Elivaldogene autotemcel Pregnancy and Breastfeeding Warnings

Brand names: Skysona

Medically reviewed by Drugs.com. Last updated on Jan 9, 2023.

Elivaldogene autotemcel Pregnancy Warnings

Safety has not been established during pregnancy. This drug is not indicated for use in female patients.

US FDA pregnancy category: Not assigned

Risk summary:
-No data available on use of this drug in pregnant women to inform a drug-related risk.
-Consider the risks associated with mobilization and conditioning agents on pregnancy and fertility.

Comments:
-Prescribing information of mobilization and conditioning agents should be referred while considering need for effective contraception.
-Effective contraception is recommended for males and their female partners (intra-uterine device or combination of hormonal and barrier contraception) of reproductive potential from start of mobilization through at least 6 months after administration of last dose.
-As appropriate, patients should be advised of the option to cryopreserve semen before treatment.

Preclinical studies have not been conducted to study reproductive and developmental toxicity. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Elivaldogene autotemcel Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Unknown

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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