Routine antenatal anti-D prophylaxis for women who are rhesus D negative

3 The technologies

3.1 D-Gam (Bio Products Laboratory) is extracted by fractionation and is suitable for intramuscular use only. It is sold as a solution ready for injection, and is available in vials containing 250, 500, 1500 or 2500 IU. The 500 IU dose has UK marketing authorisation for RAADP at 28 and 34 weeks gestation in non-sensitised women who are RhD negative, for use after potentially sensitising events that occur after 20 weeks gestation, and for use after the birth of an RhD-positive baby. The 250 IU dose has UK marketing authorisation for use after potentially sensitising events up to 20 weeks gestation, and the 1500 and 2500 IU doses have UK marketing authorisation for the treatment of large FMHs. D-Gam also has UK marketing authorisation for the treatment of people who are RhD negative and who have had transfusions of RhD-positive blood or blood products.

3.2 Partobulin SDF (Baxter BioScience) is prepared by a modified fractionation process and is suitable for intramuscular use only. It is available in prefilled syringes containing 1250 IU. For RAADP, it has UK marketing authorisation for two intramuscular doses of 1000–1650 IU given at 28 and 34 weeks gestation. It also has UK marketing authorisation for use post partum, for use after potentially sensitising events, and for the treatment of people who are RhD negative and who have had transfusions of RhD-positive blood or blood products.

3.3 Rhophylac (CSL Behring) is extracted by cation-exchange column chromatography and may be given intramuscularly or intravenously. It is available in prefilled syringes containing 1500 IU. It has UK marketing authorisation for RAADP as a single dose of 1500 IU given between 28 and 30 weeks gestation. It also has UK marketing authorisation for use post partum, for use after potentially sensitising events, and for the treatment of people who are RhD negative and who have had transfusions of RhD-positive blood or blood products.

3.4 WinRho SDF (Baxter BioScience) is extracted by anion-exchange column chromatography and may be given intravenously or intramuscularly. It is available as a powder for reconstitution. It has UK marketing authorisation for RAADP at a single dose of 1500 IU to be given at 28 weeks gestation. It also has UK marketing authorisation for use post partum, for use after potentially sensitising events, and for the treatment of people who are RhD negative and who have had transfusions of RhD-positive blood or blood products. In the UK, it is currently marketed solely for the treatment of idiopathic thrombocytopenic purpura.

3.5 All preparations of anti-D immunoglobulin carry a small risk of localised or generalised allergic reactions. Anti-D immunoglobulin is extracted from donor blood and, although blood donors are carefully screened for transmissible infections, there is always a small risk of the transmission of blood-borne infections. For full details of side effects and contraindications, see the summary of product characteristics for each technology.

3.6 D-Gam costs £27 per 500-IU vial (£54 per two-dose course). Partobulin SDF costs £35 per 1250-IU prefilled syringe (£70 per two-dose course). Rhophylac costs £46.50 per 1500-IU prefilled syringe. WinRho SDF costs £313.50 per 1500-IU vial. All costs exclude VAT and are from the 'British national formulary' (edition 53). Costs may vary in different settings because of negotiated procurement discounts.