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Onasemnogene abeparvovec Pregnancy and Breastfeeding Warnings

Brand names: Zolgensma

Medically reviewed by Drugs.com. Last updated on Mar 4, 2024.

Onasemnogene abeparvovec Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk Summary: There is no available data regarding use in pregnant women.

Comments:
-This drug is only indicated for use in patients less than 2 years old.

No animal reproductive and/or developmental toxicity studies have been conducted. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Onasemnogene abeparvovec Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its 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.

There is no information on whether breastfeeding should be restricted in mothers who may be seropositive for anti-AAV9 antibodies. This drug is only indicated for patients less than 2 years old.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information."
  2. "Product Information. Zolgensma (10.1-10.5 kg) (onasemnogene abeparvovec)." AveXis

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information."
  2. "Product Information. Zolgensma (10.1-10.5 kg) (onasemnogene abeparvovec)." AveXis

Further information

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

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