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Hexaminolevulinate Pregnancy and Breastfeeding Warnings

Hexaminolevulinate is also known as: Cysview

Hexaminolevulinate Pregnancy Warnings

Animal studies have not revealed direct or indirect harmful effects of this medicinal product. There are no controlled data in human pregnancy. It is not known whether this medicinal product can cause fetal harm or adversely affect reproductive capacity in humans.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription medicinal product products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: Not assigned.
US FDA pregnancy category: Not assigned.

Risk Summary: There are no available data on the use of this medicinal product in pregnant women to inform a drug associated risk of adverse developmental outcomes. Systemic absorption following administration is expected to be minimal.

Comments:
-Adequate methods of contraception should be encouraged.

See references

Hexaminolevulinate Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant are unknown.

No information is available on the use of this medicinal product during breastfeeding. After instillation into the bladder, only about 7% of a dose is absorbed into the maternal bloodstream, so the amount of medicinal product excreted into milk is expected to be minimal.

See references

References for pregnancy information

  1. "Product Information. Cysview (hexaminolevulinate)." Photocure Inc, Princeton, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Cysview (hexaminolevulinate)." Photocure Inc, Princeton, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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