings in animals and mechanism of action, JELMYTO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (9)]. There are no available data on JELMYTO use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of mitomycin resulted in teratogenicity (see Data). Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

Data

Animal Data
Teratological changes have been noted with mitomycin in animal studies.

Lactation

Risk Summary
There are no data on the presence of mitomycin in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with JELMYTO and for 1 week following the last dose.

Females and Males of Reproductive Potential

JELMYTO can cause fetal harm when administered to pregnant women [see Use in Specific Populations (7.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating JELMYTO.
Contraception
Females

Advise females of reproductive potential to use effective contraception during treatment with JELMYTO and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with JELMYTO and for 3 months following the last dose.