Factor VIII OnlyAdvate®

Alphanate®

Eloctate®

Helixate® FS

Hemofil M

Humate - P®

Koate® - DVI

Kogenate® FS with Vial Adapter®

Kogenate® FS with Bioset®

Monoclate - P®

NovoEight®

Recombinate

Wilate®

Xyntha®

Xyntha® Solofuse™

Antihemophilic Products

Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product’s manufacturer.

Antihemophilic Products - Factor VIII Only

800.746.6273 asdhealthcare.com

Product

Manufacturer

Advate® Antihemophilic Factor

Baxalta Inc.(800) 423-2090

baxalta.com advate.com

Alphanate® Contains von Willebrand Factor

Grifols(800) 520-2807grifolsusa.com alphanate.com

Eloctate®

Biogen(855) 693-5628eloctate.com

myeloctate.com

Indications In adults and children with Hemophilia A: control and prevention of bleeding episodes; perioperative management; routine prophylaxis to prevent or reduce the frequency of bleeding. Advate is not indicated for the treatment of von Willebrand disease.

Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Adults and children with Hemophilia A (congential Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management, routine prophylaxis to prevent or reduce frequency of bleeding episodes; Eloctate is not indicated for the treament of von Willebrand disease

Contraindications Life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione)

Life threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE

Product Source Recombinant Plasma Recombinant – rFVIIIfc

Labelling for Removal of Pathogenic Prions

N / A Yes; manufacturing process includes steps that provide a reasonable assurance that low levels of a vCJD model agent, if present in the starting material, would be removed

N / A

Viral Removal Solvent-detergent treatment; immunoaffinity chromatography; cation exchange chromatography

PEG fractionation, Affinity Chromatography and Salt precipitation

Detergent treatment; 15 nm filtration

Half-Life In patients >16 yrs: 12.03 ± 4.15 hours; infants (1 month to <2 yrs): 8.86 ± 1.78; 2 to 5 yrs old: 10.27 ± 1.94; 5 to 12 yrs old: 10.89 ± 1.60; 12 to 16 yrs old: 11.70 ± 3.72 hours

17.9 ± 9.6 hours in hemophilia A patients; 7.67 ± 3.3 hours for VWF: RCo in VWD patients; 21.6 ± 7.8 hours for FVIII: C in VWD patients

Adults: 19.7 ± 2.3 hours; 12-17 yrs: 16.4 ± 2.3 hours; 6-11 yrs: 14.6 ± 3.1 hours; 2-5 yrs: 12 ± 2.45 hours

Recovery In patients >16 yrs: 2.57 ± 0.53 IU / dL / IU / kg; infants (1 month <2 yrs): 1.96 ± 0.21; 2 to 5 yrs old: 2.05 ± 0.62; 5 to 12 yrs old: 2.21 ± 0.44; 12 to 16 yrs old: 2.26 ± 0.42 IU / dL / IU / kg

96.7 ± 14.5% (mean ± SD) hours in hemophilia A patients; 3.3 ± 1.5 (IU / dL) / (IU / kg) for VWF:RCo in VWD patients; 2.1 ± 0.6 (IU / dL) / (IU / kg) for FVIII:C in VWD patients

2.26 IU / dL / IU / kg

Packaged Product Storage

Refrigerate at 2° – 8° C (36° – 46° F); RT ≤30° C (86° F) for ≤ 6 months; do not return to refrigerated temperature; do not freeze

36 months, up to printed expiration date at ≤ 25° C (77° F); do not freeze

2° – 8° C (36° F – 46° F) refrigerate; RT ≤30° C (86° F) for ≤ 6 months; do not freeze; protect from light

Storage After Reconstitution

Use within 3 hours; do not store or refrigerate RT; use within 3 hours RT < 30° C; use within 3 hours

Stabilizer In 5 mL reconstituted vial: Tris 10 mM, calcium chloride 1.7 mM, mannitol 3.2% (w / v), sodium chloride 90 mM, α, α-trehalose 0.8% (w / v), histidine 10 mM, glutathione (reduced) 0.08 mg / mL, polysorbate 80 0.01% (w / v); In 2 mL reconstituted vial: Tris 25 mM, calcium chloride 4.2 mM, mannitol 8% (w / v), sodium chloride 225 mM, α, α-trehalose 2% (w / v), histidine 25 mM, glutathione (reduced) 0.2 mg / mL, polysorbate 80 0.025% (w / v); the final product contains no more than 2 ng VWF / IU rAHF, which will not have any clinically relevant effect in patients with von Willebrand disease

Albumin added Sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20

Diluent Volume 2 mL / 5 mL 5 mL / 10 mL 3 mL

Available Sizes 250 / 500 / 1000 / 1500 / 2000 / 3000 / 4000 IU 250 / 500 / 1000 / 1500 / 2000 IU FVIII 250 / 500 / 750 / 1000 / 1500 / 2000 / 3000 IU

While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information.  © 2015 ASD Healthcare. Chart updated November 2015.

