HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution
Indication and Usage
HYQVIA is an immune globulin with a Recombinant Human Hyaluronidase indicated for the treatment of primary humoral immunodeficiency (PI) in adults.
Limitation of Use:
Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.
HYQVIA is for subcutaneous use only.
Important Safety Information
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.
HYQVIA is contraindicated: in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to Human Immune Globulin (IgG); in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity; in patients with known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA; and in patients with known systemic hypersensitivity to human albumin (in the hyaluronidase solution).
WARNINGS and PRECAUTIONS
Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20): Non-neutralizing antibodies to the Recombinant Human Hyaluronidase component can develop. The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in adult male testes, epididymis, and sperm. The clinical significance of these antibodies or whether they interfere with fertilization in humans is unknown.
Aseptic Meningitis Syndrome (AMS): Monitor for clinical signs and symptoms of AMS.
Hemolysis: Monitor for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.
Renal Dysfunction/Failure: Monitor renal function and urine output and consider lower, more frequent dosing in patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure.
Spread of Localized Infection: Do not infuse HYQVIA into or around an infected area due to potential risk of spreading a localized infection.
Transfusion-Related Acute Lung Injury (TRALI): Monitor for pulmonary adverse reactions associated with TRALI.
Transmittable Infectious Agents: Because the Immune Globulin Infusion 10% (Human) of HYQVIA is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses and other pathogens. No cases of transmission of viral diseases or variant Creutzfeldt-Jakob disease (vCJD) have been associated with HYQVIA.
Interference with Laboratory Tests: False positive serological test results, with the potential for misleading interpretation, can occur as the result of passively transferred antibodies.
The most common adverse reactions observed in > 5% of patients in the clinical trials were: local adverse reactions, headache, antibody formation against Recombinant Human Hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting.
Please see the Full Prescribing Information, including Boxed Warning regarding Thrombosis.