coagulation factor XIII A-subunit (recombinant)
ko-ag-yoo-lay-shun fak-tor thir-teen A sub-yoo-nit re-kom-bi-nant
clotting factor replacements
Prevention of bleeding in patients with congenital factor XIII A-subunit deficiency.
Replaces deficient factor XIII A-subunit (produced by recombinant DNA technology).
Absorption: IV administration results in complete bioavalability.
Metabolism and Excretion: Unknown.
Half-life: Patients 7–58 yr– 5.1 days; patients 1– <6 yr– 7.1 days.
TIME/ACTION PROFILE (effect on Factor XIII A subunit activity)
|IV||rapid||unknown||up to a mo|
Use Cautiously in:
- Lactation: Use cautiously if breastfeeding;
- OB: Use in pregnancy only if clearly needed.
Adverse Reactions/Side Effects
Local: injection site pain
MS: extremity pain
Misc: ALLERGIC REACTIONS INCLUDING ANAPHYLAXIS, ↑ D dimer, production of neutralizing antibodies
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Should not be administered with recombinant factor VIIa .
IV (Adults and Children) 35 IU/kg once monthly (to achieve target XIII activity ≥10%); dose may be adjusted as necessary.
Lyophilized powder for IV use (requires reconstitution, may be further diluted)
- Assess for signs and symptoms of allergic reactions (angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing, dyspnea). If symptoms occur, discontinue therapy and treat symptomatically.
- Monitor for thromboembolic events in patients with risk factors (indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives, morbid obesity, immobility) during and after administration.
Lab Test Considerations:
Monitor for inhibitory antibodies. May manifest as inadequate response to therapy or breakthrough bleeding during prophylaxis. Perform assay measuring Factor XIII inhibitory antibody concentrations.
- Ineffective tissue perfusion (Indications)
- IV Push: Allow medication and diluent to come to room temperature before use. Follow manufacturer's guidelines for mixing. Final solution should be clear to slightly opalescent and colorless. Do not shake. Do not use solutions that are discolored or contain particulate matter. Use reconstituted solution within 3 hr. Do not refrigerate or freeze after reconstitution. Do not administer reconstituted solution in same tubing or container with other medications. Vials can be stored at room temperature for up to 6 mo and then should be discarded; do not return to refrigerator.
- Rate: Administer at a rate not to exceed 1–2 mL/min. Do not administer as a drip.
- Y-Site Incompatibility: Do not administer with other infusion solutions.
- Instruct patient to read Patient Information and Instructions for Use prior to starting therapy and with each refill in case of changes.
- Advise patient to notify health care professional immediately if signs and symptom of allergic reactions or a blood clot (pain, swelling, warmth, redness, lump in legs or arms, chest pain, sudden severe headache, loss of consciousness or function) occur.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
- Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Decrease in bleeding in patients with congenital factor XIII A-subunit deficiency.
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