Hizentra FAQs

What are the differences between Hizentra and Vivaglobin^®?
How does the higher Ig concentration offered by Hizentra benefit my patients?
How does room-temperature storage offered by Hizentra benefit my patients?
How long can Hizentra be stored at room temperature?
Which Ig therapy might be right for my patients?

What are the differences between Hizentra and Vivaglobin^®?
While both Hizentra and Vivaglobin are FDA-approved SCIg therapies for PIDD (primary immunodeficiency disease) manufactured by CSL Behring, there are notable differences*:

Vivaglobin is a 16% immunoglobulin solution. Hizentra is a 20% solution, thus providing more IgG with less volume per infusion
Vivaglobin must be refrigerated. Hizentra can be stored at room temperature for its entire shelf life, so there's less preparation time before a patient can self-infuse and no warmup period needed
Vivaglobin is stabilized with an amino acid called glycine. Hizentra is formulated with an amino acid called proline, which enables the product to be stored at room temperature
Vivaglobin can be infused at ≤15 mL/hr/site and gradually increased to 20 mL/hr/site, as tolerated. Hizentra can be infused at ≤20 mL/hr/site and may be increased to a maximum of 25 mL/hr/site as tolerated after the 4th infusion. The maximum flow rate for Hizentra is not to exceed 50 mL/hr for all sites combined.
Vivaglobin contains ≥96% IgG. Hizentra contains ≥98% IgG

* Information is derived from the Prescribing Information for each therapy. Vivaglobin and Hizentra have not been studied in a head-to-head clinical trial.

How does the higher Ig concentration offered by Hizentra benefit my patients?
As a 20% IgG, Hizentra has the highest concentration of immunoglobulin of any Sub-Q Ig treatment, so your patient can receive more IgG while infusing at a lower volume.

How does room-temperature storage offered by Hizentra benefit my patients?
Because Hizentra is stable at room temperature, your patients gain the freedom to do certain activities while they infuse and the flexibility to schedule infusions at a time that's most convenient for them, without a waiting period to warm the product.

How long can Hizentra be stored at room temperature?
Hizentra can be stored at room temperature (up to 77°F [25°C]), for its entire shelf life, up to 30 months.

Which Ig therapy might be right for my patients?
Research studies and experience have identified characteristics that may indicate which patients may be better suited for either an SCIg, such as Hizentra, or IVIg treatment.³ Review these characteristics to help you decide which treatment would likely be more appropriate for your patient.

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.