F
FACTOR XIII CONCENTRATE (HUMAN)
Hematologic Agent (Antihemophilic)
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: Compatible
PREGNANCY SUMMARY
Factor XIII concentrate (human) (FXIII) is a necessary therapy for patients with congenital deficiency of FXIII. In women without such therapy, severe bleeding will occur, as well as abortions if they become pregnant.
FETAL RISK SUMMARY
FXIII is a heat-treated, lyophilized coagulation factor XIII concentrate made from pooled human plasma. It is an endogenous plasma glycoprotein consisting of two A-subunits and two B-subunits that circulates in blood and is present in platelets, monocytes, and macrophages. FXIII is indicated for routine IV prophylactic treatment of congenital FXIII deficiency. The effectiveness of the product is based on maintaining a trough FXIII activity of about 5%–20%. The half-life of FXIII is about 6.6 days (1).
Reproduction studies in animal have not been conducted.
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