Ivacaftor
Other Respiratory System Products
Sold as Kaftrio · ORKAMBI · KALYDECO
- Drug class
- Other Respiratory System Products
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 25
- FDA reports (12 mo)
- 1,423
Overview
Plain-language summary, compiled from the cited regulatory records
Ivacaftor is a medication classified as an Other Respiratory System Product [1]. It is approved for the treatment of cystic fibrosis (CF) in individuals aged 1 month and older who have specific mutations in the CFTR gene that respond to ivacaftor potentiation [1]. This response is determined through clinical data and/or in vitro assay results [1].
Ivacaftor is available under various brand names, including Kalydeco [1]. In the past 12 months, there have been 1423 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include hospitalization, anxiety, infective pulmonary exacerbation of cystic fibrosis, mental disorder, and cystic fibrosis [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 15 | May 29, 2026 |
| CA Canada | Health Canada | 7 | May 19, 2026 |
| EU European Union | EMA | 2 | March 19, 2026 |
| US United States | FDA | 1 | March 23, 2026 |
GBUnited Kingdom· MHRA
15 products
Uses
1).
How to take
CACanada· Health Canada
7 products
Uses
ORKAMBI (lumacaftor/ivacaftor) is indicated for the treatment of cystic fibrosis (CF) in patients 1 year of age and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Limitations of Use The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation. 1 Pediatrics Pediatrics (<1 year of age): No data in patients younger than 1 year of age are available to Health Canada; therefore, Health Canada has not authorized the use of ORKAMBI in this age group.
2 Geriatrics Geriatrics (≥65 years of age): No data in patients aged 65 years and older are available to Health Canada; therefore, Health Canada has not authorized the use of ORKAMBI in this age group.
EUEuropean Union· EMA
2 products
Uses
1).
How to take
USUnited States· FDA
1 product
Uses
1) and Clinical Studies (14) ] . If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data.
1 , 14 ) If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
( 1 )
Drug interactions
Known interactions involving Ivacaftor. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 359. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB223520017 · revised May 15, 2026
- [2]Health Canada (DPD) · 02451379 · revised May 19, 2026
- [3]European Medicines Agency · EMEA/H/C/005269 · revised March 19, 2026
- [4]FDA DailyMed · 0ab0c9f8-3eee-4e… · revised March 23, 2026 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.