Ranibizumab ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Byooviz, Cimerli, Lucentis, Susvimo

Medically reviewed by Drugs.com. Last updated on Oct 31, 2023.

Ranibizumab ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

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

Risk Summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comment:
-This drug is potentially teratogenic and embryofetotoxic and poses a risk to female fertility based on its pharmacologic effect.
-Women of childbearing potential should use effective contraception during treatment and wait at least 3 months after the last dose before conceiving a child.

Animal studies have revealed evidence of skeletal abnormalities at doses 13-times the predicted human exposure when given to pregnant monkeys during organogenesis after a single eye treatment at the recommended clinical dose. However, when this drug was administered at doses that resulted in serum levels equivalent to the predicted human exposure, no abnormalities were reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

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Ranibizumab ophthalmic Breastfeeding Warnings

Use with caution while breastfeeding; however, some experts recommend not breastfeeding during treatment as a precautionary measure.

Excreted into human milk: Yes

Comments:
-This drug has been used without apparent harmful effects in the nursing infant.

After intraocular injection, drug levels have been found to be very low in human milk. It is likely that the gastrointestinal tract of the breastfed child will destroy any drug that is ingested and therefore, there is a low probability of drug absorption. Premature infants that have been administered this drug have had no apparent adverse effects up to their second year of life.

See references

Further information

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