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  • Gamunex C
    / Perrigo


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 gr / 10 ml

    partial basket chart 35515 7924

    Vial

    2.5 gr / 25 ml

    partial basket chart 35514 7925

    Vial

    5 gr / 50 ml

    partial basket chart 35530 7926, 7878

    Vial

    10 gr / 100 ml

    partial basket chart 35532 7927, 7879

    Dosage

    Intravenous Administration Only: ITP and CIDP
    ITP:
    Dose: 2 g/kg
    Initial Infusion Rate: 1 mg/kg/min
    Maintenance Infusion Rate (if tolerated): 8 mg/kg/min.
    CIDP:
    Dose:loading dose:
    2 g/kg maintenance dose: 1 g/kg
    Initial Infusion Rate: 2 mg/kg/min
    Maintenance Infusion Rate (if tolerated): 8 mg/kg/min Every 3 weeks.

    Intravenous or Subcutaneous Administration: PI
    DO NOT ADMINISTER SUBCUTANEOUSLY FOR ITP PATIENTS
    Intravenous (IV):
    Dose: 300-600 mg/kg
    Infusion Rate: 1 mg/kg/min
    Maintenance Infusion Rate (if tolerated): 8 mg/kg/min Every 3-4 weeks
    Subcutaneous (SC):
    Dose: 1.37 x current IV dose in mg/kg/IV dose interval in weeks
    Infusion Rate: 20 mL/hr/site
    Maintenance Infusion Rate (if tolerated): Not determined during the clinical study
    See prescribing information for full details.


    Indications

    Primary immunodeficiency (PI): Replacement therapy of PI 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.
    Idiopathic Thrombocytopenic Purpura (ITP): To rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.
    Treatment of Chronic Inflammatory Demyeliniting Polyneuropathy (CIDP)


    Contra-Indications

    GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
    GAMUNEX-C is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.


    Special Precautions

    Not compatible with saline. If dilution is required, it can be with 5% dextrose in water (D5/W). No other drug interactions or compatibilities have been evaluated. It is recommended to initiate infusion at a rate of 0.01 ml/kg/minute (1 mg/kg/minute) for the first 30 minutes. If well-tolerated, the rate may be gradually increased to a maximum of 0.08 ml/kg/minute (8 mg/kg/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. Should be infused using a separate line by itself. See prescribing information for full details. Human immune globulin I.V. products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. IGIV should therefore be administered at the minimum concentration available and the minimum rate of infusion practicable in such patients. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer. Because this product is made from human blood, it may carry a risk of transmitting infectious agents. The risk has been reduced by screening plasma donors for prior exposure to certain viruses. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections. Any vial that has been entered should be used promptly. Do not use if turbid. Solutions that have been frozen should not be used. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure. Renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, should be assessed prior to the initial infusion. See prescribing information for full details. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. IGIV recipients should be monitored for clinical signs and symptoms of hemolysis. There have been reports of noncardiogenic pulmonary edema (Transfusion-Related Acute Lung Injury TRALI) in patients administered IGIV. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1-6 hours after transfusion. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support. IGIV recipients should be monitored for pulmonary adverse reactions. Appropriate tests should be performed for the presence of anti-neutrophil antibodies in both the product and patient serum. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization and/or known or suspected hyperviscosity. The potential risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered. Should be given to a pregnant woman only if clearly needed.


    Side Effects

    Adverse effects similar to those previously reported with administration of I.V. and I.M. immunoglobulin products may occur.
    See prescribing information for full details.


    Drug interactions

    Antibodies in Gamunex may interfere with the response to live viral vaccines such as measles, mumps and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after administration.


    Manufacturer
    Grifols Therapeutics Inc., USA
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