How to Take TRIKAFTA®?

People with CF pictured
may or may not be
taking TRIKAFTA.

TRIKAFTA Packaging
Recommended Dose
How to Give Your Loved One TRIKAFTA Oral Granules
What to Do if a Dose Is Missed
TRIKAFTA Packaging
Recommended Dose
How to Give Your Loved One TRIKAFTA Oral Granules
What to Do If a Dose Is Missed

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

Make sure to give every dose of TRIKAFTA exactly as prescribed by your healthcare provider. 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)

Image of TRIKAFTA tablets for children age 2 through 5 years weighing less than 14 kg (31 lbs)

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

Image of TRIKAFTA tablets for children age 2 through 5 years weighing 14 kg (31 lbs) or more

What Is the Recommended Dose?

Your doctor will prescribe TRIKAFTA based on your loved one's age and weight.

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) (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

Morning Dose

One white and orange packet

(elexacaftor 100 mg/tezacaftor 50 mg/ ivacaftor 75 mg) (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

Your loved one should take each dose with fat-containing food

Always give your loved one food that contains fat just before or just after each dose of TRIKAFTA granules. This helps the body absorb TRIKAFTA better. Get examples of appropriate food to give your loved one. Remember, every child is different, so be sure to talk to your healthcare provider about what foods are best for your loved one when they take TRIKAFTA granules.

Preparing TRIKAFTA Oral Granules

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

Preparing TRIKAFTA Oral Granules

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

Preparing TRIKAFTA Oral Granules

Watch this video to learn how to give Trikafta oral granules to your child.

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

Close Transcript

View Transcript

Preparing TRIKAFTA
Oral Granules

Why it's important to give your loved one fat-containing food before or after each dose

Always give your loved one food that contains fat just before or just after each dose of TRIKAFTA granules. This helps the body absorb TRIKAFTA better.

Fat-containing foods to give your loved one
  • Whole milk
  • Whole-milk yogurt
  • Eggs
  • Whole-milk cheese
  • Butter
  • Peanut butter
  • Nuts
Fat-containing foods
to give your loved one
  • Whole milk
  • Whole-milk yogurt
  • Eggs
  • Whole-milk cheese
  • Butter
  • Peanut butter
  • Nuts

If you have questions about the amount or types of fat-containing food to give with TRIKAFTA, talk to your healthcare provider.

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

How do I prepare TRIKAFTA granules?

  1. Hold the packet with the cut line on top.
  2. Shake the packet gently to settle the TRIKAFTA granules.
  3. Tear or cut the packet open along the cut line.
  4. Carefully pour all of the TRIKAFTA 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.
Foods and liquids you can mix TRIKAFTA granules into
  • Puréed fruits or vegetables
  • Yogurt
  • Applesauce
  • Water
  • Milk
  • Juice
Foods and liquids you can mix
TRIKAFTA granules into
  • Puréed fruits or vegetables
  • Yogurt
  • Applesauce
  • Water
  • Milk
  • Juice
  1. Give TRIKAFTA granules to your loved one within 1 hour of mixing with food or liquid.

    Make sure they take the entire medicine mixture.

Remember, every child is different, so be sure to talk to your healthcare provider about what foods are best for your loved one when they take TRIKAFTA granules.

My Loved One Missed a Dose—What Should I Do?

What to do if a morning dose was missed

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

  • Give your loved one the missed 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 missed 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

What to do if an evening dose was missed

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

  • Give your loved one the missed 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 missed dose
  • Give your loved one the next morning dose at the usual time with fat-containing food

What to do if a morning dose was missed

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

  • Give your loved one the missed 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 missed 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

What to do if an evening dose was missed

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

  • Give your loved one the missed 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 missed 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.

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

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

TRIKAFTA Packaging
Recommended Dose
What to Do if a Dose Is Missed
TRIKAFTA Packaging
Recommended Dose
What to Do if a Dose Is Missed

Make sure to take every dose of TRIKAFTA exactly as prescribed by your healthcare provider. Because the 3 components of TRIKAFTA work together to treat the underlying cause, each and every dose matters.

How Is TRIKAFTA Packaged?

For children age 6 through 11 years
weighing less than 30 kg (~66 lb)

Image of TRIKAFTA tablets for children age 6 through 11 years weighing less than 30 kg (66 lbs)

Not actual size.

  • Each box of TRIKAFTA has 4 weekly blister cards
  • Each blister card contains 21 tablets:
    2 light orange tablets for each morning and 1 light blue tablet for each evening 
Illustration of the TRIKAFTA tablets next to an illustration of a pistachio

Here are illustrations of the TRIKAFTA tablets next to an illustration of a pistachio.

