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Hizentra and Vivaglobin

Although Hizentra and Vivaglobin® (Immune Globulin Subcutaneous [Human]) are both SCIg therapies, they are quite different. Review product features by looking at the table below, or downloading the chart for future reference.

Features of Hizentra and Vivaglobin
Product features are from the respective Prescribing Information of each product. Hizentra and Vivaglobin have not been evaluated in a head-to-head clinical comparison study.

Feature Vivaglobin Hizentra
Concentration,
form,
administration 		16% liquid SCIg 20% liquid SCIg
Storage Refrigerate at
36°F - 46°F
(2°C - 8°C) 		Room temperature up to 77°F (25°C) for 30 months
Stabilizer Glycine Proline*
Infusion rate Initial infusion at ≤ 15 mL/hr/site,as tolerated; gradually increase to 20 mL/hr/site, as tolerated Initial infusion at ≤ 15 mL/hr/site; may be increased, as tolerated, to 25 mL/hr/site†
lgA content ≤ 1700 mcg/mL1 ≤ 50 mcg/mL
lgG purity ≥ 96% ≥ 98%
Sucrose/sugars None None
Sodium 3 mg/mL Trace (≤ 10 mmol/L)
Latex-free Product and packaging Product and packaging
Vial sizes (NDC) 3 mL   (0053-7596-01)
10 mL (0053-7596-10)
20 mL (0053-7596-20) 		1 g in 5 mL
(44206-451-01)
2 g in 10 mL
(44206-452-02)
4 g in 20 mL (44206-454-04)
 

*Proline is one of 20 naturally occurring amino acids that form human proteins. It can be synthesized by the human body or obtained from dietary sources. CSL Behring chose proline as the stabilizer for Hizentra after extensive testing and analysis.1
†Infusion rate must not exceed 50 mL/hr for all sites combined.

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Review adverse events

In the clinical study, 99% of injection-site reactions with Hizentra were mild to moderate.

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Important Safety Information

Immune Globulin Subcutaneous (Human), Hizentra®, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI), age 2 and older. This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.

Hizentra should be administered subcutaneously only. Do not administer intravenously.

IgA-deficient patients with anti-IgA antibodies may be at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of Hizentra. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate.

Hizentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most common drug-related adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritis, vomiting, upper abdominal pain, pain, and migraine.

Monitor patients for thrombotic events and aseptic meningitis (AMS), which have been reported with SCIg. Also look forreactions reported to occur with IVIg treatment that might also occur with Hizentra, including renal dysfunction/failure, hemolysis, and transfusion-related acute lung injury (TRALI).

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.

Please see full prescribing information for Hizentra.