Last reviewed 2026-04-20 · How we verify

Human immunoglobulin

Human immunoglobulin, marketed by Centre Hospitalier St Anne, is positioned in the treatment of Primary Humoral Immunodeficiency. The key composition patent expires in 2028, providing a period of exclusivity that supports market stability. The primary risk is the lack of revenue data, which limits the ability to assess market performance and competitive positioning.

At a glance

Approved indications

• Primary Humoral Immunodeficiency

Boxed warnings

• WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin products, including QIVIGY. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors [see Warnings and Precautions (5.2) ] . Renal dysfunction, acute renal failure, osmotic nephrosis may occur with immune globulin intravenous (IGIV) products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs [see Warnings and Precautions (5.3) ] . For patients at risk of thrombosis, renal dysfunction or failure, administer QIVIGY at the minimum dose available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity [see Warnings and Precautions (5.2 , 5.3) ] . WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE See full prescribing information for complete boxed warning. Thrombosis may occur with immune globulin products, including QIVIGY. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors . ( 5.2 ) Renal dysfunction, acute renal failure, osmotic nephrosis may occur in predisposed patients with immune globulin intravenous (IGIV) products, including QIVIGY. Such events require immediate medical intervention; if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome. ( 5.3 ) For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer QIVIGY at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity . ( 5.2 , 5.3 )

Common side effects

• Headache
• Fatigue
• Nausea
• Infusion-related Reaction
• Coombs Direct Test Positive
• Sinusitis
• Dizziness
• Diarrhea

Drug interactions

• Live attenuated virus vaccines (measles, mumps, rubella, varicella)
• Serological testing
• Loop diuretics

Key clinical trials

• Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
• Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
• Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
• Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
• Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
• Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2, PHASE3)
• Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial (PHASE2, PHASE3)
• Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Human immunoglobulin CI brief — competitive landscape report
• Human immunoglobulin updates RSS · CI watch RSS
• Centre Hospitalier St Anne portfolio CI