IN THIS SECTION: ALSO IN THIS SECTION:

DOSING AND ADMINISTRATION^1-3

IN THIS SECTION: ALSO IN THIS SECTION:

2 to <6 Years

Dosing information^1,3

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, meats, or peanut butter
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, meats, or peanut butter
Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA

**← ~12 hours apart →**
	MORNING	EVENING
For patients aged 2 to <6 years weighing <14 kg (<31 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet	ivacaftor 59.5 mg 1 white and green packet
For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	ivacaftor 75 mg 1 white and pink packet

Recommended dosage for use of TRIKAFTA in patients aged 2 to <6 years with hepatic impairment¹
In patients with mild hepatic impairment (Child-Pugh Class A)	NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹
In patients with moderate hepatic impairment (Child-Pugh Class B)	TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: Days 1-3: one packet of elexacaftor/tezacaftor/ ivacaftor granules each day Day 4: no dose Day 5-6: one packet of elexacaftor/tezacaftor/ ivacaftor granules each day Day 7: no dose Repeat above dosing schedule each week. The evening dose of the ivacaftor granules should not be taken. Liver function tests should be closely monitored¹
In patients with severe hepatic impairment (Child-Pugh Class C)	SHOULD NOT BE USED 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
No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/min/ 1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

**← ~12 hours apart →**
	MORNING	EVENING
Drug interaction profiles and related dosing consideration
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹	CONCOMITANT USE NOT RECOMMENDED
Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹	For patients aged 2 to <6 years weighing <14 kg (<31 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 4^a elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	NO PACKET IN THE EVENING
Moderate CYP3A inhibitors including: fluconazole, erythromycin¹	For patients aged 2 to <6 years weighing <14 kg (<31 lb)² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 2^b ivacaftor 59.5 mg 1 white and green packet For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 2^b ivacaftor 75 mg 1 white and pink packet	NO PACKET IN THE EVENING

**← ~12 hours apart →**
MORNING	EVENING

For patients aged 2 to <6years weighing <14 kg (<31 lb)^1,2
RECOMMENDED DOSAGE
elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet	ivacaftor 59.5 mg 1 white and green packet
For patients aged 2 to <6years weighing ≥14 kg (≥31 lb)^1,2
RECOMMENDED DOSAGE
elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	ivacaftor 75 mg 1 white and pink packet

Recommended dosage for use of TRIKAFTA in patients aged 2 to <6 years with hepatic impairment¹

In patients with mild hepatic impairment (Child-Pugh Class A)
NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹

In patients with moderate hepatic impairment (Child-Pugh Class B)
TREATMENT IS NOT RECOMMENDED USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: Days 1-3: one packet of elexacaftor/ tezacaftor/ivacaftor granules each day Day 4: no dose Day 5-6: one packet of elexacaftor/ tezacaftor/ivacaftor granules each day Day 7: no dose Repeat above dosing schedule each week. The evening dose of the ivacaftor granules should not be taken. Liver function tests should be closely monitored¹

In patients with severe hepatic impairment (Child-Pugh Class C)
SHOULD NOT BE USED 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

No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/ min/ 1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

**← ~12 hours apart →**
MORNING	EVENING

Drug interactions profiles and related dosing consideration
2 to 5 years	6 years and older
In patients moderate hepatic impairment (Child-Pugh Class B)
USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS

Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹
CONCOMITANT USE NOT RECOMMENDED

Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹
For patients aged 2 to <6 years weighing <14 kg (<31 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 4^a elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	NO PACKET IN THE EVENING

Moderate CYP3A inhibitors including: fluconazole, erythromycin¹
For patients aged 2 to <6 years weighing <14 kg (<31 lb)² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 2^b ivacaftor 59.5 mg 1 white and green packet For patients aged 2 to >6 years weighing ≥14 kg (≥31 lb)² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 2^b ivacaftor 75 mg 1 white and pink packet	NO PACKET IN THE EVENING

← ~12 hours apart →

	MORNING	EVENING
For patients aged 2 to <6 years weighing <14 kg (<31 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg/ 1 white and blue packet	ivacaftor 59.5 mg 1 white and green packet
For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	ivacaftor 75 mg 1 white and pink packet

