HyQvia - 2 indications

Scroll down for more information on each indication:

• for the treatment of Primary Immunodeficiency; approved September 2014
• for the treatment of chronic inflammatory demyelinating polyneuropathy; approved January 2024

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 Primary Immunodeficiency in patients 2 years of age and older,
• the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. 

HyQvia is supplied as a solution for subcutaneous administration. Scroll down to see the recommended dose schedule for each indication.

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.

The mechanism of action of immunoglobulins in the treatment of CIDP in adults has not been fully elucidated but may include immunomodulatory effects.

Side Effects

Adverse reactions associated with the use of HyQvia in people with Primary Immunodeficiency may include, but are not limited to, the following:

• local reactions
• headache
• antibody formation against recombinant human hyaluronidase (rHuPH20)
• fatigue
• nausea
• pyrexia
• vomiting

Adverse reactions associated with the use of HyQvia in people with CIDP may include, but are not limited to, the following:

• local reactions
• headache
• pyrexia
• nausea
• fatigue
• erythema
• pruritus
• increased lipase
• abdominal pain
• back pain
• pain in extremities

The HyQvia drug label comes with the following Black Box warning: Thrombosis may occur with immune globulin products, including HyQvia . Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. 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

Indication 1 - Primary Immunodeficiency 

Dose/Administration

The recommended rHuPH20 dose is 80 U/g Immune globulin G (IgG), which corresponds to 0.5 mL rHuPH20 solution per 10 mL Immune Globulin Infusion 10% (Human) solution.

Initiation of Treatment with HyQvia

• 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.

Switching from Immune Globulin Intravenous (Human) [IGIV] treatment:

• Use same dose and frequency as previous intravenous treatment after the initial ramp-up. 

Naïve to Immune Globulin Subcutaneous (Human) [IGSC] treatment or switching from IGSC treatment:

•  300 to 600 mg/kg at 3 to 4-week intervals, after initial ramp-up.

Clinical Trial Results

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.

Indication 2 - chronic inflammatory demyelinating polyneuropathy

Dose/Administration

The recommended rHuPH20 dose is 80 U/g Immune globulin G (IgG), which corresponds to 0.5 mL rHuPH20 solution per 10 mL Immune Globulin Infusion 10% (Human) solution.

Switching from Immune Globulin Intravenous (Human) [IGIV] treatment:

• Patient must be on stable doses of IGIV. 
• The starting dose and dosing frequency of HyQvia is the same as the patient’s previous IGIV treatment. The typical dosing interval range in the clinical trial for HyQvia was 2 to 4 weeks

Clinical Trial Results

The FDA approval of HyQvia for CIDP based on results from a randomized, double-blinded, placebo-controlled study (ADVANCE-CIDP 1) and a single-arm, open-label, extension study (ADVANCE-CIDP 3) that evaluated the efficacy and safety of HyQvia as a maintenance therapy in adults with CIDP. The efficacy evaluation included 122 adults from ADVANCE-CIDP 1 with a confirmed diagnosis of CIDP and who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to screening. The analysis of the primary endpoint demonstrated a statistically significant difference between the relapse rates in the HyQvia group (N=57, 14.0%) compared to the placebo group (N=65, 32.3%). The treatment difference of -18.3% indicated that HyQvia demonstrated superiority over placebo in preventing relapse of CIDP.