Afamitresgene autoleucel Pregnancy and Breastfeeding Warnings

Brand names: Tecelra

Medically reviewed by Drugs.com. Last updated on Sep 17, 2024.

Afamitresgene autoleucel Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Pregnancy after administration should be discussed with the treating physician.
-It is not known if this drug can harm a developing fetus.
-There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with this drug.
-There are no data on the effect of this drug on fertility.
-Report pregnancies to Adaptimmune at 1-855-24MYADAP (1-855-246-9232).

Animal studies have not been reported. 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

Afamitresgene autoleucel Breastfeeding Warnings

Safety has not been established.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed infant due to this drug or the mother's underlying condition should be considered.

See references

Further information

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

Medical Disclaimer