More than

19,850 people age
6 years and older

have been prescribed TRIKAFTA®.*

More than

19,850 people age
6 years and older

have been prescribed TRIKAFTA®.*

More than

19,850 people age
6 years and older

have been prescribed TRIKAFTA®.*

*Based on prescriptions shipped from specialty pharmacies in the US as of November 22, 2022. Data does not include patients’ CF gene mutations and does not reflect patients who have stopped treatments.

More than

19,850 people age
6 years and older

have been prescribed TRIKAFTA®.*

More than

19,850 people age
6 years and older

have been prescribed TRIKAFTA®.*

More than

19,850 people age
6 years and older

have been prescribed TRIKAFTA®.*

*Based on prescriptions shipped from specialty pharmacies in the US as of November 22, 2022. Data does not include patients’ CF gene mutations and does not reflect patients who have stopped treatments.

Image of Olivia, a TRIKAFTA patient

Olivia, age 26
F508del/F508del

On TRIKAFTA since 2019

The most meaningful
part of my journey with TRIKAFTA so far has been seeing how my friends and family react to my progress.

The most meaningful
part of my journey with TRIKAFTA so far has been seeing how my friends and family react to my progress.

The most meaningful
part of my journey with TRIKAFTA so far has been seeing how my friends and family react to my progress.

Olivia,
on TRIKAFTA since 2019

Age 26,
F508del/F508del

Image of Jason, a TRIKAFTA patient

Jason, age 41
F508del/N1303K

On TRIKAFTA since 2019

Staying on track with TRIKAFTA is what helps me continue to move forward.

Jason,
on TRIKAFTA since 2019

Age 41,
F508del/N1303K

Image of Taylor, a TRIKAFTA patient

Taylor, age 28
F508del/F508del

On TRIKAFTA since 2019

With TRIKAFTA, I
still have CF, of course. But now I am so much more than that. CF doesn't have to define me.

Taylor,
on TRIKAFTA since 2019

Age 28,
F508del/F508del

Image of Brenna, a TRIKAFTA patient

Brenna, age 22
F508del/F508del

On TRIKAFTA since 2019

To finally see and

feel these results with TRIKAFTA has been what I hoped for.

Brenna,
on TRIKAFTA since 2019

Age 22,
F508del/F508del

Image of Massimo, a TRIKAFTA patient

Massimo, age 6
F508del/L1077P

On TRIKAFTA since 2021

He's living his life with CF on his terms, that's for sure. And he won't let CF hold him back.

 

Massimo's mom, Stacey

Image of Candi, a TRIKAFTA patient

Candi, age 35
F508del/F508del

On TRIKAFTA since 2020

I now have a different perspective on my life with CF.

 

Candi,
on TRIKAFTA since 2020

Age 35
F508del/F508del

People with CF pictured were taking TRIKAFTA as of 6/15/2022.
They may or may not be taking TRIKAFTA today.

Cystic fibrosis (CF) will always be part of the equation, but you know there’s more to who you are.
Ask your doctor about making TRIKAFTA part of the equation—a triple combination therapy that treats the underlying cause.


TRIKAFTA is a breakthrough treatment for people with CF age 6 years and older with at least one copy 
of the F508del mutation or at least one other responsive mutation.

Check Your Eligibility

TRIKAFTA is for people age 6 years and older with at least one F508del mutation or at least one other mutation in the CF gene that is responsive to TRIKAFTA. Enter your mutations to see if at least one of them is eligible.

Age:

6 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 child'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.

    You can view the list of eligible mutations here.

    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.

    Brenna Taylor Thumbnail
    Navigating Life Transitions and Moving Forward

    Brenna and Taylor share what their TRIKAFTA experience has meant to them, advice for others who may be considering it, and what they're looking forward to.

    Watch their stories
    View the TRIKAFTA Brochure, updated to include information for caregivers of children with CF age 6 through 11
    The TRIKAFTA Brochure

    Get answers to common questions, such as:

    • How does TRIKAFTA work?
    • What are the study details and results?
    • What are the possible side effects?
    View the brochure
    Vertex GPS™ Guidance & Patient Support logo

    Personalized support—for whatever is up next

    Vertex GPSTM offers eligible patients personalized, one-on-one support from day 1. Your dedicated Support Specialist has the tools, experience, and expertise to help your loved one reach their treatment goals. They'll walk you through each step and help you navigate things like insurance coverage and financial assistance options.

    But that's just the start. Your Support Specialist will stay in touch so they can meet your loved one's needs, whatever stage they are at.

    Discover more about GPS

    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 6 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 6 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 6 years of age.

    Important Safety Information  

    Do not take TRIKAFTA if you take certain medicines such as:

    • 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

    Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

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

    TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 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 6 years of age.

