Europe — EMA
Hizentra
Learn about Hizentra, a subcutaneous human normal immunoglobulin solution for immunoglobulin replacement therapy, its uses, safety, and FAQs.
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What is Human Normal Immunoglobulin?
Hizentra is a prescription solution for subcutaneous injection that contains human normal immunoglobulin (IgG) as its active ingredient. It is supplied as a sterile liquid and marketed in the European Union for immunoglobulin replacement therapy in patients with antibody deficiencies. The product provides passive immunity by delivering exogenous IgG directly into the subcutaneous tissue, and it is administered by a healthcare professional or trained caregiver.
What is Human Normal Immunoglobulin used for?
Hizentra is used as an immunoglobulin replacement therapy for individuals whose immune systems cannot produce adequate antibodies.
- Primary immunodeficiency diseases such as common variable immunodeficiency (CVID) and X-linked agammaglobulinemia. - Secondary immunodeficiency conditions resulting from chemotherapy, hematopoietic stem cell transplantation, or HIV infection. - Maintenance therapy to reduce the frequency and severity of infections in antibody‑deficient patients. - Adjunctive treatment for patients requiring regular IgG supplementation when intravenous administration is not feasible.
What are the side effects of Human Normal Immunoglobulin?
Adverse reactions to Hizentra may occur following subcutaneous administration.
Common: - Injection site reactions such as redness, swelling, or itching. - Headache. - Fatigue or malaise. - Nausea or mild gastrointestinal discomfort.
Serious: - Severe allergic reactions including anaphylaxis or angioedema. - Thromboembolic events such as deep vein thrombosis. - Renal impairment or hemolysis. - Aseptic meningitis.
What precautions apply to Human Normal Immunoglobulin?
Before using Hizentra, patients and clinicians should consider several safety precautions.
- Assess for known hypersensitivity to immunoglobulin products or any component of the formulation. - Monitor for signs of infection or worsening immune deficiency during therapy. - Use caution in individuals with a history of thromboembolic disease or cardiovascular risk factors. - Evaluate renal function periodically, especially in patients with pre‑existing kidney disease. - Adjust dosing or discontinue if severe infusion‑related reactions occur. - Consider pregnancy and lactation status; data are limited, and benefits should outweigh potential risks.
What does Human Normal Immunoglobulin interact with?
Hizentra may interact with other medications or medical conditions; certain combinations should be avoided or used carefully.
Avoid: - Concurrent use of other immunoglobulin products, which can increase the risk of hyperviscosity. - Live vaccines, because passive antibodies may reduce vaccine efficacy and increase adverse events.
Use with caution: - Anticoagulants or antiplatelet agents, as subcutaneous IgG can affect coagulation parameters. - Diuretics, due to potential fluid shifts and renal considerations. - ACE inhibitors or ARBs, because of possible additive effects on blood pressure. - Immunosuppressive therapies, which may alter the clinical response to IgG replacement.
Frequently asked questions
What is the active ingredient in Hizentra?+
How is Hizentra administered?+
Which conditions are treated with Hizentra?+
Can Hizentra be used during pregnancy?+
What are common side effects of Hizentra?+
What serious adverse reactions should be reported?+
Should Hizentra be used with other immunoglobulin products?+
Is it safe to receive live vaccines while on Hizentra?+
How does Hizentra work to protect against infections?+
What monitoring is recommended while a patient is on Hizentra?+
Can Hizentra be used in children?+
What should be done if an injection site reaction occurs?+
Product details
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