clotting factor concentrate information - ihtc.org · p 4 215 indn op rooss ntr inc. 215 indn op...

Clotting FactorConcentrate Information

helping patients thrive

©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.


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



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


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



Clotting factor concentrate, 5 ml sterile water vial, transfer device


Packaging

Xyntha®FVIII



May be stored at up to 77°F for up to 3 months or until expiration date, whichever is sooner



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



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



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



FIX Products


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.



Factor vial, 5 ml diluent syringe, transfer device

BeneFIX RT®FIX


Refrigerated or room temperature (36-86°F) for up to 2 years or until expiration date, whichever is sooner



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)



Factor, 5 ml sterile water in a syringe, 20 ml syringe for administration

FVIII & VWF Products


Packaging

Alphanate®FVIII & VWF

PD

Refrigerated or room temperature up to 77° F



Clotting factor concentrate, sterile water vial, transfer device

250-500 IU assay range: 5 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



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



Packaging

FEIBA®Bypassing

agentPD

Room temperature up to 77° F



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)



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


Packaging

Rixubis®FIX


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.



BaxJect transfer device, factor, and 5 ml sterile water vial

Mononine®PD


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 diluent1000 IU assay range: 10 ml of diluent

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

clotting factor concentrate information - ihtc.org · p 4 215 indn op rooss ntr inc. 215 indn op...

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