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4-factor prothrombin complex concentrate (PCC) Pregnancy: Safety in human pregnancy and lactation has not been established, and animal studies are not suitable to assess it - human prothrombin complex should be used during pregnancy and lactation only if clearly indicated (UK SPC 4.6). Note that parvovirus B19 infection, against which the manufacturing measures are of limited value, may be serious for pregnant women.

Dried prothrombin complex

Brand names: Beriplex, Octaplex

Dried prothrombin complex concentrate is a plasma-derived product containing vitamin K-dependent clotting factors, used to reverse vitamin K antagonist anticoagulation and to treat or prevent bleeding due to deficiency of these factors.

Adult dose

Dose: Bleeding and perioperative prophylaxis of bleeding during vitamin K antagonist treatment: the dose depends on the pre-treatment INR and body weight, given as units of factor IX per kg body weight - pre-treatment INR 2 to <4: 25 units/kg; INR 4 to 6: 35 units/kg; INR >6: 50 units/kg
Route: Intravenous, using an aseptic technique, at a rate of 0.12 ml/kg/min (approximately 3 units/kg/min), up to a maximum rate of 8 ml/min (approximately 210 units/min)
Frequency: A single dose guided by the pre-treatment INR; repeated treatment with human prothrombin complex is not usually required when vitamin K has been administered simultaneously. Monitoring of INR during treatment is mandatory, as these recommendations are empirical and recovery and duration of effect may vary
Max: Maximum single dose 2500 IU for an INR of 2 to <4, 3500 IU for an INR of 4 to 6, and 5000 IU for an INR of >6 - dose is based on body weight up to, but not exceeding, 100 kg, so these ceilings apply to patients weighing more than 100 kg
The SPC gives only general dosage guidelines; treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders, and the advice of a specialist experienced in the management of coagulation disorders should be sought. In patients with acquired deficiency of the vitamin K dependent coagulation factors (e.g. induced by vitamin K antagonist treatment), this product 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 dose of the vitamin K antagonist and/or administering vitamin K is usually sufficient. Correction of vitamin K antagonist induced impairment of haemostasis persists for approximately 6-8 hours, whereas the effects of simultaneously administered vitamin K are usually achieved within 4-6 hours. Patients receiving a vitamin K antagonist may have an underlying hypercoagulable state which infusion of prothrombin complex concentrate may exacerbate. SEPARATE INDICATION - bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when a specific coagulation factor product is not available: the dose is calculated, not tabulated. 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; required units = body weight (kg) x desired factor X rise (IU/ml) x 60, and for factor II required units = body weight (kg) x desired factor II rise (IU/ml) x 50. If the individual recovery is known, that value should be used for the calculation. Dosage intervals must be adapted to the different circulating half-lives of the individual coagulation factors in the prothrombin complex. The product contains heparin. PAEDIATRIC: no paediatric dose is published here because the SPC states 'No data are available regarding the use of Octaplex in paediatric population' - obtain paediatric guidance from a children's formulary and local major-haemorrhage protocol. 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
  • Known allergy to heparin or a history of heparin induced thrombocytopenia
  • Individuals who have IgA deficiency with known antibodies against IgA

Side effects

  • Deep vein thrombosis (common)
  • Thrombosis, hypertension, anxiety (uncommon)
  • Pulmonary embolism, bronchospasm, haemoptysis, epistaxis (uncommon)
  • Injection site burning (uncommon)
  • Increased fibrin D-dimer, increased blood thrombin, abnormal hepatic function (uncommon)
  • Thrombosis in device (uncommon)
  • Allergic or anaphylactic-type reactions including severe anaphylactic reactions (rare); post-marketing: anaphylactic shock, hypersensitivity
  • Increase in body temperature (very rare)
  • Post-marketing: tremor, cardiac arrest, tachycardia, circulatory collapse, hypotension, dyspnoea, respiratory failure, nausea, urticaria, rash, chills
  • Contains heparin - a sudden, allergy-induced fall in platelet count below 100,000/microlitre or to 50% of the starting count (type II thrombocytopenia) may rarely be observed
  • Replacement therapy may lead to circulating antibodies inhibiting one or more of the human prothrombin complex factors, manifesting as a poor clinical response
  • Theoretical risk of transmission of infective agents, as with any medicinal product prepared from human blood or plasma

Monitoring

  • Monitoring of INR during treatment is mandatory
  • Identify individual dosage requirements from regular determinations of individual plasma levels of the coagulation factors of interest, or from global tests of prothrombin complex levels (prothrombin time, INR), with continuous monitoring of the clinical condition
  • Precise monitoring of substitution therapy by coagulation assays is essential in major surgical interventions
  • Watch for thrombosis and disseminated intravascular coagulation, and for thromboembolic episodes after administration
  • Monitor the platelet count where heparin-induced thrombocytopenia is a concern (a fall below 100,000/microlitre or to 50% of the starting count)
  • Stop the infusion immediately if allergic or anaphylactic-type reactions occur, and implement standard treatment for shock
  • Record the name and batch number of the administered product each time, for traceability
  • Appropriate hepatitis A and B vaccination is recommended for patients in regular or repeated receipt of human plasma-derived prothrombin complex products

Clinical monograph

How it works

It rapidly replaces clotting factors II, VII, IX and X, restoring thrombin generation and the coagulation cascade.

Prescribing in practice

  • Carries a risk of thromboembolic complications including disseminated intravascular coagulation, so it should be reserved for clear indications and given with careful clinical assessment.
  • When used to reverse a vitamin K antagonist, concurrent intravenous vitamin K is usually required because the effect of the concentrate is temporary.
  • Being plasma-derived, it carries a theoretical risk of transmissible infection despite manufacturing safety steps, and the brand and batch should be recorded.

Monitoring

Monitor coagulation parameters such as the INR and clinical signs of bleeding or thrombosis before and after administration.

Counselling the patient

  • Tell the team about any history of clots, heart disease or previous reactions to blood products.
  • Report symptoms of a clot, such as leg swelling, chest pain or breathlessness, promptly.

Evidence & guidelines

Prothrombin complex concentrate is recommended for emergency reversal of vitamin K antagonists in major bleeding by NICE and haematology guidelines.

Reference: BSH warfarin reversal guideline; NICE NG24; NICE NG143; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. 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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