Christian, age 16
F508del/2307insA

Angel, Christian’s mom

Christian, age 16
F508del/2307insA

Angel, Christian’s mom

Christian, age 16
F508del/2307insA

Angel, Christian’s mom

TRIKAFTA® QUICK ANSWERS

 

 

trikafta® quick answers

Whether you’re just learning about TRIKAFTA or have been taking it for years, below you’ll find the answers to some frequently asked questions about TRIKAFTA.

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    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. It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

    Use the TRIKAFTA mutation eligibility tool to check if TRIKAFTA may be right for you or your loved one.

      It’s important to know the potential side effects of TRIKAFTA before starting it and while taking it. If you have questions about side effects, be sure to discuss them with your healthcare provider. Watch the TRIKAFTA Safety Information Video.

        The 3 components of TRIKAFTA work together to target the underlying cause of CF. Learn about how these 3 components of TRIKAFTA work.

          Studies 1 and 2 were carried out to determine the possible benefits and risks of TRIKAFTA.

          • Study 1 compared TRIKAFTA with placebo. A total of 403 people participated in the study. All people in the study were age 12 or older and had one copy of the F508del mutation and another mutation*. Review Study 1 results
          • In Study 2, TRIKAFTA was compared with SYMDEKO® (tezacaftor/ivacaftor and ivacaftor). A total of 107 people participated in the study. All people in the study were age 12 or older, with two copies of the F508del mutation. Review Study 2 results

          The safety and tolerability of TRIKAFTA were measured in 2 additional clinical studies (Studies 3 and 4).

          • In Study 3, 66 children with CF age 6 through 11 with either one copy of the F508del mutation and another mutation* or two copies of the F508del mutation participated in this 24-week study. Review Study 3 results
          • In Study 4, 75 children with CF age 2 through 5 with either one copy of the F508del mutation and another mutation* or two copies of the F508del mutation participated in this 24-week study. Review Study 4 results

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

          *Mutations that either do not make CFTR protein or make protein that is not responsive to ivacaftor and tezacaftor/ivacaftor.

            The efficacy and safety of TRIKAFTA were evaluated in 2 clinical studies (Studies 1 and 2) in people with CF 12 years of age and older. Review the results from the TRIKAFTA clinical studies.

              It is possible to get pregnant while taking TRIKAFTA. Before taking TRIKAFTA, tell your doctor if you 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. Learn more about TRIKAFTA and pregnancy.

                Hear what other people have shared about their personal experiences taking TRIKAFTA. Visit TRIKAFTA Stories.

                Keep in mind, everyone’s experience with TRIKAFTA is different. Your experience may be different from what is mentioned in these stories.

                Starting TRIKAFTA

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                  Always take TRIKAFTA as prescribed by your healthcare provider.

                    The 3 components of TRIKAFTA work together to target the underlying cause. Watch the full story of how TRIKAFTA works.

                      Always take TRIKAFTA with food that contains fat. This is because these types of foods help the body absorb TRIKAFTA better. There isn’t a recommended amount of fat that needs to be eaten when taking TRIKAFTA. Also, fat-containing foods are not necessarily high-fat foods. Your healthcare provider can help you choose healthy fat-containing foods and snacks. Some examples include:

                      • Eggs
                      • Nuts
                      • Butter
                      • Peanut butter
                      • Whole-milk dairy products, such as whole milk, cheese, and yogurt

                        Check out Trilandia with educational resources to help children age 2 through 11 get started on TRIKAFTA. You’ll find a fun storybook, a musical video, and a game to help your loved one learn about TRIKAFTA and how to stay on track with their treatment routine.

                          When starting TRIKAFTA, it’s important to 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. Tell your doctor if you take any of these medicines.

                            Foods and drinks that contain grapefruit should be avoided while taking TRIKAFTA because they may affect the amount of TRIKAFTA in the body. For more information on why you should avoid grapefruit, talk to your healthcare provider.

                              Jen and Dale share their experience with starting their 5-year-old son, Clayton, on TRIKAFTA. They also talk about how they made TRIKAFTA a part of Clayton’s daily treatment routine. Watch Jen, Dale, and Clayton’s story.

                              Keep in mind, everyone’s experience with TRIKAFTA is different.

                              Staying on track with TRIKAFTA

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                                Every dose of TRIKAFTA matters. You should take it exactly as prescribed by your healthcare provider. The 3 components of TRIKAFTA work together to target the underlying cause. Watch Jen, Dale, and Clayton’s story.

                                  Life gets busy. Schedules change, and disruptions happen. Sometimes interruptions are impossible to avoid. So to help you keep TRIKAFTA as part of your busy routine, check out these tips.

                                    To help you stay on track, try taking your TRIKAFTA dose at the same time each day.

                                      Each dose of TRIKAFTA should be taken about 12 hours apart. If you miss taking TRIKAFTA at your usual time, you have another 6 hours to take your dose.

                                        Brenna and Taylor talk about their journeys with CF, their experiences taking TRIKAFTA, and why it’s important to put their health first when it comes to their day-to-day. Watch Brenna and Taylor share their stories.

                                        You can also check out these tips to help you stay on track.

                                        Keep in mind, everyone’s experience with TRIKAFTA is different.

                                        Keep exploring

                                        Keep exploring

                                        Keep exploring

                                        TRIKAFTA

                                        TRIKAFTA

                                        TRIKAFTA

                                        Watch the TRIKAFTA safety information video Watch how TRIKAFTA works

                                        Xander, age 27
                                        F508del/F508del

                                        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.

                                        What is SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)?

                                        SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO.

                                        Talk to your doctor to learn if you have an indicated CF gene mutation.

                                        It is not known if SYMDEKO is safe and effective in children under 6 years of age.

                                        SYMDEKO IMPORTANT SAFETY INFORMATION

                                        Before taking SYMDEKO, tell your doctor about all of your medical conditions, including if you:

                                        • have or have had liver problems
                                        • are allergic to SYMDEKO or any ingredients in SYMDEKO. See the Patient Information for a list of ingredients
                                        • have kidney problems
                                        • are pregnant or plan to become pregnant. It is not known if SYMDEKO will harm your unborn baby. You and your doctor should decide if you will take SYMDEKO while you are pregnant
                                        • are breastfeeding or planning to breastfeed. It is not known if SYMDEKO passes into your breast milk. You and your doctor should decide if you will take SYMDEKO while you are breastfeeding

                                        Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

                                        SYMDEKO may affect the way other medicines work and other medicines may affect how SYMDEKO works. The dose of SYMDEKO 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 such as ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
                                        • antibiotics such as telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)

                                        What should I avoid while taking SYMDEKO?

                                        • SYMDEKO can cause dizziness in some people who take it. If you experience dizziness, do not drive or operate machines until symptoms improve.
                                        • Avoid food or drink that contains grapefruit while you are taking SYMDEKO

                                        What are the possible side effects of SYMDEKO?

                                        SYMDEKO can cause serious side effects, including:

                                        • High liver enzymes in the blood have been reported in people treated with SYMDEKO or treated with ivacaftor alone. Your doctor will do blood tests to check your liver:

                                         

                                        • before you start SYMDEKO
                                        • every 3 months during your first year of taking SYMDEKO
                                        • every year while you are taking SYMDEKO

                                        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 SYMDEKO. Call your doctor 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
                                        • light-headedness or dizziness

                                         

                                        • Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with SYMDEKO or with ivacaftor alone. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with SYMDEKO to look for cataracts

                                        The most common side effects of SYMDEKO include headache, nausea, sinus congestion, and dizziness.

                                        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 SYMDEKO. 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.

                                        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.

                                        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.