Am I Eligible for TRIKAFTA®?

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

TRIKAFTA is for people age 2 years and older with at least one F508del mutation or at least one other mutation in the cystic fibrosis (CF) gene that is responsive to TRIKAFTA. Enter your mutations to see if at least one of them is eligible. You can also use the chart below to determine if you are eligible for TRIKAFTA.

Age:

2 years or older

    Most people with CF have 2 CF mutations, 1 on each copy of the CF gene. However, in rare instances, 1 copy of the CF gene can have more than 1 mutation. This is called a compound, or complex, mutation.

    To enter 2 or more mutations into 1 entry field, separate them with a semicolon, space, comma, or forward slash. For example, if your mutations are R74W/V201M/D1270N and W1282R, use the Mutation 1 field to enter: R74W; V201M; D1270N and the Mutation 2 field to enter: W1282R.

    If you don’t know your or your loved one's CF gene mutations, it’s important to work with your healthcare provider to identify them. Knowing your mutations can help determine if TRIKAFTA could be right for you.

    Based on the information entered, you may be eligible for TRIKAFTA.

    Talk with your healthcare provider to see if TRIKAFTA is right for you.

    Here is some information about TRIKAFTA that may be helpful:

    Neither CF gene mutation you entered is eligible for TRIKAFTA.

    Talk with your healthcare provider to discuss your CF care plan and treatment options that may be right for you.

    You can view the list of eligible mutations here.

    We’re sorry, we do not recognize 1 or both of the mutations you entered.
    Talk with your healthcare provider to discuss your CF care plan and treatment options that may be right for you.
    You can view the list of eligible TRIKAFTA mutations here.

    See Which Mutations TRIKAFTA Is Indicated For

    TRIKAFTA is for the treatment of CF in people age 2 years and older who have at least one copy of the F508del mutation or one of the following CF gene mutations.* If you don't see your mutation in this chart, try using the tool above or talk to your healthcare provider.

    3

    • 3141del9

    5

    • 546insCTA

    A

    • A1067T
    • A455E
    • A46D
    • A349V
    • A1006E
    • A120T
    • A234D
    • A554E

    D

    • D110E
    • D110H
    • D1152H
    • D1270N
    • D579G
    • D443Y
    • D924N
    • D192G
    • D979V
    • D614G
    • D836Y
    • D443Y;G576A;R668C

    E

    • E193K
    • E56K
    • E474K
    • E116K
    • E60K
    • E588V
    • E92K
    • E403D
    • E822K

    F

    • F508del
    • F1052V
    • F1074L
    • F311L
    • F575Y
    • F1099L
    • F508C
    • F311del
    • F191V
    • F1016S
    • F508C;S1251N

    G

    • G1069R
    • G1244E
    • G1349D
    • G178R
    • G551D
    • G551S
    • G85E
    • G1061R
    • G480C
    • G27R
    • G463V
    • G628R
    • G622D
    • G126D
    • G970D
    • G194R
    • G314E
    • G194V
    • G576A
    • G1249R
    • G178E
    • G576A;R668C

    H

    • H139R
    • H1085R
    • H1085P
    • H939R
    • H1375P
    • H1054D
    • H199Y

    I

    • I502T
    • I618T
    • I175V
    • I1366N
    • I601F
    • I980K
    • I1269N
    • I1027T
    • I148T
    • I336K
    • I807M
    • I1139V

    K

    • K1060T

    L

    • L206W
    • L1077P
    • L165S
    • L1335P
    • L967S
    • L320V
    • L346P
    • L1324P
    • L997F
    • L15P
    • L453S
    • L1480P

    M

    • M1101K
    • M265R
    • M152V
    • M952I
    • M952T

    P

    • P67L
    • P5L
    • P205S
    • P574H

    Q

    • Q98R
    • Q1291R
    • Q237E
    • Q237H
    • Q359R

    R

    • R1070Q
    • R1070W
    • R117C
    • R117H
    • R347H
    • R352Q
    • R74W
    • R347P
    • R117G
    • R170H
    • R334L
    • R117L
    • R31L
    • R933G
    • R352W
    • R117P
    • R258G
    • R751L
    • R347L
    • R1283S
    • R1162L
    • R553Q
    • R792G
    • R1066H
    • R668C
    • R334Q
    • R1283M
    • R75Q
    • R74Q
    • R74W;V201M;D1270N
    • R74W;D1270N
    • R74W;V201M

    S

    • S1251N
    • S1255P
    • S549N
    • S549R
    • S945L
    • S977F
    • S13F
    • S1159F
    • S912L
    • S1159P
    • S589N
    • S341P
    • S492F
    • S737F
    • S364P

    T

    • T1053I
    • T1036N
    • T338I

    V

    • V456A
    • V456F
    • V201M
    • V562I
    • V1153E
    • V1240G
    • V1293G
    • V754M
    • V232D

    W

    • W361R
    • W1098C
    • W1282R

    Y

    • Y563N
    • Y161D
    • Y109N
    • Y1014C
    • Y161S
    • Y1032C

    *Predicted to respond to TRIKAFTA based on results in a laboratory setting. Not clinically evaluated.

    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.