Prothrombin complex concentrate (4-factor)

KCENTRA

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Prothrombin complex concentrate (4-factor) ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Prothrombin complex concentrate (4-factor) ballicule

What it isA concentrate of the four vitamin-K-dependent clotting factors (II, VII, IX, X) plus proteins C and S, for urgent warfarin reversal.

Why this oneUnlike plasma, it reverses INR rapidly at low volume without thawing; vitamin K is still needed for durable reversal.

What limits itIt is prothrombotic by nature, so use stays confined to major bleeding or truly urgent procedures.

FDA label

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BOXED WARNING Arterial and venous thromboembolic complications (fatal and non-fatal) have been reported; weigh benefits of VKA reversal against thromboembolic risk and monitor patients.

FDA dosing	Population	Start	Target	Max
Urgent reversal of VKA (e.g., warfarin) anticoagulation in acute major bleeding or need for urgent surgery/procedure	adults	INR-based, units of Factor IX/kg: INR 2–<4 = 25 units/kg; 4–6 = 35 units/kg; >6 = 50 units/kg	single individualized dose based on INR and body weight	INR 2–<4: ≤2500 units; 4–6: ≤3500 units; >6: ≤5000 units (dose weight capped at 100 kg)

Renal Undefined

Hepatic Undefined

Individualize dose by baseline INR and body weight.

Instructions

For IV use after reconstitution only; infuse at 0.12 mL/kg/min (~3 units/kg/min), max 8.4 mL/min (~210 units/min).
Administer vitamin K concurrently to maintain factor levels once KCENTRA effects diminish.
Repeat dosing safety/effectiveness not established and not recommended.

Available strengths

inj 500, 1000 units

Contraindications

Disseminated intravascular coagulation (DIC)
Known heparin-induced thrombocytopenia (HIT); KCENTRA contains heparin

Cautions

Hypersensitivity reactions
Arterial and venous thromboembolic complications
Made from human blood — risk of transmitting infectious agents

Adverse reactions

Headache
Nausea/vomiting
Hypotension
Anemia
Arthralgia

Pregnancy No data; use only if clearly needed.

Lactation No information on excretion in human milk; use only if clearly needed.

Cost

Prothrombin complex concentrate (4-factor) (KCENTRA)

Strength		#/mo	generic $/unit	CostPlus
500 units	inj	per unit		not offered
1000 units	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Prothrombin complex concentrate (4-factor) is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNING

Thromboembolic complications

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Defining liabilityPotentially fatal thromboembolism after rapid anticoagulation reversal

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