Meds & supplements › Ivacaftor
Medicine · Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Ivacaftor
KALYDECO is 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 potentiation based on clinical and/or in vitro assay data.
Selected manufacturer label information, organised into consistent sections by Sofidex. This source is written for healthcare professionals; ask your pharmacist to explain instructions that are unclear. Read the full label at DailyMed ↗
Drug facts
- Used for
- 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.
- ( 12.1, 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.
What it is used for
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.
Side effects, and when to stop
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Transaminase Elevations [ see Warnings and Precautions ]
- Hypersensitivity Reactions, Including Anaphylaxis
- Intracranial Hypertension
- Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors
- Cataracts
Who should not take it
None.
Other medicines and interactions
Potential for other drugs to affect ivacaftor
Storing it
Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F).
Cite this page
- NLM
sofidex [Internet]. Daloreum; c2026. Ivacaftor; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/ivacaftor
- APA 7th
sofidex. (2026, August 3). Ivacaftor. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/ivacaftor
- AMA 11th
Ivacaftor. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/ivacaftor
The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.