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Immune Globulin

Treatment of immunodeficiency sufficiency (hypogammaglobulinemia, agammaglobulinemia, IgG subclass deficiencies, severe combined immunodeficiency syndromes (SCIDS), Wiskott-Aldrich syndrome), idiopathic thrombocytopenic purpura; used in conjunction with appropriate anti-infective therapy to prevent or modify acute bacterial or viral infections in patients with iatrogenically-induced or disease-associated immunodepression; chronic lymphocytic leukemia (CLL) - chronic prophylaxis autoimmune neutropenia, bone marrow transplantation patients, autoimmune hemolytic anemia or neutropenia, refractory dermatomyositis/polymyositis, autoimmune diseases (myasthenia gravis, SLE, bullous pemphigoid, severe rheumatoid arthritis), Guillain-Barré syndrome; pediatric HIV infection to decrease frequency of serious bacterial infections

C

Hypersensitivity to immune globulin or any component, IgA deficiency (except with the use of Gammagard®, Polygam®)

Anaphylactic hypersensitivity reactions can occur, especially in IgA-deficient patients; studies indicate that the currently available products have no discernible risk of transmitting HIV or hepatitis B; aseptic meningitis may occur with high doses ( greater than or equal to 2 g/kg). Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure) can rarely occur; usually within 7 days of use.

1% to 10%:

Cardiovascular: Flushing of the face, tachycardia

Central nervous system: Chills

Gastrointestinal: Nausea

Respiratory: Dyspnea

<1%: Hypotension, tightness in the chest, dizziness, fever, headache, diaphoresis, hypersensitivity reactions

Increased toxicity: Live virus, vaccines (measles, mumps, rubella); do not administer within 3 months after administration of these vaccines

Stability and dilution is dependent upon the manufacturer and brand; do not mix with other drugs

Replacement therapy for primary and secondary immunodeficiencies; interference with F_c receptors on the cells of the reticuloendothelial system for autoimmune cytopenias and ITP; possible role of contained antiviral-type antibodies

I.V. provides immediate antibody levels

Half-life: 21-24 days

Children and Adults: I.V.:

Primary immunodeficiency disorders: 200-400 mg/kg every 4 weeks or as per monitored serum IgG concentrations

Chronic lymphocytic leukemia (CLL): 400 mg/kg/dose every 3 weeks

Idiopathic thrombocytopenic purpura (ITP): Maintenance dose:

400 mg/kg/day for 2-5 consecutive days; or 1000 mg/kg every other day for 3 doses, if needed or

1000 mg/kg/day for 2 consecutive days; or up to 2000 mg/kg/day over 2-7 consecutive days

Chronic ITP: 400-2000 mg/kg/dose as needed to maintain appropriate platelet counts

Kawasaki disease:

400 mg/kg/day for 4 days within 10 days of onset of fever

800 mg/kg/day for 1-2 days within 10 days of onset of fever

2 g/kg for one dose only

Acquired immunodeficiency syndrome (patients must be symptomatic):

200-250 mg/kg/dose every 2 weeks

400-500 mg/kg/dose every month or every 4 weeks

Pediatric HIV: 400 mg/kg every 28 days

Autoimmune hemolytic anemia and neutropenia: 1000 mg/kg/dose for 2-3 days

Autoimmune diseases: 400 mg/kg/day for 4 days

Bone marrow transplant: 500 mg/kg beginning on days 7 and 2 pretransplant, then 500 mg/kg/week for 90 days post-transplant

Adjuvant to severe cytomegalovirus infections: 500 mg/kg/dose every other day for 7 doses

Severe systemic viral and bacterial infections: Children: 500-1000 mg/kg/week

Prevention of gastroenteritis: Infants and Children: Oral: 50 mg/kg/day divided every 6 hours

Guillain-Barré syndrome:

