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Degarelix Pregnancy and Breastfeeding Warnings

Brand names: Firmagon

Degarelix Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is contraindicated.
-According to some authorities: There is no relevant use of this drug in women; use during pregnancy is not recommended.

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

Risk summary: Based on the mechanism of action and findings in animals, this drug can cause fetal harm and loss of pregnancy when administered to a pregnant woman.

Comments:
-This drug may impair fertility in males and females of childbearing potential.

Animal studies have revealed evidence of embryofetal lethality and increased number of abortions, pre- and post-implantation losses, early embryofetal deaths, premature deliveries, prolonged parturition, decreased number of live fetuses, increased number of minor skeletal abnormalities and variants, reversible infertility in males, and decreased fertility in females. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug 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.

See references

Degarelix Breastfeeding Warnings

There is no relevant use of this drug in women; use during breastfeeding is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available.

Comments: The effects in the nursing infant are unknown.

See references

Does Degarelix interact with my other drugs?

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See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Firmagon (degarelix)." Ferring Pharmaceuticals Inc
  4. (2020) "Product Information. Firmagon (degarelix)." Ferring Pharmaceuticals Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Firmagon (degarelix)." Ferring Pharmaceuticals Inc

Further information

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

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