
FOR PATIENTS WITH CF AGED 4 MONTHS AND OLDER WITH AT LEAST ONE MUTATION THAT IS RESPONSIVE TO KALYDECO1
CHECK TREATMENT ELIGIBILITY
Results
FOR PATIENTS WITH CF AGED 4 MONTHS AND OLDER WITH AT LEAST ONE MUTATION THAT IS RESPONSIVE TO KALYDECO1
CHECK TREATMENT ELIGIBILITY
Results
Most patients have 2 CFTR mutations, 1 for each allele. However, in rare instances, a single allele can have more than 1 mutation. This is called a compound, or complex, mutation.
To enter 2 or more mutations into 1 entry field, separate them with a semicolon, space, comma, or forward slash. For example, if your patient's genotype is R74WN201M/D1270N and W1282R, use the Mutation 1 field to enter: R74WN201M/D1270N and the Mutation 2 field to enter: W1282R.
Indications and Usage
KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
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.
Important Safety Information
Transaminase (ALT or AST) Elevations
Concomitant Use With CYP3A Inducers
Cataracts
Pediatric Use
Serious Adverse Reactions
Most Common Adverse Reactions
Click here to access full Prescribing Information.
Transaminase (AST or ALT) Elevations
Concomitant Use With CYP3A Inducers
Cataracts
Pediatric Use
Serious Adverse Reactions
Most Common Adverse Reactions
Click here to access full Prescribing Information.
Concomitant Use With CYP3A Inducers
Cataracts
Pediatric Use
Serious Adverse Reactions
Most Common Adverse Reactions
Click here to access full Prescribing Information.
Indications and Usage
KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
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.
Important Safety Information
Transaminase (ALT or AST) Elevations
Concomitant Use With CYP3A Inducers
Cataracts
Pediatric Use
Serious Adverse Reactions
Most Common Adverse Reactions
Click here to access full Prescribing Information.
Transaminase (AST or ALT) Elevations
Concomitant Use With CYP3A Inducers
Cataracts
Pediatric Use
Serious Adverse Reactions
Most Common Adverse Reactions
Click here to access full Prescribing Information.
Concomitant Use With CYP3A Inducers
Cataracts
Pediatric Use
Serious Adverse Reactions
Most Common Adverse Reactions
Click here to access full Prescribing Information.