Gamunex (Immune Globulin Intravenous Human) - Indications and Dosage

INDICATIONS AND USAGE

PRIMARY HUMORAL IMMUNODEFICIENCY (PI)

GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated as replacement therapy of primary immunodeficiency states in which severe impairment of antibody forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies^17-24.

IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)

GAMUNEX® is indicated in Idiopathic Thrombocytopenic Purpura to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery^5-10.

DOSAGE AND ADMINISTRATION

DOSAGE

GENERAL

For patients judged to be at increased risk for developing renal dysfunction, it may be prudent to reduce the amount of product infused per unit time by infusing GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, at a rate less than 8 mg/kg/min (0.08 mL/kg/min). No prospective data are presently available to identify a maximum safe dose, concentration, and rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, recommended doses should not be exceeded and the concentration and infusion rate should be the minimum level practicable. Reduction in dose, concentration, and/or rate of administration in patients at risk of acute renal failure has been proposed in the literature in order to reduce the risk of acute renal failure³⁶.

PRIMARY HUMORAL IMMUNODEFICIENCY (PI)

GAMUNEX® doses between 300 and 600 mg/kg (3 and 6 mL/kg), which represented the dose range for 92% of the subjects in the therapeutic equivalence trial (100175), may be used for infection prophylaxis. The dose should be individualized taking into account dosing intervals (e.g. 3 or 4 weeks) and GAMUNEX® dose (between 300 and 600 mg/kg). A target serum IgG trough level (i.e. prior to the next infusion) of at least 5 g/L has been proposed in the literature^{22, 37}, however no randomized controlled trial data are available to validate this recommendation. In a clinical trial with 73 subjects with Primary Immune Deficiencies, treated for nine months with GAMUNEX®, the relationship of validated infections and serum IgG levels at trough are shown in the table below:

IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)

GAMUNEX® may be administered at a total dose of 2 g/kg, divided in two doses of 1 g/kg (10 mL/kg) given on two consecutive days or into five doses of 0.4 g/kg (4 mL/kg) given on five consecutive days. If after administration of the first of two daily 1 g/kg (10 mL/kg) doses, an adequate increase in the platelet count is observed at 24 hours, the second dose of 1g/kg body weight may be withheld.

Forty-eight ITP subjects were treated with 2 g/kg GAMUNEX®, divided in two 1 g/kg doses (10 mL/kg) given on two successive days. With this dose regimen 35/39 subjects (90%) responded with a platelet count from less than or equal to 20 × 10⁹/L to more than or equal to 50 × 10⁹/L within 7 days after treatment.¹¹

The high dose regimen (1 g/kg × 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

ADMINISTRATION

GAMUNEX® is not compatible with saline. If dilution is required, GAMUNEX® may be diluted with 5% dextrose in water (D5/W). No other drug interactions or compatibilities have been evaluated.

It is recommended that GAMUNEX® should initially be infused at a rate of 0.01 mL/kg per minute (1 mg/kg per minute) for the first 30 minutes. If well-tolerated, the rate may be gradually increased to a maximum of 0.08 mL/kg per minute (8 mg/kg per minute). If side effects occur, the rate may be reduced, or the infusion interrupted until symptoms subside. The infusion may then be resumed at the rate which is comfortable for the patient.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 18 gauge needles should be used to penetrate the stopper for dispensing product from 10 mL vial sizes; 16 gauge needles or dispensing pins should only be used with 25 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.

Content of vials may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling.

It is recommended to infuse GAMUNEX® using a separate line by itself, without mixing with other intravenous fluids or medications the patient might be receiving.

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

HOW SUPPLIED

GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is supplied in the following sizes:

STORAGE

GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, may be stored for 36 months at 2-8°C (36-46°F), AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 5 months during the first 18 months from date of manufacture, after which the product must be immediately used or discarded. Do not freeze. Do not use after expiration date.

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