factor II + factor IX + factor VII + factor X + protein c + protein s: clinical use

Prescribing considerations

• Seek advice from a clinician experienced in coagulation disorders.
• For acquired deficiency, reserve use for situations requiring rapid correction, such as major bleeding or emergency surgery.
• Use a purified specific factor product for congenital deficiency when available.
• Assess thrombotic risk carefully, including coronary disease, previous myocardial infarction, liver disease, perioperative status, neonatal use and known hypercoagulability.
• Consider sodium content in patients requiring sodium restriction.
• For repeated exposure, consider hepatitis A and B immunisation and maintain product-and-batch traceability.
• Safety and efficacy in children and adolescents have not been established in controlled clinical studies.

Contraindications and cautions

• Hypersensitivity to an active component or excipient.
• Known history of heparin-induced thrombocytopenia.
• Disseminated intravascular coagulation unless the consumptive state has ended.

Monitoring

• Clinical haemostasis and ongoing bleeding.
• INR or other global prothrombin-complex tests where appropriate.
• Relevant individual clotting-factor levels for congenital deficiencies or major surgery.
• Signs of thrombosis or disseminated intravascular coagulation.
• Platelet count and new thrombotic events when heparin-induced thrombocytopenia is a concern.
• Unexpected poor response, which may indicate an inhibitor.
• Product name and batch number for every administration.

Clinical pharmacology

A plasma-derived four-factor prothrombin complex concentrate containing factors II, VII, IX and X plus proteins C and S. Intravenous administration immediately increases circulating factor levels; the components are handled similarly to endogenous coagulation proteins but persist for differing periods.

Formulation and product differences

• Supplied as powder with water for injections and requiring aseptic reconstitution before intravenous administration.
• Contains heparin, human albumin, human antithrombin III, sodium chloride and sodium citrate.
• The reconstituted solution must not be diluted or mixed with other medicinal products and should be used immediately from a microbiological perspective.