DOSING AND ADMINISTRATION1-3
2 to <6 Years
Dosing information1,3
- 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
 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
| |
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:
Repeat above dosing schedule each week. The evening dose of the ivacaftor granules should not be taken.
| |
| In patients with severe hepatic impairment (Child-Pugh Class C) | SHOULD NOT BE USED
| |
| ||
| 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 IN THE MORNING (TWICE A WEEK)  DAY 1 tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet  DAY 4a tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet For patients aged 2 to <6 years IN THE MORNING (TWICE A WEEK)  DAY 1 tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet  DAY 4a 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 ALTERNATE GRANULES EVERY MORNING  DAY 1 tezacaftor 40 mg/ ivacaftor 60 mg 1 white and blue packet  DAY 2b 1 white and green packet For patients aged 2 to <6 years ALTERNATE GRANULES EVERY MORNING  DAY 1 tezacaftor 50 mg/ ivacaftor 75 mg 1 white and orange packet  DAY 2b 1 white and pink packet | NO PACKET IN THE EVENING |
 MORNING |
 EVENING |
| For patients aged 2 to <6years weighing <14 kg (<31 lb)1,2 |
|
| RECOMMENDED DOSAGE | |
elexacaftor 80 mg/ |
ivacaftor 59.5 mg |
| For patients aged 2 to <6years weighing ≥14 kg (≥31 lb)1,2 |
|
| RECOMMENDED DOSAGE | |
elexacaftor 100 mg/ |
ivacaftor 75 mg |
| Recommended dosage for use of TRIKAFTA in patients aged 2 to <6 years with hepatic impairment1 |
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| In patients with mild hepatic impairment (Child-Pugh Class A) |
|
NO DOSE ADJUSTMENT
|
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|
|
| 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:
Repeat above dosing schedule each week. The evening dose of the ivacaftor granules should not be taken.
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| In patients with severe hepatic impairment (Child-Pugh Class C) |
|
SHOULD NOT BE USED
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MORNING |
EVENING |
| Drug interactions profiles and related dosing consideration | |
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| Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)1 |
|
| CONCOMITANT USE NOT RECOMMENDED |
|
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| Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin1 |
|
|
For patients aged 2 to
<6 years weighing <14 kg (<31 lb)2
DAY 1 elexacaftor 80 mg/ DAY 4a elexacaftor 80 mg/ For patients aged 2 to
<6 years weighing ≥14 kg (≥31 lb)2 IN THE MORNING (TWICE A WEEK)
DAY 1 elexacaftor 100 mg/ DAY 4a elexacaftor 100 mg/ |
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/
DAY 2b ivacaftor 59.5 mg For patients aged 2 to
>6 years weighing ≥14 kg (≥31 lb)2
DAY 1 elexacaftor 100 mg/ DAY 2b ivacaftor 75 mg |
NO PACKET IN THE EVENING |
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MORNING| Recommended dosage for use of TRIKAFTA in patients aged 2 to <6 years with hepatic impairment1 | ||||||||||||||||||||||||||||
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Missed dose1
MISSED MORNING DOSE
MISSED EVENING DOSE
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 dose1
MISSED MORNING DOSE
MISSED EVENING DOSE
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
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
- 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 TRIKAFTA1,3
|
Preparation |
Examples of soft foods or liquids include:
Note: Use thickened food/purée in younger patients who are adjusting to solid foods. |
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Administration |
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Give fat-containing food |
Note: The list above includes only examples. Parents/caretakers can try other fat- |
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It is important for patients to consume the entire
dose of granules within 1 hour after mixing
How to administer oral granule doses of TRIKAFTA1-3
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Examples of soft foods or liquids include:
Note: Use thickened food/purée in younger patients who are adjusting to solid foods. |
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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. |
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How to administer oral granule doses of TRIKAFTA1-3
|
Preparation |
Examples of soft foods or liquids include:
Note: Use thickened food/purée in younger patients who are adjusting to solid foods. |
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|
Administration |
||||
|
Give fat-containing food |
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
6 to <12 Years
Dosing information1,3
- 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
|
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
|
|
|
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:
Continue alternating Day 1 and Day 2 dosing thereafter No evening dose of ivacaftor should be taken
|
|
| In patients with severe hepatic impairment (Child-Pugh Class C) |
SHOULD NOT BE USED
|
|
|
||
|
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 IN THE MORNING (TWICE A WEEK)
 DAY 1tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets  DAY 4a tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets For patients aged 6 to <12 years IN THE MORNING (TWICE A WEEK)
 DAY 1 tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets  DAY 4a 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 ALTERNATE TABLETS EVERY MORNING
 DAY 1 tezacaftor 25 mg/ ivacaftor 37.5 mg 2 light orange tablets  DAY 2b 1 light blue tablet For patients aged 6 to <12 years ALTERNATE TABLETS EVERY MORNING
 DAY 1 tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets  DAY 2b 1 light blue tablet |
NO TABLET IN THE EVENING |
MORNING |
EVENING |
