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Factor ix complex Pregnancy and Breastfeeding Warnings

Factor ix complex is also known as: Bebulin, Bebulin VH, Konyne 80, Profilnine SD, Proplex T

Medically reviewed on March 7, 2017

Factor ix complex Pregnancy Warnings

Animal studies have not been reported. There are no controlled data in human pregnancy.

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 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.

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

AU TGA pregnancy category: C
US FDA pregnancy category: C

See references

Factor ix complex Breastfeeding Warnings

Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

The amount excreted in milk is likely to be very low since this drug is a large protein molecule. In addition, this drug is likely destroyed in the infant's gastrointestinal tract, thereby preventing any absorption.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Profilnine SD (Factor IX Complex)." Grifols Biologicals Inc, Los Angeles, CA.

References for breastfeeding information

  1. "Product Information. Profilnine SD (Factor IX Complex)." Grifols Biologicals Inc, Los Angeles, CA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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