helping patients thrive Clotting Factor Concentrate Information

helping patients thrive Clotting Factor Concentrate Information

LEGEND: VWF Von Willebrand factor Plasma derived IU International unit RCo Ristocetin cofactor ml Milliliter mg Milligram clotting factor concentrate generation definitions: 1st Contains albumin, exposed to human or animal proteins during production 2nd No albumin, exposed to human or animal proteins during production 3rd No human or animal protein exposure 2015 Indiana Hemophilia & Thrombosis Center, Inc. p 3

Products Advate Eloctate Room temperature up to 86 F for 6 months, not to exceed expiration date Freezing damages diluent only Room temp. up to 86 F for up to 6 months, within the expiration date on the label.. 2ml vials for assays lower than 1800 IU: butterfly, BaxJect transfer device, clotting factor concentrate, and diluent 5ml vials for higher assays: BaxJect transfer device, clotting factor concentrate, and diluent Factor vial, 3 ml diluent syringe, transfer device. NovoEight Refrigerated 36-46 F Room temp not to exceed 86 F for up to 12 months Use within 4 hours of. Factor, 4 ml sodium chloride vial, vial adaptor p 4 2015 Indiana Hemophilia & Thrombosis Center, Inc. 2015 Indiana Hemophilia & Thrombosis Center, Inc. p 1

Products (cont.) Xyntha Helixate 2nd generation May be stored at up to 77 F for up to 3 months or until expiration date, whichever is sooner Refrigerated at 36-46 F Room temperature not to exceed 77 F for up to 3 months Solofuse includes: Clotting factor concentrate, 4 ml sodium chloride diluent, Band-Aid, gauze, alcohol pad R2 Kit includes: Clotting factor concentrate, 4ml sodium chloride diluent, Band-Aid, gauze, alcohol pad, syringe with diluent and vial for factor Clotting factor concentrate, sterile water vial, Mix2Vial transfer device 250-1000 IU assay range: 2.5 ml of diluent >2000 IU assay range: 5 ml of diluent Recombinate 1st generation temperature (36-86 F). Do not put product stored at room temperature back into refrigerator Stability: up to 7 days at temperatures between 86-104 F Clotting factor concentrate, 5 ml sterile water vial, transfer device Kogenate FS 2nd generation Room temperature up to 77 F for 3 months May be stored at 36-46 F for up to 30 months or until expiration date, whichever is sooner Package includes: Clotting factor concentrate, diluent, transfer needle, filter needle, administration set Bio-set includes: Clotting factor concentrate, Band-Aid, alcohol wipe, butterfly (25 gauge), diluent in syringe 250-1000 IU assay range: 2.5 ml of diluent >2000 IU assay range: 5 ml of diluent p 2 2013 Indiana Hemophilia & Thrombosis Center, Inc. 2015 Indiana Hemophilia & Thrombosis Center, Inc. p 3

& VWF Products Products Alphanate & VWF Humate-P & VWF temperature up to 77 F temperature up to 77 F for 3 years or until expiration date on vial, whichever is sooner Stability: good until expiration date even if exposed once to temperatures up to 104 F for 2 days Clotting factor concentrate, sterile water vial, transfer device 250-500 IU assay range: 5 ml of diluent >1000 IU assay range: 10 ml of diluent Clotting factor concentrate, sterile water vial, transfer device 600 VWF:RCo range: 5ml of diluent 1200 VWF:RCo range: 10 ml of diluent 2400 VWF:RCo range: 15 ml of diluent Alprolix 3rd Generation Bene RT Ixinity Refrigerated 36-46 F Room temp. up to 86 F for 6 months, not to exceed expiration date. Do not put back in refrigerator after warming to room temperature. temperature (36-86 F) for up to 2 years or until expiration date, whichever is sooner temperature (36 F-77 F). Factor vial, 5 ml diluent syringe, transfer device Butterfly, Band-Aid, gauze, alcohol wipe, clotting factor concentrate, 5 ml of diluent in a syringe regardless of assay size, transfer device Factor, 5 ml sterile water in a syringe, 20 ml syringe for administration p 4 2015 Indiana Hemophilia & Thrombosis Center, Inc. 2015 Indiana Hemophilia & Thrombosis Center, Inc. p 5

Products Bypassing Agents Rixubis for up to 18 months or room temperature up to 86 F for up to 6 months, within the 18 month period. BaxJect transfer device, factor, and 5 ml sterile water vial FEIBA Bypassing agent Room temperature up to 77 F Clotting factor concentrate, sterile water vial, BaxJect transfer device 500-1000 IU assay range: 20 ml of diluent 2500 IU assay range: 50 ml of diluent Mononine Room temperature up to 77 F for up to 1 month Clotting factor concentrate, Sterile water vial, transfer needle, filter needle, winged infusion set, alcohol swab 500 IU assay range: 5 ml of diluent 1000 IU assay range: 10 ml of diluent NovoSeven RT Bypassing agent temperature (36-77 F) Clotting factor concentrate, Histidine diluent, transfer device Diluent amount matches assay; 5 mg assay has 5ml of diluent, 2 mg has 2ml, etc. p 6 2015 Indiana Hemophilia & Thrombosis Center, Inc. 2015 Indiana Hemophilia & Thrombosis Center, Inc. p 7

8326 Naab Rd, Indianapolis, IN 46260 Tel: 317-871-0000 Toll Free: 1-877-256-8837 Fax: 317-871-0010 www.ihtc.org Rev 7/15