Photofrin 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.
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