Recommended dosage for use of TRIKAFTA in patients aged 2 to <6 years with hepatic impairment¹

In patients with mild hepatic impairment (Child-Pugh Class A)	NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹
In patients with moderate hepatic impairment (Child-Pugh Class B)	TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: Days 1-3: one packet of elexacaftor/tezacaftor/ ivacaftor granules each day Day 4: no dose Day 5-6: one packet of elexacaftor/tezacaftor/ ivacaftor granules each day Day 7: no dose Repeat above dosing schedule each week. The evening dose of the ivacaftor granules should not be taken. Liver function tests should be closely monitored¹
In patients with severe hepatic impairment (Child-Pugh Class C)	SHOULD NOT BE USED 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
No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/min/1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

← ~12 hours apart →

	MORNING	EVENING
Drug interaction profiles and related dosing consideration
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹	CONCOMITANT USE NOT RECOMMENDED
Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹	For patients aged 2 to <6 years weighing <14 kg (<31 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 4^a elexacaftor 80 mg / tezacaftor 40 mg / ivacaftor 60 mg 1 white and blue packet For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	NO PACKET IN THE EVENING
Moderate CYP3A inhibitors including: fluconazole, erythromycin¹	For patients aged 2 to <6 years weighing <14 kg (<31 lb)² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 2^b ivacaftor 59.5 mg 1 white and green packet For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 2^b ivacaftor 75 mg 1 white and pink packet	NO PACKET IN THE EVENING

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

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

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.

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

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

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

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.

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

TRIKAFTA for aged 2 to <6 years is supplied in cartons containing 4 weekly wallets, each with 14 packets

For patients aged 2 to <6 years weighing <14 kg (<31 lb)^1,2

For patients aged 2 to <6 years
weighing <14 kg (<31 lb)^1,2

Image of TRIKAFTA in cartons for patients aged 6 through 11 years weighing ≥30 kg (≥66 lb) and 12 years and older

Fixed-dose combination oral granules containing elexacaftor 80 mg, tezacaftor 40 mg, ivacaftor 60 mg co-packaged with ivacaftor 59.5 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and blue unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and green unit-dose packet

Fixed-dose combination oral granules containing elexacaftor 80 mg, tezacaftor 40 mg, ivacaftor 60 mg co- packaged with ivacaftor 59.5 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and blue unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and green unit-dose packet

For patients aged 2 to <6 years weighing <14 kg (<31 lb)^1,2

For patients aged 2 to <6 years
weighing <14 kg (<31 lb)^1,2

Fixed-dose combination oral granules containing elexacaftor 80 mg, tezacaftor 40 mg, ivacaftor 60 mg co-packaged with ivacaftor 59.5 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and blue unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and green unit-dose packet

Fixed-dose combination oral granules containing elexacaftor 80 mg, tezacaftor 40 mg, ivacaftor 60 mg co- packaged with ivacaftor 59.5 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and blue unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and green unit-dose packet

For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)^1,2

For patients aged 2 to <6 years
weighing ≥14 kg (≥31 lb)^1,2

Fixed-dose combination oral granules containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg co-packaged with ivacaftor 75 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and orange unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and pink unit-dose packet

Fixed-dose combination oral granules containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg co-packaged with ivacaftor 75 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and orange unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and pink unit-dose packet

For patients aged 2 to <6 years weighing ≥14 kg (≥31 lb)^1,2

For patients aged 2 to <6 years
weighing ≥14 kg (≥31 lb)^1,2

Fixed-dose combination oral granules containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg co-packaged with ivacaftor 75 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and orange unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and pink unit-dose packet

Fixed-dose combination oral granules containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg co-packaged with ivacaftor 75 mg oral granules
- Elexacaftor, tezacaftor, and ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and orange unit-dose packet
- Ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter contained in a white and pink unit-dose packet

How to administer oral granule doses of TRIKAFTA^1,3

Preparation

Caregiver should hold the packet with the perforation on top, shake the packet
gently to settle the granules, and tear or cut the packet open along the
perforations
Caregiver should mix all the granules into 1 teaspoon (5 mL) of age-appropriate
soft food or liquid
Food or liquid should be at or below room temperature

Examples of soft foods or liquids include:

Puréed fruits or
vegetables Yogurt or applesauce Milk, juice
or water

Note: Use thickened food/purée in younger patients who are adjusting to solid foods.

