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Immune Globulin IV

( IGIV ) Pronouncation: (im-UM GLOB-u-lin)
Class: Immune globulin

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:
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)

Pharmacology

Feedback for Immune Globulin IV (IGIV)

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Replaces normal human immunoglobulin (Ig) G antibodies. Promotes opsonization, fixes complement, and neutralizes bacteria, viruses, fungi, and parasites, and their toxins.

Indications and Usage

Treatment of primary immunodeficiency states in patients unable to produce sufficient amounts of IgG antibodies.

Carimune NF, Gamunex

Idiopathic thrombocytopenic purpura (ITP). Consider use in situations that require a rapid, temporary rise in platelet count (eg, prior to surgery).

Carimune NF

Maintenance treatment of patients with primary immunodeficiencies (eg, common variable immunodeficiency).

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); idiopathic thrombocytopenic purpura; 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.

Unlabeled Uses

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, and GI protection.

Contraindications

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.

Dosage and Administration

B-Cell CLL
Adults and Children Gammagard S/D

IV 400 mg/kg every 3 to 4 wk.

Immunodeficiency Syndrome
Adults 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.)

ITP
Adults and Children Carimune NF

IV For induction therapy, 0.4 g/kg on 2 to 5 consecutive days.

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 inadequate increase in platelet count is observed at 24 h, withhold the second 1 g/kg dose.

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.

Carimune NF

Maintenance- 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.

Adults and Children older than 15 yr of age Privigen

IV Two 1 g/kg doses on 2 consecutive days.

Children Carimune NF

Acute 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 Syndrome
Adults 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).

Primary Immunodeficiency Diseases
Adults 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.

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.

General Advice

For administration by IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
Reconstitute powder for injection immediately before use following manufacturer's guidelines for reconstitution. Do not shake during reconstitution process to avoid foaming.
Contents of individual vials may be pooled under aseptic conditions into sterile infusion containers.
Carefully follow recommended infusion rates to reduce risk of infusion-related adverse reactions (eg, flushing, changes in BP and pulse). Generally, infusions are started at low rates and then increased as tolerated. If adverse reactions occur, the infusion rate may be reduced, or the infusion interrupted until symptoms subside, and then resumed at the rate that is comfortable for the patient.
Ensure that immune globulin IV solutions that have been refrigerated are allowed to come to room temperature before infusing.
Infuse immune globulin IV through separate IV line. Do not add any other medications or IV fluids to immune globulin IV infusion container. If other medications or IV fluids will be sequentially administered, flush IV line with dextrose 5% in water before and after infusion of immune globulin IV. Gamunex may be diluted with dextrose 5% in water if dilution required.
In-line filtration is acceptable but not required. Pore sizes of 15 microns or greater will be less likely to slow infusion.
Do not mix immune globulin IV products of different formulations or from different manufacturers.
Do not administer if solution is discolored, cloudy, or turbid, or if particulate matter is noted.

Storage/Stability

Protect immune globulin IV solutions from freezing. Do not use any immune globulin IV solution that has been frozen.
Store Carimune NF vials at controlled room temperature (less than 86°F). Administer Carimune immediately after reconstitution if reconstitution occurs outside of sterile laminar air flow conditions, or within 24 h if reconstitution is performed in sterile laminar flow hood using aseptic technique and solution is stored in refrigerator (36° to 46°F) during that time.
Store Octagam for up to 24 mo at 36° to 77°F. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.
Store Gamunex for up to 36 mo at 36° to 46°F in refrigerator. Gamunex may also be stored for up to 6 mo at controlled room temperature during the first 18 mo from date of manufacture, after which the product must be immediately used or discarded. Protect from freezing. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.
Store Flebogamma at 36° to 77°F. Protect from freezing. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.
Store Gammagard S/D at or below 76°F. Avoid freezing. When reconstitution is performed aseptically outside a sterile laminar air flow hood, administration should begin as soon as possible, but not more than 2 h after reconstitution. When reconstitution is performed aseptically in a sterile laminar air flow hood, the reconstituted product may be either maintained in the original glass container or pooled into Viaflex bags and stored at 36° to 46°F for up to 24 h.
Store Gammagard at 36° to 46°F for up to 36 mo. Do not freeze. Product may be stored at 77°F for 9 mo within the first 24 mo of the date of manufacture. After 24 mo from the date of manufacture, the product cannot be stored at room temperature.
Store Privigen at 77°F for up to 24 mo. Do not freeze. Protect from light.

