prothrombin complex concentrate (human)
pro-throm-bin com-plex kon-sen-trayt
clotting factor replacements
Urgent reversal of warfarin due to acute major bleeding or the need for urgent surgery or invasive procedure. Vitamin K should be given concurrently.
Replaces clotting factors (II, VII, IX, X and antithrombotic proteins C and S) which have become deficient as a result of warfarin.
Cessation of bleeding due to warfarin
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)
|IV||rapid||unk||at least 24 hr|
- 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
Misc: hypersensitivity reactions including anaphylaxis, transmission of infectious agents
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Reverses the effects of warfarin.
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.
Lyophilized concentrate powder for reconstitution (contains heparin): 400–620 units of Factor IX/vial, 800–1240 units of Factor IX/vial
- 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.
- Ineffective tissue perfusion (Indications)
- Administer Vitamin K concurrently to maintain Vitamin K-dependent clotting factor levels once effects of prothrombin complex concentrate human have diminished.
- 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.
- 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.
Cessation of bleeding due to Vitamin K antagonist (warfarin).