Administration

After mixing granules, caregiver should give the dose within 1 hour
Caregiver should make sure the child finishes the dose completely

Give fat-containing food

Food that contains fat must be taken just before or after the oral
granules dose. Examples of fat-containing foods include:

Eggs
Avocado
Nuts
Butter

Peanut butter
Cheese pizza
Whole-milk dairy products (eg. whole milk,
cheese, and yogurt)

Note: The list above includes only examples. Parents/caretakers can try other fat-
containing foods that work best for the patient. Food or drink containing grapefruit
should be avoided during treatment with TRIKAFTA.

It is important for patients to consume the entire
dose of granules within 1 hour after mixing

How to administer oral granule doses of TRIKAFTA^1-3

Preparation
Caregiver should hold the packet with the perforation on top, shake the packet gently to settle the granules, and tear or cut the packet open along the perforations Caregiver should mix all the granules into 1 teaspoon (5 mL) of age-appropriate soft food or liquid Food or liquid should be at or below room temperature Examples of soft foods or liquids include: Puréed fruits or vegetables Yogurt or applesauce Milk, juice, or water Note: Use thickened food/purée in younger patients who are adjusting to solid foods.

Administration
After mixing granules, caregiver should give the dose within 1 hour Caregiver should make sure the child finishes the dose completely

Give fat-containing food
Food that contains fat must be taken just before or after the oral granules dose. Examples of fat-containing foods include: Eggs Avocado Nuts Butter Peanut Butter Cheese Pizza Whole-milk dairy products (eg. whole milk, cheese, and yogurt) Note: The list above includes only examples. Parents/caretakers can try other fat-containing foods that work best for the patient. Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA.

IT IS IMPORTANT FOR PATIENTS TO CONSUME THE ENTIRE DOSE OF GRANULES WITHIN 1 HOUR AFTER MIXING

How to administer oral granule doses of TRIKAFTA^1-3

Preparation

Caregiver should hold the packet with the perforation on top, shake the packet gently to settle the granules, and tear or cut the packet open along the perforations
Food or liquid should be at or below room temperature

Examples of soft foods or liquids include:

Puréed fruits or
vegetables Yogurt or applesauce Milk, juice,
or water

Note: Use thickened food/purée in younger patients who are adjusting to solid foods.

Administration

After mixing granules, caregiver should give the dose within 1 hour
Caregiver should make sure the child finishes the dose completely

Give fat-containing food

Food that contains fat must be taken just before or after the oral granules dose

Eggs
Avocado
Nuts
Butter

Peanut butter
Cheese pizza
Whole-milk dairy products (eg. whole milk,
cheese, and yogurt)

Note: The list above includes only examples. Parents/caretakers can try other fat-containing foods that work best for the patient. Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA.

It is important for patients to consume the entire
dose of granules within 1 hour after mixing

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 1 elexacaftor/tezacaftor/ivacaftor packet twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 1 elexacaftor/tezacaftor/ivacaftor packet and 1 ivacaftor packet on alternate days.¹

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 1 elexacaftor/tezacaftor/ivacaftor packet twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 1 elexacaftor/tezacaftor/ivacaftor packet and 1 ivacaftor packet on alternate days.¹

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 1 elexacaftor/tezacaftor/ivacaftor packet twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 1 elexacaftor/tezacaftor/ivacaftor packet and 1 ivacaftor packet on alternate days.¹

See potential drug-drug interactions

View the clinical trials of TRIKAFTA

6 to <12 Years

Dosing information^1,3

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, meats, or peanut butter
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, meats, or peanut butter
Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA

**← ~12 hours apart →**
	MORNING	EVENING
For patients aged 6 to <12 years weighing <30 kg (<66 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets	ivacaftor 75 mg 1 light blue tablet
For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	ivacaftor 150 mg 1 light blue tablet

