coagulation factor XIII A-subunit


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coagulation factor XIII A-subunit (recombinant)

(ko-ag-yoo-lay-shun fak-tor thir-teen A sub-yoo-nit re-kom-bi-nant),

Catridecacog

(trade name),

Tretten

(trade name)

Classification

Therapeutic: hemostatic agents
Pharmacologic: clotting factor replacements
Pregnancy Category: C

Indications

Prevention of bleeding in patients with congenital factor XIII A-subunit deficiency.

Action

Replaces deficient factor XIII A-subunit (produced by recombinant DNA technology).

Therapeutic effects

Decreased bleeding.

Pharmacokinetics

Absorption: IV administration results in complete bioavalability.
Distribution: Unknown.
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)

ROUTEONSETPEAKDURATION
IVrapidunknownup to a mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Lactation: Use cautiously if breastfeeding; Obstetric: Use in pregnancy only if clearly needed.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Cardiovascular

  • thromboembolism (life-threatening)

Local

  • injection site pain

Musculoskeletal

  • extremity pain

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • ↑ D dimer
  • production of neutralizing antibodies

Interactions

Drug-Drug interaction

Should not be administered with recombinant factor VIIa.

Route/Dosage

Intravenous (Adults and Children) 35 IU/kg once monthly (to achieve target XIII activity ≥10%); dose may be adjusted as necessary.

Availability

Lyophilized powder for IV use (requires reconstitution, may be further diluted):

Nursing implications

Nursing assessment

  • 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.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)

Implementation

  • 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Decrease in bleeding in patients with congenital factor XIII A-subunit deficiency.
References in periodicals archive ?
Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.