| For patients aged 6 to <12 years weighing <30 kg (<66 lb)1,2 | |
| RECOMMENDED DOSAGE | |
 elexacaftor 50 mg/ |
 ivacaftor 75 mg |
| For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)1,2 | |
| RECOMMENDED DOSAGE | |
 elexacaftor 100 mg/ |
 ivacaftor 150 mg |
| 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
|
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|
|
|
|
|
|
| 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:
Continue alternating Day 1 and Day 2 dosing thereafter No evening dose of ivacaftor should be taken
|
|
|
|
|
| In patients with severe hepatic impairment (Child-Pugh Class C) |
|
SHOULD NOT BE USED
|
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|
|
|
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|
|
MORNING |
EVENING |
| Drug interactions 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
DAY 1 elexacaftor 50 mg/ DAY 4a elexacaftor 50 mg/ For patients aged 6
to <12 years weighing ≥30 kg (≥66 lb)2 IN THE MORNING (TWICE A WEEK)  DAY 1 elexacaftor 100 mg/  DAY 4a elexacaftor 100 mg/ |
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/ DAY 2b ivacaftor 75 mg For patients aged 6
to <12 years weighing ≥30 kg (≥66 lb)2
 DAY 1 elexacaftor 100 mg/  DAY 2b ivacaftor 150 mg |
NO TABLET IN THE EVENING |
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| Recommended dosage for use of TRIKAFTA in patients ages 6 to <12 years with hepatic impairment1 | ||||||||||||||||||||||||||||
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Tablets are not actual size.
Tablets are not actual size.
Missed dose1
MISSED MORNING DOSE
MISSED EVENING DOSE
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 dose1
MISSED MORNING DOSE
MISSED EVENING DOSE
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 tablets1,2
TRIKAFTA for aged 6 and older is supplied in cartons containing 4 weekly wallets, each with 21 tablets1,2
TRIKAFTA for aged 6 and older is supplied in cartons containing 4 weekly wallets, each with 21 tablets1,2
For patients aged 6 to <12 years weighing <30 kg (<66 lb)
For patients aged 6 to
<12 years weighing <30 kg (<66 lb)
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
12 Years and Older
Dosing information1,3
- 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
|
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
|
|
|
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:
Continue alternating Day 1 and Day 2 dosing thereafter No evening dose of ivacaftor should be taken
|
|
| In patients with severe hepatic impairment (Child-Pugh Class C) |
SHOULD NOT BE USED
|
|
|
||
|
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 |
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| 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 tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets  DAY 4a 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 tezacaftor 50 mg/ ivacaftor 75 mg 2 orange tablets  DAY 2b 1 light blue tablet |
NO TABLET IN THE EVENING |
MORNING |
EVENING |
| For patients aged 12 years and older | |
| RECOMMENDED DOSAGE | |
elexacaftor 100 mg/ |
ivacaftor 150 mg |
| Recommended dosage for use of TRIKAFTA in patients aged 12 years and older with hepatic impairment1 |
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| In patients with mild hepatic impairment (Child-Pugh Class A) |
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NO DOSE ADJUSTMENT
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| In patients with moderate hepatic impairment (Child-Pugh Class B) |
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| 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:
Continue alternating Day 1 and Day 2 dosing thereafter No evening dose of ivacaftor should be taken
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| In patients with severe hepatic impairment (Child-Pugh Class C) |
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SHOULD NOT BE USED
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MORNING |
EVENING |
| Drug interactions profiles and related dosing consideration | |
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| Strong CYP3A inducers including: rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort (Hypericum perforatum)1 |
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| CONCOMITANT USE NOT RECOMMENDED |
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| Strong CYP3A inhibitors including: ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, clarithromycin1 |
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For patients aged
12 years and older2 IN THE MORNING (TWICE A WEEK) DAY 1 elexacaftor 100 mg/ DAY 4a elexacaftor 100 mg/ |
NO TABLET IN THE EVENING |
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| Moderate CYP3A inhibitors including: fluconazole, erythromycin1 | |
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For patients aged
12 years and older2
DAY 1 elexacaftor 100 mg/ DAY 2b ivacaftor 150 mg |
NO TABLET IN THE EVENING |
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| Recommended dosage for use of TRIKAFTA in patients aged 12 years and older with hepatic impairment1 | ||||||||||||||||||||||||||||
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Tablets are not actual size.
Tablets are not actual size.
Missed dose1
MISSED MORNING DOSE
MISSED EVENING DOSE
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 dose1
MISSED MORNING DOSE
MISSED EVENING DOSE
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 tablets1,2
TRIKAFTA for aged 12 and older is supplied in cartons containing 4 weekly wallets, each with 21 tablets1,2
For patients aged 12 years and older
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
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
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
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; April 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; April 2023.