    Important Safety Information

    Do not take TRIKAFTA if you take certain medicines such as:

    • 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

    Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

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

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

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

     

    ¿Qué es TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor e ivacaftor)?TRIKAFTA es un medicamento recetado que se usa para el tratamiento de la fibrosis quística (FQ) en pacientes de 6 años o más que presentan al menos una copia de la mutación F508del en el gen regulador de la conductancia transmembrana de la fibrosis quística (cystic fibrosis transmembrane conductance regulator, CFTR) u otra mutación que responda al tratamiento con TRIKAFTA.

    ¿Qué es TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor e ivacaftor)?

    TRIKAFTA es un medicamento recetado que se usa para el tratamiento de la fibrosis quística (FQ) en pacientes de 6 años o más que presentan al menos una copia de la mutación F508del en el gen regulador de la conductancia transmembrana de la fibrosis quística (cystic fibrosis transmembrane conductance regulator, CFTR) u otra mutación que responda al tratamiento con TRIKAFTA.

    Hable con su médico para saber si usted presenta una mutación del gen de la FQ indicada.

    Se desconoce si TRIKAFTA es seguro y eficaz en niños menores de 6 años.

    Información Importante de Seguridad  

    No tome TRIKAFTA si está tomando ciertos medicamentos, por ejemplo:

    • antibióticos como rifampicina (RIFAMATE®, RIFATER®) o rifabutina (MYCOBUTIN®)
    • medicamentos para las convulsiones como fenobarbital, carbamazepina (TEGRETOL®, CARBATROL®, EQUETRO®), o fenitoína (DILANTIN®, PHENYTEK®)
    • hierba de San Juan

    Hable con su médico antes de tomar TRIKAFTA si toma algunos de los medicamentos o suplementos a base de hierbas que se mencionan antes.

    ¿Qué es TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor e ivacaftor)?

    TRIKAFTA es un medicamento recetado que se usa para el tratamiento de la fibrosis quística (FQ) en pacientes de 6 años o más que presentan al menos una copia de la mutación F508del en el gen regulador de la conductancia transmembrana de la fibrosis quística (cystic fibrosis transmembrane conductance regulator, CFTR) u otra mutación que responda al tratamiento con TRIKAFTA.

    Hable con su médico para saber si usted presenta una mutación del gen de la FQ indicada.

    Se desconoce si TRIKAFTA es seguro y eficaz en niños menores de 6 años.

    Información Importante de Seguridad

    No tome TRIKAFTA si está tomando ciertos medicamentos, por ejemplo:

    • antibióticos como rifampicina (RIFAMATE®, RIFATER®) o rifabutina (MYCOBUTIN®)
    • medicamentos para las convulsiones como fenobarbital, carbamazepina (TEGRETOL®, CARBATROL®, EQUETRO®), o fenitoína (DILANTIN®, PHENYTEK®)
    • hierba de San Juan

    Hable con su médico antes de tomar TRIKAFTA si toma algunos de los medicamentos o suplementos a base de hierbas que se mencionan antes.

    Antes de tomar TRIKAFTA, infórmele al médico sobre todas sus afecciones médicas, incluido lo siguiente:

    • Si tiene problemas renales
    • Si tiene o ha tenido problemas hepáticos
    • Si está embarazada o planea quedar embarazada. Se desconoce si TRIKAFTA dañará a su bebé nonato. Usted y su médico deben decidir si tomará TRIKAFTA durante el embarazo
    • Si está amamantando o planea amamantar. Se desconoce si TRIKAFTA pasa a la leche materna. Usted y su médico deben decidir si tomará TRIKAFTA mientras amamanta

    TRIKAFTA puede afectar el modo en que funcionan otros medicamentos, y otros medicamentos pueden afectar la forma en que funciona TRIKAFTA.

    Infórmele al médico sobre todos los medicamentos que toma, incluidos los medicamentos recetados y de venta libre, las vitaminas y los suplementos a base de hierbas. Es posible que la dosis de TRIKAFTA se deba ajustar cuando se toma con ciertos medicamentos.

    Pídale a su médico o farmacéutico una lista de estos medicamentos si no está seguro. Asegúrese de que la lista incluya medicamentos de todas las farmacias si tiene más de una.

    En especial, debe informarle al médico si toma:

    • medicamentos antifúngicos, que incluyen ketoconazol (como NIZORAL®), itraconazol (como SPORANOX®), posaconazol (como NOXAFIL®), voriconazol (como VFEND®) o fluconazol (como DIFLUCAN®)
    • antibióticos, que incluyen telitromicina (como KETEK®), claritromicina (como BIAXIN®) o eritromicina (como ERY-TAB®)
    • otros medicamentos, que incluyen rifampicina, rifabutina, fenobarbital, carbamazepina, fenitoína y hierba de San Juan

    Conozca los medicamentos que toma. Lleve una lista de sus medicamentos para mostrársela a su médico y al farmacéutico cuando obtenga un medicamento nuevo.

