Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study.

ABSTRACT:

Purpose

To evaluate the safety and tolerability of IgPro20 manual push (also known as rapid push) infusions at flow rates of 0.5-2.0 mL/min.

Methods

Patients with primary immunodeficiency (PID) with previous experience administering IgPro20 (Hizentra^®, CSL Behring, King of Prussia, PA, USA) were enrolled in the Hizentra^® Label Optimization (HILO) study (NCT03033745) and assigned to Pump-assisted Volume Cohort, Pump-assisted Flow Rate Cohort, or Manual Push Flow Rate Cohort; this report describes the latter. Patients administered IgPro20 via manual push at 0.5, 1.0, and 2.0 mL/min/site for 4 weeks each. Responder rates (percentage of patients who completed a predefined minimum number of infusions), safety outcomes, and serum immunoglobulin G (IgG) trough

SUBMITTER: Cowan J 

PROVIDER: S-EPMC7846525 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature