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Coagulation Factor Concentrate — Warfarin Reversal Pregnancy: The safety of human prothrombin complex for use in human pregnancy and during lactation has not been established; animal studies are not suitable to assess safety with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Human prothrombin complex should be used during pregnancy and lactation only if clearly indicated. §4.4 additionally notes that parvovirus B19 infection, against which the manufacturing measures may be of limited value, may be serious for pregnant women (foetal infection).

Prothrombin Complex Concentrate (PCC)

Brand names: Beriplex, Octaplex

Prothrombin complex concentrate (PCC) is a plasma-derived product containing vitamin K-dependent clotting factors, used for emergency reversal of warfarin and other vitamin K antagonists in major bleeding.

Adult dose

Dose: WARFARIN / VITAMIN K ANTAGONIST REVERSAL — bleeding, and perioperative prophylaxis of bleeding, during vitamin K antagonist treatment. The dose depends on the pre-treatment INR and on body weight, in units of factor IX per kg: pre-treatment INR 2 to less than 4 — 25 IU/kg; INR 4 to 6 — 35 IU/kg; INR greater than 6 — 50 IU/kg. Dose is based on body weight up to, but not exceeding, 100 kg. SCOPE — THESE FIGURES ARE OCTAPLEX'S: prothrombin complex concentrates are not interchangeable and each brand carries its own INR-banded table, so the other PCC listed on this page (Beriplex) must be dosed from its own SPC, not from this record. SECOND, DIFFERENT INDICATION in the same §4.2, given so it is not confused with the above — bleeding and perioperative prophylaxis in CONGENITAL deficiency of the vitamin K dependent factors II and X, when a specific coagulation factor product is not available: the dose is calculated, not banded. Required units of factor X = body weight (kg) x desired factor X rise (IU/mL) x 60; required units of factor II = body weight (kg) x desired factor II rise (IU/mL) x 50. These rest on the empirical finding that approximately 1 IU of factor II or X per kg body weight raises plasma factor II or X activity by 0.02 and 0.017 IU/mL respectively; if the individual recovery is known, that value should be used instead.
Route: Intravenous infusion. §4.2 Method of administration, verbatim: 'Octaplex must be administered intravenously at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8 mL/min (~210 units/min), using an aseptic technique.' Note that this page's legacy route line reads 'intravenous bolus'; the SPC specifies a rate-controlled infusion, and the SPC governs.
Frequency: A single INR- and weight-based dose in vitamin K antagonist reversal. The correction of vitamin K antagonist induced impairment of haemostasis persists for approximately 6-8 hours, whereas the effects of vitamin K, if given simultaneously, are usually achieved within 4-6 hours — so repeated treatment with human prothrombin complex is not usually required when vitamin K has been administered. These recommendations are empirical and recovery and duration of effect may vary, so monitoring of INR during treatment is mandatory.
Max: 2500 IU of factor IX as a single dose for an INR of 2 to less than 4, 3500 IU for an INR of 4 to 6, and 5000 IU for an INR greater than 6. These ceilings exist because dose is calculated on body weight up to but not exceeding 100 kg. Verbatim from the posology section: 'For patients weighing more than 100 kg, the maximum single dose (IU of factor IX) should therefore not exceed 2500 IU for an INR of 2 - < 4, 3500 IU for an INR of 4 - 6 and 5000 IU for an INR of > 6.' Each ceiling belongs to its own INR band and must be read with the matching band, not applied across bands. These are the warfarin-reversal ceilings only; the congenital factor II/X indication is calculated to a target factor level and has no stated maximum.
SPECIALIST SETTING (§4.2): 'Only general dosage guidelines are given below. Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders.' The dosage and duration of substitution therapy depend on the severity of the disorder, the location and extent of the bleeding and the patient's clinical condition; the amount and frequency should be calculated on an individual patient basis, and dosage intervals must be adapted to the different circulating half-lives of the different coagulation factors in the prothrombin complex. Individual dosage requirements can only be identified from regular determinations of the individual plasma levels of the coagulation factors of interest, or from global tests of prothrombin complex levels (prothrombin time, INR), together with continuous monitoring of the clinical condition. In major surgical interventions, precise monitoring of the substitution therapy by coagulation assays is essential. || WHEN NOT TO USE IT (§4.4): in acquired deficiency of the vitamin K dependent factors, Octaplex should only be used when rapid correction of prothrombin complex levels is necessary, such as major bleeding or emergency surgery; in other cases, reducing the vitamin K antagonist dose and/or giving vitamin K is usually sufficient. || PAEDIATRIC: §4.2 states 'No data are available regarding the use of Octaplex in paediatric population', so paedDose is null and no paediatric figure has been derived from the adult bands. || Some sections of the product information we used were incomplete — check the full SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Known allergy to heparin or history of heparin induced thrombocytopenia
  • Individuals who have IgA deficiency with known antibodies against IgA
  • PROVENANCE: §4.3 of the Octaplex SPC, complete in the bundle.

