TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

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.

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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.

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Recursos
en Español

Recursos en Español

Important Safety Information and Indication

Información Importante de Seguridad e Indicación

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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-10881-800-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.

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.

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

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

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.

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.

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