HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HYQVIA safely and effectively. See full prescribing information for HYQVIA.

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
Solution for subcutaneous administration

Initial U.S. Approval: 2014
WARNING: THROMBOSIS See full prescribing information for complete boxed warning
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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.
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For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.
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Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
RECENT MAJOR CHANGES

Dosage and Administration (2.4) 01/2015

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

Limitation of Use: (1)

Safety and efficacy of chronic use of recombinant human hyaluronidase in HYQVIA have not been established in conditions other than PI. (1)

DOSAGE 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)

DOSAGE FORMS AND STRENGTHS
 
A dual vial unit containing 10% IgG (100 mg/mL) and 160 U/mL Recombinant Human Hyaluronidase ( 3). HYQVIA is available in the following strengths:
Immune Globulin Infusion 10% (Human)
 Recombinant Human Hyaluronidase
 
Grams Protein
 Units
 
2.5
 200
 
5.0
 400
 
10.0
 800
 
20.0
 1600
 
30.0
 2400

CONTRAINDICATIONS
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History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). ( 4)
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IgA deficient patients with antibodies against IgA and a history of hypersensitivity. ( 4)
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Known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA. ( 4)
WARNINGS AND PRECAUTIONS
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IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity a