Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Selinexor
Drug ID BADD_D02493
Description Selinexor is a first-in-class selective inhibitor of nuclear transport (SINE) compound. It is currently approved for the treatment of multiple myeloma, a cancer which forms from antibody-producing plasma cells.[L7117,L7120] This condition is typically treated with high dose [bortezomib] and dexamethasone chemotherapy followed by autologous stem-cell transplant. Other chemotherapies for multiple myeloma include [lenalidomide] and [dexamethasone], [thalidomide], and may include [melphalan] if the patient is not eligible for transplant.[L7123] Selinexor was approved by the FDA in June 2019. It was granted fast track and orphan designation as well as accelerated approval based on single arm, open label trial data. The Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma (BOSTON) trial is planned to finish in 2020.[L7126]
Indications and Usage Selinexor is indicated for the treatment of relapsed or refractory multiple myeloma in combination with dexamethasone.[label] Patients must have received at least 4 prior therapies and have disease which is refractory to least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody.
Marketing Status approved; investigational
ATC Code L01XX66
DrugBank ID DB11942
KEGG ID D11222
MeSH ID C585161
PubChem ID 71481097
TTD Drug ID D00LNW
NDC Product Code 11014-0455; 72237-101; 72237-102; 72237-104; 72237-103; 11014-0393; 62009-1911; 11014-0456; 11014-0454
UNII 31TZ62FO8F
Synonyms selinexor | Xpovio | KPT-330
Chemical Information
Molecular Formula C17H11F6N7O
CAS Registry Number 1393477-72-9
SMILES C1=CN=C(C=N1)NNC(=O)C=CN2C=NC(=N2)C3=CC(=CC(=C3)C(F)(F)F)C(F)(F)F
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)
Photopsia06.02.06.004; 17.17.01.0060.000437%
Plasma cell myeloma01.14.02.004; 16.23.02.0040.009301%-
Pleural effusion22.05.02.0020.000112%
Respiratory failure14.01.04.003; 22.02.06.0020.000168%
Sarcoma15.09.03.002; 16.33.01.0020.001332%-
Stomatitis07.05.06.0050.000381%
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.000246%
Thrombocytopenia01.08.01.0020.005787%-
Vision blurred06.02.06.007; 17.17.01.0100.000437%
Visual impairment06.02.10.0130.000492%-
Vomiting07.01.07.0030.002653%
Mental status changes19.07.01.0010.000224%-
General physical health deterioration08.01.03.0180.000246%-
Tumour haemorrhage16.32.03.008; 24.07.01.0280.000112%
Pulmonary mass22.02.07.0040.000112%-
Adverse event08.06.01.0100.000381%-
Decreased appetite08.01.09.028; 14.03.01.0050.006134%
Adverse drug reaction08.06.01.0090.000381%-
Disease progression08.01.03.0380.003638%
Drug intolerance08.06.01.0130.000437%-
Renal impairment20.01.03.0100.000112%-
Peripheral arterial occlusive disease24.04.03.0100.000112%-
Meibomian gland dysfunction06.04.04.0150.000951%-
Cytopenia01.03.03.0120.000492%-
Multiple organ dysfunction syndrome08.01.03.0570.000168%
Diffuse large B-cell lymphoma refractory01.15.02.003; 16.28.02.0030.002776%-
Open angle glaucoma06.03.01.0040.000112%-
Neurofibrosarcoma15.09.03.033; 16.33.11.0010.000951%-
Taste disorder07.14.03.004; 17.02.07.0290.000381%-
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