coagulation factor xiii a-subunit (recombinant)

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Lactation: Use cautiously if breastfeeding;
OB: Use in pregnancy only if clearly needed.

Adv. Reactions/Side Effects ⬆ ⬇

CV: THROMBOEMBOLISM

Local: injection site pain

MS: extremity pain

Neuro: headache

Misc: ↑D dimer, ANAPHYLAXISALLERGIC REACTIONS INCLUDING , production of neutralizing antibodies

Interactions ⬆ ⬇

Drug-drug:

Should not be administered with recombinant factor VIIa.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

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

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

Decreased bleeding.

Classifications ⬆ ⬇

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: clotting factors replacements

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavalability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Patients 7–58 yr: 5.1 days; patients 1– <6 yr: 7.1 days.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(effect on Factor XIII A subunit activity)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unknown	up to a mo

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.

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Indications ⬇

Contraind./Precautions ⬆ ⬇