Recommended dosage for use of TRIKAFTA in patients aged 6 to <12 years with hepatic impairment¹
In patients with mild hepatic impairment (Child-Pugh Class A)	NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹
In patients with moderate hepatic impairment (Child-Pugh Class B)	TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: 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 Liver function tests should be closely monitored¹
In patients with severe hepatic impairment (Child-Pugh Class C)	SHOULD NOT BE USED 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 impairment¹
No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/min/ 1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

**← ~12 hours apart →**
	MORNING	EVENING
Drug interaction profiles and related dosing consideration
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹	CONCOMITANT USE NOT RECOMMENDED
Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹	For patients aged 6 to <12 years weighing <30 kg (<66 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets DAY 4^a elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	NO TABLET IN THE EVENING
Moderate CYP3A inhibitors including: fluconazole, erythromycin¹	For patients aged 6 to <12 years weighing <30 kg (<66 lb)² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets DAY 2^b ivacaftor 75 mg/ 1 light blue tablet For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 2^b ivacaftor 150 mg 1 light blue tablet	NO TABLET IN THE EVENING

**← ~12 hours apart →**
MORNING	EVENING

For patients aged 6 to <12 years weighing <30 kg (<66 lb)^1,2
RECOMMENDED DOSAGE
elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets	ivacaftor 75 mg 1 light blue tablet
For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)^1,2
RECOMMENDED DOSAGE
elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	ivacaftor 150 mg 1 light blue tablet

Recommended dosage for use of TRIKAFTA in patients aged 6 to <12 years with hepatic impairment¹

In patients with mild hepatic impairment (Child-Pugh Class A)
NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹


In patients with moderate hepatic impairment (Child-Pugh Class B)
TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: 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 Liver function tests should be closely monitored¹

In patients with severe hepatic impairment (Child-Pugh Class C)
SHOULD NOT BE USED 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 impairment¹

No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/ min/ 1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

**← ~12 hours apart →**
MORNING	EVENING

Drug interactions profiles and related dosing consideration
2 to 5 years	6 years and older
In patients moderate hepatic impairment (Child-Pugh Class B)
USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS

Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹
CONCOMITANT USE NOT RECOMMENDED

Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹
For patients aged 2 to <6 years weighing <14 kg (<30.8 lb) IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 4^c elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet For patients aged 2 to <6 years weighing ≥14 kg (≥30.8 lb) IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 4^c elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	NO PACKET IN THE EVENING
For patients aged 6 to <12 years weighing <30 kg (<66 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets DAY 4^a elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	NO TABLET IN THE EVENING

Moderate CYP3A inhibitors including: fluconazole, erythromycin¹
For patients aged 2 to <6 years weighing <14 kg (<30.8 lb) ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 2^e ivacaftor 59.5 mg 1 white and green packet For patients aged 2 to >6 years weighing ≥14 kg (≥30.8 lb) ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 2^e ivacaftor 150 mg 1 white and pink packet	NO PACKET IN THE EVENING
For patients aged 6 to <12 years weighing <30 kg (<66 lb)² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets DAY 2^b ivacaftor 75 mg 1 light blue tablet For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 2^b ivacaftor 150 mg 1 light blue tablet	NO TABLET IN THE EVENING

← ~12 hours apart →

	MORNING	EVENING
For patients aged 6 to <12 years weighing <30 kg (<66 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg/ 2 light orange tablets	ivacaftor 75 mg 1 light blue tablet
For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)^1,2
RECOMMENDED DOSAGE	elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	ivacaftor 150 mg 1 light blue tablet

Recommended dosage for use of TRIKAFTA in patients ages 6 to <12 years with hepatic impairment¹

In patients with mild hepatic impairment (Child-Pugh Class A)	NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹
In patients with moderate hepatic impairment (Child-Pugh Class B)	TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: 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 Liver function tests should be closely monitored¹
In patients with severe hepatic impairment (Child-Pugh Class C)	SHOULD NOT BE USED 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 impairment¹
No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/min/1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

← ~12 hours apart →

	MORNING	EVENING
Drug interaction profiles and related dosing consideration
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹	CONCOMITANT USE NOT RECOMMENDED
Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹	For patients aged 6 to <12 years weighing <30 kg (<66 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets DAY 4^a elexacaftor 50 mg / tezacaftor 25 mg / ivacaftor 37.5 mg 2 light orange tablets For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	NO PACKET IN THE EVENING
Moderate CYP3A inhibitors including: fluconazole, erythromycin¹	For patients aged 6 to <12 years weighing <30 kg (<66 lb)² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets DAY 2^b ivacaftor 75 mg 1 light blue tablet For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 2^b ivacaftor 150 mg 1 light blue tablet	NO PACKET IN THE EVENING

Tablets are not actual size.

