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Symdeko
tezacaftor/ ivacaftor and ivacaftor
Adult Dosing .
Dosage forms: convenience pack
Dosage Form Details
- [convenience pack components]
- Info: 7-day pack contains tezacaftor 100 mg/ivacaftor 150 mg tab x7 and ivacaftor 150 mg tab x7
cystic fibrosis
- [AM dose]
- Dose: 1 tab (tezacaftor 100 mg/ivacaftor 150 mg) PO qam; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from evening dose; give w/ fat-containing food
- [PM dose]
- Dose: 1 tab (ivacaftor 150 mg) PO qpm; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from morning dose; give w/ fat-containing food
renal dosing
- [see below]
- CrCl >31: no adjustment; CrCl <31: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class B: give usual dose qam and no evening dose; Child-Pugh Class C: give usual dose qam (or less frequently) and no evening dose
Peds Dosing .
- Dosage forms: convenience pack
Dosage Form Details
- [6-11 yo, <30 kg convenience pack components]
- Info: 7-day pack contains tezacaftor 50 mg/ivacaftor 75 mg tab x7 and ivacaftor 75 mg tab x7
- [6-11 yo, >30 kg convenience pack components]
- Info: 7-day pack contains tezacaftor 100 mg/ivacaftor 150 mg tab x7 and ivacaftor 150 mg tab x7
- [12 yo and older convenience pack components]
- Info: 7-day pack contains tezacaftor 100 mg/ivacaftor 150 mg tab x7 and ivacaftor 150 mg tab x7
cystic fibrosis
- [6-11 yo, <30 kg, AM dose]
- Dose: 1 tab (tezacaftor 50 mg/ivacaftor 75 mg) PO qam; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from evening dose; give w/ fat-containing food
- [6-11 yo, <30 kg, PM dose]
- Dose: 1 tab (ivacaftor 75 mg) PO qpm; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from morning dose; give w/ fat-containing food
- [6-11 yo, >30 kg, AM dose]
- Dose: 1 tab (tezacaftor 100 mg/ivacaftor 150 mg) PO qam; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from evening dose; give w/ fat-containing food
- [6-11 yo, >30 kg, PM dose]
- Dose: 1 tab (ivacaftor 150 mg) PO qpm; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from morning dose; give w/ fat-containing food
- [12 yo and older, AM dose]
- Dose: 1 tab (tezacaftor 100 mg/ivacaftor 150 mg) PO qam; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from evening dose; give w/ fat-containing food
- [12 yo and older, PM dose]
- Dose: 1 tab (ivacaftor 150 mg) PO qpm; Info: for pts w/ homozygous F508del-CFTR mutation or tezacaftor/ivacaftor-responsive CFTR gene mutations; give 12h apart from morning dose; give w/ fat-containing food
renal dosing
- [see below]
- CrCl >31: no adjustment; CrCl <31: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class B: give usual dose qam and no evening dose; Child-Pugh Class C: give usual dose qam (or less frequently) and no evening dose