Take a Closer Look at TRIKAFTA® Safety Information
Learn more about potential side effects.
Please see Important Safety Information and full Prescribing Information, including Medication Guide with Important Warning.
Please see Important Safety Information and full Prescribing Information, including Medication Guide with Important Warning.
Please see Important Safety Information and full Prescribing Information, including Medication Guide with Important Warning.
It's important to weigh the potential benefits and risks before
starting TRIKAFTA. And remember, each person may have a
different experience with TRIKAFTA.
It's important to weigh the potential benefits and risks before
starting TRIKAFTA. And remember, each person may have a
different experience with TRIKAFTA.
It's important to weigh the potential
benefits and risks before starting
TRIKAFTA. And remember, each
person may have a different
experience with TRIKAFTA.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW
ABOUT TRIKAFTA?
ABOUT TRIKAFTA?
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)
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)
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)
WHAT ARE THE POSSIBLE OR REASONABLY LIKELY
WHAT ARE THE POSSIBLE OR REASONABLY LIKELY
WHAT ARE THE POSSIBLE OR REASONABLY LIKELY
SIDE EFFECTS OF TRIKAFTA?
SIDE EFFECTS OF TRIKAFTA?
SIDE EFFECTS OF TRIKAFTA?
TRIKAFTA can cause serious side effects, including:
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
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
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
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
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
What were the most common side effects seen with TRIKAFTA?
This information is based on what was reported in a study (Study 1) of people age 12 years and older with one copy of the F508del mutation and another mutation defined in the study.*
| Most common side effects experienced in a 24-week study in people taking TRIKAFTA compared with those taking placebo | TRIKAFTA (n=202) | Placebo (n=201) |
|---|---|---|
| Headache | 17% | 15% |
| Upper respiratory tract infection (common cold) | 16% | 12% |
| Stomach (abdominal) pain | 14% | 9% |
| Diarrhea | 13% | 7% |
| Rash | 10% | 5% |
| Increase in a liver enzyme called alanine aminotransferase (ALT)† | 10% | 3% |
| Nasal congestion | 9% | 7% |
| Increase in a blood enzyme called creatine phosphokinase (CPK)‡ | 9% | 4% |
| Increase in a liver enzyme called aspartate aminotransferase (AST)† | 9% | 2% |
| Runny nose | 8% | 3% |
| Stuffy nose | 7% | 5% |
| Flu (influenza) | 7% | 1% |
| Inflamed sinuses | 5% | 4% |
| Increase in blood bilirubin† | 5% | 1% |
The safety of TRIKAFTA observed in children with cystic fibrosis (CF) age 2
through 11 years (Studies 3 and 4), with at least one copy of the F508del mutation, was similar to what was observed in the study of people with CF age 12 years and older (Study 1).§
The safety of TRIKAFTA observed in children with cystic fibrosis (CF) age 2 through 11 years (Studies 3 and 4), with at least one copy of the F508del mutation, was similar to what was observed in the study of people with CF age 12 years and older (Study 1).§
The safety of TRIKAFTA observed in children with cystic fibrosis (CF) age 2 through 11 years (Studies 3 and 4), with at least one copy of the F508del mutation, was similar to what was observed in the study of people with CF age 12 years and older (Study 1).§
The side effects listed here were experienced by at least 5% of patients taking TRIKAFTA. Additionally, they occurred at least 1% more in those taking TRIKAFTA compared to those taking placebo.
Your healthcare provider will monitor you for side effects.
Be sure to call your healthcare provider if you have any questions.
Your healthcare provider will monitor you for side effects.
Be sure to call your healthcare provider if you have any questions.
Your healthcare provider will monitor
you for side effects. Be sure to call
your healthcare provider if you have
any questions.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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.
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.
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.
Additional Safety Considerations
Additional Safety Considerations
Additional Safety Considerations
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
have or have had liver problems
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
are allergic to TRIKAFTA or any ingredients in TRIKAFTA.
See the end of the Medication Guide for a complete list of ingredients in TRIKAFTA
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 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 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
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
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
Are there any other medicines that may interact with TRIKAFTA?
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:
Especially tell your healthcare provider if you take:
Especially tell your healthcare provider if you take:
Antibiotics such as
Seizure medicines such as
Herbal supplements
Antifungal medicines including
Antibiotics including
rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
St. John’s wort
ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
Antibiotics such as
rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
Seizure medicines such as
phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
Herbal supplements
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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
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?
What should I avoid while taking TRIKAFTA?
What should I avoid while taking TRIKAFTA?
Avoid food or drink that contains grapefruit while you are taking TRIKAFTA
Avoid food or drink that contains grapefruit while you are taking TRIKAFTA
Avoid food or drink that contains grapefruit while you are taking TRIKAFTA
April, age 28
F508del/1154insTC
April, age 28
F508del/1154insTC
April, age 28
F508del/1154insTC
Keep Learning
About TRIKAFTA
About TRIKAFTA
About TRIKAFTA
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
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