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Voretigene neparvovec ophthalmic Pregnancy and Breastfeeding Warnings

Voretigene neparvovec ophthalmic is also known as: Luxturna

Medically reviewed by Drugs.com. Last updated on Oct 20, 2020.

Voretigene neparvovec ophthalmic Pregnancy Warnings

Use should be avoided.

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. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

Animal studies do not indicate direct or indirect harmful effects for reproductive toxicity; no studies have been performed to evaluate the effect on fertility.

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

Benefit should outweigh risk

Excreted into human milk: Unknown

Comments: 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 on the breastfed infant.

See references

References for pregnancy information

  1. "Product Information. Luxturna (voretigene neparvovec ophthalmic)." Spark Therapeutics, Inc., Philadelphia, PA.

References for breastfeeding information

  1. "Product Information. Luxturna (voretigene neparvovec ophthalmic)." Spark Therapeutics, Inc., Philadelphia, PA.

Further information

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