Drugs in Pregnancy and Lactation: Tenth Edition

OCRIPLASMIN

Ophthalmic

PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible

BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible

PREGNANCY SUMMARY

No reports describing the use of ocriplasmin in human pregnancy have been located. Animal reproduction studies have not been conducted. However, detectable concentrations of the drug in the systemic circulation drug are not expected. Use of the drug during pregnancy appears to be compatible.

FETAL RISK SUMMARY

Ocriplasmin, given as a single intravitreal injection, is a recombinant truncated form of human plasmin produced by recombinant DNA technology. It is indicated for the treatment of symptomatic vitreomacular adhesion. Ocriplasmin has proteolytic activity against components of the vitreous body and the vitreoretinal interface, thereby dissolving the protein matrix responsible for the vitreomacular adhesion. Because of the small dose (0.125 mg) and its rapid inactivation, detectable concentrations in the systemic circulation are not expected (1).

Animal reproduction studies have not been conducted. No carcinogenicity, mutagenicity, or impairment of fertility studies have been conducted (1).

It is not known if ocriplasmin crosses the human placenta. The molecular weight (about 27,000) and the predicted absence of detectable concentrations in the systemic circulation indicate that exposure of the embryo–fetus to clinically significant amounts will not occur.

BREASTFEEDING SUMMARY

No reports describing the use of ocriplasmin during human lactation have been located. The molecular weight (about 27,000) and the predicted absence of detectable concentrations in the systemic circulation indicate that the drug will not be excreted into breast milk.

Reference

1.Product information. Jetrea. ThromboGenics, 2012.