coagulation factor xiii a-subunit (recombinant)

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

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

Adv. Reactions/Side Effects ⬆ ⬇

CV: THROMBOEMBOLISM

Hemat: ↑D dimer levels

Local: injection site pain

MS: extremity pain

Neuro: headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), production of neutralizing antibodies

Interactions ⬆ ⬇

Drug-drug:

Should not be administered with recombinant factor VIIa.

Availability ⬆ ⬇

Lyophilized powder for injection: 2,500 IU/vial

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 bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 5.1–7.1 days.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(effect on Factor XIII A subunit activity)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unknown	up to a month

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient on appropriate steps for administration technique and disposal of equipment, if self-administration is appropriate.
Advise 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 medications.
Advise patient to notify health care professional immediately if signs/symptoms of allergic reaction (angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing, dyspnea) or a blood clot (sudden severe headache, pain, swelling, warmth, or redness in legs, arms or chest) occurs.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

ko-AG-yoo-LAY-shun FAK-tor thir-TEEN ay-SUB-yoo-nit re-KOM-bi-nant

Code ⬆

NDC Code

0169- Novo Nordisk
- 0169-7013- TRETTEN
  - 0169-7013-01- 1 KIT in 1 KIT (0169-7013-01) * 3 mL in 1 VIAL, GLASS (0169-7113-11) * 3.2 mL in 1 VIAL, GLASS (0169-7000-93)

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Indications ⬇

Contraind./Precautions ⬆ ⬇