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The PROOF is in our ITP Indication

In patients with ITP

GAMUNEX demonstrated a rapid and enduring platelet response1

GAMUNEX increased platelet levels by 2.5 times in 90% of patients1,2

GAMUNEX demonstrated a rapid and enduring platelet response - Visual Aid

Double-blind, multicenter, parallel-group trial of 97 patients with ITP randomized to receive GAMUNEX or Gamimune® N, 10% [Immune Globulin Intravenous (Human)], 1 g/kg/day given on 2 consecutive days. Patients were followed for 3 to 6 months after initial efficacy evaluation of 21 days.1

GAMUNEX demonstrated improvement in platelet levels1

  • Increase in platelet counts achieved within just 7 days after treatment2
    • 90% of patients treated with GAMUNEX achieved an increase in platelet counts from ≤20 x 109/L to >50 x 109/L
  • Increase in platelet counts maintained by day 232 (steroids permitted between day 7 and 23)1
    • 90% of patients treated with GAMUNEX achieved a platelet count of >50 x 109/L
  • Increase in platelet counts sustained for 7 days2
    • 74% of patients treated with GAMUNEX maintained the increase in platelet response for at least a week (>50 x 109/L)

Dosing regimen options for GAMUNEX in ITP

Dosing regimen options for GAMUNEX in ITP
  • Maximum approved infusion rate of 0.08 mL/kg/min2

It is recommended that initial infusion rate be used 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).2

Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.2

Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue if renal function deteriorates.2

For patients at risk of renal dysfunction or thromboembolic events, administer at the minimum infusion rate practicable.2

In clinical studies, the most common adverse reactions with Gamunex were headache, vomiting, fever, nausea, back pain, and rash.2

The most serious adverse reaction was myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related.2

Important Safety Information for GAMUNEX

Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. 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. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. 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. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.

Gamunex is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy.

Gamunex is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

In clinical studies, the most common adverse reactions with Gamunex were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Please see accompanying GAMUNEX full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:

  1. Bussel JB, Eldor A, Kelton JG, et al, and the IGIV-C in ITP Study Group. IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action, and impact on quality of life. Thromb Haemost. 2004;91:771-778.

  2. GAMUNEX [package insert]. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2008.