Gammaked Background

Clinical ITP Information

IN AN ITP STUDY, GAMMAKEDTM INCREASED PLATELET LEVELS BY 2.5 TIMES IN 90% OF PATIENTS1,2

Double-blind, multicenter, parallel-group trial of 97 patients with ITP randomized to receive Gammaked 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

In an ITP study, Gammaked demonstrated improvement in platelet levels1

INCREASE IN PLATELET COUNTS ACHIEVED WITHIN JUST 7 DAYS AFTER TREATMENT2

  • 90% of patients treated with Gammaked 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 Gammaked achieved a platelet count of > 50 x 109/L

 INCREASE IN PLATELET COUNTS SUSTAINED FOR 7 DAYS2

  • 74% of patients treated with Gammaked maintained the increase in platelet response for at least a week (> 50 x 109/L)

IN AN ITP STUDY, PATIENTS WITH ITP, GAMMAKED DEMONSTRATED A RAPID AND ENDURING PLATELET RESPONSE1

 

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. GAMMAKED [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2013.