clotting factor concentrate information - ihtc.org · p 4 215 indn op rooss ntr inc. 215 indn op...
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©2015 Indiana Hemophilia & Thrombosis Center, Inc. p 3
LEGEND:
VWF Von Willebrand factorPD Plasma derivedIU International unitRCo Ristocetin cofactorml Milliliter mg Milligram
Recombinant clotting factor concentrate generation definitions:
1st Contains albumin, exposed to human or animal proteins during production2nd No albumin, exposed to human or animal proteins during production3rd No human or animal protein exposure
©2015 Indiana Hemophilia & Thrombosis Center, Inc. p 1©2015 Indiana Hemophilia & Thrombosis Center, Inc.p 4
Product Image Product Stability Stability after Reconstitution
Packaging
Advate®FVIII
3rd generationRecombinant
Refrigerated at 36-46°F
Room temperature up to 86°F for 6 months, not to exceed expiration date
Freezing damages diluent only
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
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
Eloctate®FVIII
3rd generation
Refrigerated at 36-46°F Room temp. up to 86°F for up to 6 months, within the expiration date on the label.
Use within 3 hours of reconstitution.
Do not refrigerate after reconstitution
Factor vial, 3 ml diluent syringe, transfer device.
NovoEight® FVIII
3rd generation
Refrigerated 36-46° F Room temp not to exceed 86°F for up to 12 months
Use within 4 hours of reconstitution.
Do not refrigerate after reconstitution
Factor, 4 ml sodium chloride vial, vial adaptor
FVIII Products
©2015 Indiana Hemophilia & Thrombosis Center, Inc. p 3
FVIII Products (cont.)
©2013 Indiana Hemophilia & Thrombosis Center, Inc.p 2
Product Image Product Stability Stability after Reconstitution
Packaging
Recombinate®FVIII
1st generationRecombinant
Refrigerated or room 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
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
Clotting factor concentrate, 5 ml sterile water vial, transfer device
Product Image Product Stability Stability after Reconstitution
Packaging
Xyntha®FVIII
3rd generationRecombinant
Refrigerated at 36-46°F
May be stored at up to 77°F for up to 3 months or until expiration date, whichever is sooner
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
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
Helixate®FVIII
2nd generationRecombinant
Refrigerated at 36-46° F
Room temperature not to exceed 77°F for up to 3 months
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
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
Kogenate®FSFVIII
2nd generationRecombinant
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
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
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
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FIX Products
Product Image Product Stability Stability after Reconstitution
Packaging
Alprolix®FIX
3rd Generation
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.
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
Factor vial, 5 ml diluent syringe, transfer device
BeneFIX RT®FIX
3rd generationRecombinant
Refrigerated or room temperature (36-86°F) for up to 2 years or until expiration date, whichever is sooner
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
Butterfly, Band-Aid, gauze, alcohol wipe, clotting factor concentrate, 5 ml of diluent in a syringe regardless of assay size, transfer device
Ixinity®FIX
3rd generation
Refrigerated or room temperature (36°F-77°F)
Use within 3 hours of reconstitution.
Do not refrigerate after reconstitution
Factor, 5 ml sterile water in a syringe, 20 ml syringe for administration
FVIII & VWF Products
Product Image Product Stability Stability after Reconstitution
Packaging
Alphanate®FVIII & VWF
PD
Refrigerated or room temperature up to 77° F
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
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
Humate-P® FVIII & VWF
PD
Refrigerated or room 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
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
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
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Product Image Product Stability Stability after Reconstitution
Packaging
FEIBA®Bypassing
agentPD
Room temperature up to 77° F
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
Clotting factor concentrate, sterile water vial, BaxJect transfer device
500-1000 IU assay range: 20 ml of diluent2500 IU assay range: 50 ml of diluent
NovoSeven RT®
Bypassing agent
Recombinant
Refrigerated or room temperature (36-77°F)
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
Clotting factor concentrate, Histidine diluent, transfer device
Diluent amount matches assay; 5 mg assay has 5ml of diluent, 2 mg has 2ml, etc.
Bypassing AgentsFIX Products
Product Image Product Stability Stability after Reconstitution
Packaging
Rixubis®FIX
3rd generationRecombinant
Refrigerated at 36-46°F for up to 18 months or room temperature up to 86°F for up to 6 months, within the 18 month period.
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
BaxJect transfer device, factor, and 5 ml sterile water vial
Mononine®PD
Refrigerated at 36-46°F
Room temperature up to 77°F for up to 1 month
Use within 3 hours of reconstitution
Do not refrigerate after reconstitution
Clotting factor concentrate, Sterile water vial, transfer needle, filter needle, winged infusion set, alcohol swab
500 IU assay range: 5 ml of diluent1000 IU assay range: 10 ml of diluent