What is the generic name?

ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

What is the Trade Name for ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR?

Trikafta

What are the Indications for ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR?

• 1 INDICATIONS AND USAGE TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data [see Clinical Pharmacology (12.1) ] . If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data. TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data. ( 1 )

References: https://open.fda.gov/