Rapid and Sustained Results

Clinical response within 7 days after initial infusion (mean, 1.8 days)1-3*

Platelet Chart

The figure depicts the mean platelet count and the number of patients with bleeds reported during the first 7 days post initial treatment with octagam 10% (n=66).

* In an open-label, phase 3 clinical trial, 66 adult patients (ages 17- 88) with chronic ITP and 50 adult patients with newly diagnosed ITP were treated with octagam 10% liquid 1 g/kg/day on 2 consecutive days. Infusion rate was adjusted according to tolerability up to a maximum of 12 mg/kg/min in 54 of 90 patients (720 mg/kg/hour) and then evaluated during a 21-day study period and at a 63-day follow-up visit.

  • 82% of patients (54 of 66) reached the clinical endpoint
    • Mean time to reach clinical endpoint was 1.8 days after initial infusion
  • 78% of patients (35 of 45) with bleeding at baseline reported no bleeding on day 7
    • A decrease in severity of bleeding by day 7 was seen in 84% of patients (38 of 45)

A sustained clinical response1-3

Duration of Response Chart

  • Mean duration of clinical response was 20.9 days
  • At day 63, mean platelet count in 54 responders was 88 x 109/L

A rapid infusion rate without compromising integrity2,3

Tolerability Profile

The figure above depicts total infusion time based on the infusion rates and ramp-up schedule for octagam 10%.

  • Premedication to alleviate potential infusion reactions was only used in one patient (0.9%)
  • All drug-related adverse events (AEs) were mild or moderate in intensity and they all resolved
  • One serious drug-related AE of a moderate headache (0.9%) was reported
  • No cases of drug-related hemolysis, anaphylactic, or anaphylactoid reactions were reported

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References:
  1. Octapharma, Data on File. 2014.
  2. Octagam 10% Full Prescribing Information. Hoboken, NJ: Octapharma USA Inc; rev May 2018.
  3. Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam 10%) in patients with immune thrombocytopenia. Hematology. 2010;15(5):351-359.