Tolerability

Tolerability was evaluated in a pivotal trial of patients with ITP1,2
The most common adverse reactions observed with OCTAGAM 10% treatment were headache, fever, and increased heart rate1*
*Ready-to-use OCTAGAM 10% was investigated in a prospective phase 3 study of 116 adult patients with ITP (platelet count ≤20 x 109/L). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received OCTAGAM 10% 1 g/kg/day on 2 consecutive days, and the infusion rate was adjusted according to tolerability to a maximum of 12 mg/kg/min. The primary efficacy variable was the attainment of a clinical response, defined as an increase in platelet count to ≥50 x 109/L within 6 days of dosing. Secondary efficacy variables included the time to achieve a clinical response, the maximum platelet level achieved, assessment of bleeding, and the duration of platelet response.1,2
  • Drug-related AEs were mild or moderate in intensity and they all were resolved2
  • One serious drug-related AE of a moderate headache (0.9%) was reported1,2
  • Premedication to alleviate potential infusion reactions was allowed, but was only used in 1 patient (0.9%)1
  • No cases of drug-related anaphylactic or anaphylactoid reactions were reported2
 
REFERENCES
  1. OCTAGAM 10% [prescribing information]. Hoboken, NJ: Octapharma USA Inc; May 2018.
  2. 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.