Pivotal Trial Design—Infusion Protocol
Gammaplex 10% pivotal clinical trial: changing expectations for the IVIG infusion experience
- Gammaplex 10% was studied with a 15-minute rate escalation protocol1
Infusion Rate Protocol for Gammaplex 10%1,2
|Gammaplex 10% Infusion Rate|
|Elapsed Time (min)||(mL/kg/min)||(mg/kg/min)|
|76+ (maximum infusion rate)||0.08||8.0|
*Initial infusion rate for Gammaplex 10% was 0.005 mL/kg/min in order to provide an initial equivalent protein dose to Gammaplex 5%. Patients who tolerated the first infusion with minimal adverse reactions could begin subsequent infusions at 0.01 mL/kg/min.
- Gammaplex 10% median infusion time was 53 minutes less than Gammaplex 5% in the pivotal trial2,3
Median Infusion Duration in the Pivotal Trial
To calculate the infusion time or see the infusion protocol for an individual patient, please see the Gammaplex 10% Infusion Calculator.
- Monitor vital signs throughout the infusion
- Slow or stop the infusion if adverse reactions occur; if symptoms subside, the infusion may be resumed at a lower rate that is comfortable for the patient
- Ensure that patients with pre-existing renal insufficiency are not volume depleted
- For patients at increased risk of renal dysfunction, thrombotic events, or volume overload, administer Gammaplex 10% at the minimum infusion rate practicable. Consider discontinuing Gammaplex 10% administration if renal function deteriorates
Gammaplex 10% is the first 10% IVIG with a 15-minute rate escalation protocol specified in Prescribing Information
- Gammaplex 10% rate escalation protocol allows patients to reach maximum recommended infusion rate in 1 hour and 15 minutes, compared to 2 hours and 30 minutes with a 30-minute rate escalation protocol
Infusion Rate Protocols for Gammaplex 10% and a
10% IVIG with 30-min Rate Escalation Protocol2
- Gammaplex 10% rate escalation protocol allows for shorter IVIG infusion times
Example: Total Infusion Time for a 70-kg Patient Receiving
500 mg/kg IVIG (Total Dose of 35 g)2
References: 1. Wasserman RL, et al. J Clin Immunol. 2017 Apr;37(3):301-310. 2. Gammaplex® 10% (Immune Globulin Intravenous [Human], 10% Liquid) Prescribing Information. Durham, NC: BPL Limited. 2017. 3. Data on File. BPL-GMX07-0816.