Incorrect dose administered
Drugs: DUPIXENT
- Safetyreportversion
- 1
- Safetyreportid
- 26940080
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-SA-2026SA0118387
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- SANOFI AVENTIS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Incorrect dose administered
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugauthorizationnumb
- 761055
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 2
- Drugintervaldosagedefinition
- 803
- Drugdosagetext
- 300MG QOW
- Drugindication
- Asthma
- Drugstartdateformat
- 602
- Drugstartdate
- 2024
- Drugenddateformat
- 610
- Drugenddate
- 202603
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugauthorizationnumb
- 761055
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 2
- Drugintervaldosagedefinition
- 803
- Drugdosagetext
- 300MG QOW
- Drugstartdateformat
- 102
- Drugstartdate
- 20260618
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20240101