Helixate® FS

CSL Behring(800) 504-5434

cslbehring-us.com helixatefs.com

Hemofil MAntihemophilic Factor ( Human ), Method M, Monoclonal Purified

Baxalta Inc. (800) 423-2090

baxalta.com

Humate-P® Contains von Willebrand Factor

CSL Behring(800) 504-5434

cslbehring-us.com humate-p.com

Control and prevention of bleeding episodes and peri-operative management in adults and children (0 – 16 years) with Hemophilia A; routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with Hemophilia A without pre-existing damage

Hemophilia A for the prevention and control of hemorrhagic episodes

Hemophilia A for treatment and prevention of bleeding in adult patients; von Willebrand disease for the treatment of spontaneous and trauma-induced bleeding episodes and prevention of excessive bleeding during and after surgery; not indicated for the prophylaxis of spontaneous bleeding episodes in VWD

Life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product

Hypersensitivity to the active substance, to excipients, or to mouse proteins

Anaphylactic or severe systemic reaction to antihemophilic factor or VWF preparations

Recombinant Plasma Plasma

N / A N / A N / A

Solvent detergent; ion exchange chromatography; monoclonal antibody immunoaffinity chromatography

Solvent-detergent treatment; immunoaffinitychromatography; nanofiltration

Cryoprecipitation; Al(OH)3 adsorption, glycine precipitation, NaCl precipitation studied in combination; heat treatment at 60° C for 10 hours in aqueous solution; lyophilization

13.74 ± 1.82 hours (adult); 10.7 hours (children) 14.8 ± 3 hours 12.2 hours; 10.3 hours von Willebrand disease

2.2 ± 0.34 IU / dL / IU/kg (adult); 1.9 IU / dL / IU / kg (children)

2.0 IU / dL / IU / kg 2 IU / dL / IU / kg von Willebrand disease

2° – 8° C (36° – 46° F) refrigerate; RT ≤25° C (77° F) for ≤12 months; do not freeze; protect from light

2° C – 8° C (36° F to 46° F); RT < 30° C (86° F), until expiration date noted on the package; do not freeze

Up to 36 months at ≤25° C (77° F); do not freeze

RT; use within 3 hours RT; use within 3 hours Use within 3 hours

Sucrose; glycine; histidine Contains a maximum of 12.5 mg / mL Albumin and per AHF International Unit; 0.07 mg polyethylene glycol (3350) and 0.39 mg histidine

Albumin added

2.5 mL / 5 mL 10 mL 5 mL / 10 mL / 15 mL

250 / 500 / 1000 / 2000 / 3000 IU approximate F VIII activity 250 / 500 / 1000 / 1700 IU 600:250 / 1200:500 / 2400:1000 RCoF:FVIII

Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product’s manufacturer.

Antihemophilic Products - Factor VIII Only

800.746.6273 asdhealthcare.com

Product

Manufacturer

Koate®-DVI

Kedrion BioPharma, Inc.(855) 353-7466

kedrion.comkoate-dviusa.com

Kogenate® FS with Bioset®

Bayer Healthcare(888) 842-2937

bayerhealthcare.comkogenatefs.com

Kogenate® FS with Vial Adapter®

Bayer Healthcare(888) 842-2937

bayerhealthcare.comkogenatefs.com

Monoclate-P®

CSL Behring(800) 504-5434

cslbehring-us.com

Indications Hemophilia A, for temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or to perform emergency and elective surgery for patients with Hemophilia A

Hemophilia A Hemophilia A Hemophilia A

Contraindications None Hypersensitivity to any components, mouse or hamster proteins

Hypersensitivity to any components, mouse or hamster proteins

Hypersensitivity to mouse protein

Product Source Plasma Recombinant Recombinant Plasma

Viral Removal TNBP / polysorbate 80 treatment and dry heat

Solvent detergent; ion exchange chromatography; monoclonal antibody immunaffinity chromatography

Solvent detergent; ion exchange chromatography; monoclonal antibody immunaffinity chromatography

Pasteurization; heat; precipitation

Half-Life 16.12 hours 14.07 ± 2.62 hours 14.60 ± 4.38 hours 17.5 hours

Recovery 1.9% IU / kg 2.43 ± 0.60 IU / kg 2.11 ± 0.37 IU / kg 1.9 IU / dL / IU / kg

Packaged Product Storage

2° – 8° C (36° – 46° F) refrigerate; RT ≤25° C (77° F) for ≤ 6 months; do not freeze

2° – 8° C (36° – 46° F) refrigerate; RT ≤25° C for ≤ 12 months; do not freeze; protect from light

2° – 8° C (36° – 46° F) refrigerate for up to 30 months or expiration date; RT ≤25° C for ≤ 12 months or expiration date; do not freeze; protect from light; once stored at RT do not return to refrigeration

2° – 8° C (36° – 46° F) refrigerate; RT ≤25° C (77° F) for ≤ 6 months; do not freeze

