Hizentra (Human Normal Immunoglobulin)

Hizentra is indicated for patients who require immunoglobulin replacement therapy due to insufficient endogenous IgG.

• Primary immunodeficiency diseases such as common variable immunodeficiency, X‑linked agammaglobulinemia, and severe combined immunodeficiency where patients cannot produce adequate IgG.
• Secondary immunodeficiency resulting from hematologic malignancies (e.g., chronic lymphocytic leukemia, multiple myeloma) or from immunosuppressive therapies that lower IgG levels.
• Hypogammaglobulinemia associated with chronic lymphocytic leukemia or other B‑cell disorders that increase susceptibility to bacterial infections.
• Immune reconstitution after hematopoietic stem cell transplantation when endogenous IgG production is delayed.
• Patients with recurrent sinopulmonary or systemic bacterial infections linked to documented IgG deficiency.

• Hizentra supplies pooled human IgG antibodies derived from thousands of donors, providing passive immunity. The administered IgG binds to a broad range of pathogens, neutralizing toxins and facilitating opsonization. By supplementing deficient endogenous IgG, it restores humoral immunity, enhances complement activation, and supports antibody‑dependent cellular cytotoxicity, thereby reducing the risk of infection in immunodeficient individuals through improved pathogen clearance.

Adverse reactions to Hizentra are generally related to the subcutaneous route and the immunoglobulin protein content.

Common

• Injection site erythema, swelling, or itching.
• Headache or mild dizziness.
• Fatigue or generalized weakness.
• Nausea, abdominal discomfort, or low‑grade fever.

Serious

• Severe allergic reactions including anaphylaxis or angioedema.
• Thromboembolic complications such as deep vein thrombosis or pulmonary embolism.
• Acute renal failure or worsening renal function.
• Hemolytic anemia or aseptic meningitis.

Before initiating Hizentra, clinicians should evaluate patient-specific factors and monitor for potential complications.

• Screen for IgA deficiency and the presence of anti‑IgA antibodies, as severe reactions may occur.
• Assess baseline renal function and monitor creatinine during therapy.
• Evaluate individual thrombotic risk, especially in patients with a history of clotting disorders.
• Avoid use in patients with known severe hypersensitivity to immunoglobulin products.
• Consider pregnancy and lactation status; use only if the potential benefit justifies the potential risk.
• Review concomitant anticoagulant or antiplatelet therapy for bleeding risk.
• Ensure proper subcutaneous injection technique to minimize local reactions.

Hizentra may interact with other medicines that affect immune function or blood clotting.

Avoid

• Live vaccines, because passive antibodies can interfere with vaccine efficacy.
• Concurrent use of other immunoglobulin products unless medically justified.

Use with caution

• Anticoagulants or antiplatelet agents, due to potential increased bleeding risk.
• ACE inhibitors, as rare cases of angioedema have been reported.
• Immunosuppressive agents, which may alter infection risk.
• Diuretics, because of possible changes in plasma volume.