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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 with elexacaftor/tezacaftor/ivacaftor; hepatic injury reported within 1-15mo of elexacaftor/tezacaftor/ivacaftor tx start; monitor LFTs before tx start, then qmo x6mo, then q3mo x12mo, then at least q12mo, or if hepatic disease history, elevated baseline LFTs, or elevated LFTs history with elexacaftor, tezacaftor, or ivacaftor-containing product consider monitoring more frequently; interrupt tx if significant LFT elevations or if hepatic injury signs/symptoms occur, consider hepatologist referral, and monitor closely until resolution; if abnormalities resolve, only restart tx if benefit outweighs risk with closer monitoring; avoid use in patients with severe hepatic impairment; in patients with moderate hepatic impairment, use not recommended or may use with close monitoring
Adult Dosing .
Dosage forms: TAB: 10 mg/50 mg/125 mg
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 patients with at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give with 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: TAB: 4 mg/20 mg/50 mg, 10 mg/50 mg/125 mg
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 patients with at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give with 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 patients with at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give with 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 patients with at least one F508del-CFTR mutation or vanzacaftor/tezacaftor/deutivacaftor-responsive CFTR gene mutation; give with 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