DOSING AND ADMINISTRATION1,2

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

NightEVENING

Patients aged 6 through 11 years weighing <30 kg (<66 lb)
RECOMMENDED DOSAGE

Two 50mg tablets

elexacaftor 50 mg/
tezacaftor  25 mg/
ivacaftor 37.5 mg
2 light orange tablets

150mg tablet

ivacaftor 75 mg
1 light blue tablet

Patients aged 6 through 11 years weighing ≥30 kg (≥66 lb) and 12 years and older
RECOMMENDED DOSAGE

Two 100mg tablets

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

150mg tablet

ivacaftor 150 mg
1 light blue 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
 
For patients aged 6 through 11 years
weighing <30 kg (<66 lb)


IN THE MORNING (TWICE A WEEK)

Two 100mg tablets

DAY 1

elexacaftor 50 mg/
tezacaftor 25 mg/
ivacaftor 37.5 mg 
2 light orange tablets


Two 100mg tablets

DAY 4c

elexacaftor 50 mg/
tezacaftor 25 mg/
ivacaftor 37.5 mg 
2 light orange tablets

For patients aged 6
through 11 years weighing ≥30 kg (≥66 lb) and 12 years
and older


IN THE MORNING (TWICE A WEEK)

Two 100mg tablets

DAY 1

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


Two 100mg tablets

DAY 4c

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

NO TABLET IN THE EVENING

 

 

Moderate CYP3A inhibitors including: fluconazole, erythromycin
For patients aged 6
through 11 years
weighing <30 kg (<66 lb)


ALTERNATE TABLETS EVERY MORNING

Two 100mg tablets

DAY 1

elexacaftor 50 mg/
tezacaftor 25 mg/
ivacaftor 37.5 mg 
2 light orange tablets


150mg tablet

DAY 2d

ivacaftor 75 mg
1 light blue tablet

For patients aged 6
through 11 years
weighing ≥30 kg (≥66 lb) and
and older


ALTERNATE TABLETS EVERY MORNING

Two 100mg tablets

DAY 1

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


150mg tablet

DAY 2d

ivacaftor 150 mg
1 light blue tablet

NO TABLET IN THE EVENING


Tablets are not actual size.

aLiver function tests should be closely monitored.1
bTRIKAFTA is not recommended for patients with moderate hepatic impairment. If TRIKAFTA is used in patients with moderate hepatic impairment, it should be with caution and at a reduced dose, as follows1:

  • Day 1: Patients should take 2 elexacaftor/tezacaftor/ivacaftor tablets in the morning
  • Day 2: Patients should take 1 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  
  Morning 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
 
  NightMISSED 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 tablets1,2

For patients aged 6 through
11 years weighing <30 kg (<66 lb)

Not actual size.

  • TRIKAFTA is a co-package of fixed-dose combination tablets containing elexacaftor
    50 mg, tezacaftor 25 mg, and ivacaftor 37.5 mg, and ivacaftor 75 mg tablets
    • The elexacaftor, tezacaftor, and ivacaftor tablets are light orange, capsule-shaped, and debossed with "T50" on one side and plain on the other
    • The ivacaftor tablets are light blue, capsule-shaped, and printed with "V 75" in black ink on one side and plain on the other
       

For patients aged 6 through
11 years weighing ≥30 kg (≥66 lb) and
12 years and older

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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lb, pounds.