Immune globulin infusion

HYQVIA is an Immune Globulin Infusion (Human), 10% with a Recombinant Human Hyaluronidase (rHuPH20) indicated for the treatment of Primary Immunodeficiency (PI) in adults and pediatric patients two years of age and older. Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)

The Immune Globulin Infusion (Human), 10% provides the therapeutic effect of HYQVIA. The Recombinant Human Hyaluronidase of HYQVIA increases dispersion and absorption of the Immune Globulin Infusion (Human), 10%. The Immune Globulin Infusion (Human), 10% 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 (Human), 10% 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 (Human), 10% of HYQVIA have not been fully elucidated.

For subcutaneous use only 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 (Human), 10% solution for both indications. PI. 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. CIDP. Switching from Immune Globulin Intravenous (Human) [IGIV] treatment: Patient must be on stable doses of IGIV.

HYQVIA is contraindicated in: Patients who have had a history of anaphylactic or severe systemic reactions to the administration of IgG. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. Patients with known systemic hypersensitivity to hyaluronidase including rHuPH20 of HYQVIA. Patients with known systemic hypersensitivity to human albumin (in the hyaluronidase solution)]. History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). IgA deficient patients with antibodies against IgA and a history of hypersensitivity. Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA.

Boxed warning (thrombosis): 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. IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with immune globulin products including HYQVIA. Antibodies to rHuPH20 can develop. The potential exists for such antibodies to cross-react with endogenous Hyaluronidase (PH20) which is known to be expressed in the adult male testes, epididymis, and sperm. It is unknown whether these antibodies may interfere with fertilization in humans.

PI: The most common adverse reactions observed in >5% of patients were local reactions, headache, antibody formation against rHuPH20, fatigue, nausea, pyrexia, and vomiting. CIDP: The most common adverse reactions observed in >5% of patients were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus.

Passive transfer of antibodies can transiently impair the immune responses to live attenuated virus vaccines, such as mumps, rubella, and varicella for up to 6 months and for a year or more to measles. Admixtures of HYQVIA with other drugs solutions have not been evaluated. Do not mix or administer components of HYQVIA with other products. Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, and rubella.

Do not freeze. Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months. Room Temperature: up to 25°C [77°F] for up to 3 months during the first 24 months from the date of manufacturing (Mfg date) printed on the carton. HYQVIA must be used within 3 months after removal to room temperature but within the expiration date on the carton and vial label. Do not return HYQVIA to the refrigerator after it has been stored at room temperature. Keep the vials in the carton in order to protect from light.