Pegunigalsidase alfa Pregnancy and Breastfeeding Warnings

Brand names: Elfabrio

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

Pegunigalsidase alfa Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There is no data available on the use of this drug in pregnant patients to inform a drug-associated risk.

Comments:
-As an enzyme replacement therapy, this drug is not expected to cause adverse maternal or fetal outcomes.
-If a patient becomes pregnant during treatment, healthcare providers should report drug exposure by contacting the Pregnancy Safety Study for this drug. For information, call 1-888-661-9260 or visit https://chiesirarediseases.com/contact-us/medical-information-form

Animal studies in rats did not detect adverse maternal or fetal outcomes at exposures 3.6 times the human recommended dose; however, maternal toxicity and adverse embryofetal effects were observed in rabbits at exposures 3.2 times or greater than the human recommended dose. Evidence of teratogenicity was not observed in animal studies. No effect on fertility was detected in rats at the highest doses tested. There are no controlled data in human pregnancy.

Exposures to this drug during pregnancy should be reported to the manufacturer's ongoing Pregnancy Safety Study.

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

Pegunigalsidase alfa Breastfeeding Warnings

Safety has not been established.

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

Comments:
-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.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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