Antihemophilic Products

Transcription

1 Antihemophilic Products Factor IX Only AlphaNine SD Alprolix Kit BEBULIN VH BeneFIX RT Mononine Profilnine SD Additional Antihemophilic Products ATryn Corifact FEIBA Kcentra NovoSeven RT RiaSTAP RIXUBIS Stimate Nasal Spray Thrombate III

2 Antihemophilic Products - Factor IX Only asdhealthcare.com Product AlphaNine SD Factor IX Alprolix Kit Factor IX Recombinant BEBULIN VH Factor IX Manufacturer Grifols (800) grifols.com Biogen Idec, Inc. (855) alprolix.com myalprolix.com Baxalta Inc. (800) baxalta.com Indications Factor IX deficiency due to Hemophilia B Adults and children with Hemophilia B for: control and prevention of bleeding episodes; perioperative management; routine prophylaxis to prevent or reduce the frequency of bleeding episodes Contraindications None known Hypersensitivity reactions, including anaphylaxis, to the product or its excipients Product Source Plasma Recombinant Plasma Labelling for Removal of Pathogenic Prions Viral Removal Viral Inactivation Process Ion exchange chromatography; dual affinity chromatography and nanofiltration Solvent/detergent treatment with a mixture of tri (n-butyl) phosphate (TNBP) and polysorbate 80 Column chromatography; nanofiltration Prevention and control of bleeding episodes in adult Hemophilia B (congenital Factor IX deficiency or Christmas disease) patients; not indicated for use in the treatment of Factor VII deficiency; no clinical studies show benefit from this product in treating deficiencies other than Factor IX deficiency Hypersenstivity reactions to the product; heparin allergy; history of heparin-induced thrombocytopenia Nanofiltration; vapor-heat treatment; DEAE-Sephadex adsorption Half-Life 21 hours hours 19.4 ± 3.8 hours, 24.6 ± 3.2 hours, and ± 8.24 hours depending on testing methodology Recovery Approximately 48% IU / dl per IU / kg FIX: ~0.8 IU / dl / IU / kg; In vivo recovery was found to be 53.3% ± 9.6%, 57.5% ± 21.8%, and 53.24% ± 16.95% depending on testing methodology Packaged Product Storage Storage After Reconstitution 2 8 C (36 46 F), do not freeze diluent; stable at room temperature not to exceed 30 C (86 F) for up to 1 month RT 37 C (44.6 F); use within 3 hours Store in original package to protect from light; 2 8º C (36 46 F); RT <30º C (86 F) for a single 6 month period; do not freeze RT <30º C (86 F); use within 3 hours; protect from direct sunlight Stabilizer Heparin and dextrose Sucrose; mannitol; sodium chloride; L-histidine and polysorbate 20 2º 8º C (36 46 F) refrigerate; do not freeze Do not refrigerate; use within 3 hours 4 mg sodium citrate / ml, and 8 mg / ml sodium chloride; no preservatives Diluent Volume 10 ml 5 ml 20 ml Available Sizes 500 / 1000 / 1500 IU 500 / 1000 / 2000 / 3000 IU 500 / 700 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 BeneFIX RT Factor IX Recombinant Pfizer Inc. (800) pfizer.com benefix.com Adult and pediatric patients with Hemophilia B for: control and prevention of bleeding episodes; perioperative management Mononine Factor IX Prevention and control of bleeding in Hemophilia B patients; not indicated in treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII Profilnine Factor IX Grifols (800) grifols.com (factor IX complex) indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B) Life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein Hypersensitivity to mouse protein None known Recombinant Plasma Plasma Chromatography; membrane nanofiltration Monoclonal antibody immunoaffinity chromotography; chemical treatment; nanofiltration Ion exchange chromatography and nanofiltration Solvent/detergent treatment with a mixture of tri (n-butyl) phosphate (TNBP) and polysorbate ± 5.4 hours (range 11 to 36 hours) 25.3 hours ± 8.29 hours 37.8% ± 14.0% 0.68 IU / dl rise / IU / kg 1.15 ± 0.16 IU / dl per IU infused per kg body weight 2 30 C (36 86 F) RT; 2 8 C (36 46 F) refrigerate; RT 30 (86 F) for 6 months prior to expiration date; do not freeze RT; use within 3 hours Sucrose; sodium chloride; L-hisitidine; glycine & polysorbate º C (36 46 F) refrigerate; RT 25 C (77 F) for 1 month; do not freeze Do not refrigerate; use within 3 hours Histidine; sodium chloride; mannitol and polysorbate 80 Store at or below 25 C (77 F); do not freeze Do not refrigerate; use within 3 hours 5 ml 5 ml / 10 ml 5 ml / 10 ml 250 / 500 / 1000 / 2000 / 3000 IU 500 / 1000 IU FIX 500 / 1000 / 1500 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.

