Trade Names:Carimune NF- Injection, lyophilized powder for solution immune globulin (human) 3, 6, 12 g
Trade Names:Flebogamma 5%- Injection immune globulin (human) 5% (50 mg/mL)
Trade Names:Gammagard- Injection immune globulin (human) 10% (100 mg/mL)
Trade Names:Gammagard S/D- Injection immune globulin (human) 5% (50 mg/mL)
Trade Names:Gamunex- Injection immune globulin (human) 10% (100 mg/mL)
Trade Names:Iveegam EN- Injection, freeze-dried powder for solution immune globulin (human) 5 g
Trade Names:Octagam- Injection immune globulin (human) 5% (50 mg/mL)
Trade Names:Privigen- Injection immune globulin (human) 10% (100 mg/mL)Gammagard S/D (Canada)Sandoglobulin NF Liquid (Canada)
Replaces normal human immunoglobulin (Ig) G antibodies. Promotes opsonization, fixes complement, and neutralizes bacteria, viruses, fungi, and parasites, and their toxins.
Treatment of primary immunodeficiency states in patients unable to produce sufficient amounts of IgG antibodies.Carimune NF
Maintenance treatment of patients with primary immunodeficiencies (eg, common variable immunodeficiency).Carimune NF, Gamunex
Idiopathic thrombocytopenic purpura (ITP). Consider use in situations that require a rapid, temporary rise in platelet count (eg, prior to surgery).Flebogamma, Gamunex
Primary (inherited) humoral immunodeficiency disorders (eg, variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency, Wiskott-Aldrich Syndrome).Gammagard
Primary immunodeficiency diseases (congenital X-linked gammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies).Gammagard S/D
Primary immunodeficiency diseases; B-cell chronic lymphocytic leukemia (CLL); ITP; Kawasaki syndrome.Gamunex
Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).Ivvegam EN
Primary immunodeficiency diseases (eg, common variable immunodeficiency, X-linked agammaglobulinemia, hyper IgM syndromes, and Wiskott-Aldrich syndrome); Kawasaki syndrome.Octagam
Treatment of primary immune deficient diseases (eg, congenital agammaglobulinemia and hypogammaglobulinemia, Wiskott-Aldrich syndrome).Privigen
Primary immunodeficiency diseases; chronic immune thrombocytopenia purpura.
Posttransfusion purpura, Guillain-Barre syndrome, and chronic inflammatory demyelinating polyneuropathy (as an alternative to plasma exchange). Prevention or treatment of autoimmune diseases (eg, rhesus hemolytic disease, rheumatoid arthritis), IgG4 subclass deficiencies, intractable epilepsy, cystic fibrosis, trauma, thermal injury (eg, severe burns), cytomegalovirus infection, neuromuscular disorders; prophylaxis of infections associated with bone marrow transplantation; GI protection; multiple sclerosis; myasthenia gravis.
Immediate hypersensitivity to human antibody product; selective IgA deficiency and circulating anti-IgA antibodies; possible aseptic meningitis syndrome; hypersensitivity or intolerance to any component of the product. History of severe or anaphylactic reaction to blood or blood-derived products.
IV 400 mg/kg every 3 to 4 wk.CIDPAdults Gamunex
2 g/kg (20 mL/kg) in divided doses over 2 to 4 consecutive days.Maintenance dose
1 g/kg (10 mL/kg) over 1 day, or divided into 2 doses of 0.5 g/kg (5 mL/kg) given on 2 consecutive days, every 3 wk.Immunodeficiency SyndromeAdults and Children Carimune NF
IV 0.2 g/kg once a month. (If clinical response is inadequate, increase dose to 0.3 g/kg or repeat infusion more frequently than once a month.)ITPAdults and Children Carimune NF
IV For induction therapy, 0.4 g/kg on 2 to 5 consecutive days.Carimune NF
IVMaintenance- Chronic ITP
If after induction therapy the platelet count falls below 30,000/mcL and/or the patient manifests bleeding, 0.4 g/kg may be given as a single infusion. If an adequate response does not result, the dose can be increased to 0.8 to 1 g/kg given as a single infusion.Gammagard S/D
IV 1 g/kg. Additional doses of up to 3 separate doses may be given on alternate days if needed, based on clinical response and platelet count.Gamunex
IV 2 doses of 1 g/kg given on 2 consecutive days or 5 doses of 0.4 mg/kg given on 5 consecutive days. If, after the first of 2 daily 1 g/kg doses, an adequate increase in platelet count is observed at 24 h, withhold the second 1 g/kg dose.Adults and Children older than 15 yr of age Privigen
IV Two 1 g/kg doses on 2 consecutive days.Children Carimune NF
IVAcute ITP Childhood
If an initial platelet count response to the first 2 doses is adequate (30,000 to 50,000/mcL), therapy may be discontinued after the second day of the 5-day course.Kawasaki SyndromeAdults and Children Gammagard S/D
IV 1 g/kg as a single dose or 400 mg/kg for 4 consecutive days beginning within 7 days of the onset of fever, administered with aspirin 80 to 100 mg/kg/day in 4 divided doses.Iveegam EN
400 mg/kg daily for 4 consecutive days or as a single 2 g/kg dose given over a 10-h period initiated within 10 days of disease onset. Administer with aspirin 80 to 100 mg/kg/day.Primary Immunodeficiency DiseasesAdults and Children Flebogamma , Gammagard , Gammagard S/D , Gamunex , Octagam
IV 300 to 600 mg/kg administered every 3 to 4 wk. Adjust dose over time to achieve desired trough levels and clinical response.Iveegam EN
200 mg/kg per month. Dose may be increased up to 4-fold or intervals between infusions shortened if desired results are not obtained.Adults and Children 3 yr of age and older Privigen
IV 200 to 800 mg/kg at a dosing interval of 3 or 4 wk for 12 mo.
