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Ocriplasmin ophthalmic Pregnancy and Breastfeeding Warnings

Ocriplasmin ophthalmic is also known as: 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

See references

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 references

References for pregnancy information

  1. "Product Information. Jetrea (ocriplasmin ophthalmic)." ThromboGenics Inc, Iselin, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Jetrea (ocriplasmin ophthalmic)." ThromboGenics Inc, Iselin, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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