4 Antihemophilic Products - Additional Antihemophilic Products asdhealthcare.com Product Manufacturer Indications ATryn Antithrombin Recombinant revo Biologics (508) revobiologics.com atryn.com Prevention of perioperative and peripartum thromboembolic events in hereditary antithrombin deficient patients; it is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients Corifact Factor XIII corifact.com Adult and pediatric patients with congential Factor XIII deficiency for routine prophylactic treatment and perioperative management of surgical bleeding Contraindications Known hypersensitivity to goat and goat milk proteins Patients with known anaphylactic or severe systemic reactions to human plasma-derived products Product Source Recombinant Plasma Labelling for Removal of Pathogenic Prions Viral Removal Viral Inactivation Process Ion exchange chromatography; nanofiltration; heat treatment Half-Life hours 6.6 ± 2.29 hours Recovery Not reported Packaged Product Storage Storage After Reconstitution Refrigerate between 2 8 C (36 46 F) Use within 24 hours of preparation when stored at RT C (68 77 F) Precipitation / absorption; ion exchange chromatography; heat-treatment; virus filtration over 2 nm filters in series Refrigerate at 2 8 C (36 46 F); keep in original carton to protect from light; do not freeze; within the expiration date, Corifact may be stored at RT <25 C (77 F) for up to 6 months; do not re-refrigerate RT <25 C (77 F); do not refrigerate or freeze; use within 4 hours after reconstitution Stabilizer None Not reported Diluent Volume 10 ml WFI 20 ml Available Sizes 525 / 1750 IU IU F XIII 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 FEIBA Anti-Inhibitor Coagulation Complex Baxalta Inc. (800) baxalta.com feiba.com Kcentra 4 - Factor Prothrombin Complex kcentra.com NovoSeven RT with MixPro Factor VIIa Recombinant Novo Nordisk (800) novonordisk.com novosevenrt.com In Hemophilia A and B patients with inhibitors for: control and prevention of bleeding episodes; perioperative management; routine prophylaxis to prevent or reduce the frequency of bleeding episodes; not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation Factor VIII or coagulation Factor IX Patients who have known anaphylactic or severe hypersensitivity reactions to product or any of its components, including factors of the kinin generating system; patients with disseminated intravascular coagulation (DIC); patients with acute thrombosis or embolism (including myocardial infarction) Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antogonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure Patients with known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin; disseminated intravascular coagulation; known heparin-induced thrombocytopenia Congenital Hemophilia A or B with inhibitors; acquired Hemophilia; congenital Factor VII deficiency; Glanzmann s Thrombasthenia None known Plasma Plasma Recombinant Nanofiltration; vapor-heat treatment; DEAE-Sephadex adsorption Precipitation/absorption; ion exchange chromatography; heat-treatment; virus filtration; lyophilized Chromatography Per individual factor hours IU / dl 30% 71% RT 25º C (77º F); store in original package to protect from light; do not freeze Use within 3 hours after reconstitution; do not refrigerate after reconstitution Reconstituted product contains 4 mg of trisodium citrate and 8 mg of sodium chloride per ml Store between 2 25 C (36 77 F); do not exceed 25 C (77 F); do not freeze; store in original carton to protect from light Store between 2 25 C (36 77 F); if cooled, solution should be warmed to C (68 77 F) prior to administration; do not freeze; use within 4 hours following reconstitution None Prior to reconstitution, keep refrigerated or store at RT between 2 25º C (36 77º F); do not freeze; protect from light RT or refrigerate; use within 3 hours; do not freeze Sodium chloride; calcium chloride dihydrate; glycylglycine; polysorbate 80; mannitol; sucrose; methionine 20 ml / 50 ml 20 ml / 40 ml 1.1 / 2.1 / 