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Cenegermin ophthalmic Pregnancy and Breastfeeding Warnings

Cenegermin ophthalmic is also known as: Oxervate

Medically reviewed by Drugs.com. Last updated on Jan 8, 2019.

Cenegermin ophthalmic Pregnancy Warnings

Subcutaneous administration to animals have not shown direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. There are no controlled data in human pregnancy.

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.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data in pregnant women to inform any drug associated risks; animal studies did not show adverse effects in offspring at clinically relevant doses.

Comments: Some authorities advise against used during pregnancy as a precautionary measure.

See references

Cenegermin ophthalmic 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.

See references

References for pregnancy information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "Product Information. Oxervate (cenegermin ophthalmic)." Dompe U.S. Inc., San Bruno, CA.

References for breastfeeding information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "Product Information. Oxervate (cenegermin ophthalmic)." Dompe U.S. Inc., San Bruno, CA.

Further information

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

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