CytomegalovirusCytogam®

IntramuscularGamaSTAN® S/D

Hepatitis BHepaGAM B®

HyperHEP B® S/D

Nabi - HB®

RabiesHyperRAB® S/D

IMOGAM® Rabies - HT

TetanusHyperTET® S/D

Rho(D)HyperRho® S/D

RhoGAM® UF PLUS

Rhophylac®

WinRho® SDF Liquid

Hyper-Immune Globulin

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.

Hyper-Immune Globulin

800.746.6273 asdhealthcare.com

Product

Manufacturer

Cytogam®

Cytomegalovirus

CSL Behring (800) 683-1288 cslbehring.comcytogam.com

GamaSTAN® S/DIntramuscular Immune Globulin (Human)

Grifols (800) 520-2807

grifols.comhypermunes.com

Indications Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart

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 Liquid Liquid

Available Sizes 50mL 2mL / 10mL vials

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

Viral Safety Process

Solvent/detergent viral inactivation step; precipitation 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) 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 13–45 days during third to fifth month posttransplant; CMV antibody detectable for up to 2 months following last dose

Unknown; the half-life of IgG in the circulation of individuals with normal IgG levels is 23 days

Packaged Product Storage

2° – 8° C (36° – 46° F) 2° – 8° C (36° – 46° F);do not freeze

Shelf life From Date of Manufacture

N / A 36 months

Potency 50 ± 10 mg / mL N / A

Protein Concentration

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

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.

HepaGAM B®

Hepatitis B Immune Globulin

Emergent(800) 768-2304

emergentbiosolutions.comhepagamb.com

HyperHEP B® S/DHepatitis B Immune Globulin

Grifols(800) 520-2807

grifols.comhypermunes.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

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

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

Liquid Liquid

1mL, 5mL 0.5mL, 1mL syringes; 1mL, 5mL vials

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

Solvent/detergent virus inactivation step; chromatography; virus filtration

Precipitation; depth filtration; solvent / detergent treatment; the final container incubation step used during the manufacture of the product contributes to virus inactivation

22 – 25 Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days

2° – 8° C (36° – 46° F);do not freeze

2° – 8° C (36° – 46° F);do not freeze

36 months 36 months

Minimum of >312 IU / mL; the measured potency of each lot is stamped on the vial label

Minimum of 220 IU / mL

5% 15 – 18%

Single-dose vial Preservative (thimerosol)-free and latex-free vials and syringes

IV using an infusion pump; IM IM administration only; 0.06 mL / kg of body weight (refer to the package insert for complete prescribing details)

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.

Hyper-Immune Globulin

800.746.6273 asdhealthcare.com

Product

Manufacturer

Nabi-HB®

Hepatitis B Immune Globulin

Biotest Pharmaceuticals(800) 458-4244

biotestpharma.com

HyperRAB® S/DRabies Immune Globulin

Grifols(800) 520-2807

grifols.comhypermunes.com

Indications 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

Rabies post-exposure prophylaxis

Contraindications Anaphylaxis to IG; anaphylaxis to IgA; IgA deficiency with IgA antibodies

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

Form Liquid Liquid

Available Sizes 1mL, 5mL 2mL, 10mL vials

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

Viral Safety Process

Precipitation of cohn fraction III; cuno filtration; solvent / detergent virus inactivation step; nanofiltration

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

2° – 8° C (36° – 46° F);do not freeze

2° – 8° C (36° – 46° F);do not freeze

Shelf life From Date of Manufacture

39 months 36 months

Potency 1mL dose: >312 IU; 5mL dose: > 1560 IU

Average 150 IU / mL

Protein Concentration

5 ± 1% 15 – 18%

How Supplied Single-dose vial Preservative (thimerosol)-free and latex-free single dose vials

Administration IM administration only IM administration only;0.133 mL / kg of body weight

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.

