Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ivacaftor
Drug ID BADD_D01220
Description Ivacaftor (also known as Kalydeco or VX-770) is a drug used for the management of Cystic Fibrosis (CF). It is manufactured and distributed by Vertex Pharmaceuticals. It was approved by the Food and Drug Administration on January 31, 2012[L768], and by Health Canada in late 2012.[L6841] Ivacaftor is administered as a monotherapy and also administered in combination with other drugs for the management of CF.[L6814,L6979,L6847] Cystic Fibrosis is an autosomal recessive disorder caused by one of several different mutations in the gene for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, an ion channel involved in the transport of chloride and sodium ions across cell membranes. CFTR is active in epithelial cells of organs such as of the lungs, pancreas, liver, digestive system, and reproductive tract. Alterations in the CFTR gene result in altered production, misfolding, or function of the protein and consequently abnormal fluid and ion transport across cell membranes.[A20298, A20299] As a result, CF patients produce thick, sticky mucus that clogs the ducts of organs where it is produced making patients more susceptible to complications such as infections, lung damage, pancreatic insufficiency, and malnutrition.[A20302] Prior to the development of ivacaftor, management of CF primarily involved therapies for the control of infections, nutritional support, clearance of mucus, and management of symptoms rather than improvements in the underlying disease process or lung function (FEV1). Notably, ivacaftor was the first medication approved for the management of the underlying causes of CF (abnormalities in CFTR protein function) rather than control of symptoms.[A20297]
Indications and Usage When used in combination with the drug [DB09280] as the product Orkambi, ivacaftor is indicated for the management of CF patients age 6 years and older who are homozygous for the F508del mutation in the CFTR gene.
Marketing Status Prescription
ATC Code R07AX02
DrugBank ID DB08820
KEGG ID D09916
MeSH ID C545203
PubChem ID 16220172
NDC Product Code 43798-005; 66039-900; 51167-300; 46708-896; 67651-0263; 51167-600; 59651-588; 51167-200; 14501-0019; 65129-1450; 51167-400; 24538-770
Synonyms ivacaftor | N-(2,4-di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide | N-(2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide | 3-quinolinecarboxamide, N-(2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl)-1,4-dihydro-4-oxo- | VX-770 | Kalydeco
Chemical Information
Molecular Formula C24H28N2O3
CAS Registry Number 873054-44-5
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 pain07.01.05.002-
Abdominal pain upper07.01.05.003-
Abortion spontaneous18.01.04.001--Not Available
Acne23.02.01.001--Not Available
Aggression19.05.01.001-Not Available
Alanine aminotransferase increased13.03.01.003-
Aspartate aminotransferase increased13.03.01.006-
Asthma22.03.01.002; Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Blister23.03.01.001; Available
Blood bilirubin increased13.03.01.008--
Blood creatine phosphokinase increased13.04.01.001-
Blood glucose increased13.02.02.002-Not Available
Body temperature increased13.15.01.001-Not Available
Breast mass21.05.04.002--Not Available
Chest discomfort22.02.08.001;; Available
Chest pain22.02.08.003;; Available
Chronic myeloid leukaemia16.01.07.001; Available
Crying19.04.02.002;;; Available
Cystic fibrosis07.18.03.001;; Available
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