Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in females
Pregnancy status of females of child-bearing potential should be verified prior to initiating treatment with TALVEY.

Females of reproductive potential should use effective contraception during treatment and for 3 months after the last dose of TALVEY.

Pregnancy

There are no available data on the use of TALVEY in pregnant women or animal data to assess the risk of TALVEY in pregnancy. Human IgG is known to cross the placenta after the first trimester of pregnancy. Therefore, talquetamab has the potential to be transmitted from the mother to the developing foetus. The effects of TALVEY on the developing foetus are unknown. TALVEY is not recommended for women who are pregnant or for women of childbearing potential not using contraception.

If TALVEY is taken during pregnancy, a reduced immune response to vaccines may be expected in newborns. Consequently, newborn vaccinations with live vaccines such as BCG vaccine should be postponed until 4 weeks.

Breast-feeding

It is not known whether talquetamab is excreted in human milk. Because the potential for serious adverse reactions in breast-fed infants is unknown for TALVEY, patients should not breast-feed during treatment with TALVEY and for at least 3 months after the last dose.
Fertility

There are no data on the effect of talquetamab on fertility. Effects of talquetamab on male and female fertility have not been evaluated in animal studies.