Tezacaftor

What it is used for

ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein.

If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.

Side effects, and when to stop

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Drug-Induced Liver Injury and Liver Failure
• Hypersensitivity Reactions, Including Anaphylaxis
• Patients Who Discontinued or Interrupted Elexacaftor-, Tezacaftor-, or Ivacaftor-Containing Drugs Due to Adverse Reactions
• Intracranial Hypertension
• Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors
• Cataracts

Who should not take it

None.

Storing it

Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).