Hizentra®
Immune Globulin Subcutaneous (Human) 20% Liquid
For primary immunodeficiency patients who are seeking an alternative to intravenous immunoglobulin therapy, Hizentra is the first and only FDA-approved subcutaneous 20% liquid immunoglobulin. Hizentra can be self-administered with physician’s approval.
Immune Globulin Subcutaneous (Human), Hizentra, is indicated
for the treatment of patients with primary immune deficiency.
NDC Number |
Product Description |
| 44206-451-01 |
5 mL vial |
| 44206-452-02 |
10 mL vial |
| 44206-454-04 |
20 mL vial |
Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI). 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 known antibody against IgA and a history of hypersensitivity.
All IgA-deficient patients with anti-IgA antibodies are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. 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 subjects in the clinical trial) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue.
Monitor patients for reactions reported to occur with IVIg treatment that might also occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), 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.
No overall differences in safety or efficacy were observed in patients over 65 or in pediatric patients. In the clinical study, desired serum IgG levels were achieved in pediatric patients without pediatric-specific dose requirements.
Please read
full prescribing information for Hizentra.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch
or call 1-800-FDA-1088.
To learn more about Hizentra®, please visit www.Hizentra.com
Last Updated: 04 August 2011