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GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.15,22
DOSAGE AND ADMINISTRATION
GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) should be at room temperature during administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter and/or discoloration is observed. Only clear or slightly opalescent and colorless or pale yellow solutions are to be administered. GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) should only be administered intravenously. Other routes of administration have not been evaluated. The use of an in-line filter is optional.
For patients with Primary Immunodeficiency, monthly doses of approximately 300 - 600 mg/kg infused at 3 to 4 week intervals are commonly used.23,24 As there are significant differences in the half-life of IgG among patients with Primary Immunodeficiency, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response. The minimum serum concentration of IgG necessary for protection varies among patients and has not been established by controlled clinical studies.
Rate of Administration
During the first infusion of the Phase 3 clinical study, GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) was infused at an initial rate of 0.5 mL/kg/hr (0.8 mg/kg/min). The rate was gradually increased every 30 minutes to a rate of 5.0 mL/kg/hr (8.9 mg/kg/min) if it was well tolerated. However, some patients completed the infusion before the maximum rate could be obtained. During subsequent infusions the initial rate and the rate of escalation were based on their previous infusion history; however, the maximum rate attained during the first infusion was used throughout the remainder of the study. The mean rate attained by all patients was 4.3 mL/kg/hr. Fifty-eight subjects (95%) achieved a maximum rate of 4.0 mL/kg/hr or greater and of these, 16 subjects (26%) attained a rate of 5.0 mL/kg/hr. In general, it is recommended that patients beginning therapy with IGIV or switching from one IGIV product to another be started at the lower rates and then advanced to the maximal rate if they have tolerated several infusions at intermediate rates of infusion. It is important to individualize rates for each patient.
As noted in the WARNINGS section, patients who have underlying renal disease or who are judged to be at risk of developing thrombotic events should not be infused rapidly with any IGIV product. Although there are no prospective studies demonstrating that any concentration or rate of infusion is completely safe, it is believed that risk is decreased at lower rates of infusion.46 Therefore, as a guideline, it is recommended that these patients who are judged to be at risk of renal dysfunction or thrombotic complications be gradually titrated up to a more conservative maximal rate of less than 3.3 mgIgG/kg/min ( < 2mL/kg/hr).
A rate of administration that is too rapid may cause flushing and changes in pulse rate and blood pressure. Slowing or stopping the infusion usually results in the prompt disappearance of signs. The infusion may then be resumed at a rate that is comfortable for the patient.
Antibodies in IGIV products may interfere with patient responses to live vaccines, such as those for measles, mumps and rubella.47,48,49 The immunizing physician should be informed of recent therapy with IGIV products so that appropriate precautions can be taken. Admixtures of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMMAGARD LIQUID be administered separately from other drugs or medications that the patient may be receiving. The product should not be mixed with IGIV products from other manufacturers.
Normal saline should not be used as a diluent. If dilution is preferred, GAMMAGARD LIQUID may be diluted with 5% dextrose in water (D5W).50 No other drug interactions or compatibilities have been evaluated.
GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) is supplied in single use bottles as follows:
Refrigeration: 36 months storage at refrigerated temperature 2° to 8°C (36°-46°F). Do not freeze. Room Temperature: 9 months storage at room temperature 25°C, (77°F) within the first 24 months of the date of manufacture. See below for detailed storage information. The total storage time of GAMMAGARD LIQUID (immune globulin intravenous (human) 10%) depends on the point of time the vial is transferred to room temperature. Examples for total storage times are illustrated in Figure 1. The new expiration date must be recorded on the package when the product is transferred to room temperature.
Figure 1: Storage Guidelines
Months from Date of Manufacture
- Example 1: If the product is taken out of the refrigerator after 3 months from date of manufacture, it can be stored for 9 months at room temperature. Total storage time is 12 months.
- Example 2: If the product is taken out of the refrigerator after 21 months
from the date of manufacture, it can be stored for 3 additional months at
room temperature. Total storage time is
- After 24 months from date of manufacture, product cannot be stored at room temperature.
15. Stiehm ER. Standard and special human immune serum globulins as therapeutic agents. Pediatrics. 1979;63:301-319.
22. Schiff RI, Rudd C. Alterations in the half-life and clearance of IgG during therapy with intravenous gamma-globulin in 16 patients with severe primary humoral immunodeficiency. J Clin Immunol. 1986;6:256-264.
46. Tan E, Hajinazarian M, Bay W, Neff J, Mendell JR. Acute renal failure resulting from intravenous immunoglobulin therapy. Arch Neurol. 1993;50:137-139.
47. Morbidity and Mortality Weekly Report. Measles, Mumps, and Rubella; Vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps. Recommendations for the Advisory Committee on Immunization Practices (ACIP). 98 A.D.;47.
48. Peter G. Summary of major changes in the 1994 Red Book: American Academy of Pediatrics. Report of the Committee on Infectious Disease. Pediatrics. 1994;93:1000-1002.
49. Siber GR, Werner BG, Halsey NA, et al. Interference of immune globulin with measles and rubella immunization. J Pediatr. 1993;122:204-211.
50. Data on file, Baxter Healthcare Corporation.
To enroll in the confi dential, industry-wide Patient Notifi cation System,
call 1-888-UPDATE U (1-888-873-2838).
Baxter Healthcare Corporation, Westlake Village, CA 91362 USA. april 2005. FDA rev date: n/a
Last reviewed on RxList: 9/9/2008
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