Prothrombin complex concentrate (4-factor)
KCENTRA
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.
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.
⚠ BOXED WARNING
- Thromboembolic complications
Classes and tags
Clinical profile
Mechanism of action: Prothrombin complex concentrate (4-factor) ballicule
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