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Antihemophilic factor/von willebrand factor Pregnancy and Breastfeeding Warnings

Brand names: Alphanate, Dried Factor VIII Fraction Type 8Y, Haemate P, Humate-P, Optivate, Wilate, Wilstart

Medically reviewed by Drugs.com. Last updated on Jan 22, 2024.

Antihemophilic factor/von willebrand factor Pregnancy Warnings

Safety has not been established during pregnancy; use only if clearly needed.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: C

There are no controlled data in human pregnancy.

Delivery confers an increased risk of hemorrhagic events in patients with von Willebrand disease.

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.

See references

Antihemophilic factor/von willebrand factor Breastfeeding Warnings

AU and UK: Safety has not been established; use only if clearly needed.
US: Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Humate-P (antihemophilic factor-von Willebrand factor). CSL Behring LLC. 2022.
  4. Product Information. Wilate (antihemophilic factor-von Willebrand factor). Octapharma USA. 2022.
  5. Product Information. Alphanate (antihemophilic factor-von Willebrand factor). Alpha Therapeutic Corporation. 2022.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Humate-P (antihemophilic factor-von Willebrand factor). CSL Behring LLC. 2022.
  4. Product Information. Wilate (antihemophilic factor-von Willebrand factor). Octapharma USA. 2022.
  5. Product Information. Alphanate (antihemophilic factor-von Willebrand factor). Alpha Therapeutic Corporation. 2022.

Further information

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