IMOGAM® Rabies-HTRabies Immune Globulin

Sanofi Pasteur(800) 822-2463sanofipasteur.us

HyperTET® S/DTetanus Immune Globulin

Grifols(800) 520-2807

grifols.comhypermunes.com

Rabies post exposure prophylaxis Tetanus post-exposure prophylaxis

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

Liquid Liquid

2mL 250 unit prefilled disposable syringe

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

Cold alcohol fractionation; heat-treatment 60° C 10 hrs; precipitation III stage of manufacturing

Precipitation; depth filtration; solvent/detergent treatment; the final container incubation step used during the manufacture of the product contributes to virus inactivation

N / A Unknown; the half-life of IgG in the circulation of individuals with normal IgG levels is 23 Days

2° – 8° C (36° – 46° F);do not freeze

2° – 8° C (36° – 46° F);do not freeze

N / A 36 months

150 IU / mL Minimum of 250 AU (anti-toxin units) / syringe

10 – 18% 15 – 18%

Vial Preservative (thimerosol)-free, in a latex-free delivery system

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

IM administration only (refer to the package insert for complete prescribing details)

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.

Hyper-Immune Globulin

800.746.6273 asdhealthcare.com

Product

Manufacturer

HyperRho® S/DRho(D) Immune Globulin

Grifols(800) 520-2807

grifols.com

RhoGAM® Ultra-Filtered PLUSRho(D) Immune Globulin

Kedrion BioPharma, Inc.(855) 353-7466

kedrion.comrhogam.com

Indications For prevention of isoimmunization and prevention of Rh hemolytic disease of the newborn (refer to the package insert for complete prescribing details)

Rh Isoimmunization supression

Contraindications 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.

Rh +

Form Liquid Liquid

Concentration 15 – 18% 300 μg

Available Sizes Mini-Dose: 250 IU prefilled disposable syringe in 10pk;Full Dose: 1500 IU prefilled disposable syringe in 10pk and single syringe

1500 IU

Labelling for Removal of Pathogenic Prions

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 Method

Precipitation; depth filtration; solvent / detergent treatment; the final container incubation step used during the manufacture of HyperRHO® S / D contributes to virus inactivation

Fractionation; filtration; inactivation

IgA Conent N / A <15 μg / dose

Stabilizer Glycine Glycine; polysorbate 80

Sugar Content N / A N / A

Sodium Content N / A 2.9 mg / mL

pH 6.4 – 7.2 6.2 – 7

Osmolality (m0sm/kg)

N / A N / A

Half-Life (days) Unknown; the half-life of IgG in the circulation of individuals with normal IgG levels is approximately 23 to 26 Days

31

Storage 2˚ – 8˚ C; do not freeze 2˚ – 8˚ C; do not freeze

Shelf-Life 36 months 24 months

Reconstitution Fluid/Diluent

N/A N / A

Administration IM administration only Intramuscular only

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.

Rhophylac®

Rho(D) Immune Globulin

CSL Behring800-683-1288cslbehring.comrhophylac.com

WinRho® SDF LiquidRho(D) Immune Globulin

Emergent(800) 768-2304hepagamb.com

emergentbiosolutions.com

Adults with chronic ITP; Rh Isoimmunization suppression Children with chronic or acute ITP; adults with chronic ITP; children and adults with ITP secondary to HIV infection; 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

Infant for suppression of Rh isoimmunization; anaphylaxis to IG; IgA deficiency; history of autoimmune hemolytic anemia, preexisting hemolysis, or high risk of hemolysis

Liquid (ready-to-use) Liquid

300 μg (1500 IU) 300 / 500 / 1000 / 3000 μg

2 mL prefilled syringe 1500 / 2500 / 5000 / 15000 IU Vials

N / A N / A

Solvent / detergent; nanofiltration Sovent / detergent; planova 20 N viral filtration; ion exchange chromatography

<5 μg / mL 5 μg / mL

Albumin Maltose; polysorbate 80

N / A 10% Maltose

0.25 M N / A

N / A 5.0 – 6.5

N / A N / A

IV 16 ± 4; IM 18 ± 5

24 – 30

2˚ – 8˚ C; do not freeze 2˚ – 8˚ C; do not freeze

36 months 36 months

N / A N / A

Idiopathic Thrombocytopenic Purpura — IV only; Rh Isoimmunization Suppression — IV or Intramuscular; Idiopathic Thrombocytopenic Purpura: 2mL / 15 – 60 sec

Idiopathic Thrombocytopenic Purpura — IV only; Rh Isoimmunization Suppression — IV or Intramuscular

Hyper-Immune Globulin

800.746.6273 asdhealthcare.com

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