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:

• Refer package insert for reconstitution procedure

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:

• Refer package insert for reconstitution procedure

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

Note:

• Not for use in patients with congenital factor XIII B-subunit deficiency

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• 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 Category:C

Breastfeeding: Safety unknown. Manufacturer recommends caution.

• CNS: Headache
• LOCAL: Injection site pain
• HEMA: Increase in fibrin D dimer levels
• MISC: Pain in the extremities

• 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:
• Age: 7-58 years: 5.1 days
• Age: 1 to < 6 years: 7.1 days

US Trade Name(s)

• Tretten

US Availability

Tretten

• PWDR for INJ: 2000-3125 IU

Canadian Trade Name(s)

• Tretten

Canadian Availability

Tretten

• PWDR for INJ: 2500 IU/vial

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Coagulation Factor/thrombotic Agent