Prab at 17:17, 22 March 2025

2025-03-22T17:17:52Z

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2025-02-04T08:41:39Z

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Prab at 11:58, 7 April 2024

2024-04-07T11:58:13Z

New page

== '''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.

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== '''What are the uses of this medicine?''' ==

This medicine is used for the urgent reversal of acquired [[coagulation factor]] deficiency induced by [[Vitamin K antagonists|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 event|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 event|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)|Creutzfeldt-Jakob disease]] (CJD) agent.

== '''What to do in case of emergency/overdose?''' ==

* {{overdose}}

== '''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.
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[[Category:Blood products]]
[[Category:Coagulation system]]
[[Category:Orphan drugs]]
[[Category:Transfusion medicine]]
[[Category:World Health Organization essential medicines]]

Prothrombin complex concentrate (human) - Revision history

Prab at 17:17, 22 March 2025

Prab: CSV import

Prab at 11:58, 7 April 2024