Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vinflunine
Drug ID BADD_D02362
Description Vinflunine is a third-generation member of the vinca alkaloid family with anti-tumour actions. It was first described in 1998 at the Pierre Fabre research center in France. Like other vinca agents, vinflunine is an anti-mitotic agent that induces a cell cycle arrest at the G2/M phase and promotes cell death via apoptosis [L1396]. Vinflunine is a microtubule inhibitor that binds to tubulin at or near to the vinca binding sites to inhibits its polymerization into microtubules during cell proliferation [L1396]. In murine tumors and human tumor xenografts, vinflunine exhibits an antitumor efficacy than [DB00361], [DB00570], and [DB00541] [A31975]. Having an incidence of 429,700 new cases per year worldwide, urothelial carcinoma of the bladder is one of the most common malignancies that mostly affects individuals aged 50–79 years [A32626]. Some patients with advanced urothelial carcinoma experience inadequate therapeutic response from a prior platinum-containing regimen. While these patients have a median survival of approximately 4 months and a poor prognosis [L1396], there is currently no standard therapy in patients with advanced urothelial carcinoma [A32626]. In 2009, vinflunine was approved by the European Medicines Agency (EMA) as a second-line therapy of metastatic and advanced urothelial cancer after failure of platinum-based treatment [A32626]. Vinflunine ditartrate is an active ingredient in the EMA-authorised product Javlor for intravenous infusion. Efficacy and safety of vinflunine has not been studied in patients with performance status of 2 or less. The clinical use of vinflunine in other urologic malignancies, such as inoperable cancer of the penis, are currently have been investigated [A32626].
Indications and Usage Efficacy and safety of vinflunine has not been studied in patients with performance status of 2 or less.
Marketing Status Not Available
ATC Code L01CA05
DrugBank ID DB11641
KEGG ID D09032
MeSH ID C111217
PubChem ID 10629256
TTD Drug ID D0OT9S
NDC Product Code Not Available
Synonyms vinflunine | Javlor
Chemical Information
Molecular Formula C45H54F2N4O8
CAS Registry Number 162652-95-1
SMILES CCC12C=CCN3C1C4(CC3)C(C(C2OC(=O)C)(C(=O)OC)O)N(C5=CC(=C(C=C45)C6(CC7CC(CN(C7)CC8 =C6NC9=CC=CC=C89)C(C)(F)F)C(=O)OC)OC)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abscess11.01.08.001--Not Available
Acidosis14.01.03.002--
Acute respiratory distress syndrome22.01.03.001--
Ageusia17.02.07.001; 07.14.03.003--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Anaemia01.03.02.001--
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Bacteraemia11.01.11.001--
Bladder pain20.02.02.001--Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.001--
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Cardio-respiratory arrest02.03.04.002; 22.02.06.007--Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
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