Apadamtase alfa, recombinant Pregnancy and Breastfeeding Warnings

Brand names: Adzynma

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Apadamtase alfa, recombinant Pregnancy Warnings

Safety has not been established during pregnancy; benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Health care providers should consider the potential benefits and risks when considering treatment with this drug in pregnant women.

Animal studies have failed to reveal evidence of embryofetal toxicity and adverse maternal outcomes when pregnant rats were administered this drug at doses up to 10 times the human equivalent dose. There are no controlled data in human pregnancy; however, 4 patients were exposed to this drug during clinical trials under varying circumstances. For 2 patients, no data are available regarding the stage of pregnancy at the first time of exposure; the other 2 patients were exposed while receiving prophylaxis with this drug during the first trimester of pregnancy. The outcome of all cases is inconclusive to inform a drug-associated risk of adverse developmental outcomes and maternal safety.

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

Apadamtase alfa, recombinant Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There is no data on the presence of this drug in human milk or its effects on a breastfed child or milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and potential adverse effects on the infant.

See references

Further information

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