Storage After Reconstitution

RT; use within 3 hours RT; use within 3 hours RT; use within 3 hours RT ≤ 37° C; use within 3 hours

Stabilizer Glycine Sucrose; glycine; histidine Sucrose; glycine; histidine Albumin; no von Willebrand Factor

Diluent Volume 5 mL / 10 mL 2.5 mL / 5 mL 2.5 mL / 5 mL 2.5 mL / 5 mL / 10 mL

Available Sizes 250 / 500 / 1000 IU 250 / 500 / 1000 / 2000 / 3000 IU 250 / 500 / 1000 / 2000 / 3000 IU 250 / 500 / 1000 / 1500 IU approximate FVIII activity

While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information.  © 2015 ASD Healthcare. Chart updated November 2015.

NovoEight®

Novo Nordisk(800) 727-6500

novonordisk-us.com novoeight.com

Recombinate Antihemophilic Factor

Baxalta Inc.(800) 423-2090

baxalta.com recombinate.com

Wilate® Contains von Willebrand Factor

Octapharma(888) 766-4860

octapharma.comwilateusa.com

Xyntha® Xyntha® Solofuse™

Pfizer Inc.(800) 438-1985

pfizer.comxyntha.com/solofuse

Hemophilia A Hemophilia A for the prevention and control of hemorrhagic episodes; perioperative management

von Willebrand disease in adult and pediatric patients for on-demand treatment and control of bleeding, and perioperative management of bleeding

Hemophilia A

Life-threatening hypersensitivity reactions, including anaphylaxis, to NovoEight or its components, including hamster proteins

Life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse or hamster proteins

Hypersensitivity with known anaphylaxis or severe systemic reaction to human plasma-derived products, any ingredient in the formulation or components of the container

Life-threatening hypersensitivity, including anaphylaxis, to the product or its components, including hamster proteins

Recombinant Recombinant; human albumin added as a stabilizer & excipient, is from plasma

Plasma Recombinant

Detergent treatment; nanofiltration Immunoaffinity column chromatography; ion exchange chromatography

Solvent detergent treatment; terminal dry heat 100° C for 120 minutes; ion exchange chromatography

Affinity chromotography; solvent detergent viral inactivation step; virus-retaining nanofiltration step

10.8 – 12.0 hours in adults 14.6 ± 4.9 hours VWF: 15.8 ± 11 hours;FVIII: 19.6 ± 6.9 hours

11.8 ± 6.2 hours

0.020 – 0.028 (IU / mL) / (IU / kg) in adults ~2.0 IU / dL / IU / kg VWF: RCo: 1.9 ± 0.4% IU / kg;FVIII: C: 2.2 ± 0.5 IU / kg

2.47 ± 0.84 IU / dL / IU / kg

2° – 8°C (36°F – 46°F) refrigerate for up to 30 months from the date of manufacture until the expiration date; RT ≤30° C (86° F) for ≤12 months; do not freeze; store in original package to protect from light

2° – 8° C (36° – 46° F) refrigerate; RT ≤ 30° C (86°F); do not freeze

2° – 8° C (36° F – 46° F) for 36 months; RT<25° C (77° F) for ≤ 6 months; once stored at room temperature, the product must not be returned to the refrigerator; do not freeze

2° – 8° C (36° – 46° F) refrigerate; RT ≤ 25° C for ≤ 3 months; do not freeze; protect from light

RT; use within 4 hours; store the reconsituted product in the vial

RT; use within 3 hours Use immediately RT; use within 3 hours

Sodium chloride; sucrose; calcium chloride dihydrate

In 5 mL reconstituted vial: 25 mg / mL Albumin (human), 0.40 mg / mL calcium, 3 mg / mL polyethylene glycol (3350), 360 mEq / L sodium, 110 mM histidine, 1.5 μg / Factor VIII IU polysorbate-80In 10 mL reconstituted vial: 12.5 mg / mL Albumin (human), 0.20 mg / mL calcium, 1.5 mg / mL polyethylene glycol (3350), 180 mEq / L sodium, 55 mM histidine, 1.5 μg / Factor VIII (IU) polysorbate-80; the final product for both diluent sizes contains not more than 2 ng rvWF / IU rFVIII, which will not have any clinically relevant effect in patients with von Willebrand disease

N / A Sucrose; sodium chloride; L-histadine; calcium; polysorbate 80

4 mL sodium chloride diluent 5 mL / 10 mL 5 mL / 10 mL 4 mL

250 / 500 / 1000 / 1500 / 2000 / 3000 IU 250 / 500 / 1000 / 1500 / 2000 IU 500 / 1000 IU R2 Kit: 250 / 500 / 1000 / 2000 IU; Xyntha Solofuse: (dual chamber syringe) 250 / 500 / 1000 / 2000 / 3000 IU

Antihemophilic Products - Factor VIII Only

800.746.6273 asdhealthcare.com

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Connect at www.asdhealthcare.comCustomer Service 800.746.6273

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