Atidarsagene autotemcel Pregnancy and Breastfeeding Warnings

Brand names: Lenmeldy

Atidarsagene autotemcel Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk. Based on the risks associated with myeloablative conditioning, this drug should not be administered during pregnancy.

Comments:
-A negative serum pregnancy test must be confirmed in females of childbearing potential prior to starting mobilization, before conditioning procedures, and prior to administration of this drug.
-Males capable of fathering a child and females of childbearing age should use an effective method of contraception from the start of mobilization through at least 6 months after administration of this drug.
-Pregnancy after therapy should be discussed with the treating physician.
-Advise children of the option to cryopreserve semen or ova before treatment, if appropriate, due to the risk of infertility with myeloablative conditioning.

There are no animal reproductive or developmental toxicity studies to assess the risk of fetal harm or the effects of this drug on fertility. In clinical studies, myeloablative conditioning was associated with a risk of infertility; ovarian failure was reported in 50% of treated female patients. 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

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Atidarsagene autotemcel Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-Breastfeeding should be discontinued during myeloablative conditioning due to the potential for serious adverse effects.
-Breastfeeding after treatment with this drug should be discussed with the treating physician.
-Children receiving breast milk during treatment may continue to do so under the advice of their treating physician.
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

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Further information

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