GammaplexImmune Globulin Intravenous
(Human), 5% Liquid

Dosing and
Administration

Dosing and infusion rates for Gammaplex¹

Gammaplex is licensed in the U.S. for the following indications: Replacement therapy in adults with primary humoral immunodeficiency. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and SCID.

The recommended dose of Gammaplex for patients with PI is 300 to 800 mg/kg (6 to 16 mL/kg), administered every 3 to 4 weeks. Adjust the dosage over time to achieve the desired serum trough levels and clinical response. If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.

Gammaplex is also indicated for treatment of adults with chronic ITP to raise platelet counts. The recommended dose of Gammaplex for patients with ITP is 1 g/kg (1000 mg/kg, 20 mL/kg) on 2 consecutive days, providing a total dose of 2 g/kg (2000 mg/kg). Carefully consider the relative risks and benefits before prescribing the high-dose regimen (i.e. 1 g/kg/day [1000 mg/kg/day] for 2 days) in patients at increased risk of thrombosis, hemolysis, acute kidney injury or volume overload. Adequate data on the platelet response to the low-dose regimen (e.g. 400 mg/kg per day for 5 consecutive days) are not available for Gammaplex.

Administration¹

Gammaplex should be given by IV infusion. The maximum dose is determined by body weight. An infusion rate of 0.01 mL/kg/minute (0.5 mg/kg/min) is recommended for the first 15 minutes, gradually increasing to 0.08 mL/kg/minute (4 mg/kg/min) at 15 minute intervals.

Gammaplex infusion time on initiation of therapy*
Initial Rate
Maximum Rate
Total Infusion Time
0.01 mL/kg/min
0.08 mL/kg/min
2 hours 15 mins

* Estimated infusion duration for a 70 kg patient receiving a 400 mg/kg dose based on incremental increases in infusion rate as described under Dosage and Administration in the Full Prescribing Information

Please see Important Safety Information and full prescribing information.

 

1. Gammaplex Prescribing Information, 2014 VSUS5PI

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