Vertex Pharmaceuticals (U.K.) Limited, Israel

Transmembrane Conductance Regulator Potentiator. Ivacaftor 50, 75, 150 mg.
SACHET (granules): 56×50, 75mg.
FILM COAT. TABS: 56×150mg. Pts. wt.<14 kg: 50 mg granules taken orally every 12 hrs. with fat contain. food total dly. dose 100 mg.
Pts.≥14 kg-<25 kg: 75 mg granules taken orally every 12 hrs. with fat-contain. food, total dly. dose 150 mg.
Pts. ≥25 kg: 150 mg tab. taken orally every 12 hrs. with fat-contain. food, total dly. dose 300 mg. See lit.
Tmt. of pts. with CF aged 6 yrs. and older and weighing 25 kg or more who have one of the follow. gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
The granules are indic. for the tmt. of child. with CF aged 2 yrs. and older and weighing less than 25 kg who have one of the follow. gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
C/I: Hypersens.

Transmembrane Conductance Regulator Potentiator. Tezacaftor 50 mg, 100 mg, Ivacaftor 75 mg, 150 mg.
FC Tab. fixed dose combin. 28 X 100 mg tezacaftor +150 mg ivacftor & 28 X 150 mg ivacaftor. Lower dose combin.: 28 X 50 mg tezacaftor+75 mg ivacaftor & 28 X 75 mg ivacaftor
One combined tab. in the morning and one ivacaftor tab. in the evening. Admin. lower dose combin. for chldr. aged 6-12, weighing <30 kg. See full prescript. info.
Tmt. of pts. with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutat. or who have at least one mutat. in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clin. evidence.If the pt’s genotype is unknown, a health author. cleared CF mutat. test should be used to detect the presence of a CFTR mutat. followed by verif. with bi-directional sequenc. when recommended by the mutat. test instruct. for use.  
C/I:Hypersens.

Transmembrane Conductance Regulator Potentiator. Elexacaftor 80 mg, 100 mg, 50 mg,, Tezacaftor 25 mg, 40 mg, 50 mg, Ivacaftor 60 mg, 75 mg, 150 mg.
80mg/40mg/60mg X 28 gran.sachets & 59.5mg X 28 gran.sachets
100mg/50mg/75mg X 28 gran. sachets and 75mg X 28 gran.sachets
50mg/25mg/37.5mg X 56 tabs & 75mg X 28 Tabs
100mg/50mg/75mg  X 56  tabs & 150mgX 28 Tabs
Two comb. tabs. in the morning and one ivacaftor tab. in the evening.
For pts. aged 2-6 admin. granules: one comb. sachet in the morning and one ivacaftor sachet in the evening. See full prescript. info.
Tmt. of cystic fibrosis (CF) in pts aged 2 years and older who have at least one F508del mutat. in the CFTR gene or a mutat. in the CFTR gene that is responsive based on in vitro data
C/I: Hypersens.