Human immunoglobulin G
- First approval year
- 2006
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Unknown
- Drug name
- Human immunoglobulin G
- Flebogamma dif (previously flebogammadif)
- flebogamma dif previously flebogammadif
- gammagard
- Gammagard
- gamunex
- Gamunex
- hizentra
- Hizentra
- human immunoglobulin g component of hyqvia
- Human immunoglobulin g component of hyqvia
- kiovig
- Kiovig
- octagam
- Octagam
- privigen
- Privigen
- 10 intravenous immunoglobulin ivig
- 10% intravenous immunoglobulin (IVIg)
- bt 295
- Bt-295
- csl 787
- CSL-787
- csl787
- Csl787
- CSL787
- csl787 nebulized ig
- CSL787 NEBULIZED IG
- Cutaquig component Immunoglobulin (human)
- cutaquig component immunoglobulin human
- flebogamma dif
- Flebogamma dif
- flebogammadif
- Flebogammadif
- gamastan
- Gamastan
- gammagard liquid
- Gammagard liquid
- gammaplex
- Gammaplex
- Gammaplex® (Human Normal Immunoglobulin)
- globulin immune
And 124 more, listed on the interactive page.
- CAS registry numbers
- 308067-58-5
- ChEMBL ID
- CHEMBL1201599
- RxNorm IDs (RxCUI)
- 1426680
- FDA ingredient codes (UNII)
- 66Y330CJHS
- Patents
- 0
- Designations
- 11
- Earliest recorded loss of exclusivity
- 15 Jul 2028
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Boxed warning
- Yes
- Drug name stem
- -bulin
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Cardiomyopathies
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000318
- Subject identifier
- D009202
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Dermatomyositis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Scleroderma, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000404
- Subject identifier
- D045743
- Condition
- Epilepsy
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Immune System Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neuroblastoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Whooping Cough
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000650
- Subject identifier
- D014917
- Condition
- Scleroderma, Systemic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000717
- Subject identifier
- D012595
- Condition
- HIV Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Anthrax
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000778
- Subject identifier
- D000881
- Condition
- Down Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001064
- Subject identifier
- D004314
- Condition
- Multiple Myeloma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Pregnancy
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002950
- Subject identifier
- D011247
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Peripheral Nervous System Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003100
- Subject identifier
- D010523
- Condition
- Heart Failure
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Motor Neuron Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003782
- Subject identifier
- D016472
- Condition
- Lupus Erythematosus, Cutaneous
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0003834
- Subject identifier
- D008178
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
And 55 more, listed on the interactive page.
- Condition identifier
- EFO_0000318
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000398
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000404
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000474
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000551
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000650
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000763
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000778
- Condition identifier
- EFO_0001064
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002950
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003100
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003782
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003834
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004145
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004149
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004246
- Condition identifier
- EFO_0004256
- Condition identifier
- EFO_0004276
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004775
- Highest recorded phase
- 3
And 181 more, listed on the interactive page.
- Warning
- Black Box Warning
- Warning
- Black Box Warning
- Effect
- nephrotoxicity
- Warning
- Black Box Warning
- Country
- United States
- Warning
- Black Box Warning
- Effect
- nephrotoxicity
- Country
- United States
- Event
- administration site swelling
- Reports
- 100
- Reporting signal score
- 399.561
- Event
- bronchitis
- Reports
- 437
- Reporting signal score
- 309.233
- Event
- chills
- Reports
- 1,098
- Reporting signal score
- 1,215.51
- Event
- ear infection
- Reports
- 274
- Reporting signal score
- 361.173
- Event
- haemolysis
- Reports
- 219
- Reporting signal score
- 427.882
- Event
- headache
- Reports
- 2,350
- Reporting signal score
- 1,199.21
- Event
- infusion related reaction
- Reports
- 660
- Reporting signal score
- 657.657
- Event
- infusion site bruising
- Reports
- 129
- Reporting signal score
- 438.291
- Event
- infusion site erythema
- Reports
- 527
- Reporting signal score
- 1,629.03
- Event
- infusion site extravasation
- Reports
- 313
- Reporting signal score
- 729.323
- Event
- infusion site haemorrhage
- Reports
- 114
- Reporting signal score
- 320.008
- Event
- infusion site nodule
- Reports
- 145
- Reporting signal score
- 566.065
- Event
- infusion site pain
- Reports
- 464
- Reporting signal score
- 1,199.04
- Event
- infusion site pruritus
- Reports
- 255
- Reporting signal score
- 884.916
- Event
- infusion site swelling
- Reports
- 432
- Reporting signal score
- 1,374.71
- Event
- meningitis aseptic
- Reports
- 355
- Reporting signal score
- 984.348
- Event
- pyrexia
- Reports
- 1,374
- Reporting signal score
- 482.13
- Event
- sinusitis
- Reports
- 1,408
- Reporting signal score
- 2,144.55
- Event
- upper respiratory tract infection
- Reports
- 405
- Reporting signal score
- 370.981
- NCT00000720
- NCT00000751
- NCT00639938
- NCT03174951
- NCT00000935
- NCT00176059
- NCT01502267
- NCT01594424
- NCT00001287
- NCT00001550
- NCT03749096
- NCT00002809
- NCT00004286
- NCT00004772
- NCT00220740
- NCT01225276
- NCT02549170
- NCT02638207
- NCT00004422
- NCT00004744
- NCT00033293
- NCT00090194
- NCT02586051
- NCT00115778
- NCT00138697
And 140 more, listed on the interactive page.
- Dose
- 300-800 mg/kg
- Route
- Intravenous
- How often
- Every 21 or 28 days
- Do not use if solution is cloudy or contains particulate matter
- Don't freeze or shake
- Infuse using a separate infusion line
- Infuse within 24 hours of pooling
- Inspect for particulate matter and discoloration before use
- Monitor vital signs throughout the infusion
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 76179-010
- 69800-0250
- 69800-6502
- 69800-6503
Related records
Trials (260)
- A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
- A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
- A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
- A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
- A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
- A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)
- A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
- A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)
- A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
- A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
- A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency
- A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
- A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
- A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
- A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
- A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
- A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Approved for (5)
- Autoimmune thrombocytopenic purpura
- Guillain-Barre syndrome
- Immunodeficiency disease
- Inborn error of immunity
- Kawasaki disease
In development for (74)
- Acute myocardial infarction Phase 3
- Agammaglobulinemia Phase 3
- Alzheimer disease Phase 3
- Anthrax infection Phase 1
- Asthma Phase 3
- Atrioventricular block Phase 3
- Autoimmune encephalitis Phase 3
- Biliary atresia Phase 1
- Bronchiectasis Phase 1
- Bullous pemphigoid Phase 3
- Cardiomyopathy Phase 3
- Cerebellar ataxia Phase 2
- Childhood malignant neoplasm Phase 2
- Chronic inflammatory demyelinating polyradiculoneuropathy Phase 3
- Chronic kidney disease Phase 3
- Chronic obstructive pulmonary disease Phase 2
- Chronic renal failure syndrome Phase 2
- Common variable immunodeficiency Phase 3
- Complex regional pain syndrome Phase 3
- COVID-19 Phase 3
Other linked conditions (3)
- Diabetic neuropathy
- Polyradiculoneuropathy
- Viral infectious disease