While you work on your next move, TRIKAFTA® works on the underlying cause.

Christian, age 16 F508del/2307insA

How TRIKAFTA works
Who TRIKAFTA is for
Safety and side effects
Staying on track with TRIKAFTA
Fat-containing foods

People with CF pictured have taken TRIKAFTA and were compensated for their participation.

People with CF pictured have taken TRIKAFTA and were compensated for their participation.

People with CF pictured have taken TRIKAFTA and were compensated for their participation.

EVERY DOSE MATTERS

It’s important to take TRIKAFTA as prescribed. The 3 components of TRIKAFTA work together to target the underlying cause.

See how TRIKAFTA works

Illustrations are artistic representations.

MOVING FORWARD

ON TRIKAFTA

“I still have cystic fibrosis (CF), of course. But with TRIKAFTA, I am so much more than that.”

–Taylor, age 28
F508del/F508del

Watch their stories

FOR KIDS:

TREATMENT TIME IN TRILANDIA

Check out Trilandia educational resources to help your loved one learn about TRIKAFTA and how to stay on track.

Check out Trilandia educational resources to help your loved one learn about TRIKAFTA and how to stay on track.

Explore Trilandia

ENCUENTRE

INFORMACIÓN Y RECURSOS

Visite TRIKAFTA en español

Arturo, 20 años
F508del y (TG)12-5T/(TG)10-9 T

GET THE TRIKAFTA

BROCHURE

Find out how TRIKAFTA works, review study details and results, and learn about possible side effects.

Download it now
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Recursos 
en Español

Recursos 
en Español

Recursos en Español

Important Safety Information, including Important Warning, and Indication

Información Importante de Seguridad e Indicación

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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 people 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 healthcare provider 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

What is the most important information I should know about TRIKAFTA?

TRIKAFTA can cause serious liver damage and liver failure. Liver failure leading to transplantation and death has been seen in some people with or without a history of liver problems taking TRIKAFTA.

Your healthcare provider will do blood tests to check your liver:

  • before you start TRIKAFTA
  • then every month during your first 6 months of taking TRIKAFTA 
  • then every 3 months during the next 12 months of taking TRIKAFTA 
  • then at least every year while you are taking TRIKAFTA

 

Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury.

Stop taking TRIKAFTA and call your healthcare provider right away if you have any of the following symptoms of liver problems:

  • pain, swelling, or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • mental changes
  • nausea or vomiting
  • dark, amber-colored urine
  • loss of appetite
  • fluid in your stomach area (ascites)
  • pain, swelling, or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • mental changes
  • nausea or vomiting
  • dark, amber-colored urine
  • loss of appetite
  • fluid in your stomach area (ascites)

What should I tell my healthcare provider before taking TRIKAFTA?

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

  • have or have had liver problems
  • are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the end of the Medication Guide for a complete list of ingredients in TRIKAFTA
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your healthcare provider 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 healthcare provider should decide if you will take TRIKAFTA while you are breastfeeding

Tell your healthcare provider 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 healthcare provider or pharmacist for a list of these medicines if you are not sure.

Especially tell your healthcare provider 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®)

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking TRIKAFTA?

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

What are the possible or reasonably likely side effects of TRIKAFTA?

TRIKAFTA can cause serious side effects, including:

  • See “What is the most important information I should know about TRIKAFTA?”
  • Serious Allergic Reactions can happen 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) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your healthcare provider 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
  • constipation 

Tell your healthcare provider 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 healthcare provider 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 Medication Guide with Important Warning.

 

Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury.

Stop taking TRIKAFTA and call your healthcare provider right away if you have any of the following symptoms of liver problems:

  • pain, swelling, or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • mental changes
  • nausea or vomiting
  • dark, amber-colored urine
  • loss of appetite
  • fluid in your stomach area (ascites)
  • pain, swelling, or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • mental changes
  • nausea or vomiting
  • dark, amber-colored urine
  • loss of appetite
  • fluid in your stomach area (ascites)

What should I tell my healthcare provider before taking TRIKAFTA?

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

  • have or have had liver problems
  • are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the end of the Medication Guide for a complete list of ingredients in TRIKAFTA
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your healthcare provider 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 healthcare provider should decide if you will take TRIKAFTA while you are breastfeeding

Tell your healthcare provider 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 healthcare provider or pharmacist for a list of these medicines if you are not sure.

Especially tell your healthcare provider 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®)

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking TRIKAFTA?

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

What are the possible or reasonably likely side effects of TRIKAFTA?

TRIKAFTA can cause serious side effects, including:

  • See “What is the most important information I should know about TRIKAFTA?”
  • Serious Allergic Reactions can happen 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) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your healthcare provider 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
  • constipation 

Tell your healthcare provider 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 healthcare provider 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 Medication Guide with Important Warning.

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

TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in people 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 healthcare provider 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

What is the most important information I should know about TRIKAFTA?

TRIKAFTA can cause serious liver damage and liver failure. Liver failure leading to transplantation and death has been seen in some people with or without a history of liver problems taking TRIKAFTA.

Your healthcare provider will do blood tests to check your liver:

  • before you start TRIKAFTA
  • then every month during your first 6 months of taking TRIKAFTA 
  • then every 3 months during the next 12 months of taking TRIKAFTA 
  • then at least every year while you are taking TRIKAFTA

 

Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury.

Stop taking TRIKAFTA and call your healthcare provider right away if you have any of the following symptoms of liver problems:

  • pain, swelling, or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • mental changes
  • nausea or vomiting
  • dark, amber-colored urine
  • loss of appetite
  • fluid in your stomach area (ascites)
  • pain, swelling, or discomfort in the upper right stomach (abdominal) area
  • yellowing of your skin or the white part of your eyes
  • mental changes
  • nausea or vomiting
  • dark, amber-colored urine
  • loss of appetite
  • fluid in your stomach area (ascites)

What should I tell my healthcare provider before taking TRIKAFTA?

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

  • have or have had liver problems
  • are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the end of the Medication Guide for a complete list of ingredients in TRIKAFTA
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your healthcare provider 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 healthcare provider should decide if you will take TRIKAFTA while you are breastfeeding

Tell your healthcare provider 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 healthcare provider or pharmacist for a list of these medicines if you are not sure.

Especially tell your healthcare provider 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®)

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while taking TRIKAFTA?

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

What are the possible or reasonably likely side effects of TRIKAFTA?

TRIKAFTA can cause serious side effects, including:

  • See “What is the most important information I should know about TRIKAFTA?”
  • Serious Allergic Reactions can happen 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) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your healthcare provider 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
  • constipation 

Tell your healthcare provider 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 healthcare provider 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 Medication Guide with Important Warning.