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Clotting Factor
Concentrate Information
FVIII Products
Product
Advate®
FVIII
3rd generation
Recombinant
Image
Product Stability
Stability after
Reconstitution
Packaging
Refrigerated at 36-46°F
Use within 3 hours of
reconstitution
2ml vials for assays lower than 1800 IU: butterfly,
BaxJect transfer device, clotting factor concentrate,
and diluent
Room temperature up to
86°F for 6 months, not to
exceed expiration date
Do not refrigerate after
reconstitution
Freezing damages
diluent only
LEGEND:
VWF
Von Willebrand factor
PD
Plasma derived
IU
International unit
RCo
Ristocetin cofactor
ml
Milliliter
mg
Milligram
Recombinant 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
5ml vials for higher assays: BaxJect transfer device,
clotting factor concentrate, and diluent
Xyntha®
FVIII
3rd generation
Recombinant
Refrigerated at 36-46°F
Kogenate®FS
FVIII
2nd generation
Recombinant
Room temperature up to Use within 3 hours of
77°F for 3 months
reconstitution
Package includes: Clotting factor concentrate, diluent,
transfer needle, filter needle, administration set
May be stored at 36Do not refrigerate after
46°F for up to 30 months reconstitution
or until expiration date,
whichever is sooner
Bio-set includes: Clotting factor concentrate, Band-Aid,
alcohol wipe, butterfly (25 gauge), diluent in syringe
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
Solofuse includes: Clotting factor concentrate, 4 ml
sodium chloride diluent, Band-Aid, gauze, alcohol pad
Do not refrigerate after
reconstitution
R2 Kit includes: Clotting factor concentrate, 4ml
sodium chloride diluent, Band-Aid, gauze, alcohol pad,
syringe with diluent and vial for factor
250-1000 IU assay range: 2.5 ml of diluent
>2000 IU assay range: 5 ml of diluent
©2013 Indiana Hemophilia & Thrombosis Center, Inc.
p1
FVIII & VWF Products
FVIII Products (cont.)
Product
Helixate®
FVIII
2nd generation
Recombinant
Recombinate®
FVIII
1st generation
Recombinant
Image
Product Stability
Stability after
Reconstitution
Packaging
Refrigerated at 36-46° F
Use within 3 hours of
reconstitution
Clotting factor concentrate, sterile water vial,
Mix2Vial transfer device
Do not refrigerate after
reconstitution
250-1000 IU assay range: 2.5 ml of diluent
Room temperature not
to exceed 77°F for up to 3
months
Refrigerated or room
temperature (36-86°F).
Use within 3 hours of
reconstitution
Do not put product stored at
room temperature back into
refrigerator
Do not refrigerate after
reconstitution
Product
Humate-P®
FVIII & VWF
PD
>2000 IU assay range: 5 ml of diluent
Clotting factor concentrate, 5 ml sterile water
vial, transfer device
Image
Product Stability
Stability after
Reconstitution
Packaging
Refrigerated or room
temperature up to
77°F for 2 years or
until expiration date,
whichever is sooner
Use within 3 hours of
reconstitution
Clotting factor concentrate, sterile water vial, transfer
device
Do not refrigerate after
reconstitution
600 VWF:RCo range: 5ml of diluent
Stability: good until
expiration date even
if exposed once to
temperatures up to
104°F for 2 days
Alphanate®
FVIII & VWF
PD
Refrigerated or room
temperature up to 77° F
Stability: up to 7 days at
temperatures between 86104°F
p2
©2013 Indiana Hemophilia & Thrombosis Center, Inc.
©2013 Indiana Hemophilia & Thrombosis Center, Inc.
1200 VWF:RCo range: 10 ml of diluent
2400 VWF:RCo range: 15 ml of diluent
Use within 3 hours of
reconstitution
Clotting factor concentrate, sterile water vial, transfer
device
Do not refrigerate after
reconstitution
250-500 IU assay range: 5 ml of diluent
>1000 IU assay range: 10 ml of diluent
p3
FIX Products
Product
BeneFIX RT®
FIX
3rd generation
Recombinant
Rixubis®
FIX
3rd generation
Recombinant
Mononine®
PD
p4
Image
Bypassing Agents
Product Stability
Stability after
Reconstitution
Packaging
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
Butterfly, Band-Aid, gauze, alcohol wipe, clotting
factor concentrate, 5 ml of diluent in a syringe
regardless of assay size, transfer device
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
Refrigerated at 36-46°F
Do not refrigerate after
reconstitution
Room temperature up to
77°F for up to 1 month
Do not refrigerate after
reconstitution
Image
Product Stability
Stability after
Reconstitution
Packaging
NovoSeven
RT®
Bypassing
agent
Recombinant
Refrigerated or room
temperature
(36-77°F)
Use within 3 hours of
reconstitution
Clotting factor concentrate, Histidine diluent, transfer
device
Do not refrigerate after
reconstitution
Diluent amount matches assay; 5 mg assay has 5ml of
diluent, 2 mg has 2ml, etc.
FEIBA®
Bypassing
agent
PD
Room temperature up
to 77° F
Use within 3 hours of
reconstitution
Clotting factor concentrate, sterile water vial, BaxJect
transfer device
Do not refrigerate after
reconstitution
500-1000 IU assay range: 20 ml of diluent
2500 IU assay range: 50 ml of diluent
BaxJect transfer device, factor, and 5 ml sterile water
vial
Do not refrigerate after
reconstitution
Use within 3 hours of
reconstitution
Product
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
©2013 Indiana Hemophilia & Thrombosis Center, Inc.
©2013 Indiana Hemophilia & Thrombosis Center, Inc.
p5
8402 Harcourt Road, Suite 500, Indianapolis, IN 46260 | Tel: 317-871-0000 | Toll Free: 1-877-256-8837 Fax: 317-871-0010 | www.ihtc.org
Rev 9/13