DOSING AND ADMINISTRATION1-3

IN THIS SECTION: ALSO IN THIS SECTION:

    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
    ← ~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 4a

    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 4a

    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 2b

    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 2b

    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
    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 4a

    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 4a

    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 2b

    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 2b

    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)1CONCOMITANT 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 4a

    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 4a

    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 2b

    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 2b

    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 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

    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

    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

    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 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

    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 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

    Step 1

    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.

    Step 2

    Administration

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

    Step 3

    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 TRIKAFTA1-3

    Step 1Preparation

    • 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.

     

    Step 2Administration

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

     

    Step 3Give 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 TRIKAFTA1-3

    Step 1

    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.

    Step 2

    Administration

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

    Step 3

    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

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

    DAY 4a

    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)
    Two 100mg tablets

    DAY 1

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

      DAY 4a

    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
    Two 50mg tablets

    DAY 1

    elexacaftor 50 mg/
    tezacaftor 25 mg/
    ivacaftor 37.5 mg
    2 light orange tablets
    75mg tablet

    DAY 2b

    ivacaftor 75 mg/
    1 light blue tablet

    For patients aged 6 to <12 years 
    weighing ≥30 kg (≥66 lb)2

    ALTERNATE TABLETS EVERY MORNING
    Two 100mg tablets

    DAY 1

    elexacaftor 100 mg/
    tezacaftor 50 mg/
    ivacaftor 75 mg
    2 orange tablets
    150mg tablet

    DAY 2b

    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
    Two 50mg tablets

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

    75mg tablet

    ivacaftor 75 mg
    1 light blue tablet

    For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)1,2
    RECOMMENDED DOSAGE
    Two 100mg tablets

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

    150mg tablet

    ivacaftor 150 mg
    1 light blue tablet

     

    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
    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 4c

    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 4c

    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)

    Two 50mg tablets

    DAY 1

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


    Two 50mg tablets

    DAY 4a

    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)

    Two 100mg tablets

    DAY 1

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


    Two 100mg tablets

    DAY 4a

    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 2e

    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 2e

    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

    Two 50mg tablets

    DAY 1

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


    75mg tablet

    DAY 2b

    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


    150mg tablet

    DAY 2b

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

     

    Two 100mg tablets
    elexacaftor 100 mg/
    tezacaftor 50 mg/
    ivacaftor 75 mg
    2 orange tablets
    150mg tablet
    ivacaftor 150 mg
    1 light blue tablet
    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)
    Two 50mg tablets

    DAY 1

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

    DAY 4a

    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)
    Two 100mg tablets

    DAY 1

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

    DAY 4a

    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
    Two 50mg tablets

    DAY 1

    elexacaftor 50 mg/ tezacaftor 25 mg/ ivacaftor 37.5 mg
    2 light orange tablets
    75mg tablet

    DAY 2b

    ivacaftor 75 mg
    1 light blue tablet

    For patients aged 6 to <12 years weighing ≥30 kg (≥66 lb)2
    ALTERNATE TABLETS EVERY MORNING
    Two 100mg tablets

    DAY 1

    elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg
    2 orange tablets
    150mg tablet

    DAY 2b

    ivacaftor 150 mg
    1 light blue tablet

    NO PACKET IN
    THE EVENING

    Tablets are not actual size.

    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 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 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)

    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)

    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)

    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 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)

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

    DAY 1

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

      DAY 4a

    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
    Two 100mg tablets

    DAY 1

    elexacaftor 100 mg/
    tezacaftor 50 mg/
    ivacaftor 75 mg
    2 orange tablets
    150mg tablet

      DAY 2b

    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
    Two 100mg tablets

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

    150mg tablet

    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
    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 4c

    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 4c

    elexacaftor 100 mg/
    tezacaftor 50 mg/
    ivacaftor 75 mg 
    1 white and orange packet

    NO PACKET IN THE EVENING

    For patients aged 
    12 years and older2

    IN THE MORNING (TWICE A WEEK)

    Two 100mg tablets

    DAY 1

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


    Two 100mg tablets

    DAY 4a

    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 2e

    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 2e

    ivacaftor 150 mg
    1 white and pink packet

    NO PACKET IN THE EVENING

    For patients aged
    12 years and older2


    ALTERNATE TABLETS EVERY MORNING

    Two 100mg tablets

    DAY 1

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


    150mg tablet

    DAY 2b

    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

     

    Two 100mg tablets
    elexacaftor 100 mg/
    tezacaftor 50 mg/
    ivacaftor 75 mg
    2 orange tablets
    150mg tablet
    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)
    Two 100mg tablets

    DAY 1

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

    DAY 4a

    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
    Two 100mg tablets

    DAY 1

    elexacaftor 100 mg/ tezacaftor 50 mg/ ivacaftor 75 mg
    2 orange tablets
    150mg tablet

    DAY 2b

    ivacaftor 150 mg
    1 light blue tablet

    NO TABLET IN
    THE EVENING

    Tablets are not actual size.

    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 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 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

    Image of TRIKAFTA in cartons 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

    Image of TRIKAFTA in cartons 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

    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.