Davis's Drug Guide

prothrombin complex concentrate (human)

General

Pronunciation:
pro-throm-bin com-plex kon-sen-trayt


Trade Name(s)

  • Kcentra
  • Octaplex [Canada]

Pregnancy Category
Category C

Ther. Class.
antidotes

Pharm. Class.
clotting factor replacements

Indications

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

Action

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

Therapeutic Effect(s):

Cessation of bleeding due to warfarin

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Rapidly distributed

Metabolism and 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;

TIME/ACTION PROFILE (reversal of warfarin effects)

ROUTEONSETPEAKDURATION
IVrapid unkat least 24 hr

Contraindication/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: Lactation: Use during pregnancy or lactation only if clearly needed
  • Pedi: Safety and effectiveness not established.

Adverse Reactions/Side Effects

CNS: headache, mental status changes

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

GI: nausea/vomiting

MS: arthralgis

Misc: hypersensitivity reactions including anaphylaxis, transmission of infectious agents

* CAPITALS indicate life-threatening.
Italics indicate most frequent.

Interactions

Drug-Drug

Reverses the effects of warfarin .

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.

Availability

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

Assessment

  • Assess bleeding (vital signs, incisions, orifices) during therapy.
  • Monitor for signs and symptoms of hypersensitivity reactions (flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, bronchospasm). If severe reaction occurs, discontinue infusion and institute supportive treatment.
  • Monitor closely for signs and symptoms of thromboembolism (limb or abdomen swelling and/or pain; chest pain or pressure; shortness of breath; loss of sensation or motor power; altered consciousness, vision, or speech) during and after administration.
  • Monitor for infections (viruses, Creutzfeldt-Jakob) potentially transmitted from therapy. Infections thought to be from transmission should be reported by health care professional to CSL Behring Pharmacovigilance Department at 1–866–915–6958 or FDA at 1–800–FDA-1088 or www.fda.gov/medwatch.

Lab Test Considerations:

Measure INR prior to therapy close to time of dosing; base dose on INR value and patient body weight. Monitor INR and clinical response during and after infusion.

Potential Diagnoses

Implementation

  • Administer Vitamin K concurrently to maintain Vitamin K-dependent clotting factor levels once effects of prothrombin complex concentrate human have diminished.

IV Administration

  • Intermittent Infusion: Follow reconstitution instructions in provided for Mix2Vial transfer set. Reconstitute with 20 mL of diluent provided in kit. Do not use beyond expiration date. Solution is colorless and clear to opalescent; do not use solutions that are discolored, cloudy or contain particulate matter. Do not allow blood to enter syringe during infusion, may cause fibrin clot formation. Concentration: Final concentration in Factor IX units will range from 20–31 units/mL when reconstituted. Actual potency is listed on carton. If patient is to receive multiple vials, may pool contents; use a separate unused Mix2Vial transfer set for each vial. Administration should begin promptly or within 4 hrs of reconstitution. Record lot number of product in patient's chart when administered. Store between 2–25° C; do not freeze. For single use only; discard unused portions.
  • Rate: 0.12 mL/kg/min up to maximum rate of 8.4 mL/kg/min
  • Y-Site Incompatibility Do not mix with other solutions or medicines. Administer through separate infusion line.

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.

Evaluation/Desired Outcomes

Cessation of bleeding due to Vitamin K antagonist (warfarin).

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