20:28.16 Hemostatics
Generic Name
Synonym
Coagulation factor VIIa (recombinant) is available in forms prepared by differing processes. Coagulation factor VIIa (recombinant) (NovoSeven RT, Novo Nordisk) is prepared using the human coagulation factor VII gene in baby hamster kidney (BHK) cells.3371 Coagulation factor VIIa (recombinant)-jncw (Sevenfact, Hema Biologics) is prepared from mammary secretions of rabbits genetically engineered to express human coagulation factor VII.3372
NovoSeven RT: Coagulation factor VIIa (recombinant) (NovoSeven RT, Novo Nordisk) is available as a lyophilized powder in preservative-free single-dose vials containing 1, 2, 5, or 8 mg of coagulation factor VIIa (recombinant) to be reconstituted with the manufacturer-provided histidine diluent.3371 Each vial also contains sodium chloride, calcium chloride, diglycine, polysorbate 80, mannitol, sucrose, and methionine.3371 Trace amounts of mouse or bovine IgG and protein from BHK cells and media may be present.3371 Each 1-, 2-, 5-, or 8-mg vial of coagulation factor VIIa (recombinant) is packaged in a kit with a histidine diluent for reconstitution in either 1.1-, 2.1-, 5.2-, or 8.1-mL vials, respectively, or 1-, 2-, 5-, or 8-mL pre-filled syringes, respectively.3371 Each mL of the histidine diluent contains histidine 1.6 mg (10 mmol) in water for injection.3371
Coagulation factor VIIa (recombinant) should be reconstituted only with the provided histidine diluent according to the product labeling.3371 Prior to reconstitution, the drug and histidine diluent should be allowed to come to room temperature not exceeding 37°C.3371 The manufacturer states that the drug and histidine diluent may be warmed by holding the containers in the hands.3371
Each 1-mg vial of the drug should be reconstituted using 1.1 mL histidine diluent from the vial or the 1-mL histidine diluent prefilled syringe.3371 Each 2-mg vial of the drug should be reconstituted using 2.1 mL histidine diluent from the vial or the 2-mL histidine diluent prefilled syringe.3371 Each 5-mg vial of the drug should be reconstituted using 5.2 mL histidine diluent from the vial or the 5-mL histidine diluent prefilled syringe.3371 Each 8-mg vial of the drug should be reconstituted using 8.1 mL histidine diluent from the vial or the 8-mL histidine diluent prefilled syringe.3371
When adding histidine diluent from the vial to the drug vial using a syringe, the stream of diluent should be directed toward the vial wall and not directly on the lyophilized powder.3371 The vial should be gently swirled until the contents are dissolved.3371
Following reconstitution, the solution contains approximately 1 mg/mL of coagulation factor VIIa (recombinant).3371
Sevenfact: Coagulation factor VIIa (recombinant)-jncw (Sevenfact, Hema Biologics) is available as a lyophilized powder in preservative-free single-dose vials containing 1 or 5 mg of coagulation factor VIIa (recombinant)-jncw to be reconstituted with the manufacturer-provided sterile water for injection.3372 Each vial also contains arginine hydrochloride, isoleucine, trisodium citrate dihydrate, glycine, lysine hydrochloride, and polysorbate 80.3372 Trace amounts of rabbit proteins may be present.3372 Each 1- or 5-mg vial of coagulation factor VIIa (recombinant)-jncw is packaged in a kit with sterile water for injection for reconstitution in 1.1- or 5.2-mL prefilled syringes, respectively.3372
Coagulation factor VIIa (recombinant)-jncw should be reconstituted with the provided sterile water for injection diluent according to the product labeling.3372 Prior to reconstitution, the drug and diluent should be allowed to come to room temperature.3372 The manufacturer states that the drug and diluent may be warmed by holding the containers in the hands.3372
Following reconstitution, the solution contains approximately 1 mg/mL of coagulation factor VIIa (recombinant)-jncw.3372
pH
Reconstituted solutions have a pH of approximately 6.3371; 3372
Trade Name(s)
NovoSeven RT, Sevenfact
NovoSeven RT: Coagulation factor VIIa (recombinant) (NovoSeven RT, Novo Nordisk) is administered intravenously by slow bolus injection over 2 to 5 minutes or as a continuous infusion at a rate of 50 mcg/kg/hr.3371 If needed, sodium chloride 0.9% may be used to flush the infusion line prior to or after administration of the drug.3371 Do not mix with other infusion solutions.3371
Sevenfact: Coagulation factor VIIa (recombinant)-jncw (Sevenfact, Hema Biologics) is administered by intravenous injection over 2 minutes or less.3372
NovoSeven RT: Coagulation factor VIIa (recombinant) (NovoSeven RT, Novo Nordisk) is a white lyophilized powder that forms a clear, colorless solution upon reconstitution with the provided diluent.3371 Intact containers of coagulation factor VIIa (recombinant) and histidine diluent should be stored at 2 to 25°C and protected from light.3371 Do not freeze.3371 Reconstituted solutions may be stored in the vial at room temperature or refrigerated for up to 3 hours; do not freeze or store in syringes.3371 The solution should be used within 3 hours of reconstitution.3371 Any unused solution should be discarded.3371
Sevenfact: Coagulation factor VIIa (recombinant)-jncw (Sevenfact, Hema Biologics) is a white to off-white lyophilized powder that forms a clear to slightly opaque solution upon reconstitution with the provided sterile water for injection.3372 Intact containers of coagulation factor VIIa (recombinant)-jncw and sterile water for injection diluent should be stored at 2 to 30°C and protected from light.3372 Do not freeze.3372 Reconstituted solutions may be stored in the vial at 2 to 30°C for up to 4 hours; do not freeze or store in syringes.3372 The solution should be used within 4 hours of reconstitution.3372 Any unused solution should be discarded 4 hours after reconstitution.3372
Syringes
Manufacturers state that reconstituted solutions should not be stored in syringes.3371; 3372
For a list of references cited in the text of this monograph, search the monograph titled References.