General Information

HyQvia is a combination of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase. The Immune Globulin Infusion 10% (Human) provides the therapeutic effect of HyQvia.

HyQvia is specifically indicated for the treatment of adults with Primary Immunodeficiency.

HyQvia is supplied as a solution for subcutaneous administration. The recommended dose schedule is as follows:

Initiation of Treatment with HyQvia
• For patients previously on another IgG treatment, administer the first dose approximately one week after the last infusion of their previous treatment.
• Increase the dose and frequency from a 1-week dose to a 3- or 4-week dose. Please see the drug label for the specific ramp-up dosing schedule.

For patients naïve to IgG treatment or switching from Immune Globulin Subcutaneous (Human): 300 to 600 mg/kg at 3 to 4 week intervals, after initial ramp-up.

For patients switching from Immune Globulin Intravenous (Human) [IGIV] treatment: Use same dose and frequency as previous intravenous treatment after the initial ramp-up.

For patients at risk of thrombosis, administer HyQvia at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Clinical Results

FDA Approval

The FDA approval of HyQvia was based on a prospective, open-label, non-controlled, multi-center trial was conducted in the US to determine the efficacy, tolerability and pharmacokinetics (PK) of HyQvia in adults with PI. The trial enrolled 89 subjects into two cohorts. Thirty-one subjects had been treated intravenously for three months and then subcutaneously each week at 137% of the intravenous dose for approximately one year before transitioning to the HyQvia trial. The remaining subjects also were treated intravenously for 3 months and then immediately began treatment with HyQvia in the trial. One week after the last intravenous or subcutaneous infusion, each subject began subcutaneous treatment with HyQvia. After placing the subcutaneous needle set, the hyaluronidase of HyQvia was infused through the needle set followed within 10 minutes by the immune globulin of HyQvia at 108% of the intravenous dose. Dosing began with a 1-week equivalent dose. One week later, a 2-week dose was administered, followed 2 weeks later with a 3-week dose. For those subjects who were on a 4-week dose interval prior to entering the trial, 3 weeks later the 4-week dose was administered. Subsequently, subjects continued the 3- or 4-week dosing for the remainder of the trial. After 3 doses at the full volume, a serum IgG trough level was obtained for all subjects, and used to individually adapt the subcutaneous dose of HyQvia to compensate for individual variation from the mean value of 108%. All subjects who completed the trial received a minimum of 12 infusions at this individually adapted dose. The period after the ramp-up was considered the efficacy period and used for safety and efficacy analyses. Outcome measures included the rate of infections, adverse reactions and number of infusion sites per month. The annualized rate of ASBI while treated with HyQvia was 0.025, with an upper 99% confidence limit of 0.046, which is significantly less than (p < 0.0001) the rate of one infection per year. The mean infections per patient per year was 2.97. An objective of the trial was to achieve the same number or fewer infusions with HyQvia per month as with intravenous administration and significantly fewer than with conventional subcutaneous administration. The median monthly number of infusion sites per month was 1.34 for intravenous administration and 1.09 for HyQvia. Subcutaneous treatment with Immune Globulin Infusion 10% (Human) required a median of 21.43 sites each month.

Mechanism of Action

The Immune Globulin Infusion 10% (Human) provides the therapeutic effect of HyQvia. The Recombinant Human Hyaluronidase of HyQvia increases dispersion and absorption of the Immune Globulin Infusion 10% (Human). The Immune Globulin Infusion 10% (Human) of HyQvia supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. The Immune Globulin Infusion 10% (Human) also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanisms of action of IgG in the Immune Globulin Infusion 10% (Human) of HyQvia have not been fully elucidated.