Table 1: Coagulation-factor concentrates used in Canada for the management of hemophelia* | |||||||
Factor concentrate | Manufacturer | Viral inactivation procedure | Purity standard | Maximum specific activity, IU/mg protein | BOB licensed | Funded by CBA and available through CRC | Cost per unit+ |
Factor VIII | |||||||
Factor VII HP | CRC-Bayer | Solvent-detergent treatment | High | 50-60~ | Yes | Yes | 0.20 |
Hemofil M | Baxter | Solvent-detergent treatment | Ultra high | >= 3000~ | Yes | Yes | 0.76 |
Kogenate | Bayer | No specific step§ | Recombinant | >= 3000~ | Yes | Yes | 0.75 |
Recombinate | Baxter | No specific step§ | Recombinant | >= 3000~ | Yes | No|| | 1.06 |
Haemate P | Behring | Pasteurization | Intermediate | 2.3-5 | No¶ | Yes | 1.00 |
Hyate:C (porcine Factor VIII) | Speywood | No specific step | High | >= 140 | Yes | Yes | 1.35 |
Factor IX (prothrombin complex) | |||||||
Bebulin | Immuno | Vapour heating | Intermediate | 1-3 | Yes | Yes | 0.26 |
FEIBA | Immuno | Vapour heating | Low to intermediate | 0.75-2.5 | Yes | Yes | 1.02 |
Factor IX (high purity) | |||||||
Alphanine SD | Alpha | Solvent-detergent treatment | High | 182 ± 34 | No¶ | Yes | 0.58 |
Immunine | Immuno | Vapour heating | High | 100 ± 50 | No¶ | Yes | 0.58 |
Mononine | Armour | Sodium thiocyanate treatment plus ultrafiltration | High | 188 ± 14 | No | No|| | 0.74 |
Factor VIIa | |||||||
Niastase | Novo Nordisk | No specific step | Recombinant | NA | No | No** | NA |
*BOB=Bureau of Biologics, CBA=Canadian Blood Agency, CRC=Canadian Red Cross Society Blood Services, NA=not available
+In Canadian dollars as of February 1995. Cost will vary according to contracts and availability.
~Before human albumin is added as a stabilizer. The specific activity in the final formulation containing added human albumin is much less.
§Specific viral inactivation procedures are not used, but some of the manufacturing or purification steps have virus reduction or removal capability.
||May be obtained by special application when adverse reactions to equivalent products occur.
¶BOB licensure has been applied for.
**May be obtained for specific patients on compassionate release basis.