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Porfimer Pregnancy and Breastfeeding Warnings

Porfimer is also known as: Photofrin

Porfimer Pregnancy Warnings

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.

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.

See references

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 references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Photofrin (porfimer)." Sanofi Winthrop Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. "Product Information. Photofrin (porfimer)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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