Lumacaftor
Active ingredient
Sold as Orkambi
- Drug class
- -
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 5
Overview
Lumacaftor is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 3 | May 19, 2026 |
| EU European Union | EMA | 1 | June 2, 2026 |
| GB United Kingdom | MHRA | 1 | May 29, 2026 |
CACanada· Health Canada
3 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
1 product
Uses
1).
How to take
GBUnited Kingdom· MHRA
1 product
Uses
1).
How to take
Drug interactions
Known interactions involving Lumacaftor. Select one for details. This list is informational and not a complete interaction checker.
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]Health Canada (DPD) · 02483831 · revised May 19, 2026
- [2]European Medicines Agency · EMEA/H/C/003954 · revised June 2, 2026
- [3]MHRA (UK) · PLGB223520006 · revised May 29, 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.