Ocriplasmin ophthalmic Pregnancy and Breastfeeding Warnings
Brand names: Jetrea
Ocriplasmin ophthalmic Pregnancy Warnings
Animal reproduction studies have not been conducted. There are no controlled data in human pregnancy. The systemic exposure is expected to be low after intravitreal injection.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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 recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B2
US FDA pregnancy category: C
Ocriplasmin ophthalmic Breastfeeding Warnings
Benefit should outweigh risk.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comment: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Jetrea (ocriplasmin ophthalmic). ThromboGenics Inc. 2012.
References for breastfeeding information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Jetrea (ocriplasmin ophthalmic). ThromboGenics Inc. 2012.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
