Immune globulin IV (Human)
Immune globulin Intravenous (Human) (IGIV)
Immune Globulin IV (Human)
(im- MYOUN GLOH-byou-lin)
Pregnancy Category: C Gamimune N 5% and 10% Gammabulin Immuno Gammagard S/D Gammar-P I.V. Iveegam Polygam Polygam S/D Sandoglobulin Venoglobulin-I Venoglobulin-S Solvent Detergent Treated (Rx)

Classification: Immunoglobulin G antibody product. NOTE: The available products differ significantly with respect to the process by which they are made (e.g., donor pool and fractionation/purification) as well as isotonicity. Thus, information on each product should be carefully read before use. NOTE: Gammagard has been replaced by Gammagard S/D. Also, Gammagard S/D is a higher concentration than Gammagard; thus, the drug can be infused more quickly. Certain products have been treated by compounds that are capable of inactivating several blood-borne viruses.

Action/Kinetics: Derived from a human volunteer pool. Contains the various IgG antibodies normally occurring in humans. The products may also contain traces of IgA and IgM. Plasma in the manufacturing pool has been found nonreactive for hepatitis B antigen. Have been no documented cases of viral transmission. Antibodies present in the products will cause both opsonization and neutralization of microbes and toxins. Reconstituted products may contain sucrose, maltose, protein, and/or small amounts of sodium chloride. Immune globulin IV provides immediate antibody levels. The percentage of IgG in the products is over 90%. t 1/2: Gamimune N and Sandoglobulin, 3 weeks; Venoglobulin-I, 29 days.

Uses: All products: Severe combined immunodeficiency and primary immunoglobulin deficiency syndromes, including congenital agammaglobulinemia, X-linked agammaglobulinemia with or without hyper IgM, combined immunodeficiency, and Wiskott-Aldrich syndrome. Investigational: Chronic fatigue syndrome, quinidine-induced thrombocytopenia.
Gamimune N, Gammagard S/D, Polygam S/D, Sandoglobulin, Venoglobulin-I and Venoglobulin-S: Acute and chronic ITP in both children and adults.

Contraindications: Clients with selective IgA deficiency who have antibodies to IgA (the products contain IgA). Sensitivity to human immune globulin.

Special Concerns: The various products are used for different conditions and at different doses; thus, check information carefully.

Side Effects: CNS:
Headache, malaise, feeling of faintness. Aseptic meningitis syndrome, including symptoms of severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, N&V.; Allergic: Hypersensitivity or anaphylactic reactions. Body as a whole: Fever, chills. GI: Headache, nausea, vomiting. Miscellaneous: Chest tightness, dyspnea; chest, back, or hip pain; mild erythema following infiltration; burning sensation in the head; tachycardia.
Agammaglobulinemic and hypogammaglobulinemic clients never having received immunoglobulin therapy or where the time from the last treatment is more than 8 weeks may manifest side effects if the infusion rate exceeds 1 mL/min. Symptoms include flushing of the face, hypotension, tightness in chest, chills, fever, dizziness, diaphoresis, and nausea.

How Supplied: Injection: 50 mg/mL, 100 mg/mL; Powder for injection: 1 g, 2.5 g, 3 g, 5 g, 6 g, 10 g, 12 g

Dosage
NOTE: Due to differences in products, dosage must be listed separately for each product. ?IV Only for All Products
Gamimune n Immunodeficiency syndrome.
100-200 mg/kg given once a month; if response is satisfactory, dose can be increased to 400 mg/kg or infusion may be repeated more frequently than once a month. Rate of infusion for all uses: 0.01-0.02 mL/kg/min for 30 min; if no discomfort is experienced, the rate can be increased up to 0.08 mL/kg/min.
ITP.
400 mg/kg for 5 consecutive days or 1,000 mg/kg/day for 1 day or 2 consecutive days. Maintenance: If platelet count falls to less than 30,000/mm ³ or if bleeding occurs, 400 mg/kg may be given as a single infusion. If an adequate response is not seen, the dose can be increased to 800-1,000 mg/kg given as a single infusion. Maintenance infusions are given, as needed, to maintain platelet counts greater than 30,000/mm ^3.
Bone marrow transplantation.
500 mg/kg beginning on days 7 and 2 pretransplant or at the time conditioning therapy for transplantation is initiated; then, give weekly throughout the 90-day post-transplant period.
Pediatric HIV infection.
400 mg/kg q 28 days.

