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Alyftrek
vanzacaftor/ tezacaftor/ deutivacaftor
Black Box Warnings .
Hepatotoxicity
elevated transaminases observed during tx; serious and potentially fatal drug-induced hepatic injury and hepatic failure reported w/ elexacaftor/tezacaftor/ivacaftor; hepatic injury reported w/in 1-15mo of elexacaftor/tezacaftor/ivacaftor tx start; monitor LFTs before tx start, then qmo x6mo, then q3mo x12mo, then at least q12mo or consider more frequently if hepatic dz hx, baseline LFTs elevated, or elevated LFT hx w/ elexacaftor-, tezacaftor-, or ivacaftor-containing products; interrupt tx if significant LFT elevations or if hepatic injury s/sx occur, consider hepatologist referral, and monitor closely until resolution; if abnormalities resolve, only restart tx if benefit outweighs risk w/ closer monitoring; avoid use in pts w/ severe hepatic impairment; in pts w/ moderate hepatic impairment, use not recommended or may use w/ close monitoring
Adult Dosing .
Dosage forms: convenience pack
Special Note
- [convenience pack components]
- Info: 7-day pack contains vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg tab x14
cystic fibrosis
- [2 tabs (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg) PO qd (1 dose = vazacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg)]
- Info: for pts w/ at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give w/ fat-containing food
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: avoid use; Info: caution advised if Child-Pugh Class A or B
Peds Dosing .
- Dosage forms: convenience pack
Special Note
- [6-11 yo, <40 kg convenience pack components]
- Info: 7-day pack contains vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg tab x21
- [6-11 yo, >40 kg convenience pack components]
- Info: 7-day pack contains vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg tab x14
- [12 yo and older convenience pack components]
- Info: 7-day pack contains vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg tab x14
cystic fibrosis
- [6-11 yo, <40 kg]
- Dose: 3 tabs (vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg) PO qd (1 dose = vanzacaftor 12 mg/tezacaftor 60 mg/deutivacaftor 150 mg); Info: for pts w/ at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give w/ fat-containing food
- [6-11 yo, >40 kg]
- Dose: 2 tabs (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg) PO qd (1 dose = vazacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg); Info: for pts w/ at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give w/ fat-containing food
- [12 yo and older]
- Dose: 2 tabs (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg) PO qd (1 dose = vazacaftor 20 mg/tezacaftor 100 mg/deutivacaftor 250 mg); Info: for pts w/ at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give w/ fat-containing food
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: avoid use; Info: caution advised if Child-Pugh Class A or B