Table V.
Clotting Factor Concentrates Available in the USA
| Brand | Manufacturer | Source | Fractionation | Viral inactivation | Comments on production and final formulation | Diluent and volumea | Shelf‐lifeb and storagec | Dosagesd and infusion ratee |
|---|---|---|---|---|---|---|---|---|
| Recombinant factor VIII concentrates | ||||||||
| Advate | Baxter | CHOf | IACg, IECh | TNBPi/PS80j | No added animal or human proteins in any step, no vWFk, trehalose as a stabilizer | Water; 5 | 24; R or RT 6 mos | A; 5–10 |
| Helixate FS | ZLB Behring | BHKl | IEC, IAC | TNBP/PS80,TX100m | HSAn as a cell nutrient; formulated with sucrose, no vWF | Water; 2.5 | 23; R | B; 5–10 |
| Kogenate FS | Bayer | BHK | IE, IAC | TNBP/PS80,TX100 | HSA as a cell nutrient; formulated with sucrose, no vWF | Water; 2.5 | 24; R RT (3 mos) | B; 5–10 |
| Recombinate | Baxter | CHO | IEC, IAC | IAC, IEC | BSAo as a cell nutrient; HSA added, no vWF | Water; 10 | 36; R or RT | B; 10 |
| ReFacto | Wyeth | CHO | IE | TNBP/TX100, nanofiltration | HSA as a cell nutrient; formulated with sucrose, no vWF | Saline; 4 | 24; R or RT (3 mos) | C; several minutes |
| Plasma derived factor VIII concentrates | ||||||||
| Alphanate | Grifols | US plasma | HLCp | TNBP/PS80, dry heat | Albumin added, contains vWF | 5 (500 IU) 10 (others) | 24; R or RT (2 mos) | A; 10 |
| Hemofil M | Baxter | US plasma | MACq, IEC | TNBP/Octoxynol 9 | Albumin added, no functional vWF | 10 | 30; R RT (3 mos) | C; 10 |
| Humate P | ZLB Behring | plasma | Multiple precipitation | Pasteurizationr | Human albumin added, contains vWF | 10 (250 IU) 20 (500IU) 30 (1000 IU); R or RT (6 mos) | 24; 4 ml per min | A; 10 |
| Koate DVI | Bayer | US plasma | Multiple precipitation, SECs | TNBP/PS80, dry heat | Albumin added, contains vWF | 5 (250, 500 IU) 10 (1000 IU) | 24; R or RT (6 mos) | A; 5–10 |
| Monoclate P | ZLB Behring | US plasma | MAC, IEC | Pasteurization | Albumin added, no functional vWF | 10 (250, 500) 20 (1000, 1500) | 24; R or RT 6 mos | A; 2 |
| Recombinant factor IX concentrate | ||||||||
| BeneFIX | Wyeth | CHO | AC, nanofiltration | None | No albumin added | 5 (250, 500 IU) 10 (1000 IU) | 24; R or RT (6 mos) | A; several minutes |
| Highly purified plasma derived factor IX concentrates | ||||||||
| Alphanine | Grifols | US plasma | IEC, CLCt | TNBP/PS80, nanofiltration | No albumin added | 10 (500, 1000, 1500) | 24; R or RT 1 month | D; 10 |
| Mononine | ZLB Behring | US plasma | IAC | Sodium thiocyanate, dual ultrafiltration | Histidine and mannitol added | 2.5 (250 IU) 5 (500) 10 (1000 IU) | 24; R or RT (1 month) | A; 2 |
| Prothrombin complex concentrates | ||||||||
| Bebulin | Baxter | US plasma | IEC | Vapor heatu | Heparin added | 20 | 24 | 500–700 |
| Profilnine SD | Grifols | US plasma | DEAEv cellulose adsorption | TNBP/PS80 | No albumin or heparin added | 5 (500) 10 (1000, 1500 IU | 24 | D |
| Proplex T | Baxter | US plasma | Tri‐calcium phosphate and PEG adsorption | 20% ethanol, dry heat (60°C for 144 hr) | Heparin added | 30 | 24 | 700–3900 |
| Inhibitor bypassing agents | ||||||||
| FEIBA VH | Baxter | US plasma | IEC | Vapor heat | No heparin added | 20 | 24 | 400–2500 |
| NovoSeven | NovoNordisk | BHK | ACw | Solvent detergent | No albumin | 2.2, 4.3, 8.5 | 36 | 1.2, 2.4, 4.8x |
Diluent volume (ml) for injection.
Shelf‐life in months, do not use beyond the expiration date printed on the bottle.
R, refrigeration; RT, room temperature (duration in months).
Dosages available in International Units (IU): A, 250, 500, 1000, 1500; B, 250, 500, 1000; C, 250, 500, 1000, 2000; D, 500, 1000, 1500.
Infusion rate not to be exceeded as recommended by the manufacturer in ml per minute.
CHO, Chinese hamster ovary cells.
IAC, immunoaffinity chromatography.
IEC, Ion exchange chromatography.
TNBP, tri(n‐butyl)phosphate.
Polysorbate 80.
vWF, von willebrand factor.
BHK, baby hamster kidney cells.
TX‐100, Triton X‐100.
HAS, human serum albumin.
BSA, bovine serum albumin.
HLC, heparin ligand chromatography.
MAC, monoclonal antibody affinity chromatography.
60°C, 10 hr.
SEC, size exclusion chromatography.
CLC, carbohydrate ligand chromatography.
60°C, 10 hr at 190 mbar then 80°C for 1 hr at 375 mbar.
DEAE, diethylaminoethyl‐.
AC, affinity chromatography.
Recombinant activated factor VII dosage in mg.
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