Dosing and Administration
Gammaplex 10% is indicated for the treatment of primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older and for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults.1
| Use | Dose | Initial infusion rate | Maintenance infusion rate (if tolerated) |
|---|---|---|---|
| PI | 300–800 mg/kg (3–8 mL/kg) every 3–4 weeks | 0.5 mg/kg/min (0.005 mL/kg/min) for 15 min | Increase gradually every 15 minutes to 8 mg/kg/min (0.08 mL/kg/min) |
| ITP | 1 g/kg (10 mL/kg) for 2 consecutive days | 0.5 mg/kg/min (0.005 mL/kg/min) for 15 min | Increase gradually every 15 minutes to 8 mg/kg/min (0.08 mL/kg/min) |
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% allows for shorter infusion times1
Infusion Rate Protocols for Gammaplex 10% and a
10% IVIG with 30-minute Rate Escalation Protocol1
- 96% of Gammaplex 10% infusions reached the maximum recommended infusion rate while following the 15-minute titration protocol in the PI pivotal trial3
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
References: 1. Gammaplex® 10% (Immune Globulin Intravenous [Human], 10% Liquid) Prescribing Information. Durham, NC: BPL Limited. 2019. 2. Wasserman RL, Melamed IR, Stein MR, et al. J Clin Immunol. 2017;37(3):301-310. 3. Data on File. BPL-GMX07-0816.