Pivotal Trial Design—Infusion Protocol
Gammaplex 10% is the first 10% IVIG product studied with an infusion rate protocol that increased every 15 minutes to shorten overall infusion time1,2
Infusion Rate Protocol for Gammaplex 10%1,2
Gammaplex 10% Infusion Rate | ||
---|---|---|
Elapsed Time (min) | (mL/kg/min) | (mg/kg/min) |
0–15 | 0.005* | 0.5 |
16–30 | 0.01 | 1.0 |
31–45 | 0.02 | 2.0 |
46–60 | 0.04 | 4.0 |
61–75 | 0.06 | 6.0 |
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.3
- Gammaplex 10% median infusion time was 53 minutes less than Gammaplex 5% in the pivotal trial2,3
Median Infusion Duration in the Pivotal Trial2,3
To calculate the infusion time or see the infusion protocol for an individual patient, please see the Gammaplex 10% Infusion Calculator.
Gammaplex 10% Infusion Calculator
Infusion Considerations
- 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 administered using a rate escalation protocol with 15-minute intervals2
- 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 protocol2
Infusion Rate Protocols for Gammaplex 10% and a
10% IVIG with 30-min Rate Escalation Protocol2
Gammaplex 10% allows for shorter infusion times2
Example: Total Infusion Time for a 70-kg Patient Receiving
500 mg/kg IVIG (Total Dose of 35 g)2
References: 1. Wasserman RL, Melamed IR, Stein MR, et al. J Clin Immunol. 2017;37(3):301-310. 2. Gammaplex® 10% (Immune Globulin Intravenous [Human], 10% Liquid) Prescribing Information. Durham, NC: BPL Limited. 2019. 3. Data on File. BPL-GMX07-0816.