400 mg/kg/day for 4 days

1000 mg/kg/day for 2 days

2000 mg/kg/day for one day

Refractory dermatomyositis: 2 g/kg/dose every month x 3-4 doses

Refractory polymyositis: 1 g/kg/day x 2 days every month x 4 doses

Chronic inflammatory demyelinating polyneuropathy:

400 mg/kg/day for 5 doses once each month

800 mg/kg/day for 3 doses once each month

1000 mg/kg/day for 2 days once each month

Dosing adjustment/comments in renal impairment: Cl_cr <10 mL/minute: Avoid use

No information available to require special precautions

No effects or complications reported

This medication can only be administered by infusion. You will be monitored closely during the infusion. If you experience nausea ask for assistance, do not get up alone. Do not have any vaccinations for the next 3 months without consulting prescriber. Immediately report chills; chest pain, tightness, or rapid heartbeat; acute back pain; or difficulty breathing. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

I.V. use only; for initial treatment, a lower concentration and/or a slower rate of infusion should be used

Monitor platelet count, vital signs

Stability: Parenteral admixture at room temperature (25°C): 30 days; parenteral admixture at refrigeration temperature (4°C): 36 months

Injection: Gamimune® N: 5% [50 mg/mL] (10 mL, 50 mL, 100 mL, 250 mL); 10% [100 mg/mL] (10 mL, 50 mL, 100 mL, 200 mL)

Powder for injection, lyophilized:

Gammar®-P I.V. (5% IgG and 3% albumin): 1 g, 2.5 g, 5 g, 10 g

Polygam®: 0.5 g, 2.5 g, 5 g, 10 g

Sandoglobulin®: 1 g, 3 g, 6 g, 12 g

Venoglobulin®-I: 0.5 g, 2.5 g, 5 g, 10 g

Detergent treated:

Gammagard® S/D: 2.5 g, 5 g, 10 g

Polygam® S/D: 2.5 g, 5 g, 10 g

Venoglobulin®-S: 5% [50 mg/mL] (50 mL, 100 mL, 200 mL); 10% [100 mg/mL] (50 mL, 100 mL, 200 mL)

Intravenous Immune Globulin Product Comparison:

Gamimune®N:

FDA indication: Primary immunodeficiency, ITP

Contraindication: IgA deficiency

IgA content: 270 mcg/mL

Adverse reactions (%): 5.2

Plasma source: >2000 paid donors

Half-life: 21 days

IgG subclass (%):

IgG₁ (60-70): 60

IgG₂ (19-31): 29.4

IgG₃ (5-8.4): 6.5

IgG₄ (0.7-4): 4.1

Monomers (%): >95

Gammaglobulin (%): >98

Storage: Refrigerate

Recommendations for initial infusion rate: 0.01-0.02 mL/kg/minute

Maximum infusion rate: 0.08 mL/kg/minute

Maximum concentration for infusion (%):10

Gammagard®SD:

FDA indication: Primary immunodeficiency, ITP, CLL prophylaxis

Contraindication: None (caution with IgA deficiency)

IgA content: 0.92-1.6 mcg/mL

Adverse reactions (%): 6

Plasma source: 4000-5000 paid donors

Half-life: 24 days

IgG subclass (%):

IgG₁ (60-70): 67 (66.8)*

IgG₂ (19-31): 25 (25.4)

IgG₃ (5-8.4): 5 (7.4)

IgG₄ (0.7-4): 3 (0.3)

Monomers (%): >95

Gammaglobulin (%): >90

Storage: Room temperature

Recommendations for initial infusion rate: 0.5 mL/kg/hour

Maximum infusion rate: 4 mL/kg/hour

Maximum concentration for infusion (%): 5

Gammar®-IV:

FDA indication: Primary immunodeficiency

Contraindication: IgA deficiency

IgA content: <20 mcg/mL

Adverse reactions (%): 15

Plasma source: >8000 paid donors

Half-life: 21-24 days

IgG subclass (%):

