Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 28 August 2018

Indication(s)

HYQVIA is an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. (1)

Limitation of Use:
Safety and efficacy of chronic use of recombinant human hyaluronidase in HYQVIA have not been established in conditions other than PI.

Full Prescribing information

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Advisory information

contraindications
• History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). (4)
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity. (4)
• Known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA. (4)
Special warnings and precautions

WARNING: THROMBOSIS
See full prescribing information for complete boxed 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.
• 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.


• IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. (5.1)
• Thrombosis may occur following treatment with immune globulin products including HYQVIA. (5.2)
• 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)
• Aseptic Meningitis Syndrome (AMS) may occur. Discontinue treatment if AMS symptoms appear. (5.4)
• Acute intravascular hemolysis may occur. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. (5.5)
• Infusion into or around an infected area can spread a localized infection. (5.7)
• Monitor for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). (5.8)
• 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)

Adverse reactions

The most common adverse reactions observed in clinical trials in >5% of subjects were: local reactions, headache, antibody formation against recombinant human hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting. (6.1)

Usage information

Dosing and administration

For subcutaneous use only.

Initial Treatment Interval/Dosage Ramp-Up Schedule
Week Infusion Number Dose Interval Example for 30
grams per 4 weeks
1 1st infusion 1-week-dose 7.5 grams
2 2nd infusion 2-week-dose 15 grams
3 No infusion
4 3rd infusion 3-week-dose 22.5 grams
5 No infusion
6 No infusion
7 4th infusion (if required) 4-week-dose 30 grams

Naïve to IgG treatment or switching from Immune Globulin Subcutaneous (Human) [IGSC]: 300 to 600 mg/kg at 3 to 4 week intervals, after initial ramp-up. (2.1)
Switching from Immune Globulin Intravenous (Human) [IGIV] treatment: Use same dose and frequency as previous intravenous treatment after the initial ramp-up. (2.1)

Use in special populations

• Pregnancy: No human data. Use only if clearly indicated. Pregnancy registry available. (8.1)
• 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)

Interactions

Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, and rubella. (7)

More information

Category Value
Authorisation number BLA125402
Orphan designation No
Product NDC 0944-2510; 0944-2511; 0944-2512; 0944-2513; 0944-2514
Date First Approved 12-09-2014
Marketing authorisation holder Baxalta US Inc.