    ¿Qué debo evitar mientras tomo TRIKAFTA?

    • TRIKAFTA puede provocar mareos en algunas personas que lo toman. No conduzca automóviles, no utilice maquinaria ni realice ninguna actividad que requiera que esté alerta hasta saber de qué forma lo afecta TRIKAFTA
    • Evite los alimentos y las bebidas que contengan toronja (pomelo) mientras toma TRIKAFTA

    ¿Cuáles son los posibles efectos secundarios de TRIKAFTA?

    TRIKAFTA puede provocar efectos secundarios graves, incluidos los siguientes:

    • Daño hepático y deterioro de la función hepática en personas con enfermedades graves del hígado que podrían volverse serias y requerir trasplante. También hubo casos de daño hepático en personas sin antecedentes de enfermedades del hígado.
    • Los aumentos de las enzimas hepáticas en la sangre son un efecto secundario frecuente en personas tratadas con TRIKAFTA. Estos pueden ser graves y pueden ser un signo de daño hepático. El médico le realizará análisis de sangre para controlar el hígado:
    • antes de comenzar a tomar TRIKAFTA
    • cada 3 meses durante el primer año de tomar TRIKAFTA
    • cada año mientras está tomando TRIKAFTA

    Es posible que el médico le realice análisis de sangre para controlar el hígado con mayor frecuencia si ha presentado aumentos de las enzimas hepáticas en la sangre en el pasado.

    Llame al médico inmediatamente si presenta algunos de los siguientes síntomas de problemas hepáticos:

    • dolor o malestar en el área (abdominal) superior derecha del estómago
    • color amarillo en la piel o en la parte blanca de los ojos
    • pérdida del apetito
    • náuseas o vómitos
    • orina oscura y de color ámbar
    • Anomalías en el cristalino del ojo (catarata) han ocurrido en algunos niños y adolescentes que recibieron tratamiento con TRIKAFTA. Si es niño o adolescente, su médico debe realizar exámenes oculares antes del tratamiento con TRIKAFTA, y durante este, para ver si tiene cataratas

    Los efectos secundarios más frecuentes de TRIKAFTA incluyen:

    • dolor de cabeza
    • infección de las vías respiratorias superiores (resfrío común), incluidas congestión y secreción nasal
    • dolor de estómago (abdominal)
    • diarrea
    • erupción
    • aumento en las enzimas hepáticas
    • aumento en una enzima de la sangre llamada creatina fosfocinasa
    • gripe (influenza)
    • inflamación de los senos paranasales
    • aumento de la bilirrubina en sangre

    Estos no son todos los posibles efectos secundarios de TRIKAFTA. Llame al médico para obtener asesoramiento médico acerca de los efectos secundarios. Le recomendamos informar los efectos secundarios a la Administración de Alimentos y Medicamentos (Food and Drug Administration, FDA) al teléfono 1-800-FDA-1088.

    Para obtener información adicional consulte la Información de Prescripción completa, incluida la Información para el Paciente.

     

     

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

    TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 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 6 years of age.

    Important Safety Information

    Do not take TRIKAFTA if you take certain medicines such as:

    • 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

    Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

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

     

    Antes de tomar TRIKAFTA, infórmele al médico sobre todas sus afecciones médicas, incluido lo siguiente:

    • Si tiene problemas renales
    • Si tiene o ha tenido problemas hepáticos
    • Si está embarazada o planea quedar embarazada. Se desconoce si TRIKAFTA dañará a su bebé nonato. Usted y su médico deben decidir si tomará TRIKAFTA durante el embarazo
    • Si está amamantando o planea amamantar. Se desconoce si TRIKAFTA pasa a la leche materna. Usted y su médico deben decidir si tomará TRIKAFTA mientras amamanta

    TRIKAFTA puede afectar el modo en que funcionan otros medicamentos, y otros medicamentos pueden afectar la forma en que funciona TRIKAFTA.

    Infórmele al médico sobre todos los medicamentos que toma, incluidos los medicamentos recetados y de venta libre, las vitaminas y los suplementos a base de hierbas. Es posible que la dosis de TRIKAFTA se deba ajustar cuando se toma con ciertos medicamentos.

    Pídale a su médico o farmacéutico una lista de estos medicamentos si no está seguro. Asegúrese de que la lista incluya medicamentos de todas las farmacias si tiene más de una.

