factor xiii concentrate, human (fxiii) concentrate (human)

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/Excretion: Unknown.

Half-Life: 6 days.

Time/Action Profile ⬆ ⬇

(hemostatic effect)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	28 days

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Known severe hypersensitivity reactions to human plasma-derived products or any other components in the product.

Use Cautiously in:

OB: Use during pregnancy only if clearly needed; pregnancy is associated ↑ risk of thrombosis;
Lactation: Use only if clearly needed.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: bruising, rash

EENT: epistaxis

GI: ↑liver enzymes, abdominal pain, diarrhea, vomiting

Hemat: EMBOLISM, THROMBOSIS

MS: arthralgia, joint/limb injury

Neuro: headache

Misc: allergic reactions including anaphylaxis, antibody formation, fever, flu-like syndrome

Interactions ⬆ ⬇

Drug-drug:

None noted.

Route/Dosage ⬆ ⬇

IV (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

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.

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.

IV Administration:

IV Push: 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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