Europe — EMA
Hizentra
Hizentra (human normal immunoglobulin) subcutaneous solution for immune globulin therapy – indications, mechanism, safety, and precautions.
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What is Human Normal Immunoglobulin?
Hizentra is a prescription subcutaneous solution containing human normal immunoglobulin (IgG) as its active ingredient. It is supplied in a ready‑to‑use formulation for subcutaneous administration and is marketed in the European Union for immune globulin therapy. It is indicated for patients with primary immunodeficiency and certain autoimmune neuropathies, providing passive immunity through regular dosing. The product is stored refrigerated and must be administered by a healthcare professional or trained caregiver.
What is Human Normal Immunoglobulin used for?
Hizentra is used as immune globulin replacement therapy in several immunodeficiency and autoimmune conditions.
- Primary immunodeficiency diseases such as common variable immunodeficiency (CVID) - X‑linked agammaglobulinemia (XLA) - Severe combined immunodeficiency (SCID) requiring IgG supplementation - Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy - Secondary immunodeficiencies with low IgG levels - Patients undergoing hematopoietic stem cell transplantation who need IgG support
What are the side effects of Human Normal Immunoglobulin?
Adverse reactions to Hizentra are reported across a range of frequencies and severities.
Common: - Injection site redness or swelling - Mild headache - Low‑grade fever
Serious: - Anaphylaxis with respiratory distress - Thrombotic events such as deep‑vein thrombosis - Acute renal impairment or hemolysis
What precautions apply to Human Normal Immunoglobulin?
Before initiating Hizentra, clinicians should evaluate patient history and monitor specific clinical parameters.
- Assess for known IgA deficiency or anti‑IgA antibodies, which increase risk of severe reactions - Verify renal function; dose adjustment may be needed in impaired kidneys - Monitor for signs of thrombosis, especially in patients with cardiovascular risk factors - Use caution in pregnant or breastfeeding individuals; safety data are limited - Ensure proper storage and handling to maintain product stability - Review vaccination status; live vaccines should be avoided during treatment
What does Human Normal Immunoglobulin interact with?
Hizentra may interact with other agents that affect immune function or blood viscosity.
Avoid: - Concomitant use of other immunoglobulin products or plasma‑derived therapies due to additive volume load - High‑dose aspirin or other antiplatelet agents that increase bleeding risk
Use with caution: - Live attenuated vaccines, which may have reduced efficacy - Anticoagulants (e.g., warfarin) because immunoglobulin can alter INR - Diuretics, as volume shifts may affect fluid balance - ACE inhibitors, due to potential for angioedema
Frequently asked questions
What type of medication is Hizentra?+
How is Hizentra administered?+
Which conditions are treated with Hizentra?+
Can Hizentra be used in children?+
What should be checked before starting Hizentra?+
What are common side effects of Hizentra?+
What serious adverse reactions can occur with Hizentra?+
How should Hizentra be stored?+
Are there any drug interactions with Hizentra?+
Is Hizentra safe during pregnancy?+
Can live vaccines be given while receiving Hizentra?+
What monitoring is required while a patient is on Hizentra?+
Product details
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