Gammagard s/d Immunodeficiency syndrome.
200-400 mg/kg (minimum of 100 mg/kg/month).
B-cell CLL.
400 mg/kg q 3-4 weeks.
ITP.
1,000 mg/kg; additional doses depend on platelet count (up to three doses can be given on alternate days). Rate of infusion: 0.5 mL/kg/min initially; may be increased gradually, not to exceed 4 mL/kg/hr if there is no client distress.

Gammar-p i.v. Immunodeficiency syndrome.
200-400 mg/kg q 3-4 weeks. An alternative is a loading dose of at least 200 mg/kg at more frequent intervals and then 200-600 mg/kg at 3-week intervals once a therapeutic plasma level has been reached. Rate of infusion: 0.01 mL/kg/min, increasing to 0.02 mL/kg/min after 15 to 30 min. Most clients will tolerate a gradual increase to 0.03-0.06 mL/kg/min.

Iveegam Immunodeficiency syndrome.
200 mg/kg/month. If desired effect not achieved, the dose may be increased up to fourfold (i.e., up to 800 mg/kg/month) or the intervals between doses shortened. Rate of infusion for all uses: 1 mL/min to a maximum of 2 mL/min of the 5% solution. The product may be further diluted with saline or 5% dextrose.
Kawasaki syndrome.
400 mg/kg/day for 4 consecutive days or a single dose of 2,000 mg/kg given over a 10-hr period. Treatment should be initiated within 10 days of onset and should include aspirin, 100 mg/kg each day through the 14th day of illness; then, aspirin is given at a dose of 3-5 mg/kg/day for 5 weeks.

Polygam s/d Immunodeficiency syndrome.
Initial: 200-400 mg/kg may be given; then 100 mg/kg/month. Rate of administration for all uses: Initially, 0.5 mL/kg/hr. If there is no distress, the rate can be gradually increased, not to exceed 4 mL/kg/hr. Those who tolerate the 5% solution at a rate of 4 mL/kg/hr can receive the 10% solution starting at 0.5 mL/kg/hr.
B-cell CLL.
400 mg/kg q 3 to 4 weeks.
ITP.
1 g/kg. Depending on response, additional doses can be given--three separate doses on alternate days can be given, if needed.

Sandoglobulin Immunodeficiency syndrome.
200 mg/kg/month; increase to 300 mg/kg if client response satisfactory (i.e., IgG serum level of 300 mg/dL). Rate of administration for all uses: 3% solution at an initial rate of 0.5-1 mL/min; after 15-30 min can increase to 1.5-2.5 mL/min (subsequent infusions at a rate of 2-2.5 mL/min). If the 6% solution is used, the initial infusion rate should be 1-1.5 mL/min and increased after 15-30 min to a maximum of 2.5 mL/min.
ITP.
400 mg/kg for 2-5 consecutive days.

Venoglobulin-i Immunodeficiency disease.
200 mg/kg/month by IV infusion; can increase to 300-400 mg/kg if response is insufficient or can repeat infusion more frequently than once monthly. Rate of infusion for all uses: 0.01 to 0.02 mL/kg/min for the first 30 min; if no distress is noted, the rate may be increased to 0.04 mL/kg/min. Higher rates may be used if tolerated. The drug can be given sequentially into a primary IV line containing normal saline; it is not compatible with 5% dextrose solution.
ITP.
Induction: Up to 2,000 mg/kg for 2 to 7 consecutive days; those who respond to induction therapy (platelet count of 30,000/mm ³-50,000/mm ³) may be discontinued after two to seven daily doses. Maintenance: Single infusion of 2,000 mg/kg q 2 weeks, as needed to maintain a platelet count of 30,000/mm ³ in children and 20,000/mm ³ in adults or to prevent bleeding episodes between infusions.

Venoglobulin-s Immunodeficiency disease.
200 mg/kg/month; can increase to 300-400 mg/kg if response is insufficient or can repeat infusion more frequently than once monthly. Rate of infusion for all uses: Initially, 0.01-0.02 mL/kg/min or 1.2 mL/kg/hr for the first 30 min. If no discomfort is noted, the rate for the 5% solution may be increased to 0.04 mL/kg/min or 2.4 mL/kg/hr and the rate for the 10% solution may be increased to 0.05 mL/kg/min or 3 mL/kg/hr.
ITP.
Induction: 2,000 mg/kg over a maximum of 5 days. Maintenance: 1,000 mg/kg as needed to maintain platelet counts of 30,000/mm ³ for children and 20,000/mm ³ for adults or to prevent bleeding episodes between infusions.