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

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

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.

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

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

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

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.

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

TRIKAFTA for aged 6 and older is supplied in cartons containing 4 weekly
wallets, each with 21 tablets^1,2

TRIKAFTA for aged 6 and older is supplied in cartons containing 4 weekly wallets, each with 21 tablets^1,2

For patients aged 6 to <12 years weighing <30 kg (<66 lb)

For patients aged 6 to
<12 years weighing <30 kg (<66 lb)

Image of TRIKAFTA in cartons 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

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 to <12 years weighing <30 kg (<66 lb)

For patients aged 6 to
<12 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

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 to <12 years weighing ≥30 kg (≥66 lb)

For patients aged 6 to <12
years weighing ≥30 kg (≥66 lb)

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

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

For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)

For patients aged 6 to <12
years weighing ≥30 kg (≥66 lb)

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

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

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.¹

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.¹

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.¹

See potential drug-drug interactions

View the clinical trials of TRIKAFTA

12 Years and Older

Dosing information^1,3

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, meats, or peanut butter
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, meats, or peanut butter
Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA

**← ~12 hours apart →**
	MORNING	EVENING
For patients aged 12 years and older
RECOMMENDED DOSAGE	elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	ivacaftor 150 mg 1 light blue tablet

Recommended dosage for use of TRIKAFTA in patients aged 12 years and older with hepatic impairment¹
In patients with mild hepatic impairment (Child-Pugh Class A)	NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹
In patients with moderate hepatic impairment (Child-Pugh Class B)	TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: 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 Liver function tests should be closely monitored¹
In patients with severe hepatic impairment (Child-Pugh Class C)	SHOULD NOT BE USED 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 impairment¹
No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/min/ 1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

**← ~12 hours apart →**
	MORNING	EVENING
Drug interaction profiles and related dosing consideration
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹	CONCOMITANT USE NOT RECOMMENDED
Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹	For patients aged 12 years and older² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	NO TABLET IN THE EVENING
Moderate CYP3A inhibitors including: fluconazole, erythromycin¹	For patients aged 12 years and older² ALTERNATE GRANULES EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 2^b ivacaftor 150 mg/ 1 light blue tablet	NO TABLET IN THE EVENING

**← ~12 hours apart →**
MORNING	EVENING


For patients aged 12 years and older
RECOMMENDED DOSAGE
elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	ivacaftor 150 mg 1 light blue tablet

Recommended dosage for use of TRIKAFTA in patients aged 12 years and older with hepatic impairment¹

In patients with mild hepatic impairment (Child-Pugh Class A)
NO DOSE ADJUSTMENT Liver function tests should be closely monitored¹

In patients with moderate hepatic impairment (Child-Pugh Class B)
TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: 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 Liver function tests should be closely monitored¹

In patients with severe hepatic impairment (Child-Pugh Class C)
SHOULD NOT BE USED 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 impairment¹

No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/ min/ 1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

**← ~12 hours apart →**
MORNING	EVENING

Drug interactions profiles and related dosing consideration
2 to 5 years	6 years and older
In patients moderate hepatic impairment (Child-Pugh Class B)
USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS

Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹
CONCOMITANT USE NOT RECOMMENDED

Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹
For patients aged 2 to <6 years weighing <14 kg (<30.8 lb) IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 4^c elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet For patients aged 2 to <6 years weighing ≥14 kg (≥30.8 lb) IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 4^c elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet	NO PACKET IN THE EVENING
madhu For patients aged 12 years and older² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	NO TABLET IN THE EVENING

