Immune Globulin IV

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)

HOW SUPPLIED:

10mL - Injectable Vial

25mL - Injectable Vial

50mL - Injectable Vial

100mL - Injectable Vial

200mL - Injectable Vial

Pharmacology

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.

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

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

Primary (inherited) humoral immunodeficiency disorders (eg, variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency, Wiskott-Aldrich Syndrome).

Primary immunodeficiency diseases (congenital X-linked gammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies).

Primary immunodeficiency diseases; B-cell chronic lymphocytic leukemia (CLL); ITP; Kawasaki syndrome.

Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

Primary immunodeficiency diseases (eg, common variable immunodeficiency, X-linked agammaglobulinemia, hyper IgM syndromes, and Wiskott-Aldrich syndrome); Kawasaki syndrome.

Treatment of primary immune deficient diseases (eg, congenital agammaglobulinemia and hypogammaglobulinemia, Wiskott-Aldrich syndrome).

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; GI protection; multiple sclerosis; myasthenia gravis.

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

IV 400 mg/kg every 3 to 4 wk.

IV

2 g/kg (20 mL/kg) in divided doses over 2 to 4 consecutive days.

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.

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.)

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

IV

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.

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.

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.

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

IV

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.

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.

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.

IV 300 to 600 mg/kg administered every 3 to 4 wk. Adjust dose over time to achieve desired trough levels and clinical response.

200 mg/kg per month. Dose may be increased up to 4-fold or intervals between infusions shortened if desired results are not obtained.

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, changes in BP and pulse, flushing). 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 is required.
• In-line filtration is acceptable but not required. Pore sizes of 15 microns or more 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.
• Gamunex is incompatible with saline.
• Do not mix immune globulin IV with other medications.

Storage/Stability

• Protect immune globulin IV solutions from freezing. Do not use any immune globulin IV solution that has been frozen.
• Store Gamunex for up to 36 mo at 34° to 46°F. Gamunex also may be stored at temperatures not exceeding 77°F for up to 6 mo any time during the 36-mo shelf life, after which the product must be immediately discarded. Do not freeze.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Safety and efficacy not established in neonates or infants.

Safety and efficacy not established.

Safety and efficacy not established in children younger than 3 yr of age.

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 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

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

Hemolysis

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

Hyperproteinemia

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.

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 of 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 both 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 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.