Uncover GAMUNEX-C efficacy and dosing for ITP treatment
GAMUNEX-C DEMONSTRATED A RAPID AND ENDURING PLATELET RESPONSE IN PATIENTS WITH ITP1
GAMUNEX-C increased platelet levels by 2.5 times in 90% of patients1
Double-blind, multicenter, parallel-group trial of 97 patients with ITP randomized to receive GAMUNEX-C 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-C DEMONSTRATED IMPROVEMENT IN PLATELET LEVELS1
- Increase in platelet counts achieved within 7 days after treatment1
- 90% of patients treated with GAMUNEX-C 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 days 7 and 23)1
- 90% of patients treated with GAMUNEX-C achieved a platelet count of ≥50 x 109/L
- Increase in platelet counts sustained for 7 days1
- 74% of patients treated with GAMUNEX-C maintained the increase in platelet response for at least a week (≥50 x 109/L)
GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
ADVERSE REACTIONS IN ITP TRIAL
The most common adverse reactions observed in the ITP study with GAMUNEX-C were headache, vomiting, fever, nausea, back pain, and rash.
The most serious adverse reaction was myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related.
GAMUNEX-C OFFERS A PROVEN DOSING REGIMEN WITH LOADING AND MAINTENANCE DOSES FOR ITP2
|INDICATION||DOSE||INITIAL INFUSION RATE||MAINTENANCE INFUSION RATE (IF TOLERATED)|
|ITP||2 g/kg||1 mg/kg/min |
|8 mg/kg/min |
It is recommended that the 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).
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.
Ensure that patients with preexisting renal insufficiency are not volume depleted; discontinue if renal function deteriorates.
For patients at risk of renal dysfunction or thromboembolic events, administer at the minimum infusion rate practicable.
GAMUNEX-C is not approved for subcutaneous use in patients with ITP or CIDP. Due to potential risk of hematoma formation, GAMUNEX-C should not be administered subcutaneously in patients with ITP.
GAMUNEX-C is a proven formulation for a wide range of patients.2,3
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