Moderate CYP3A inhibitors including: fluconazole, erythromycin¹
For patients aged 2 to <6 years weighing <14 kg (<30.8 lb) ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 80 mg/ tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet DAY 2^e ivacaftor 59.5 mg 1 white and green packet For patients aged 2 to >6 years weighing ≥14 kg (≥30.8 lb) ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet DAY 2^e ivacaftor 150 mg 1 white and pink packet	NO PACKET IN THE EVENING
For patients aged 12 years and older² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 2^b ivacaftor 150 mg 1 light blue tablet	NO TABLET IN THE EVENING

← ~12 hours apart →

	MORNING	EVENING
For patients aged 12 years and older
RECOMMENDED DOSAGE	elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	ivacaftor 150 mg 1 light blue tablet

Recommended dosage for use of TRIKAFTA in patients aged 12 years and older with hepatic impairment¹

In patients with mild hepatic impairment (Child-Pugh Class A)	NO DOSE ADJUSTMENTS Liver function tests should be closely monitored¹
In patients with moderate hepatic impairment (Child-Pugh Class B)	TREATMENT IS NOT RECOMMENDED. USE SHOULD ONLY BE CONSIDERED WHEN THERE IS A CLEAR MEDICAL NEED AND THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISKS If used, TRIKAFTA should be used with caution at a reduced dose, as follows: 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 Liver function tests should be closely monitored¹
In patients with severe hepatic impairment (Child-Pugh Class C)	SHOULD NOT BE USED 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 impairment¹
No dose adjustment is recommended in patients with mild (eGFR 60 to <90 mL/min/1.73 m²) or moderate (eGFR 30 to <60 mL/min/1.73 m²) 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

← ~12 hours apart →

	MORNING	EVENING
Drug interaction profiles and related dosing consideration
Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)¹	CONCOMITANT USE NOT RECOMMENDED
Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin¹	For patients aged 12 years and older² IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 4^a elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets	NO TABLET IN THE EVENING
Moderate CYP3A inhibitors including: fluconazole, erythromycin¹	For patients aged 12 years and older² ALTERNATE TABLETS EVERY MORNING DAY 1 elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets DAY 2^b ivacaftor 150 mg 1 light blue tablet	NO TABLET IN THE EVENING

Tablets are not actual size.

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

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

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.

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

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

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

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.

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

TRIKAFTA for aged 12 and older is supplied in cartons containing 4 weekly wallets, each with 21 tablets^1,2

For patients aged 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

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

For patients aged 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

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

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.¹

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.¹

eGFR, estimated glomerular filtration rate; lb, pounds.

^aContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets twice a week, approximately 3 to 4 days apart.¹

^bContinue dosing with 2 elexacaftor/tezacaftor/ivacaftor tablets and 1 ivacaftor tablet on alternate days.¹

See potential drug-drug interactions

View the clinical trials of TRIKAFTA

Important Safety Information

Warnings and Precautions

Elevated Transaminases and Hepatic Injury

Liver failure leading to transplantation has been reported in a patient with cirrhosis and portal hypertension while receiving TRIKAFTA. Avoid use of TRIKAFTA in patients with pre-existing advanced liver disease (e.g., as evidenced by cirrhosis, portal hypertension, ascites, hepatic encephalopathy) unless the benefits are expected to outweigh the risks. If used in these patients, they should be closely monitored after the initiation of treatment

Isolated elevations of transaminases or bilirubin have been observed in patients with CF treated with TRIKAFTA. In some instances, transaminase elevations have been associated with concomitant elevations in total bilirubin and/or international normalized ratio (INR) and have resulted in patients being hospitalized for intervention, including in patients without a history of pre-existing liver disease

Indications and Usage

TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data.

If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data.

