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Tablets

Granules

Recommended Dose

How to Give Granules

Late vs Missed Doses

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Preparing TRIKAFTA
oral granules

Preparing TRIKAFTA
oral granules

Preparing TRIKAFTA oral granules

THE RECOMMENDED

THE RECOMMENDED

THE RECOMMENDED

DOSE OF TRIKAFTA

DOSE OF TRIKAFTA

DOSE OF TRIKAFTA

 

 

 

 

Your doctor will prescribe TRIKAFTA based on your loved one's age and weight. Make sure to give every dose of TRIKAFTA oral granules as prescribed. Because the 3 components of TRIKAFTA work together to treat the underlying cause, each and every dose matters.

For children age 2 through 5 years weighing less than 14 kg (~31 lb)

For children age 2 through 5 years weighing 14 kg (~31 lb) or more

For children age 2 through 5 years weighing less than 14 kg (~31 lb)

For children age 2 through 5 years weighing less than 14 kg (~31 lb)

Morning Dose

One white and blue packet

(elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) mixed with 1 teaspoon (5 mL) of soft food or liquid and given with a fat-containing food

About 12 hours later

Evening Dose

One white and green packet

(ivacaftor 59.5 mg) mixed with 1 teaspoon (5 mL) of soft food or liquid and given with a fat-containing food

For children age 2 through 5 years weighing 14 kg (~31 lb) or more

For children age 2 through 5 years weighing 14 kg (~31 lb) or more

Morning Dose

One white and orange packet

(elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) mixed with 1 teaspoon (5 mL) of soft food or liquid and given with a fat-containing food

About 12 hours later

Evening Dose

One white and pink packet

(ivacaftor 75 mg) mixed with 1 teaspoon (5 mL) of soft food or liquid and given with a fat-containing food

(ivacaftor 75 mg) mixed with 1 teaspoon (5 mL) of soft food or liquid and given with a fat-containing food

(ivacaftor 75 mg) mixed with 1 teaspoon (5 mL) of soft food or liquid and given with a fat-containing food

Each dose must be given with fat-containing food to help your loved one’s body absorb TRIKAFTA

Give your loved one a food that contains fat just before or just after each dose of TRIKAFTA oral granules.

Fat-containing foods to give your loved one

Fat-containing foods to give your loved one

Fat-containing foods to give your loved one

Whole milk

Whole milk

Whole milk

Whole-milk cheese

Whole-milk cheese

Whole-milk cheese

Whole-milk yogurt

Whole-milk yogurt

Whole-milk yogurt

Peanut butter

Peanut butter

Peanut butter

Eggs

Eggs

Eggs

Butter

Butter

Butter

Remember, every child is different, so be sure to talk to your healthcare provider about the amount or types of foods to give your loved one when they take TRIKAFTA oral granules.

Get more food ideas

Avoid foods and drinks that contain grapefruit while taking TRIKAFTA because they may affect the amount of TRIKAFTA in your loved one's body.

Talk to your healthcare provider about all the medicines your loved one takes, as the dose of TRIKAFTA may need to be adjusted. It's important to give TRIKAFTA as your healthcare provider tells you to.

PREPARING TRIKAFTA

ORAL GRANULES

 

Watch this video to learn how to give TRIKAFTA oral granules to your loved one.

View Important Safety Information and full Prescribing Information, including Patient Information, for TRIKAFTA.

6 simple steps to preparing TRIKAFTA oral granules

  1. Hold the packet with the cut line on top.
  2. Shake the packet gently to settle the TRIKAFTA oral granules.
  3. Tear or cut the packet open along the cut line.
  4. Carefully pour all of the TRIKAFTA oral granules in the packet into 1 teaspoon (5 mL) of soft food or liquid in a small container. Food or liquid should be refrigerated or at room temperature.
  5. Mix the granules with the 1 teaspoon (5 mL) of food or liquid. Find food examples to mix with below.
  6. Give TRIKAFTA oral granules to your loved one within 1 hour of mixing with food or liquid. Make sure they take the entire medicine mixture.

Foods and liquids you can mix TRIKAFTA granules into

Foods and liquids you can mix TRIKAFTA granules into

Foods and liquids you can mix TRIKAFTA granules into

Yogurt

Water

Applesauce

Juice

Milk

Puréed fruits or vegetables

  • Yogurt
  • Applesauce
  • Milk
  • Water
  • Juice
  • Puréed fruits or vegetables

 

WHAT'S THE DIFFERENCE?

WHAT'S THE DIFFERENCE?

WHAT'S THE DIFFERENCE?

LATE vs MISSED DOSES

LATE vs MISSED DOSES

LATE vs MISSED DOSES

 

 

 

 

Each dose of TRIKAFTA should be taken about 12 hours apart, as prescribed by your loved one's healthcare provider. But if your loved one is late for a dose, it's important to know that they have 6 hours to take it before it becomes a missed dose. See below for guidance on what to do if a morning or evening dose is late.

Morning dose

 

If it's been 6 hours or LESS since you usually give your loved one their morning dose:

  • Give your loved one the late dose with fat-containing food as soon as possible
  • Then give your loved one the next dose at the usual time with fat-containing food

If it's been MORE than 6 hours since you usually give your loved one their morning dose:

  • Give your loved one the late dose with fat-containing food as soon as possible
  • Do not give your loved one the evening dose. Resume regular dosing schedule the next day

 

 

 

Evening dose

Evening dose

Evening dose

If it's been 6 hours or LESS since you usually give your loved one their evening dose:

  • Give your loved one the late dose with fat-containing food as soon as possible
  • Then give your loved one the next dose at the usual time with fat-containing food

If it's been MORE than 6 hours since you usually give your loved one their evening dose:

  • Do not give your loved one the late dose
  • Give your loved one the next morning dose at the usual time with fat-containing food

 

 

Do not give your loved one more than the usual dose of TRIKAFTA to make up for a missed dose.

