Dosing and Administration
Gammaplex 10% is indicated for the treatment of primary humoral immunodeficiency (PI) in adults and chronic immune thrombocytopenic purpura (ITP) in adults.
|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% was studied with a 15-minute titration protocol in the pivotal clinical trial1
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% titration 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 titration protocol
Infusion Rate Protocols for Gammaplex 10% and a
10% IVIG with 30-minute Titration Protocol2
- In the pivotal clinical trial, 96% (159/166) of Gammaplex 10% infusions followed the 15-minute titration protocol and reached maximum recommended infusion rate2
- 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. 2017. 2. Data on File, BPL-GMX07-0816.