Factor XIII Pregnancy and Breastfeeding Warnings

Brand names: Corifact, Tretten

Medically reviewed by Drugs.com. Last updated on Jan 29, 2024.

Factor XIII Pregnancy Warnings

Animal studies have not been conducted. 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 B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Use may be considered if needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-Miscarriage is a known complication in congenital factor XIII deficiency; of 136 pregnancies without routine factor XIII prophylaxis 91% experienced miscarriage, versus 11% of 45 pregnancies receiving routine factor XIII prophylaxis.

See references

Factor XIII Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
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.
-According to some authorities the large molecular size of this product makes excretion into milk unlikely, and absorption of intact proteinaceous molecules is unlikely.

See references

Further information

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