immune globulin (gamma globulin, IG, immune serum globulin, ISG)

immune globulin for I.M. use (IGIM)
BayGam

immune globulin for I.V. use (IGIV)
Gamimune N (5%, 10%), Gammagard S/D, Gammar-P IV, Iveegam, Polygam S/D, Sandoglobulin, Venoglobulin-I, Venoglobulin-S

Pharmacologic classification: immune serum
Therapeutic classification: antibody production stimulator
Pregnancy risk category C


Available forms
Available by prescription only
IGIM
Injection: 2-ml, 10-ml vials
IGIV
I.V.: Gamimune N-5% and 10% solution in 10-ml, 50-ml, 100-ml, and 250-ml single-use vials; Gammagard S/D-2.5-g, 5-g, and 10-g single-use vials for reconstitution; Gammar-P IV-1-g, 2.5-g, and 5-g vials with diluent and 10-g vials with administration set and diluent; Iveegam-1-g, 2.5-g, and 5-g vials with diluent; Polygam S/D-2.5-g, 5-g, and 10-g single-use vials with diluent; Sandoglobulin-1-g, 3-g, 6-g, and 12-g vials or kits with diluent or bulk packs without diluent; Venoglobulin-I-2.5-g and 5-g vials with or without reconstitution kits with sterile water, 10-g vials with reconstitution kit and administration set, and 0.5-g vials with reconstitution kit; Venoglobulin-S-5% and 10% in 50-ml, 100-ml, and 200-ml vials

Indications and dosages
 Agammaglobulinemia, hypogammaglobulinemia, immune deficiency. IGIV. Adults and children: For Gamimune N only, 100 to 200 mg/kg or 2 to 4 ml/kg I.V. infusion monthly. Infusion rate is 0.01 to 0.02 ml/kg/minute for 30 minutes. Rate can then be increased to maximum of 0.08 ml/kg/minute for remainder of infusion.
 Treatment of primary defective antibody synthesis, such as agammaglobulinemia or hypogammaglobulinemia, in patients at increased risk for infection. Adolescents and children: 200 mg/kg I.V. every 3 to 4 weeks. Adjust dosage according to clinical effect and to maintain IgG at desired level.
 For Gammagard S/D only, initially 200 to 400 mg/kg I.V., followed by 100 mg/kg monthly. Start infusion at 0.5 ml/kg/hour, gradually increasing to maximum of 4 ml/kg/hour.
 For Gammar-P IV only, 200 to 400 mg/kg q 3 to 4 weeks. Infusion rate is 0.01 ml/kg/minute, increasing to 0.02 ml/kg/minute after 15 to 30 minutes, with gradual increase to 0.06 ml/kg/minute.
 For Iveegam only, 200 mg/kg I.V. monthly. If response is inadequate, doses may be increased up to 800 mg/kg or the drug may be administered more frequently. Infuse at 1 to 2 ml/minute.
 For Polygam S/D only, 100 mg/kg I.V. monthly. An initial dose of 200 to 400 mg/kg may be administered. Start infusion at 0.5 ml/kg/hour, gradually increasing to maximum of 4 ml/kg/hour.
 For Sandoglobulin, 200 mg/kg I.V. monthly. Start with 0.5 to 1 ml/minute of a 3% solution; increase up to 2.5 ml/minute gradually after 15 to 30 minutes.
 For Venoglobulin-I only, 200 mg/kg I.V. monthly; may be increased to 300 to 400 mg/kg and may be repeated more frequently than once monthly. Infuse at 0.01 to 0.02 ml/kg/minute for 30 minutes, then increase to 0.04 ml/kg/minute or higher, if tolerated.
 For Venoglobulin-S only, 200 mg/kg I.V. monthly. Increase dose to 300 to 400 mg/kg monthly or administer more frequently if adequate IgI levels aren’t achieved. Start infusion at 0.01 to 0.02 ml/kg/ minute for 30 minutes, then increase 5% solutions to 0.04 ml/kg/minute and 10% solutions to 0.05 ml/kg/minute, if tolerated.
 Hepatitis A exposure. IGIM. Adults and children: 0.02 to 0.04 ml/kg I.M. as soon as possible after exposure. May give up to 0.1 ml/kg after prolonged or intense exposure.
 Measles exposure. IGIM. Adults and children: 0.2 to 0.25 ml/kg within 6 days after exposure.
 Postexposure prophylaxis of measles for immunosuppressed patients. IGIM. Adults and children: 0.5 ml/kg I.M. within 6 days after exposure.
 Chickenpox exposure ◇. IGIM. Adults and children: 0.6 to 1.2 ml/kg I.M. as soon as exposed.
 Rubella exposure in first trimester of pregnancy ◇. IGIM. Women: 0.55 ml/kg I.M. as soon as exposed.
 Idiopathic thrombocytopenic purpura. IGIV. Adults and children: Initially, 400 mg/kg daily of Sandoglobulin or Gamimune N (5% or 10%) I.V. for 2 to 5 consecutive days depending on platelet count and clinical response. Maintenance dose is 400 to 1,000 mg/kg I.V. of Gamimune N 5%, 10%, or Sandoglobulin as a single infusion to maintain a platelet count greater than 30,000/mm3. Or 1,000 mg/kg of Gammagard S/D and Polygam S/D as a single dose. May give up to three doses on alternate days if needed.
 Bone marrow transplantation. IGIV. Adults older than age 20: Gamimune N 10%, 500 mg/kg on day 7 and day 2 before transplantation; then weekly through 90 days after transplantation.

