coagulation factor XIII A-subunit (recombinant) [IV]

Adult Dosing

Clotting disorder congenital factor XIII A-subunit deficiency

35 IU/kg IV qmonth to achieve a target trough level of FXIII activity 10% using a validated assay
Administer at a rate not exceeding 1-2 mL per minute
Do not administer with other infusion solutions or as drip

Note:

Pediatric Dosing

Clotting disorder congenital factor XIII A-subunit deficiency

35 IU/kg qmonth to achieve a target trough level of FXIII activity 10% using a validated assay
Administer at a rate not exceeding 1-2 mL per minute
Do not administer with other infusion solutions or as drip

Note:

[Outline]

Indications ⬆ ⬇

Used for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency

Note:

Contraindications ⬆ ⬇

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

Allergic-type hypersensitivity reactions, including urticaria, rash, tightness of the chest, wheezing, hypotension have been reported following administration of coagulation Factor XIII A-Subunit, discontinue therapy if such allergic reactions occur and institute appropriate treatment
Thromboembolic complications may occur with therapy. Closely monitor patients with conditions that predispose to thrombosis for signs and symptoms of thrombosis after administration of therapy
Inhibitory antibodies may occur with therapy. Analyze for neutralizing antibodies if FXIII activity fails to reach expected levels or if reduced therapeutic effect is observed

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer recommends caution.

Adverse Reactions ⬆ ⬇

Clinical Pharmacology ⬆ ⬇

Coagulation factor/thrombotic agent; FXIII when activated by thrombin at the site of vessel injury maintains hemostasis by cross linking fibrin and other proteins in the fibrin clot
Metabolism: Unknown
Excretion: Unknown
Half life:

Brands and Availability ⬆ ⬇