Hyper-Immune Globulin

Transcription

1 Cytomegalovirus Cytogam Intramuscular GamaSTAN S/D Hepatitis B HepaGAM B HyperHEP B S/D Nabi - HB Rabies HyperRAB S/D IMOGAM Rabies - HT Tetanus HyperTET S/D (D) HyperRho S/D RhoGAM UF PLUS Rhophylac WinRho SDF

2 asdhealthcare.com Product Manufacturer Indications Cytogam Cytomegalovirus CSL Behring (800) cslbehring.com cytogam.com Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart GamaSTAN S/D Intramuscular Immune Globulin (Human) hypermunes.com Hepatitis A post-exposure prophylaxis; rubeola; rubella; varicella Contraindications IgA deficiency with IgA antibodies; anaphylaxis to IgA Patients with isolated IgA deficiency; should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate IM injections Form Available Sizes 50mL 2mL / 10mL vials Labelling for Removal of Pathogenic Prions Viral Safety Process Half-Life (Days) Packaged Product Storage Shelf life From Date of Manufacture Solvent/detergent viral inactivation step; precipitation Renal transplant patients receiving 50-mg/kg doses once daily for first 3 days posttransplant followed by once every 21 days for 4 months: 5 13 days during first 2 months posttransplant and days during third to fifth month posttransplant; CMV antibody detectable for up to 2 months following last dose 2 8 C (36 46 F) Potency 50 ± 10 mg / ml Protein Concentration 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 Precipitation; depth filtration; solvent / detergent treatment; the final container incubation step used during the manufacture of the product contributes to virus inactivation Unknown; the half-life of IgG in the circulation of individuals with normal IgG levels is 23 days 36 months 5% 15 18% How Supplied Single-dose vial Preservative (thimerosol)-free, latex-free single dose vials Administration IV through a 15µ in-line filter and IVAC pump or equivalent IM administration only 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 HepaGAM B Hepatitis B Immune Globulin Emergent (800) emergentbiosolutions.com hepagamb.com HyperHEP B S/D Hepatitis B Immune Globulin hypermunes.com Prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients; hepatitis B post exposure prophylaxis of: acute exposure to blood containing HBsAg; perinatal exposure of infants born to HbsAg-positive mothers; sexual exposure to an HBsAg-positive person; household exposure to persons with acute HBV infection Anaphylactic or severe systemic reactions to human globulins; IgA deficiency with increased risk of anaphylactic reaction; IM injections 1mL, 5mL Solvent/detergent virus inactivation step; chromatography; virus filtration Post-exposure prophylaxis of: acute exposure to blood containing HBsAg; perinatal exposure of infants born to HbsAg-positive mothers; sexual exposure to an HBsAg-positive person; household exposure to persons with acute HBV infection None known; should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations; epinephrine should be available; in patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Hepatitis B Immune Globulin (Human) should be given only if the expected benefits outweigh the risks 0.5mL, 1mL syringes; 1mL, 5mL vials 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 Precipitation; depth filtration; solvent / detergent treatment; the final container incubation step used during the manufacture of the product contributes to virus inactivation Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days 36 months 36 months Minimum of >312 IU / ml; the measured potency of each lot is stamped on the vial label 5% 15 18% Minimum of 220 IU / ml Single-dose vial IV using an infusion pump; IM Preservative (thimerosol)-free and latex-free vials and syringes IM administration only; 0.06 ml / kg of body weight (refer to the package insert for complete prescribing details) 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 asdhealthcare.com Product Manufacturer Nabi-HB Hepatitis B Immune Globulin Biotest Pharmaceuticals (800) biotestpharma.com HyperRAB S/D Rabies Immune Globulin hypermunes.com Indications Contraindications Treatment of acute exposure to blood containing HBsAg; perinatal exposure of infants born to HBsAg-positive mothers; sexual exposure to HBsAg-positive persons; household exposure to persons with acute HBV infection Anaphylaxis to IG; anaphylaxis to IgA; IgA deficiency with IgA antibodies Form Available Sizes 1mL, 5mL 2mL, 10mL vials Labelling for Removal of Pathogenic Prions Viral Safety Process Precipitation of cohn fraction III; cuno filtration; solvent / detergent virus inactivation step; nanofiltration Rabies post-exposure prophylaxis None known; should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations; the attending physician who wishes to administer HyperRAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions; such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA; as with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders 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 Precipitation; depth filtration; solvent / detergent treatment; the final container incubation step used during the manufacture of the product contributes to virus inactivation Half-Life (Days) 23.1 ± 5.5 days Unknown; detectable