The light orange tablet is approximately 12 mm by 6 mm.

The light blue tablet is approximately 13 mm by 7 mm.

For children age 6 through 11 years
weighing 30 kg (~66 lb) or more

and people age 12 years and older

Image of TRIKAFTA tablets for children age 6 through 11 years weighing 30 kg (66 lbs) or more and people age 12 years and older

Not actual size.

  • Each box of TRIKAFTA has 4 weekly blister cards
  • Each blister card contains 21 tablets:
    2 orange tablets for each morning and 1 light blue tablet for each evening 
Illustration of the TRIKAFTA tablets next to an illustration of a pistachio

Here are illustrations of the TRIKAFTA tablets next to an illustration of a pistachio.

The orange tablet is approximately 16 mm by 8 mm.

The light blue tablet is approximately 17 mm by 8 mm.

What Is the Recommended Dose?

Your doctor will prescribe TRIKAFTA based on your age and weight.

For children age 6 through 11 years weighing less than 30 kg (~66 lb)

Morning Dose

Two light orange tablets

(elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg) with fat-containing food

About 12 hours later

Evening Dose

One light blue tablet

(ivacaftor 75 mg)
with fat-containing food

For children age 6 through 11 years weighing 30 kg (~66 lb) or more

and people age 12 years and older

Morning Dose

Two orange tablets

(elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) with fat-containing food

About 12 hours later

Evening Dose

One light blue tablet

(ivacaftor 150 mg)
with fat-containing food

Each dose must be taken with fat-containing food:

  • Always take TRIKAFTA with a meal or snack that contains fat to help your body absorb the medicine
  • Examples of fat-containing foods include butter, peanut butter, eggs, nuts, meat, and whole-milk dairy products such as whole milk, cheese, and yogurt 

Talk to your healthcare provider about all of the medicines you take, as the dose of TRIKAFTA may need to be adjusted.
It’s important to take TRIKAFTA exactly as your healthcare provider tells you.

Talk to your healthcare provider about all of the medicines you take, as the dose of TRIKAFTA may need to be adjusted.
It’s important to take TRIKAFTA exactly as your healthcare provider tells you.

Talk to your healthcare provider about all of the medicines you take, as the dose of TRIKAFTA may need to be adjusted.

It’s important to take TRIKAFTA exactly as your healthcare provider tells you.

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

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

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

A Dose Was Missed—What Should I Do?

What to do if a morning dose was missed

If it's been 6 hours or LESS since the morning dose is usually taken:

  • Take the missed dose with fat-containing food as soon as possible
  • Then take the next dose at the usual time with fat-containing food

If it's been MORE than 6 hours since the morning dose is usually taken:

  • Take the missed dose with fat-containing food as soon as possible
  • Do not take the evening dose. Resume regular dosing schedule the next day

What to do if an evening dose was missed

If it's been 6 hours or LESS since the evening dose is usually taken:

  • Take the missed dose with fat-containing food as soon as possible
  • Then take the next dose at the usual time with fat-containing food

If it's been MORE than 6 hours since the evening dose is usually taken:

  • Do not take the missed dose
  • Take the next morning dose at the usual time with fat-containing food

What to do if a morning dose was missed

If it's been 6 hours or LESS since the morning dose is usually taken:

  • Take the missed dose with fat-containing food as soon as possible
  • Then take the next dose at the usual time with fat-containing food

If it's been MORE than 6 hours since the morning dose is usually taken:

  • Take the missed dose with fat-containing food as soon as possible
  • Do not take the evening dose. Resume regular dosing schedule the next day

What to do if an evening dose was missed

If it's been 6 hours or LESS since the evening dose is usually taken:

  • Take the missed dose with fat-containing food as soon as possible
  • Then take the next dose at the usual time with fat-containing food

If it's been MORE than 6 hours since the evening dose is usually taken:

  • Do not take the missed dose
  • Take the next morning dose at the usual time with fat-containing food

Do not take more than the usual dose of TRIKAFTA to make up for a missed dose.

Do not take more than the usual dose of TRIKAFTA to make up for a missed dose.

Do not take more than the usual dose of TRIKAFTA to make up for a missed dose.

Take a trip to Trilandia with your loved one for stories, videos, and a game to help them learn about taking TRIKAFTA and sticking with a treatment routine.

Explore Trilandia with your loved one

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.

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

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.

 

What is Trikafta? 

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  

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. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines.

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
  • 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 or 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.
 

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.