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

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.

Availability ⬆ ⬇

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

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).

US Brand Names ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: blood products, clotting factors replacements

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

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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Indications ⬇

Contraind./Precautions ⬆ ⬇