DOSING AND ADMINISTRATION1

Dosing information

  • For oral use. Patients should be instructed to swallow the tablets whole
  • TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) should be taken with fat-containing meals or snacks. Examples include food prepared with butter or oils or those containing eggs, cheeses, nuts, whole milk, or meats
  • Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA
← ~12 hours apart →
morning iconMORNING night iconEVENING
Recommended dosage

Two 100mg tablets

elexacaftor 100 mg/
tezacaftor 50 mg/
ivacaftor 75 mg 
2 tablets

150mg tablet

ivacaftor 150 mg
1 tablet

 

 

In patients with severe hepatic impairment (Child-Pugh Class C)
SHOULD NOT BE USED
In patients moderate hepatic impairment (Child-Pugh Class B) 
USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFIT EXCEEDS THE RISKa,b
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)
 CONCOMMITANT USE NOT RECOMMENDED

 

 

Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin

IN THE MORNING (TWICE A WEEK)

Two 100mg tablets

DAY 1

elexacaftor 100 mg/
tezacaftor 50 mg/
ivacaftor 75 mg 
2 tablets
Two 100mg tablets

DAY 4c

elexacaftor 100 mg/
tezacaftor 50 mg/
ivacaftor 75 mg 
2 tablets

NO TABLET IN THE EVENING

 

 

Moderate CYP3A inhibitors including: fluconazole, erythromycin

ALTERNATE TABLETS EVERY MORNING

Two 100mg tablets

DAY 1

elexacaftor 100 mg/
tezacaftor 50 mg/
ivacaftor 75 mg 
2 tablets
Two 100mg tablets

DAY 2d

ivacaftor 150 mg
1 tablet

NO TABLET IN THE EVENING

Tablets are not actual size.

aLiver function tests should be closely monitored.1
bUse in patients with moderate hepatic impairment should only be considered when there is a clear medical need and the benefit exceeds the risk.1
If TRIKAFTA is used, it should be with caution and at a reduced dose, as follows:

  • Day 1: take two elexacaftor/tezacaftor/ivacaftor tablets in the morning 
  • Day 2: take one elexacaftor/tezacaftor/ivacaftor tablet in the morning 
  • Continue alternating Day 1 and Day 2 dosing thereafter
  • No evening dose of ivacaftor should be taken 

cContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.1
dContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.1

  • No dose adjustment is required for patients with mild hepatic impairment. Liver function tests should be closely monitored1
  • TRIKAFTA has not been studied in patients with severe hepatic impairment, but the exposure is expected to be higher than in patients with moderate hepatic impairment. TRIKAFTA should not be used in patients with severe hepatic impairment1
  • No dose adjustment is recommended in patients with mild or moderate renal impairment. TRIKAFTA has not been studied in patients with severe renal impairment or end stage renal disease and should be used with caution in these patients1
  MISSED DOSE1  
  MISSED MORNING DOSE  
 
  • If ≤6 hours have passed, take as soon as possible and take evening dose as scheduled
  • If >6 hours have passed, take the missed dose as soon as possible but do not take evening dose and continue as scheduled the following day
 
   MISSED EVENING DOSE  
 
  •  If ≤6 hours have passed, take as soon as possible and take next morning dose as scheduled
  •  If >6 hours have passed, do not take missed dose and take next morning dose as scheduled the following day
 

Morning and evening doses should not be taken at the same time.

TRIKAFTA is supplied in cartons containing 4 weekly wallets, each with 21 tablets 
(NDC: 51167-331-01)1

Trikafta packaging

Not actual size.

  • TRIKAFTA is a co-package of fixed-dose combination tablets containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg, and ivacaftor 150 mg tablets
    • The elexacaftor, tezacaftor, and ivacaftor tablets are orange, capsule-shaped, and debossed with "T100" on one side and plain on the other
    • The ivacaftor tablets are light blue, capsule-shaped, and printed with "V 150" in black ink on one side and plain on the other
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