Side effects

  • Common: deep vein thrombosis
  • Uncommon: thrombosis, hypertension, pulmonary embolism, bronchospasm, haemoptysis, epistaxis, anxiety, injection site burning, fibrin D-dimer increased, blood thrombin increased, hepatic function abnormal, thrombosis in device
  • Rare: allergic or anaphylactic-type reactions, including severe anaphylactic reactions
  • Very rare: increase in body temperature
  • Risk of thromboembolic episodes following administration of human prothrombin complex
  • Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors; if such inhibitors occur the condition manifests as a poor clinical response
  • Post-marketing (frequency not estimable): anaphylactic shock, hypersensitivity, tremor, cardiac arrest, tachycardia, circulatory collapse, hypotension, dyspnoea, respiratory failure, nausea, urticaria, rash, chills
  • Octaplex contains heparin: a sudden allergy-induced fall in platelet count below 100,000/microlitre or to 50% of the starting count may rarely be observed (thrombocytopenia type II). In patients not previously hypersensitive to heparin this may occur 6-14 days after the start of treatment; in patients with previous heparin hypersensitivity it may happen within a few hours. Treatment must be stopped immediately in patients showing this reaction, and they must not receive heparin-containing medicinal products in future
  • PROVENANCE AND CAVEAT: §4.8 of the Octaplex SPC, which ENDS AT THE SOURCE-FETCH TRUNCATION MARKER — this list is therefore not the label's complete safety profile.

Monitoring

  • INR monitoring during treatment is MANDATORY — the dosing recommendations are empirical and recovery and duration of effect may vary
  • Observe closely for signs or symptoms of intravascular coagulation or thrombosis; there is a risk of thrombosis or disseminated intravascular coagulation in both congenital and acquired deficiency, particularly with repeated dosing
  • Exercise close monitoring when giving human prothrombin complex to patients with a history of coronary heart disease and to patients with liver disease (the §4.4 sentence listing these groups is cut off at the truncation marker)
  • Patients receiving a vitamin K antagonist may have an underlying hypercoagulable state that infusion of prothrombin complex concentrate may exacerbate
  • Platelet count — Octaplex contains heparin; watch for heparin-induced thrombocytopenia type II
  • Stop the infusion immediately if allergic or anaphylactic-type reactions occur, and implement standard medical treatment for shock
  • Specific coagulation factor assays and/or global tests for prothrombin complex levels are essential for precise monitoring in major surgical interventions
  • Record the name and batch number of the administered product every time it is given, to maintain the link between patient and batch (traceability of a plasma-derived biological)
  • Appropriate hepatitis A and B vaccination is recommended for patients in regular or repeated receipt of human plasma-derived prothrombin complex products
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

It rapidly replaces coagulation factors II, VII, IX and X (with proteins C and S), immediately restoring thrombin generation that vitamin K antagonists have suppressed.

Prescribing in practice

  • Administer intravenous vitamin K at the same time, because the effect of PCC is temporary and vitamin K is needed for sustained correction of the INR.
  • It carries a risk of thromboembolism, so use only for genuine indications such as major or life-threatening haemorrhage or urgent surgery, and weigh the thrombotic risk.
  • Dosing is typically guided by body weight and the baseline INR according to local major-haemorrhage protocols and the SPC.

Monitoring

Check the INR before and after administration to confirm reversal, and monitor for bleeding control and any signs of thrombosis.

Counselling the patient

  • Explain to the patient or family that this product rapidly reverses the effect of blood-thinning medication during serious bleeding.
  • Note that vitamin K is given alongside it to keep the reversal durable.
  • Inform the team to remain alert for clotting complications afterwards.

Evidence & guidelines

NICE recommends prothrombin complex concentrate with intravenous vitamin K for emergency reversal of vitamin K antagonist anticoagulation in major bleeding.

Reference: NICE NG185; BSH Guideline on Anticoagulant Reversal 2022; BCSH Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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Prothrombin Complex Concentrate (PCC) is a core drug in the following exam-focused workups on our sister siteReviseMRCEM.

MRCEM Primary / Intermediate / OSCE candidates: each pathway includes exam-style questions, RCEM/NICE citations, and FAQ summaries.