5.2 / 8.1 ml Histidine diluent 500 / 1000 / 2500 IU 500 IU vial ( IU FIX) 1000 IU vial ( IU FIX) 1 / 2 / 5 / 8 mg 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 - Additional Antihemophilic Products asdhealthcare.com Product Manufacturer Indications Contraindications RiaSTAP Fibrinogen Concentrate riastap.com Treatment of acute bleeding episodes in patients with congential fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia; not indicated for dysfibrinogenemia Anaphylactic or severe reactions to RiaSTAP or its components RIXUBIS Coagulation Factor IX Recombinant Baxalta Inc. (855) baxalta.com rixubis.com Adults and children with Hemophilia B for: control and prevention of bleeding episodes, perioperative management and routine prophylaxis; not indicated for induction of immune tolerance in patients with Hemophilia B Hypersensitivity to RIXUBIS or its excipients including hamster protein; disseminated intravascular coagulation (DIC); signs of fibrinolysis Product Source Plasma Recombinant Labelling for Removal of Pathogenic Prions Viral Removal Viral Inactivation Process Cryoprecipitation; Al(OH)3 adsorption / glycine precipitation / Al(OH)3 adsorption; heat treatment (+60º C for 20 hours in an aqueous solution); two subsequent glycine precipitation steps (initial and main glycine precipitation steps) Solvent / detergent; nanofiltration Half-Life 78.7 ± ( ) [In patients 12 years of age: after single dose 26.7 ± 9.6 hours; range: hours; after repeat dose 25.4 ± 6.9 hours, range hours]; [PTPs 12 years: 25.7 ± 1.5 hours]; [6 <12 years: 23.2 ± 1.6 hours; <6 years: 27.7 ± 2.7 hours] Recovery 1.7 mg / dl (range mg / dl) increase per mg / kg Pediatrics: ~0.67 (± 0.16) IU / dl / IU / kg; adults: ~22% higher than pediatrics; for dosing purposes, per PI pediatrics: 0.7 IU / dl / IU / kg; adults: 0.9 IU / dl / IU / kg Packaged Product Storage Storage After Reconstitution Store between 2 25 C (36 77 F); RiaSTAP is stable for the period indicated by the expiration date on the carton and vial label (up to 30 months); keep RiaSTAP in its original carton until ready to use; do not freeze; protect from light RiaSTAP is stable for 8 hours after reconstitution when stored at 20 25º C and should be administered within this time period Refrigerate 2 8º C (36º 46º F) for <24 months; RT <30º C (86º F) for <12 months within the 24 month time period; do not return to refrigerator after storage at RT; do not freeze Do not refrigerate; use within 3 hours Stabilizer None L-histidine 20 mm; sodium chloride 60 mm; calcium chloride 4 mm; mannitol 110 mm; sucrose 35 mm; polysorbate % Diluent Volume 50 ml (not included) 5 ml Available Sizes mg 250 / 500 / 1000 / 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.

7 Stimate Nasal Spray Desmopression Acetate stimate.com Hemophilia A with Factor VIII coagulant activity levels greater than 5%; patients with mild to moderate classic von Willebrand s disease (Type I) with Factor VIII levels greater than 5% Thrombate III Antithrombin III Grifols (800) grifols.com thrombate.com Treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism None None Synthetic analogue of natural hormone vasopressin Plasma 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 Nanofiltration for effective removal of viruses as small as 18 nm Heat treatment in solution at 60 C for not less than 10 hours hours 3.8 days 1.4 (for every unit / kg administered, the activity level of antithrombin will be raised by 1.4%) Store at <25 C (77 F); store bottle in upright position Store at room temperature not to exceed 25 C (77 F); freezing should be avoided as breakage of the diluent bottle might occur Store at <25 C (77 F); discard 6 months after being opened; store in upright position Administer within 3 hours after reconstitution; do not refrigerate Alanine for reconstituted product 10 ml 1.5 mg / ml 2.5 ml bottle 500 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.

8 Antihemophilic Products - Factor IX 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.