IgG₁ (60-70): 69

IgG₂ (19-31): 23

IgG₃ (5-8.4): 6

IgG₄ (0.7-4): 2

Monomers (%): >98

Gammaglobulin (%): >98

Storage: Room temperature

Recommendations for initial infusion rate: 0.01-0.02 mL/kg/minute

Maximum infusion rate: 0.06 mL/kg/minute

Maximum concentration for infusion (%): 5

Polygram®:

FDA indication: Primary immunodeficiency, ITP, CLL

Contraindication: None (caution with IgA deficiency)

IgA content: 0.74 ± 0.33 mcg/mL

Adverse reactions (%): 6

Plasma source: 50,000 voluntary donors

Half-life: 21-25 days

IgG subclass (%):

IgG₁ (60-70): 67

IgG₂ (19-31): 25

IgG₃ (5-8.4): 5

IgG₄ (0.7-4): 3

Monomers (%): >95

Gammaglobulin (%): >90

Storage: Room temperature

Recommendations for initial infusion rate: 0.5 mL/kg/hour

Maximum infusion rate: 4 mL/kg/hour

Maximum concentration for infusion (%): 10

Sandoglobulin®:

FDA indication: Primary immunodeficiency, ITP

Contraindication: IgA deficiency

IgA content: 720 mcg/mL

Adverse reactions (%): 2.5-6.6

Plasma source: 8000-15,000 voluntary donors

Half-life: 21-23 days

IgG subclass (%):

IgG₁ (60-70): 60.5 (55.3)*

IgG₂ (19-31): 30.2 (35.7)

IgG₃ (5-8.4): 6.6 (6.3)

IgG₄ (0.7-4): 2.6 (2.6)

Monomers (%): >92

Gammaglobulin (%): >96

Storage: Room temperature

Recommendations for initial infusion rate: 0.01-0.03 mL/kg/minute

Maximum infusion rate: 2.5 mL/minute

Maximum concentration for infusion (%): 12

Venoglobulin®-I:

FDA indication: Primary immunodeficiency, ITP

Contraindication: IgA deficiency

IgA content: 20-24 mcg/mL

Adverse reactions (%): 6

Plasma source: 6000-9000 paid donors

Half-life: 29 days

IgG subclass (%):

IgG₁ (60-70): 62.3**

IgG₂ (19-31): 32.8

IgG₃ (5-8.4): 2.9

IgG₄ (0.7-4): 2

Monomers (%): >98

Gammaglobulin (%): >98

Storage: Room temperature

Recommendations for initial infusion rate: 0.01-0.02 mL/kg/minute

Maximum infusion rate: 0.04 mL/kg/minute

Maximum concentration for infusion (%):10

*Skvaril F and Gardi A, "Differences Among Available Immunoglobulin Preparations for Intravenous Use," Pediatr Infect Dis J, 1988, 7:543-48.

**Roomer J, Morgenthaler JJ, Scherz R, et al, "Characterization of Various Immunoglobulin Preparations for Intravenous Application," Vox Sang, 1982, 42:62-73.

ASHP Commission on Therapeutics, "ASHP Therapeutic Guidelines for Intravenous Immune Globulin," Am J Hosp Pharm, 1992, 49(3):652-4.

Blanchette VS, Luke B, Andrew M, et al, "A Prospective Randomized Trial of High-Dose Intravenous Immune Globulin G Therapy, Oral Prednisone Therapy, and No Therapy in Childhood Acute Immune Thrombocytopenic Purpura," J Pediatr, 1993, 123(6):989-95.

NIH Consensus Conference, "Intravenous Immunoglobulin, Prevention and Treatment of Disease," JAMA, 1990, 264(24):3189-93.

"University Hospital Consortium Expert Panel for Off-Label Use of Polyvalent Intravenously Administered Immunoglobulin Preparations Consensus Statement," JAMA, 1995, 273(23):1865-70.