Assessments of liver function tests (ALT, AST, and bilirubin) are recommended prior to initiating TRIKAFTA, every 3 months during the first year of treatment, and annually thereafter

In the event of significant elevations in liver function tests, e.g. ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN, dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve. Following the resolution of liver function test elevations, consider the benefits and risks of resuming treatment

For patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered

Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the postmarketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue TRIKAFTA and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with TRIKAFTA

Concomitant Use With CYP3A Inducers

Exposure to ivacaftor is significantly decreased and exposure to elexacaftor and tezacaftor are expected to decrease by the concomitant use of strong CYP3A inducers, which may reduce the therapeutic effectiveness of TRIKAFTA. Co‑administration with strong CYP3A inducers is not recommended

Concomitant Use With CYP3A Inhibitors

Exposure to elexacaftor, tezacaftor, and ivacaftor are increased when co-administered with strong or moderate CYP3A inhibitors. The dose of TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors

Cataracts

Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow‑up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA

ADVERSE REACTIONS

Serious Adverse Reactions

Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs <1%) and influenza (1% vs 0)

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA (N=202) and higher than placebo (N=201) by ≥1% in the 24-week placebo-controlled, parallel-group Phase 3 trial (Trial 1) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, and blood bilirubin increased
The safety profile for the patients with CF receiving TRIKAFTA (N=55) enrolled in the 4-week, randomized, double-blind, active-controlled Phase 3 trial (Trial 2) was similar to that observed in Trial 1
The safety profile in patients age 6 through 11 years from an open-label trial (Trial 3; N=66) was similar to that observed in Trial 1. The safety profile in patients age 2 through 5 years from an open-label trial (Trial 4; N=75) was similar to that observed in Trial 1

Use in Specific Populations

Pediatric Use

The safety and effectiveness of TRIKAFTA in patients with CF younger than 2 years of age have not been established

Click here to access full Prescribing Information for TRIKAFTA.

References:

1. TRIKAFTA [prescribing information]. Boston, MA: Vertex Pharmaceuticals Incorporated; August 2023. 2. Data on file. Vertex Pharmaceuticals Incorporated. Boston, MA. REF-6607 (v2.0); 2021. 3. TRIKAFTA [patient information leaflet]. Boston, MA: Vertex Pharmaceuticals Incorporated; August 2023.

EXPAND

COLLAPSE

Indications and Usage TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data.

Indications and Usage

Important Safety Information

Warnings and Precautions

Elevated Transaminases and Hepatic Injury

Liver failure leading to transplantation has been reported in a patient with cirrhosis and portal hypertension while receiving TRIKAFTA. Avoid use of TRIKAFTA in patients with pre-existing advanced liver disease (e.g., as evidenced by cirrhosis, portal hypertension, ascites, hepatic encephalopathy) unless the benefits are expected to outweigh the risks. If used in these patients, they should be closely monitored after the initiation of treatment
Isolated elevations of transaminases or bilirubin have been observed in patients with CF treated with TRIKAFTA. In some instances, transaminase elevations have been associated with concomitant elevations in total bilirubin and/or international normalized ratio (INR) and have resulted in patients being hospitalized for intervention, including in patients without a history of pre-existing liver disease

Indications and Usage

Important Safety Information

Warnings and Precautions

Elevated Transaminases and Hepatic Injury

Liver failure leading to transplantation has been reported in a patient with cirrhosis and portal hypertension while receiving TRIKAFTA. Avoid use of TRIKAFTA in patients with pre-existing advanced liver disease (e.g., as evidenced by cirrhosis, portal hypertension, ascites, hepatic encephalopathy) unless the benefits are expected to outweigh the risks. If used in these patients, they should be closely monitored after the initiation of treatment
Isolated elevations of transaminases or bilirubin have been observed in patients with CF treated with TRIKAFTA. In some instances, transaminase elevations have been associated with concomitant elevations in total bilirubin and/or international normalized ratio (INR) and have resulted in patients being hospitalized for intervention, including in patients without a history of pre-existing liver disease
Assessments of liver function tests (ALT, AST, and bilirubin) are recommended prior to initiating TRIKAFTA, every 3 months during the first year of treatment, and annually thereafter
In the event of significant elevations in liver function tests, e.g. ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN, dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve. Following the resolution of liver function test elevations, consider the benefits and risks of resuming treatment
For patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered

Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the postmarketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue TRIKAFTA and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with TRIKAFTA

Concomitant Use With CYP3A Inducers

Exposure to ivacaftor is significantly decreased and exposure to elexacaftor and tezacaftor are expected to decrease by the concomitant use of strong CYP3A inducers, which may reduce the therapeutic effectiveness of TRIKAFTA. Co‑administration with strong CYP3A inducers is not recommended

