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Coagulation factor ix Pregnancy and Breastfeeding Warnings

Coagulation factor ix is also known as: Alphanine SD, Alprolix, BeneFIX 250 Int'l Units, BeneFix, Idelvion, Ixinity, Mononine, Rebinyn, Rixubis

Medically reviewed by Drugs.com. Last updated on Dec 18, 2019.

Coagulation factor ix Pregnancy Warnings

Animal studies are not available. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

This drug should be used during pregnancy only if clearly needed.

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

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Some products are AU TGA pregnancy category B2.

See references

Coagulation factor ix Breastfeeding Warnings

Caution is recommended.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Ixinity (coagulation factor IX)." Cangene bioPharma, Inc., Baltimore, MD.
  2. "Product Information. BeneFIX (coagulation factor IX)." Wyeth Laboratories, Philadelphia, PA.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):

References for breastfeeding information

  1. "Product Information. BeneFIX (coagulation factor IX)." Wyeth Laboratories, Philadelphia, PA.
  2. "Product Information. Ixinity (coagulation factor IX)." Cangene bioPharma, Inc., Baltimore, MD.

Further information

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