Pharmacodynamics
Immune action: Immune globulin provides passive immunity by increasing antibody titer. The mechanism by which IGIV increases platelet counts in idiopathic thrombocytopenic purpura isn’t fully known.

Pharmacokinetics
Absorption: Slow I.M. absorption.
Distribution: Distributed evenly between intravascular and extravascular spaces.
Metabolism: No information available.
Excretion: Serum half-life is reportedly 21 to 24 days in immunocompetent patients.

Route Onset Peak Duration
I.V. Immediate Varies Unknown
I.M. Unknown 2 days Unknown


Contraindications and precautions
Contraindicated in patients hypersensitive to drug. There is a possible association between IGIV administration and thrombotic events. Because the exact relationship is unknown, use caution when prescribing and infusing IGIV in patients with a history of CV disease or thrombotic episodes.

Interactions
Drug-drug. Live-virus vaccines: May interfere with the immune response to live virus vaccines (such as measles, mumps, rubella). Don’t give live-virus vaccines within 3 months after administration of immune globulin.

Adverse reactions
CNS: faintness, headache, severe headache requiring hospitalization, malaise, fever, aseptic meningitis syndrome.
CV: chest pain, MI, heart failure, chest tightness.
GI: nausea, vomiting.
GU: oliguria, anuria, acute renal failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis.
Musculoskeletal: hip pain, joint pain, muscle stiffness (at injection site).
Respiratory: dyspnea, shortness of breath, pulmonary embolism, transfusion-related acute lung injury.
Skin: erythema, urticaria.
Other: anaphylaxis, chills, infusion reactions.

Effects on lab test results
• May increase BUN and creatinine levels.

Overdose and treatment
Excessively rapid I.V. infusion can precipitate an anaphylactoid reaction.
 If signs and symptoms of anaphylactoid reaction occur, slow or stop infusion. Maintain airway, and provide appropriate treatment.

Special considerations
• Obtain a thorough history of allergies and reactions to immunizations.
• Have epinephrine solution 1:1,000 available to treat allergic reactions.
• Inject I.M. formulation into different sites, preferably into buttocks. Don’t inject more than 3 ml per injection site.
• Don’t give for hepatitis A exposure if 2 weeks or more have elapsed since exposure or after onset of clinical illness.
• Store Sandoglobulin and Gammagard S/D at room temperature not exceeding 77° F (25° C); Gamimune N and Iveegam, at 36° to 46° F (2° to 8° C) but don’t freeze; Gammar-P IV, at room temperature below 86° F (30° C) but don’t freeze; Venoglobulin-I at room temperature below 86° F (30° C).
• Immune globulin has been studied in the treatment of various conditions, including Kawasaki disease, asthma, allergic disorders, autoimmune neutropenia, myasthenia gravis, and platelet transfusion rejection. It also has been used in the prophylaxis of infections in immunocompromised patients.
• Gamimune N can be diluted with D5W.
• Reconstitute Gammagard S/D with diluent (sterile water for injection) and transfer device provided by manufacturer. Administration set (provided) contains a 15-micron in-line filter that must be used during administration.
• Reconstitute Sandoglobulin with diluent supplied (normal saline solution).
• If there is a risk of a thrombotic event, the infusion concentration should be no more than 5%, and the infusion rate should be initiated no faster than 0.5 ml/kg/hour and advanced slowly only if well tolerated to a maximum rate of 4 ml/kg/hour.
• Closely monitor blood pressure in patient receiving IGIV, especially if it’s patient’s first infusion of immune globulin.
Pregnant patients
• Although pregnancy isn’t a contraindication to use, it’s unknown whether immune globulin can cause fetal harm.
Breast-feeding patients
• It isn’t known whether immune globulin appears in breast milk. Use cautiously in breast-feeding women.

Patient education
• Explain that patient’s chances of getting AIDS or hepatitis after receiving immune globulin are minute because of stringent government standards that require testing for these viruses.
• Instruct patient to promptly report headache, skin changes, difficulty breathing, decreased urine output, sudden weight gain, swelling, and shortness of breath.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use