Concomitant Use With CYP3A Inhibitors

Exposure to elexacaftor, tezacaftor, and ivacaftor are increased when co-administered with strong or moderate CYP3A inhibitors. The dose of TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors

Cataracts

Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow‑up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA

ADVERSE REACTIONS

Serious Adverse Reactions

Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs <1%) and influenza (1% vs 0)

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA (N=202) and higher than placebo (N=201) by ≥1% in the 24-week placebo-controlled, parallel-group Phase 3 trial (Trial 1) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, and blood bilirubin increased
The safety profile for the patients with CF receiving TRIKAFTA (N=55) enrolled in the 4-week, randomized, double-blind, active-controlled Phase 3 trial (Trial 2) was similar to that observed in Trial 1
The safety profile in patients age 6 through 11 years from an open-label trial (Trial 3; N=66) was similar to that observed in Trial 1. The safety profile in patients age 2 through 5 years from an open-label trial (Trial 4; N=75) was similar to that observed in Trial 1

Use in Specific Populations

Pediatric Use

The safety and effectiveness of TRIKAFTA in patients with CF younger than 2 years of age have not been established

Click here to access full Prescribing Information for TRIKAFTA.

References:

Assessments of liver function tests (ALT, AST, and bilirubin) are recommended prior to initiating TRIKAFTA, every 3 months during the first year of treatment, and annually thereafter
In the event of significant elevations in liver function tests, e.g. ALT or AST >5x the upper limit of normal (ULN) or ALT or AST >3x ULN with bilirubin >2x ULN, dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve. Following the resolution of liver function test elevations, consider the benefits and risks of resuming treatment
For patients with a history of hepatobiliary disease or liver function test elevations, more frequent monitoring should be considered

Hypersensitivity Reactions, Including Anaphylaxis

Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported in the postmarketing setting. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue TRIKAFTA and institute appropriate therapy. Consider the benefits and risks for the individual patient to determine whether to resume treatment with TRIKAFTA

Concomitant Use With CYP3A Inducers

Exposure to ivacaftor is significantly decreased and exposure to elexacaftor and tezacaftor are expected to decrease by the concomitant use of strong CYP3A inducers, which may reduce the therapeutic effectiveness of TRIKAFTA. Co‑administration with strong CYP3A inducers is not recommended

Concomitant Use With CYP3A Inhibitors

Exposure to elexacaftor, tezacaftor, and ivacaftor are increased when co-administered with strong or moderate CYP3A inhibitors. The dose of TRIKAFTA should be reduced when used concomitantly with moderate or strong CYP3A inhibitors

Cataracts

Cases of non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens. Baseline and follow‑up ophthalmological examinations are recommended in pediatric patients initiating treatment with TRIKAFTA

ADVERSE REACTIONS

Serious Adverse Reactions

Serious adverse reactions that occurred more frequently in patients treated with TRIKAFTA compared to placebo were rash (1% vs <1%) and influenza (1% vs 0)

Most Common Adverse Reactions

The most common adverse reactions occurring in ≥5% of patients treated with TRIKAFTA (N=202) and higher than placebo (N=201) by ≥1% in the 24-week placebo-controlled, parallel-group Phase 3 trial (Trial 1) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, and blood bilirubin increased
The safety profile for the patients with CF receiving TRIKAFTA (N=55) enrolled in the 4-week, randomized, double-blind, active-controlled Phase 3 trial (Trial 2) was similar to that observed in Trial 1
The safety profile in patients age 6 through 11 years from an open-label trial (Trial 3; N=66) was similar to that observed in Trial 1. The safety profile in patients age 2 through 5 years from an open-label trial (Trial 4; N=75) was similar to that observed in Trial 1

Use in Specific Populations

Pediatric Use

The safety and effectiveness of TRIKAFTA in patients with CF younger than 2 years of age have not been established

Click here to access full Prescribing Information for TRIKAFTA.

References:

DOSING AND ADMINISTRATION1-3

DOSING AND ADMINISTRATION^1-3