10.
Document the infusion:
Remove the peel-off label from each Immune Globulin Infusion 10% (Human) vial of HYQVIA used and affix to the patient’s treatment record or infusion log. In addition, record the time, date, dose, infusion site location and any reactions after each infusion.

For self-administration, provide the patient with instructions and training for infusion in the home or other appropriate setting.

3 DOSAGE FORMS AND STRENGTHS

HYQVIA is a dual vial unit consisting of one vial of a liquid solution containing Immune Globulin Infusion 10% (Human) and one vial of a liquid solution containing 160 U/mL Recombinant Human Hyaluronidase.
 
4 CONTRAINDICATIONS

HYQVIA is contraindicated in:

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patients who have had a history of anaphylactic or severe systemic reactions to the administration of IgG.
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IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
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patients with known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA.
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5 WARNINGS AND PRECAUTIONS

5.1 HypersensitivitySevere hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG. In case of hypersensitivity, discontinue the HYQVIA infusion immediately and institute appropriate treatment.

Immune Globulin Infusion 10% (Human) of HYQVIA contains trace amount of IgA (average concentration of 37μg/mL). Patients with antibodies to IgA potentially are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

5.2 ThrombosisThrombosis may occur following treatment 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 central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, such as those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. 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 for hyperviscosity. [see Boxed Warning, Dosage and Administration (2), Patient Counseling Information (17)].

5.3 Immunogenicity of Recombinant Human Hyaluronidase (PH20)Eighteen percent (15 of 83) of subjects receiving HYQVIA in clinical studies developed non-neutralizing antibodies to the recombinant human hyaluronidase component. The potential exists for such antibodies to cross-react with endogenous 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. The clinical significance of these antibodies is not known.

5.4 Aseptic Meningitis Syndrome (AMS)AMS has been reported to occur wi