Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Blinatumomab
Drug ID BADD_D00282
Description Blinatumomab is a BiTE-class (bi-specific T-cell engagers) constructed monoclonal antibody indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto™. A full treatment regimen consisting of two cycles of four weeks each, is priced at $178 000 USD. Blinatumomab was approved in December 2014 under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
Indications and Usage Indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Marketing Status approved; investigational
ATC Code L01FX07
DrugBank ID DB09052
KEGG ID D09325
MeSH ID C510808
PubChem ID Not Available
TTD Drug ID D0K4RK
NDC Product Code 55513-160; 17504-0011
UNII 4FR53SIF3A
Synonyms blinatumomab | MT-103 antibody | antibody MT-103 | Blincyto | MEDI-538
Chemical Information
Molecular Formula Not Available
CAS Registry Number 853426-35-4
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acute respiratory failure22.02.06.001; 14.01.04.004--Not Available
Alanine aminotransferase increased13.03.04.005--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Anaemia01.03.02.001--
Aphasia19.21.01.001; 17.02.03.001--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Back pain15.03.04.005--
Blood bilirubin increased13.03.04.018--
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Capillary leak syndrome24.06.03.001; 08.01.07.012--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Colitis07.08.01.001--
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dyspnoea02.11.05.003; 22.02.01.004--
Dyspnoea exertional02.11.05.005; 22.02.01.005--Not Available
Encephalopathy17.13.02.001--
Enteritis07.08.03.002--
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