    En especial, debe informarle al médico si toma:

    • medicamentos antifúngicos, que incluyen ketoconazol (como NIZORAL®), itraconazol (como SPORANOX®), posaconazol (como NOXAFIL®), voriconazol (como VFEND®) o fluconazol (como DIFLUCAN®)
    • antibióticos, que incluyen telitromicina (como KETEK®), claritromicina (como BIAXIN®) o eritromicina (como ERY-TAB®)
    • otros medicamentos, que incluyen rifampicina, rifabutina, fenobarbital, carbamazepina, fenitoína y hierba de San Juan

    Conozca los medicamentos que toma. Lleve una lista de sus medicamentos para mostrársela a su médico y al farmacéutico cuando obtenga un medicamento nuevo.

    ¿Qué debo evitar mientras tomo TRIKAFTA?

    • TRIKAFTA puede provocar mareos en algunas personas que lo toman. No conduzca automóviles, no utilice maquinaria ni realice ninguna actividad que requiera que esté alerta hasta saber de qué forma lo afecta TRIKAFTA
    • Evite los alimentos y las bebidas que contengan toronja (pomelo) mientras toma TRIKAFTA

    ¿Cuáles son los posibles efectos secundarios de TRIKAFTA?

    TRIKAFTA puede provocar efectos secundarios graves, incluidos los siguientes:

    • Daño hepático y deterioro de la función hepática en personas con enfermedades graves del hígado que podrían volverse serias y requerir trasplante. También hubo casos de daño hepático en personas sin antecedentes de enfermedades del hígado.
    • Los aumentos de las enzimas hepáticas en la sangre son un efecto secundario frecuente en personas tratadas con TRIKAFTA. Estos pueden ser graves y pueden ser un signo de daño hepático. El médico le realizará análisis de sangre para controlar el hígado:
    • antes de comenzar a tomar TRIKAFTA
    • cada 3 meses durante el primer año de tomar TRIKAFTA
    • cada año mientras está tomando TRIKAFTA

    Es posible que el médico le realice análisis de sangre para controlar el hígado con mayor frecuencia si ha presentado aumentos de las enzimas hepáticas en la sangre en el pasado.

    Llame al médico inmediatamente si presenta algunos de los siguientes síntomas de problemas hepáticos:

    • dolor o malestar en el área (abdominal) superior derecha del estómago
    • color amarillo en la piel o en la parte blanca de los ojos
    • pérdida del apetito
    • náuseas o vómitos
    • orina oscura y de color ámbar
    • Anomalías en el cristalino del ojo (catarata) han ocurrido en algunos niños y adolescentes que recibieron tratamiento con TRIKAFTA. Si es niño o adolescente, su médico debe realizar exámenes oculares antes del tratamiento con TRIKAFTA, y durante este, para ver si tiene cataratas

    Los efectos secundarios más frecuentes de TRIKAFTA incluyen:

    • dolor de cabeza
    • infección de las vías respiratorias superiores (resfrío común), incluidas congestión y secreción nasal
    • dolor de estómago (abdominal)
    • diarrea
    • erupción
    • aumento en las enzimas hepáticas
    • aumento en una enzima de la sangre llamada creatina fosfocinasa
    • gripe (influenza)
    • inflamación de los senos paranasales
    • aumento de la bilirrubina en sangre

    Estos no son todos los posibles efectos secundarios de TRIKAFTA. Llame al médico para obtener asesoramiento médico acerca de los efectos secundarios. Le recomendamos informar los efectos secundarios a la Administración de Alimentos y Medicamentos (Food and Drug Administration, FDA) al teléfono 1-800-FDA-1088.

    Para obtener información adicional consulte la Información de Prescripción completa, incluida la Información para el Paciente.

     

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

    TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 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 6 years of age.

    Important Safety Information  

    Do not take TRIKAFTA if you take certain medicines such as:

    • 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

    Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to 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 6 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 6 years of age.

    Important safety information  

    Important Safety Information

    Do not take TRIKAFTA if you take certain medicines such as:

    • 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

    Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

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

    Do not take TRIKAFTA if you take certain medicines such as:

    • 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

    Talk to your doctor before taking TRIKAFTA if you take any of the medicines or herbal supplements listed above.

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

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

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

    • 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

    TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works.

    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.

    Ask your doctor or pharmacist for a list of these medicines if you are not sure. Make sure the list includes medicines from all your pharmacies, if you have more than one. 

    Especially tell your doctor if you take:

    • antifungal medicines including ketoconazole (such as NIZORAL®), itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
    • antibiotics including telithromycin (such as KETEK®), clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
    • other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John’s wort

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

    What should I avoid while taking TRIKAFTA?

    • TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you
    • 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 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
    • Abnormality of the eye lens (cataract) 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

    These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

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