To avoid inactivating vaccines containing live viruses or bacteria, give live vaccines 2 to 4 wk before or 3 to 11 mo after immune globulin IV, depending on dose.
Blood-group antibodies may be transferred to immune globulin IV recipients, causing confusion regarding recipient's blood type.Octagam
Contains maltose, which may be misinterpreted as glucose by certain types of blood glucose testing systems (eg, systems based on glucose-dye-oxidoreductase methods).
Cardiac arrest, hypertension, hypotension, thromboembolism, vascular collapse (postmarketing).
Aseptic meningitis, asthenia, coma, dizziness, fatigue, headache, loss of consciousness, pyrexia/hyperthermia, seizures, tremor (postmarketing).
Bullous dermatitis, diaphoresis, ecchymosis, epidermolysis, erythema multiforme, flushing, petechiae, pruritus, purpura, rash, Stevens-Johnson syndrome, urticaria (postmarketing).
Ear pain, epistaxis, nasal congestion, nasopharyngitis, rhinorrhea, sore throat.
Abdominal pain, diarrhea, increased conjugated bilirubin, nausea, stomach discomfort, vomiting.
Acute renal failure, acute tubular necrosis, osmotic nephrosis, proximal tubular nephropathy.
Decreased hematocrit, hemolysis, hemolytic anemia, hemorrhage, leukopenia, pancytopenia, positive direct antiglobulin (Coombs) test, thrombocytopenia (postmarketing).
Hepatic dysfunction (postmarketing).
Increased BUN and creatinine.
Arthralgia, back pain, leg cramps, limb pain, neck pain, rigors (postmarketing).
Acute respiratory distress syndrome, apnea, asthma, bronchitis, bronchospasm, cyanosis, dyspnea, hypoxemia, increased cough, pharyngitis, pulmonary edema, rhinitis, sinusitis, transfusion-related acute lung injury, upper respiratory tract infection, wheezing (postmarketing).
Accidental injury, chills, fever, pain, pain in extremities, tightness in chest.
Immune globulin products have been associated with renal function impairment, acute renal failure, osmotic nephrosis, and death. Products containing sucrose as a stabilizer account for a disproportionate share of the total number of cases of renal function impairment and acute renal failure. For patients judged to be at increased risk of developing renal function impairment, it may be prudent to reduce amount of product infused per unit time. Do not exceed recommended doses, and ensure that the concentration and infusion rate are at the minimum level practicable.
Monitor for signs and symptoms of hemolysis and pulmonary adverse reactions. Consider a baseline assessment of blood viscosity in patients at risk for hyperviscosity. Periodically monitor renal function and urinary output.
Category C .
Safety and efficacy not established.Gammagard
Safety and efficacy not established in neonates or infants.Gamunex treatment of CIDP
Safety and efficacy not established.Privigen Primary immunodeficiency
Safety and efficacy not established in children younger than 3 yr of age.Chronic ITP
Safety and efficacy not established in children younger than 15 yr of age.
Use with caution in patients older than 65 yr of age and judged to be at increased risk of developing renal function impairment.
Hypersensitivity, including anaphylaxis, may occur.
Use with caution in patients with preexisting renal insufficiency and in patients judged to be at risk of developing renal function impairment. Has been associated with renal function impairment, acute renal failure, osmotic nephrosis, and death. Ensure that immune globulin IV is administered at the minimum concentration available and at the minimum rate of infusion practical in patients predisposed to acute renal failure. Ensure that renal function (BUN, serum creatinine) is evaluated before starting therapy and periodically thereafter in patients determined to be at risk for acute renal failure. Monitor urine output during infusion of immune globulin IV. Be prepared to discontinue therapy.
Aseptic meningitis syndrome (including drowsiness, fever, nausea, painful eye movements, photophobia, rigidity at nape of neck, severe headache, and vomiting) may occur.
Positive direct antiglobulin reaction and hemolysis may occur. Monitor patient for signs and symptoms of hemolysis (eg, jaundice, splenomegaly, unexplained fatigue).
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
Patients with agammaglobulinaemia or extreme hypogammaglobulinemia who have never received immunoglobulin substitution treatment or whose time from last treatment is more than 1 mL/min may be at risk of developing inflammatory reactions with an infusion rate of more than 1 mL/min.
Immune globulin IV is made from human plasma and may contain infectious agents, such as viruses, that can cause disease.
Noncardiogenic pulmonary edema (TRALI) may occur. Monitor patient for adverse pulmonary reactions. Ensure that tests for antineutrophil antibodies in both the immune globulin IV and patient are performed and evaluated.
Copyright © 2009 Wolters Kluwer Health.