Rapid and Sustained Results
Clinical response within 7 days after initial infusion (mean, 1.8 days)1-3*
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
- 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
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
- Octapharma, Data on File. 2014.
- Octagam 10% Full Prescribing Information. Paramus, NJ: Octapharma USA Inc; rev June 2021.
- 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.