Safety and Possible Side Effects | TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)

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

Take a Closer Look at TRIKAFTA® Safety Information

Learn more about potential side effects.

Take a Closer Look at TRIKAFTA® Safety Information

Learn more about potential side effects.

View Important Safety Information and
full Prescribing Information, including Patient Information, for TRIKAFTA.

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ERIC: Hannah.

HANNAH: Eric, what’s up?

ERIC: Just left my CF Center.

HANNAH: How’d it go?

ERIC: My doc and I talked about TRIKAFTA, the triple combination therapy. TRIKAFTA is for people with CF aged 6 or older, who have an F508del mutation or another mutation responsive to TRIKAFTA.

HANNAH: Oh. I have the F508del mutation.

ERIC: I have another mutation that is responsive to TRIKAFTA.

HANNAH: What did your doc say about TRIKAFTA?

ERIC: She walked me through this brochure on the TRIKAFTA site. It’s got a lot of key info.

HANNAH: Any details on safety? What about side effects? I’m thinking of bringing it up with my CF Center.

ERIC: Yeah, it’s got all that and more. Let me send you the link.

VOICE-OVER: TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis, or 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, or 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.

Do not take TRIKAFTA if you take certain medicines such as: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; 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, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including: telithromycin, clarithromycin, or erythromycin; 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.

HANNAH: Okay, got it.

ERIC: My doc also told me about some possible side effects. Some of them could be serious.

VOICE-OVER: 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, and 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.

HANNAH: Hmm. Okay, that makes sense.

VOICE-OVER: Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

ERIC: Oh, and she said some people need eye exams before starting and during treatment with TRIKAFTA. Check with your doc to see if you’d need one.

HANNAH: Hmm. What’s the exam for?

ERIC: Here’s what the brochure says.

VOICE-OVER: TRIKAFTA can cause serious side effects, including:

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

HANNAH: Okay, got it. The brochure only recommends an eye exam for kids and adolescents.

ERIC: Yeah, my doc said the same thing. Then she talked about the most common side effects.

VOICE-OVER: The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or 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 the FDA at 1-800-FDA-1088.

HANNAH: Okay, I finished reading the safety info. Thanks for sharing.

ERIC: That’s all the info I’ve got.

HANNAH: This was super helpful. I’m going to talk to my doc about TRIKAFTA.

ERIC: Let me know how it goes.

HANNAH: Will do. Thanks.

VOICE-OVER: To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com.

Please see the links for Important Safety Information and full Prescribing Information, including Patient Information, below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.

Take a Closer Look at TRIKAFTA® Safety Information

Learn more about potential side effects.

It's important to weigh the potential benefits and risks before starting TRIKAFTA. And remember, each person may have a different experience with TRIKAFTA.

What 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

What Were the Most Common Side Effects Seen With TRIKAFTA?

This information is based on what was reported in a study of people age 12 years and older with one copy of the F508del mutation and another mutation defined in the study.*

Most common side effects experienced in a 24-week study in people taking TRIKAFTA compared with those taking placebo	TRIKAFTA (n=202)	Placebo (n=201)
Headache	17%	15%
Upper respiratory tract infection (common cold)	16%	12%
Stomach (abdominal) pain	14%	9%
Diarrhea	13%	7%
Rash	10%	5%
Increase in a liver enzyme called alanine aminotransferase (ALT)†	10%	3%
Nasal congestion	9%	7%
Increase in a blood enzyme called creatine phosphokinase (CPK)‡	9%	4%
Increase in a liver enzyme called aspartate aminotransferase (AST)†	9%	2%
Runny nose	8%	3%
Stuffy nose	7%	5%
Flu (influenza)	7%	1%
Inflamed sinuses	5%	4%
Increase in blood bilirubin†	5%	1%

The safety of TRIKAFTA observed in children with CF age 6 through 11 years was similar to what was observed in the study of people with CF age 12 years and older.^§

*Mutations that either do not make a CFTR protein or make a protein that tezacaftor and/or ivacaftor cannot act on.
^†Elevated levels of these blood tests could mean there is liver irritation or injury.
^‡This enzyme is measured to help determine if there has been irritation to muscles.
^§These people had one copy of the F508del mutation and another mutation defined in the study.

Your healthcare provider will monitor you for side effects. Be sure to call your healthcare provider if you have any questions.

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.

Kate, age 29

F508del/F508del

Keep Learning About TRIKAFTA

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

See the study results

Check your eligibility

Important Safety Information and Indication

Información Importante de Seguridad e Indicación

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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)?

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.