Tolerability in Pediatric and Adults Patients With PI
The most common adverse reactions observed during treatment with octagam 5% during clinical trial
(> 5%) were headache and nausea1,2
|Adverse reactions observed with octagam 5%1|
|No. of subjects (%)||No. of infusions (%)|
|Total||46 (100)||654 (100)|
|Headache||7 (15)||18 (3)|
|Nausea||3 (7)||4 (0.6)|
Clinical trial database includes a multicenter study in 46 children and adults with PI (mean age, 31.5 years). Subjects participated in the study for a mean of 346 days and received 300-450 mg/kg every 21 days or 400-600 mg/kg every 28 days. Infusions were initiated at a rate of 30 mg/kg/hr for first 30 minutes, and, if tolerated, could be advanced to a maximum tolerated rate not exceeding 200 mg/kg/hr. Over half of subjects were male (n=28; 61%); more than half were on the 28-day schedule (n=27; 59%)
- Pre-medications were used in 165/654 infusions (25%) and in 14/46 patients (30%)
- Infusions were slowed or interrupted in 9/489 infusions (1.8%) without pre-medication and in 10/165 infusions (6%) with pre-medication
- Among 12 serious adverse events were reported in 6 patients, 11 were unrelated to octagam 5%
- One serious adverse event (Calculus renal NOS) was reported just before the next infusion, and was not temporarily related to the previous infusion
No subject withdrew from the study due to an adverse event or adverse reaction
- Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.
- Ochs HD, Pinciaro PJ. The octagam® Study Group. Octagam® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004;24(3):309-314.