How Are TRIKAFTA Oral Granules Packaged?

  • Each carton of TRIKAFTA has 56 oral granule packets, organized in 4 weekly wallets
  • Each wallet has 1 packet for the morning (elexacaftor/tezacaftor and ivacaftor) and 1 packet for the evening (ivacaftor) for the 7 days of the week

For children age 2 through 5 years weighing less than 14 kg (~31 lb)

For children age 2 through 5 years weighing 14 kg (~31 lb) or more

For children age 2 through 5 years
weighing less than 14 kg (~31 lb)

For children age 2 through 5 years
weighing 14 kg (~31 lb) or more

For help sticking with your TRIKAFTA treatment routine, turn to Vertex GPSTM: Guidance & Patient Support for personalized, one-on-one support.

Learn more

Staying
on Track

Staying
on Track

Staying on Track

with TRIKAFTA

with TRIKAFTA

with TRIKAFTA

Visit Treatment Time in Trilandia (for kids) Get TRIKAFTA dose reminders

Xander, age 27
F508del/F508del

What is TRIKAFTA® (elexacaftor/tezacaftor/ ivacaftor and ivacaftor)?

TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you:

  • are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients
  • have kidney problems
  • have or have had liver problems
  • are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant
  • are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

  • antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
  • seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
  • St. John’s wort
  • antifungal medicines including ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
  • antibiotics including telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)

What should I avoid while taking TRIKAFTA?

  • Avoid food or drink that contains grapefruit while you are taking TRIKAFTA

What are the possible side effects of TRIKAFTA?

TRIKAFTA can cause serious side effects, including:

  • Liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease
  • High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver:
  • before you start TRIKAFTA
  • every 3 months during your first year of taking TRIKAFTA
  • every year while you are taking TRIKAFTA

Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems:

  • pain or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • loss of appetite
  • nausea or vomiting
  • dark, amber-colored urine
  • Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
  • rash or hives
  • tightness of the chest or throat or difficulty breathing
  • swelling of the face, lips, and/or tongue, or difficulty swallowing
  • light-headedness or dizziness
  • Abnormality of the eye lens (cataract), which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts

The most common side effects of TRIKAFTA include:

  • headache
  • upper respiratory tract infection (common cold) including stuffy and runny nose
  • stomach (abdominal) pain
  • diarrhea
  • rash
  • increase in liver enzymes
  • increase in a certain blood enzyme called creatine phosphokinase
  • flu (influenza)
  • inflamed sinuses
  • increase in blood bilirubin

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For further information, please see full Prescribing Information, including Patient Information.

Arrow icon arrow icon

Important Safety Information and Indication

Información Importante de Seguridad e Indicación

EXPAND

AMPLIAR

COLLAPSE

REDUCIR

What is TRIKAFTA® (elexacaftor/tezacaftor/ ivacaftor and ivacaftor)?

TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you:

  • are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients
  • have kidney problems
  • have or have had liver problems
  • are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant
  • are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

  • antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
  • seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
  • St. John’s wort
  • antifungal medicines including ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
  • antibiotics including telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)

What should I avoid while taking TRIKAFTA?

  • Avoid food or drink that contains grapefruit while you are taking TRIKAFTA

What are the possible side effects of TRIKAFTA?

TRIKAFTA can cause serious side effects, including:

  • Liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease
  • High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver:
  • before you start TRIKAFTA
  • every 3 months during your first year of taking TRIKAFTA
  • every year while you are taking TRIKAFTA

Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems:

  • pain or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • loss of appetite
  • nausea or vomiting
  • dark, amber-colored urine
  • Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
  • rash or hives
  • tightness of the chest or throat or difficulty breathing
  • swelling of the face, lips, and/or tongue, or difficulty swallowing
  • light-headedness or dizziness
  • Abnormality of the eye lens (cataract), which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts

The most common side effects of TRIKAFTA include:

  • headache
  • upper respiratory tract infection (common cold) including stuffy and runny nose
  • stomach (abdominal) pain
  • diarrhea
  • rash
  • increase in liver enzymes
  • increase in a certain blood enzyme called creatine phosphokinase
  • flu (influenza)
  • inflamed sinuses
  • increase in blood bilirubin

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For further information, please see full Prescribing Information, including Patient Information.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

  • antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
  • seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
  • St. John’s wort
  • antifungal medicines including ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
  • antibiotics including telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)

What should I avoid while taking TRIKAFTA?

  • Avoid food or drink that contains grapefruit while you are taking TRIKAFTA

What are the possible side effects of TRIKAFTA?

TRIKAFTA can cause serious side effects, including:

  • Liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease
  • High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver:
  • before you start TRIKAFTA
  • every 3 months during your first year of taking TRIKAFTA
  • every year while you are taking TRIKAFTA

Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems:

  • pain or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • loss of appetite
  • nausea or vomiting
  • dark, amber-colored urine
  • Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
  • rash or hives
  • tightness of the chest or throat or difficulty breathing
  • swelling of the face, lips, and/or tongue, or difficulty swallowing
  • light-headedness or dizziness
  • Abnormality of the eye lens (cataract), which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts

The most common side effects of TRIKAFTA include:

  • headache
  • upper respiratory tract infection (common cold) including stuffy and runny nose
  • stomach (abdominal) pain
  • diarrhea
  • rash
  • increase in liver enzymes
  • increase in a certain blood enzyme called creatine phosphokinase
  • flu (influenza)
  • inflamed sinuses
  • increase in blood bilirubin

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For further information, please see full Prescribing Information, including Patient Information.