Drug Interactions

Live vaccines

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.

Incompatibility

Admixture

Do not mix immune globulin IV with other medications.

Laboratory Test Interactions

Blood type

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).

Adverse Reactions

Cardiovascular

Hypotension; cardiac arrest, thromboembolism, vascular collapse (postmarketing).

CNS

Asthenia; dizziness; fatigue; headache; aseptic meningitis, coma, loss of consciousness, pyrexia/hyperthermia, seizures, tremor (postmarketing).

Dermatologic

Diaphoresis; ecchymosis; flushing; petechiae; pruritus; purpura; rash; urticaria; bullous dermatitis, epidermolysis, erythema multiforme, Stevens-Johnson syndrome (postmarketing).

EENT

Ear pain; epistaxis; nasal congestion; nasopharyngitis; rhinorrhea; sore throat.

GI

Abdominal pain; diarrhea; increased conjugated bilirubin; nausea; stomach discomfort; vomiting.

Genitourinary

Acute renal failure; acute tubular necrosis; osmotic nephrosis; proximal tubular nephropathy.

Hematologic-Lymphatic

Decreased hematocrit; hemolysis; hemorrhage; thrombocytopenia; hemolytic anemia, leukopenia, pancytopenia, positive direct antiglobulin (Coombs) test (postmarketing).

Hepatic

Hepatic dysfunction (postmarketing).

Lab Tests

Increased BUN and creatinine.

Local

Injection-site reaction.

Musculoskeletal

Arthralgia; back pain; leg cramps; limb pain; neck pain; rigors (postmarketing).

Respiratory

Asthma; bronchitis, bronchospasm, increased cough; pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; wheezing; acute respiratory distress syndrome, apnea, cyanosis, dyspnea, hypoxemia, pulmonary edema, transfusion-related acute lung injury (postmarketing).

Miscellaneous

Accidental injury; chills; fever; pain; pain in extremities; tightness in chest.

Precautions

Warnings

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 the concentration and infusion rate should be the minimum level practicable.

Monitor

Monitor for signs and symptoms of hemolysis and pulmonary adverse reactions. Consider a baseline assessment of blood viscosity in patients at risk of hyperviscosity. Periodically monitor renal function and urinary output.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Flebogamma

Safety and efficacy not established.

Gammagard

Safety and efficacy not established in neonates or infants.

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.

Elderly

Use with caution in patients older than 65 yr of age and judged to be at increased risk of developing renal function impairment.

Hypersensitivity

Hypersensitivity, including anaphylaxis, may occur.

Renal Function

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 patient predisposed to acute renal failure. Ensure that renal function (BUN, serum creatinine) is evaluated before starting therapy and periodically thereafter in patient 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

Aseptic meningitis syndrome (including severe headache, rigidity at nape of neck, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting) may occur.

Hemolysis

Positive direct antiglobulin reaction and hemolysis may occur. Monitor patient for signs and symptoms of hemolysis (eg, unexplained fatigue, jaundice, splenomegaly).

Hypogammaglobulinemia

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 more than 1 mL/min.

Infection transmission

Immune globulin IV is made from human plasma and may contain infectious agents, such as viruses, that can cause disease.

Thrombotic events

May occur.

Transfusion-related acute lung injury (TRALI)

Noncardiogenic pulmonary edema (TRALI) may occur. Monitor patient for adverse pulmonary reactions. Ensure that tests for antineutrophil antibodies in the immune globulin IV and patient are performed and evaluated.

Patient Information

Explain names, actions, and potential adverse reactions of the treatment regimen. Review the treatment regimen, including duration of treatment and monitoring that will be required.
Review benefits of therapy and risks, including potential to transmit disease and unknown infectious agents.
Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
Instruct patient to immediately report any of the following to health care provider: decreased urine output, fever, fluid retention or swelling, painful eye movements, persistent or worsening nausea and vomiting, sensitivity to bright light, severe headache, stiff neck, sudden weight gain, unexplained drowsiness or fatigue, unexplained shortness of breath.