factor XIII concentrate, human concentrate

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factor XIII concentrate, human (FXIII) concentrate (Human)

(fak-tor thir-teen) ,

Corifact

(trade name)

Classification

Therapeutic: none assigned
Pharmacologic: blood products
Pregnancy Category: C

Indications

Routine preventive treatment of congenital Factor XIII deficiency.Perioperative management of surgical bleeding in patients with congenital Factor XIII deficiency

Action

Factor XIII is a calcium- and thrombin-activated proenzyme. Once activated it catalyzes cross-linking of fibrin resulting in stabilization and resistance to fibrinolysis. Also prevents degradation of fibrin clot by plasmin; result is clot stabilization.

Therapeutic effects

Replaces deficient Factor XIII thereby preventing or managing bleeding in congenital deficiency.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 6 days.

Time/action profile (hemostatic effect)

ROUTEONSETPEAKDURATION
IVrapidend of infusion28 days

Contraindications/Precautions

Contraindicated in: Known severe hypersensitivity reactions to human plasma-derived products or any other components in the product.
Use Cautiously in: Obstetric: Use during pregnancy only if clearly needed; pregnancy is associated ↑ risk of thrombosis; Lactation: Use only if clearly needed.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Ear, Eye, Nose, Throat

  • epistaxis

Gastrointestinal

  • abdominal pain
  • diarrhea
  • ↑ liver enzymes
  • vomiting

Dermatologic

  • bruising
  • rash

Hematologic

  • embolism (life-threatening)
  • thrombosis (life-threatening)

Musculoskeletal

  • arthralgia
  • joint/limb injury

Miscellaneous

  • allergic reactions including anaphylaxis
  • antibody formation
  • fever
  • flu-like syndrome

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravenous (Adults and Children) 40 units/kg; subsequent doses should be adjusted to maintain a trough FXIII level of 5–20% (should be given every 28 days for routine prophylaxis) (need for additional doses to manage perioperative bleeding based on patients FXIII level, type of surgery, and clinical response).

Availability

Concentrate for IV infusion (requires reconstitution and further dilution): 1000–1600 units/vial

Nursing implications

Nursing assessment

  • Monitor for hypersensitivity reactions (allergy, rash, pruritus, erythema, urticaria, chest tightness, wheezing, hypotension). If signs occur, discontinue infusion and institute appropriate treatment. Pyrogenic reactions (fever, chills) may also occur.
  • Monitor for development of inhibitory antibodies. May manifest as inadequate response to treatment or breakthrough bleeding during prophylaxis. If suspected, perform an assay that measures FXIII inhibitory antibody concentrations.
  • Lab Test Considerations: Monitor trough FXIII activity levels with each treatment.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)

Implementation

  • Dose is based on the most recent trough. If trough level is < 5%, ↑ dose by 5 units/kg, if trough level is 5–20% continue with 40 units/kg dose; if two trough levels >20% or one trough level >25% ↓ dose by 5 units/kg.
    • Record the batch number of the product in the medical record every with each administration.
  • Intravenous Administration
  • Ensure vial is at room temperature. Do not use beyond expiration date. Reconstitute Mix2Vial as directed by manufacturer. Solution is colorless to slightly yellowish, slightly opalescent and free from visible particles. Do not administer solution that is discolored or contains a precipitate. Administer within 4 hr of reconstitution. Do not refrigerate or freeze reconstituted solution. Withdraw solution into syringe and attach syringe to IV administration set. If multiple vials are used, vial contents may be pooled using a separate Mix2Vial transfer set for each vial.
  • Rate: Infuse at a rate not to exceed 4 mL/min.
  • Y-Site Incompatibility: Administer through separate infusion line. Do not mix with other medications or solutions.

Patient/Family Teaching

  • Instruct patient to read the Patient Product Information before using and with each refill; new information may be available.
  • Inform patient of signs and symptoms of hypersensitivity reactions; caution patient to notify health care professional promptly if these occur.
  • Instruct patient to report bleeding to health care professional as a sign of immunogenicity.
  • Advise patient to notify health care professional immediately if signs and symptoms of thrombosis (limb or abdomen swelling and/or pain, shortness of breath, loss of sensation or motor power, altered consciousness, vision, or speech) occur.
  • Inform patient that because factor XIII concentrate is made from human blood, it may carry risk of transmitting infectious agents (viruses, Creutzfeldt-Jakob).
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs or aspirin without consulting health care professional.
  • Advise patient to notify health care professional if planning to travel.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Prevention of bleeding by replacement of deficient Factor XIII.
References in periodicals archive ?
Corifact is the only FDA-approved treatment for congenital Factor XIII deficiency, reported to be one of the rarest bleeding disorders in the world.
To date, Corifact has only been available through two specialty pharmacy providers.
Corifact is a perfect match for our service model due to the small population it treats.
Approvals and launches of new products such as Riastap, Corifact and Atryn, and the anticipated launch of recombinant products, will boost growth in the critical care market in the forecast period.
The growth of the overall critical care market during the forecast period is expected to be largely due to an increasing preference in the market for factor concentrates such as Riastap, Corifact, rFXIII (which has been launched in the EU and is expected to be launched in the US later this year), the expanded indication for Antithrombin (AT) III and factor concentrates, and rising demand for albumin from countries in the Asia-Pacific region.
In 2011, Corifact became the first and only FXIII concentrate approved in the U.
The expanded indication is based on use of Corifact in peri-operative situations as part of both a 12-month, prospective, open-label, multicenter efficacy and safety study as well as a nine-year investigator-initiated clinical study.
Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin- P, is the first and only FXIII concentrate approved in the U.
FDA approval of Corifact is a very special opportunity to make a positive difference in the lives of people who need our safe, high-quality therapies, while continuing to enhance our extensive portfolio of products for people with bleeding disorders," said Lynne Powell, CSL Behring Senior Vice President, North America Commercial Operations.
Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency.