Porfimer Pregnancy and Breastfeeding Warnings
Brand names: Photofrin
Medically reviewed by Drugs.com. Last updated on Jul 21, 2023.
Porfimer Pregnancy Warnings
Use is not recommended unless clearly needed.
US FDA pregnancy category: C
Comments: Women of childbearing potential should use effective contraception during and for at least 90 days following PDT treatment and have a pre-treatment pregnancy test performed.
Animal studies have revealed evidence of an embryocidal effect, but no major malformations or developmental changes. Doses to animals 0.64 to 0.65 times the recommended human dose on a mg/m2 basis for 10 to 13 days caused maternal and fetal toxicity resulting in increased resorptions, decreased litter size, and reduced fetal body weight. No fertility impairment has been observed in animals; however, long-term dosing caused hypertrophy of the testes and discoloration of testes and ovaries. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Porfimer Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2001) "Product Information. Photofrin (porfimer)." Sanofi Winthrop Pharmaceuticals
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
References for breastfeeding information
- (2001) "Product Information. Photofrin (porfimer)." Sanofi Winthrop Pharmaceuticals
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
