prothrombin complex concentrate (human)

REMS

Urgent reversal of warfarin due to acute major bleeding or the need for urgent surgery or invasive procedure. Vitamin K should be given concurrently.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to any components.
Disseminated intravascular coagulation
History of heparin-induced thrombocytopenia

Use Cautiously in:

Thromboembolic events in previous 3 mos
OB: Use during pregnancy or lactation only if clearly needed
Pedi: Safety and effectiveness not established.

Adv. Reactions/Side Effects ⬆ ⬇

CV: ARTERIAL/VENOUS THROMBOEMBOLISM, DISSEMINATED INTRAVASCULAR COAGULATION, hypertension, hypotension, tachycardia

GI: nausea/vomiting

MS: arthralgis

Neuro: headache, mental status changes

Misc: hypersensitivity reactions including anaphylaxis, transmission of infectious agents

Interactions ⬆ ⬇

Drug-drug:

Reverses the effects of warfarin.

Availability ⬆ ⬇

Lyophilized concentrate powder for reconstitution (contains heparin): 400–620 units of Factor IX/vial; 800–1240 units of Factor IX/vial

Route/Dosage ⬆ ⬇

Dose based on units of Factor IX . Vitamin K should be given concurrently.)
PO (Adults ): Pre-treatment INR 2– <4—)25 units/kg (not to exceed 2500 units; pre-treatment INR 4–6: 35 units/kg (not to exceed 3500 units; pre-treatment INR >6: 50 units/kg (not to exceed 5000 units). Repeat doses are not recommended.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Replaces clotting factors (II, VII, IX, X and antithrombotic proteins C and S) which have become deficient as a result of warfarin.

Therapeutic effects:

Cessation of bleeding due to warfarin

Classifications ⬆ ⬇

Therapeutic Classification: antidotes

Pharmacologic Classification: clotting factors replacements

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Rapidly distributed

Metabolism/Excretion: Utilized in reversal of bleeding

Half-Life: Factor II: 59.7 hr; Factor VII: 4.2 hr; Factor IX: 16.7 hr; Factor X: 30.7 hr;

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(reversal of warfarin effects)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unk	at least 24 hr

Patient/Family Teaching ⬆ ⬇

Inform patient of purpose of prothrombin complex concentrate human.
Inform patient of risk for transmitting infectious agents due to origin from human blood.
Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

pro-THROM-bin COM-plex KON-sen-trayt

Code ⬆

NDC Code

68982- Octapharma USA Inc
- 68982-261- Balfaxar
  - 68982-261-01- 1 VIAL, GLASS in 1 CARTON (68982-261-01) / 20 mL in 1 VIAL, GLASS (68982-261-81)

68982- Octapharma USA Inc
- 68982-261- Balfaxar
  - 68982-261-02- 1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82)

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Indications ⬇