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Treatment Eligibility

Are your patients eligible for SYMDEKO?

Enter your patient's mutations below to see if they are eligible for SYMDEKO.

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.

Age: For patients 6 years and older

1.

Please check to see if the mutation was entered correctly.

Please check to see if the mutation was entered correctly.

Alternatively, please also reference the table below.

CFTR mutations with clinical data

CFTR mutations with in vitro data only

CFTR Mutations That Produce CFTR Protein Responsive to SYMDEKO Based on Clinical and In Vitro Data1-3*

F508del/F508del*
c.1521_1523delCTT/
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+5G→A
c.2657+5G>A

D1270N
c.3808G>A

P67L
c.200C>T

3272-26A→G
c.3140-26A>G

D579G
c.1736A>G

R1070W
c.3208C>T

3849+10kbC→T
c.3718-2477C>T

E193K
c.577G>A

R117C
c.349C>T

711+3A→G
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.

EVOLVE (Trial 1)

studied patients age 12 years and older homozygous for the F508del mutation in the CFTR gene

EXPAND (Trial 2)

studied patients age 12 years and older heterozygous for the F508del mutation with a mutation predicted to be responsive to SYMDEKOa

aPatients who have one responsive mutation do not also need to have an F508del mutation.

Trial 4

studied patients age 6 through 11 years homozygous for the F508del mutation or heterozygous for a F508del mutation predicted to be responsive to SYMDEKO