nd anaphylactic reactions. ( 5.1)
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Thrombosis may occur following treatment with immune globulin products including HYQVIA. ( 5.2)
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Antibodies to PH20 (recombinant human hyaluronidase) can develop. 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. ( 5.3)
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Aseptic Meningitis Syndrome (AMS) may occur. Discontinue treatment if AMS symptoms appear. ( 5.4)
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Acute intravascular hemolysis may occur. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. ( 5.5)
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Infusion into or around an infected area can spread a localized infection. ( 5.7)
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Monitor for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). ( 5.8)
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May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ( 5.9)
DRUG INTERACTIONS
Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, and rubella. (7)
USE IN SPECIFIC POPULATIONS
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Pregnancy: No human data. Use only if clearly indicated. Pregnancy registry available. ( 8.1)
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Geriatric: In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and consider infusing HYQVIA at lower, more frequent doses. ( 8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2016
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: THROMBOSIS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage 2.2 Administration 2.3 Preparation and Handling 2.4 Instructions for Administration 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity 5.2 Thrombosis 5.3 Immunogenicity of Recombinant Human Hyaluronidase (PH20) 5.4 Aseptic Meningitis Syndrome (AMS) 5.5 Hemolysis 5.6 Renal Dysfunction/Failure 5.7 Spread of Localized Infection 5.8 Transfusion-Related Acute Lung Injury (TRALI) 5.9 Transmittable Infectious Agents 5.10 Interference with Laboratory Tests 6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
HYQVIA is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.
