Prothrombin complex concentrate (human)

What is Prothrombin complex concentrate (human)?

• Prothrombin complex concentrate (human) (KCENTRA) is a blood coagulation factor replacement product used for the urgent reversal of acquired coagulation factor deficiency.

What are the uses of this medicine?

This medicine is used for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:

• acute major bleeding or
• need for an urgent surgery/invasive procedure.

How does this medicine work?

• KCENTRA contains the Vitamin K-dependent coagulation Factors II (FII), VII (FVII), IX (FIX), and X (FX), together known as the Prothrombin Complex, and the antithrombotic Protein C and Protein S.
• A dose-dependent acquired deficiency of the Vitamin K-dependent coagulation factors occurs during Vitamin K antagonist treatment.

Vitamin K antagonists exert anticoagulant effects by blocking carboxylation of glutamic acid residues of the Vitamin K-dependent coagulation factors during hepatic synthesis, lowering both factor synthesis and function.

• The administration of KCENTRA rapidly increases plasma levels of the Vitamin K-dependent coagulation Factors II, VII, IX, and X as well as the antithrombotic Proteins C and S.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known anaphylactic or severe systemic reactions to KCENTRA or any components in KCENTRA including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin.
• with disseminated intravascular coagulation (DIC).
• with known heparin-induced thrombocytopenia (HIT). KCENTRA contains heparin

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with KCENTRA.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

• KCENTRA dosing should be individualized based on the patient's baseline International Normalized Ratio (INR) value, and body weight.
• Administer Vitamin K concurrently to patients receiving KCENTRA to maintain factor levels once the effects of KCENTRA have diminished.

Recommended Dosage:

• Administer reconstituted KCENTRA at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min).

Administration

• Reconstitute KCENTRA using aseptic technique with 20 mL (nominal potency 500 U kit) or 40 mL (nominal potency 1000 U kit) of Sterile Water for Injection (diluent) provided in the kit.
• Do not use KCENTRA beyond the expiration date on the vial label and carton.
• KCENTRA is for single-dose only. Contains no preservatives. Discard partially used vials.
• Do not mix KCENTRA with other medicinal products; administer through a separate infusion line.
• Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration whenever solution and container permit. Reconstituted KCENTRA solution should be colorless, clear to slightly opalescent, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates.
• Use aseptic technique when administering KCENTRA.
• Administer at room temperature.
• Administer by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min).
• No blood should enter the syringe, as there is a possibility of fibrin clot formation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a white or slightly colored lyophilized concentrate in a single-dose vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S.

This medicine is available in fallowing brand namesː

• KCENTRA

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea/vomiting
• hypotension
• anemia

The serious side effects of this medicine include:

• thromboembolic events including stroke
• pulmonary embolism
• deep vein thrombosis

What special precautions should I follow?

• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment.
• Arterial and venous thromboembolic complications have been reported in patients receiving KCENTRA. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. KCENTRA was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months.
• KCENTRA is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no data with KCENTRA use in pregnancy to inform on drug-associated risk.
• It is not known whether KCENTRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Can this medicine be used in children?

• The safety and efficacy of KCENTRA in the pediatric population has not been studied.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• PROTHROMBIN
• COAGULATION FACTOR VII HUMAN
• COAGULATION FACTOR IX HUMAN
• COAGULATION FACTOR X HUMAN
• Protein C
• Protein S Human

Inactive ingredients:

• Heparin
• Antithrombin III Human
• Albumin Human
• Sodium chloride
• Sodium citrate, unspecified form
• Hydrochloric acid
• Sodium hydroxide

Who manufactures and distributes this medicine?

• Manufactured by:

CSL Behring GmbH 35041 Marburg Germany

• Distributed by:

CSL Behring LLC Kankakee, IL 60901 USA

What should I know about storage and disposal of this medication?

Storage and Handling

Prior to Reconstitution

• KCENTRA is for single-dose only.
• Contains no preservatives.
• Store KCENTRA between 2–25°C (36–77°F), this includes room temperature, not to exceed 25°C (77°F). Do not freeze.
• KCENTRA is stable for 36 months from the date of manufacture, up to the expiration date on the carton and vial labels.
• Do not use KCENTRA beyond the expiration date on the vial label and carton.
• Store the vial in the original carton to protect it from light.

After Reconstitution

• KCENTRA must be used within 4 hours following reconstitution.
• Reconstituted KCENTRA can be stored at 2–25°C.
• If cooled, the solution should be warmed to 20–25°C prior to administration.
• Do not freeze.
• Discard partially used vials.

• Dailymed label info on Prothrombin complex concentrate (human)
• FDA Prothrombin complex concentrate (human)

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