passive rabies antibody titers were observed in the serum by 24 hours post injection and persisted for 21 days, following the IM administration of 20 IU / kg Packaged Product Storage Shelf life From Date of Manufacture Potency Protein Concentration 39 months 36 months 1mL dose: >312 IU; 5mL dose: > 1560 IU 5 ± 1% 15 18% Average 150 IU / ml How Supplied Single-dose vial Preservative (thimerosol)-free and latex-free single dose vials Administration IM administration only IM administration only; ml / kg of body weight 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 Rabies post exposure prophylaxis IMOGAM Rabies-HT Rabies Immune Globulin Sanofi Pasteur (800) sanofipasteur.us Tetanus post-exposure prophylaxis HyperTET S/D Tetanus Immune Globulin hypermunes.com Do not administer in repeated doses once vaccine treatment has been initiated; repeating the dose may interfere with maximum active immunity expected from the vaccine None known; should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations; in patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HyperTET S / D should be given only if the expected benefits outweigh the risks 2mL Cold alcohol fractionation; heat-treatment 60 C 10 hrs; precipitation III stage of manufacturing 250 unit prefilled disposable syringe 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 Precipitation; depth filtration; solvent/detergent treatment; the final container incubation step used during the manufacture of the product contributes to virus inactivation Unknown; the half-life of IgG in the circulation of individuals with normal IgG levels is 23 Days 36 months 150 IU / ml Minimum of 250 AU (anti-toxin units) / syringe 10 18% 15 18% Vial For wound infiltration and intramuscular administration only; the recommended dose is 20 IU / kg (0.133 ml / kg) or 9 IU / lb (0.06 ml/lb) of body weight administered at the time of the first vaccine dose Preservative (thimerosol)-free, in a latex-free delivery system IM administration only (refer to the package insert for complete prescribing details) 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 asdhealthcare.com Product Manufacturer HyperRho S/D (D) Immune Globulin RhoGAM Ultra-Filtered PLUS (D) Immune Globulin Kedrion BioPharma, Inc. (855) kedrion.com rhogam.com Indications Contraindications For prevention of isoimmunization and prevention of Rh hemolytic disease of the newborn (refer to the package insert for complete prescribing details) None known; Rho(D) Immune Globulin (Human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations; the attending physician who wishes to administer Rho(D) Immune Globulin (Human) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions; such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA; as with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders. Form Concentration 15 18% 300 μg Available Sizes Labelling for Removal of Pathogenic Prions Viral Removal Method Mini-Dose: 250 IU prefilled disposable syringe in 10pk; Full Dose: 1500 IU prefilled disposable syringe in 10pk and single syringe 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 Precipitation; depth filtration; solvent / detergent treatment; the final container incubation step used during the manufacture of HyperRHO S / D contributes to virus inactivation Rh Isoimmunization supression Rh IU IgA Conent <15 μg / dose Fractionation; filtration; inactivation Stabilizer Glycine Glycine; polysorbate 80 Sugar Content Sodium Content 2.9 mg / ml ph Osmolality (m0sm/kg) Half-Life (days) Unknown; the half-life of IgG in the circulation of individuals with normal IgG levels is approximately 23 to 26 Days Storage 2 8 C; 2 8 C; Shelf-Life 36 months 24 months Reconstitution Fluid/Diluent N/A Administration IM administration only Intramuscular only 31 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 Rhophylac (D) Immune Globulin CSL Behring cslbehring.com rhophylac.com Adults with chronic ITP; Rh Isoimmunization suppression Anaphylaxis to IG; selective IgA deficiency with IgA antibodies and hypersensitivity; do not administer to newborn of a mother that received Rhophylac postpartum WinRho SDF (D) Immune Globulin Emergent (800) hepagamb.com emergentbiosolutions.com Children with chronic or acute ITP; adults with chronic ITP; children and adults with ITP secondary to HIV infection; Rh Isoimmunization suppression Infant for suppression of Rh isoimmunization; anaphylaxis to IG; IgA deficiency; history of autoimmune hemolytic anemia, preexisting hemolysis, or high risk of hemolysis (ready-to-use) 300 μg (1500 IU) 300 / 500 / 1000 / 3000 μg 2 ml prefilled syringe 1500 / 2500 / 5000 / IU Vials Solvent / detergent; nanofiltration Sovent / detergent; planova 20 N viral filtration; ion exchange chromatography <5 μg / ml 5 μg / ml Albumin Maltose; polysorbate M 10% Maltose IV 16 ± 4; IM 18 ± C; months 36 months 2 8 C; Idiopathic Thrombocytopenic Purpura IV only; Rh Isoimmunization Suppression IV or Intramuscular; Idiopathic Thrombocytopenic Purpura: 2mL / sec Idiopathic Thrombocytopenic Purpura IV only; Rh Isoimmunization Suppression IV or Intramuscular 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.

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