Plasma derivatives
These are licensed pharmaceutical products. Table 5 (below) provides summary information. Product descriptions are available from manufacturers and in the British National Formulary (BNF).
Coagulation factor concentrates
Recombinant factor VIII and factor IX
In the UK, most patients with severe haemophilia now receive recombinant coagulation factor replacement to avoid risks of transmission of virus infections.
Factor VIII concentrate and factor IX concentrate (plasma derived)
Produced by fractionation of large pools of plasma. Current licensed products are all treated to inactivate viral infections and are not reported to transmit hepatitis or HIV. In many parts of the world, cryoprecipitate or plasma are used to treat haemophilia because plasma derivatives are not available or are, like recombinant products, very expensive.
Factor II, VII, IX and X concentrate (prothrombin complex concentrate, PCC: plasma derived)
The main indication is warfarin overdose where there is life-threatening bleeding (see Table 7). It has been used in patients with haemorrhage, particularly where there is a contraindication to the use of FFP. It has not been tested in clinical trials in this situation. It does not contain factor V or VIII.
Recombinant factor VIIa (NovoSeven®)
This was originally developed for use in haemophilia patients with inhibitors and is licensed for this indication. Other indications for use are still being established. It works by activating coagulation and platelet adhesion, but only if tissue factor is exposed. It requires the presence of platelets and other coagulation factors. Case reports show it can be effective in stopping traumatic, surgical or obstetric haemorrhage, allowing a major bleeding source to be dealt with surgically. The product is not licensed for this indication. There may be risks of thrombotic complications, and as the drug is currently extremely expensive, UK hospitals have special procedures for making it available. It must be used according to local guidelines. Consult hospital blood bank or haematology specialist.
Table 5 Human plasma derivatives
| Human albumin | |
Unit | 4.5% solution or 20% solution Various volumes | |
Active constituents include: | Human albumin | |
Other constituents include: | Sodium: 130−150 mmol/l Other plasma proteins Stabiliser varies with product | |
Licensed indications | Albumin − core SPC covers both 4−5% and 20% products Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. | |
Prescribing and administration | 20% solution: hyperoncotic − risk of fluid overload. 5% solution: use carefully if patient is at risk of sodium retention. | |
Storage | Room temperature. |
| Human immunoglobulin | |
| Intramuscular | Intravenous | |
Unit | Varies with product and supplier | |
Active constituents include: | Human IgG from a large pool of unselected donors or from donors with high levels of anti RhD or anti-viral antibodies | Human IgG from a large pool of unselected donors | |
Other constituents include: | Other immunoglobulins Other plasma proteins | Other immunoglobulin classes Other plasma proteins Stabilisers vary with product | |
Licensed indications | IM / SC immunoglobulin − normal Replacement therapy antibody deficiency syndromes (see Primary antibody deficiency). Hepatitis A prophylaxis. Prevention of RhD immunisation in RhD negative women. (see Prevention of HDN) | IV immunoglobulin Replacement therapy antibody deficiency syndromes (see Primary antibody deficiency). Prevention of RhD immunisation in RhD negative women. (see Prevention of HDN) Treatment of immunological disorders. (see Immunological disorders) | |
Prescribing and administration | Must never be given by IV route. | Closely observe manufacturer’s instructions on infusion rate and dose. | |
Storage | Follow supplier’s instructions. | Follow supplier’s instructions. |
| Clotting factor concentrates |
| Factor VIII | Factor IX | Prothrombin complex concentrate | Others |
Unit | Typically 250−1000 iu in each vial | - FEIBA (factor VIII bypassing activity) concentrate
- Factor VII
- Antithrombin
- Fibrinogen
- Fibrin sealant
- VW factor concentrate
- Protein C
- C1 esterase inhibitor
Recombinant products Factor VIII, IX, VIIa, activated protein C See suppliers’ information |
Active constituents include: | Factor VIII; some products contain vWF | Factor IX | Factors II, IX, X; some products contain factor VII |
Other constituents include: | Other human plasma proteins are present |
Licensed indications | Factor VIII * Treatment and prophylaxis of bleeding in patients with haemophilia A and von Willebrand disease. | Factor IX * Treatment and prophylaxis of bleeding in patients with haemophilia B. | Prothrombin complex concentrate * Treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiencies of factors IX, II or X (and VII), Partial or complete reversal of anticoagulant therapy. (see above and Table 7) | |
Prescribing and administration | Should be used under the guidance of a specialist clinician. | |
Storage | Follow supplier’s instructions. | |
Note:
* In the UK, recombinant products are generally used. |
[Table 5 resources: View large format or download as Word™ document]