Generic Name and Formulations:
Coagulation Factor XIII A-Subunit (recombinant) 2000–3125 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Indications for TRETTEN:
Routine prophylaxis of bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency. Limitations of use: not for use in patients with congenital factor XIII B-subunit deficiency.
Adults and Children:
Give by IV inj at a rate of max 1–2mL/min. Initially 35 IU/kg once monthly to achieve a target trough FXIII activity level ≥10% using a validated assay. Consider dose adjustment if adequate coverage not achieved. Do not administer with other infusion solutions.
Should be initiated under supervision of an experienced physician. Discontinue immediately and treat appropriately if anaphylaxis or hypersensitivity reactions occur. Conditions that predispose to thrombosis; monitor for signs/symptoms of thrombosis after administration. Measure FXIII inhibitory antibody concentrations if expected plasma FXIII activity levels not attained or if breakthrough bleeding occurs. Pregnancy (Cat. C). Nursing mothers.
Thrombosis risk with concomitant factor VIIa; avoid.
Headache, pain in the extremities, injection site pain, increase in fibrin D-dimer levels; hypersensitivity reactions.
Single-use vials—1 (w. diluent, supplies)
Neurology Advisor Articles
- Excess Abdominal Obesity Linked to Severe Disability in Multiple Sclerosis
- Change in Dietary Patterns Over 5 Years in Early Multiple Sclerosis
- High-Dose Biotin May Be an Effective Treatment for Progressive MS
- Biobank Data Suggest Vitamin D Reduces Risk for Multiple Sclerosis
- Serious Adverse Events Profile for Cladribine Confirmed With Extended Data
- Unintended Pregnancy Common in Women With Epilepsy
- Aggressive Blood Pressure Lowering in Intracerebral Hemorrhage May Be Harmful
- Risk of Opioid-Benzodiazepine Overlap Up for Dual Prescribing
- Minority Residents Experience Burdens Linked to Race/Ethnicity
- Tips Provided for Budgeting in Medical Residency