SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of patients with cystic fibrosis (CF) age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

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CFTR Mutations That Produce CFTR Protein Responsive to SYMDEKO1-3*

F508del/F508del*
c.1521_1523delCTT
E56K
c.166G>A
R347H
c.1040G>A
A1067T
c.3199G>A
E831X
c.2491G>T
R352Q
c.1055G>A
A455E
c.1364C>A
F1052V
c.3154T>G
R74W
c.220C>T
D110E
c.330C>A
F1074L
c.3222T>A
S945L
c.2834C>T
D110H
c.328G>C
K1060T
c.3179A>C
S977F
c.2930C>T
D1152H
c.3454G>C
L206W
c.617T>G
2789+5GA
c.2657+5G>A
D1270N
c.3808G>A
P67L
c.200C>T
3272-26AG
c.3140-26A>G
D579G
c.1736A>G
R1070W
c.3208C>T
3849+10kbCT
c.3718-2477C>T
E193K
c.577G>A
R117C
c.349C>T
711+3AG
c.579+3A>G

A patient must have 2 copies of the F508del mutation or at least one copy of a responsive mutation listed above in this table to be indicated.

Additional mutations determined to be responsive to tezacaftor/ivacaftor based on in vitro data and were not studied in a clinical setting were: A1067T, D110E, D1270N, E193K, E56K, F1052V, F1074L, K1060T, R74W1