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Voretigene neparvovec ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Luxturna

Medically reviewed by Drugs.com. Last updated on Oct 20, 2023.

Voretigene neparvovec ophthalmic Pregnancy Warnings

Use should be avoided.

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

Comment: There are no or limited amount of data from the use of this drug in pregnant women.

There are no controlled data in human pregnancy. Animal studies do not indicate direct or indirect harmful effects for reproductive toxicity; no studies have been performed to evaluate the effect on fertility.

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

Voretigene neparvovec ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comment: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Luxturna (voretigene neparvovec ophthalmic)." Spark Therapeutics, Inc.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Luxturna (voretigene neparvovec ophthalmic)." Spark Therapeutics, Inc.

Further information

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

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