Antihemophilic Products

Transcription

1 Antihemophilic Products Factor VIII Only Advate 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

2 Antihemophilic Products - Factor VIII Only asdhealthcare.com Product Advate Antihemophilic Factor Alphanate Contains von Willebrand Factor Eloctate Manufacturer Baxalta Inc. (800) baxalta.com advate.com Grifols (800) grifolsusa.com alphanate.com Biogen (855) eloctate.com myeloctate.com Indications Contraindications 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. 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) 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 Life threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components 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 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 Viral Removal Half-Life Recovery Packaged Product Storage Storage After Reconstitution Stabilizer N / A Solvent-detergent treatment; immunoaffinity chromatography; cation exchange chromatography In patients >16 yrs: ± 4.15 hours; infants (1 month to <2 yrs): 8.86 ± 1.78; 2 to 5 yrs old: ± 1.94; 5 to 12 yrs old: ± 1.60; 12 to 16 yrs old: ± 3.72 hours 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 Refrigerate at 2 8 C (36 46 F); RT 30 C (86 F) for 6 months; do not return to refrigerated temperature; 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 PEG fractionation, Affinity Chromatography and Salt precipitation 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 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 36 months, up to printed expiration date at 25 C (77 F); N / A Detergent treatment; 15 nm filtration Adults: 19.7 ± 2.3 hours; yrs: 16.4 ± 2.3 hours; 6-11 yrs: 14.6 ± 3.1 hours; 2-5 yrs: 12 ± 2.45 hours 2.26 IU / dl / IU / kg 2 8 C (36 F 46 F) refrigerate; RT 30 C (86 F) for 6 months; ; protect from light Use within 3 hours; do not store or refrigerate RT; use within 3 hours RT < 30 C; use within 3 hours 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 % (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 % (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 Diluent Volume 2 ml / 5 ml 5 ml / 10 ml 3 ml Sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20 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 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.

3 Helixate FS CSL Behring (800) cslbehring-us.com helixatefs.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 Hemofil M Antihemophilic Factor ( Human ), Method M, Monoclonal Purified Baxalta Inc. (800) baxalta.com Hemophilia A for the prevention and control of hemorrhagic episodes Humate-P Contains von Willebrand Factor CSL Behring (800) cslbehring-us.com humate-p.com 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; immunoaffinity chromatography; 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 ± 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 RT 25 C (77 F) for 12 months; ; protect from light 2 C 8 C (36 F to 46 F); RT < 30 C (86 F), until expiration date noted on the package; Up to 36 months at 25 C (77 F); 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 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 ASD Healthcare. Chart updated November 2015.

4 Antihemophilic Products - Factor VIII Only asdhealthcare.com Product Koate -DVI Kogenate FS with Bioset Kogenate FS with Vial Adapter Monoclate-P Manufacturer Kedrion BioPharma, Inc. (855) kedrion.com koate-dviusa.com Bayer Healthcare (888) bayerhealthcare.com kogenatefs.com Bayer Healthcare (888) bayerhealthcare.com kogenatefs.com CSL Behring (800) 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 Contraindications None Hypersensitivity to any components, mouse or hamster proteins Hemophilia A Hemophilia A Hemophilia A 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 hours ± 2.62 hours ± 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 Storage After Reconstitution RT 25 C (77 F) for 6 months; RT 25 C for 12 months; ; 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; ; protect from light; once stored at RT do not return to refrigeration RT 25 C (77 F) for 6 months; 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 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.

5 NovoEight Recombinate Antihemophilic Factor Wilate Contains von Willebrand Factor Xyntha Xyntha Solofuse Novo Nordisk (800) novonordisk-us.com novoeight.com Baxalta Inc. (800) baxalta.com recombinate.com Octapharma (888) octapharma.com wilateusa.com Pfizer Inc. (800) pfizer.com xyntha.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 hours in adults 14.6 ± 4.9 hours VWF: 15.8 ± 11 hours; FVIII: 19.6 ± 6.9 hours (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 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; ; store in original package to protect from light RT; use within 4 hours; store the reconsituted product in the vial Sodium chloride; sucrose; calcium chloride dihydrate RT 30 C (86 F); 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; 11.8 ± 6.2 hours 2.47 ± 0.84 IU / dl / IU / kg RT 25 C for 3 months; ; protect from light RT; use within 3 hours Use immediately RT; use within 3 hours 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-80 In 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 4 ml sodium chloride diluent 5 ml / 10 ml 5 ml / 10 ml 4 ml N / A Sucrose; sodium chloride; L-histadine; calcium; polysorbate / 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 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 ASD Healthcare. Chart updated November 2015.

6 Antihemophilic Products - Factor VIII Only Others asdhealthcare.com aspire. ASD Healthcare delivers. When you re in the business of saving lives, you depend on exceptional customer service from your healthcare partners. So when you want a life-saving medication within hours, or need an extensive range of plasma-derived and recombinant therapeutics, connect with ASD Healthcare. Our people are here to help you get the products you need, when you need them. That s standard business for us, a part of our True Blue culture that makes going the extra mile an ordinary part of our day. Others aspire to meet our exceptional service. ASD Healthcare simply delivers. Convenient Connection ASD Healthcare makes it easy to order and reorder your inventory any time, any day, anywhere. Connect at Customer Service Emergency on-call phone orders 365 / 24 / 7 Expedited orders for same-day delivery in 48 states Expertise and resources for access to critical care products Your Patients. Your Purpose. Our Priority.