Safety and Tolerability

Safety and tolerability of OCTAGAM 10% administered at 1 g/kg daily over 2 consecutive days1
The most common adverse reactions observed with OCTAGAM 10% treatment were headache, pyrexia, 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 cITP 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
  • No patient withdrew from the study due to a drug-related adverse event2
  • One patient experienced a serious adverse reaction (headache)1
  • 0.9% (1 of 116) of patients received premedication in this study1†
Premedication to alleviate potential adverse drug reactions was allowed.
REFERENCES
  1. OCTAGAM 10% [prescribing information]. Hoboken, NJ: Octapharma USA Inc.; 2018.
  2. Data on file. Octapharma USA Inc.