human prothrombin complex at a glance
Medicine class
Plasma-derived coagulation-factor concentrate containing factors II, VII, IX and X.
Main licensed role
Rapid correction of vitamin K-dependent clotting-factor deficiency during bleeding or around surgery.
Administration
Reconstituted and given slowly into a vein under specialist supervision.
Important risk
It can occasionally cause harmful blood clots, so patients require observation.
What is human prothrombin complex used for?
Licensed uses represented by the selected product include:
Treating bleeding or preventing bleeding around surgery when acquired deficiency of vitamin K-dependent factors requires rapid correction, including deficiency caused by vitamin K antagonists.
Treating bleeding or preventing perioperative bleeding in congenital deficiency of vitamin K-dependent factors when an appropriate purified individual-factor concentrate is unavailable.
Specialists may also use it for severe bleeding associated with some direct oral anticoagulants, but this is not a licensed indication of the selected product.
How does human prothrombin complex work?
It replaces vitamin K-dependent clotting factors II, VII, IX and X. These support thrombin generation and the conversion of fibrinogen into fibrin, temporarily correcting the clotting defect so a stable clot can form.
human prothrombin complex preparations and strengths
Injection
Route: Parenteral
Strengths: 500 units, 1500 units
How to take human prothrombin complex
This intravenous treatment is prepared from powder and sterile water, then administered by trained healthcare professionals.
The prepared solution should be clear or slightly opalescent; cloudy solutions or those containing deposits must not be used.
It must not be mixed with other medicines in the same preparation.
Food and drink do not affect its administration.
human prothrombin complex side effects
Common or expected effects
- Fever
- Headache
- Nausea or vomiting
- Flushing
- Itching, rash or hives
Get urgent medical advice
- Severe allergic reaction, including wheezing, swelling, low blood pressure or anaphylactic shock
- Arterial or venous blood clots, including heart attack, stroke, deep-vein thrombosis or pulmonary embolism
- Disseminated intravascular coagulation
- Antibodies against clotting factors, which may cause a poor response
human prothrombin complex in pregnancy
Safety during pregnancy has not been established. Use should be limited to situations where a specialist considers it clearly indicated. Clinicians should also consider the residual risk from plasma-derived infections, particularly parvovirus B19.
human prothrombin complex while breastfeeding
There are insufficient data to establish safety during breastfeeding. Use should be limited to situations where a specialist considers it clearly indicated.
human prothrombin complex interactions
Formal interaction studies are limited. Important practical interactions include:
Vitamin K antagonists, such as warfarin
Human prothrombin complex counteracts their anticoagulant effect by replacing depleted clotting factors.
Other intravenous medicines
Do not mix them with human prothrombin complex because compatibility, effectiveness and tolerability may be impaired.
Common questions about human prothrombin complex
Answers are fully visible for fast scanning and source review.
Is human prothrombin complex made from donated blood?
Yes. It is manufactured from pooled human plasma using donor screening, testing and pathogen-reduction processes, although infection transmission cannot be completely excluded.
Which clotting factors does it contain?
The selected product contains factors II, VII, IX and X, together with co-purified protein C.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.