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Ranibizumab ophthalmic Pregnancy and Breastfeeding Warnings

Ranibizumab ophthalmic is also known as: Lucentis

Medically reviewed on Apr 28, 2017

Ranibizumab ophthalmic Pregnancy Warnings

Animal studies have revealed a low incidence of fetal skeletal abnormalities with some doses but not with others; no effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity were observed in animals. No studies on the effects on fertility have been conducted. 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.

Use during pregnancy only if clearly needed.

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

Comments:
-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.

See references

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: Unknown
Excreted into animal milk: Data not available

Comments: Due to this drug being a large protein molecule with a molecular weight of 48,000, the amount of this drug in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

An infant whose mother received this drug did not show any noticeable harm while being breastfed following maternal drug injections, and vascular endothelial growth factor (VEGF) levels in breastmilk were not changed following the drug injections.

See references

References for pregnancy information

  1. "Product Information. Lucentis (ranibizumab ophthalmic)." Genentech, South San Francisco, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Lucentis (ranibizumab ophthalmic)." Genentech, South San Francisco, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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