Get answers to common questions and download tools to help you decide with your doctor if ALYFTREKTM is right for you.
ALYFTREK is the first-ever once-daily* CFTR modulator (see “What is ALYFTREK?”)
*Taken with fat-containing food.
- 2 of the 3 components of ALYFTREK are unique compared to those in other CFTR modulators
- ALYFTREK is approved for 31 more mutations than TRIKAFTA
See Indication and Important Safety Information, including Important Warning for TRIKAFTA.
ALYFTREK is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Talk to your healthcare provider to learn if you have an indicated CF gene mutation.
The CFTR gene tells the cells in your body how to make CFTR proteins. If there’s a disease-causing mutation in the CFTR gene, the cells may not be able to make CFTR proteins at all, or the proteins they make may not work the way they should.
The 3 components of ALYFTREK work together to help improve CFTR function by targeting defects in CFTR proteins.
Yes, if you’re eligible for ALYFTREK, you may be able to transition from another CFTR modulator. Talk to your healthcare provider to see if it could be right for you. You can find more tips and resources on transitioning treatments below.
ALYFTREK was evaluated in 3 separate clinical trials, including over 1,000 people with CF. 971 people age 12 years and older participated across 2 studies comparing ALYFTREK to TRIKAFTA. 78 children age 6-11 years participated in a study evaluating the safety and tolerability of ALYFTREK.
In 2 studies for people age 12 years and older, the change in lung function seen with ALYFTREK was similar to (not worse than) the change in lung function seen with TRIKAFTA through 24 weeks.
ALYFTREK reduced sweat chloride levels further than TRIKAFTA through 24 weeks. Compared with people taking TRIKAFTA, people taking ALYFTREK saw a reduction in sweat chloride of 8.4 mmol/L on average in one study, and 2.8 mmol/L on average in the other study.
The clinical importance of these differences in sweat chloride has not been shown in clinical trials.
The study results of ALYFTREK are an average of all people studied and differed among individuals. Your experience may be different.
The safety profile of ALYFTREK was evaluated in 3 studies that included over 1,000 people with CF. In people age 12 years and older, the most common side effects included cough, pain or swelling of the nose or throat, upper respiratory tract infection, headache, mouth or throat pain, the flu, tiredness, increase in liver enzymes, rash, and sinus congestion.
The purpose of this study was to look at the safety and tolerability of ALYFTREK in children with CF age 6-11 years.
Safety results were generally similar to what was observed in the studies for people age 12 years and older.
FEV1 is forced expiratory volume, which is how much air a person can exhale in a forced breath in 1 second. It is a way to measure lung function. Lung function refers to how well your lungs work to help you breathe. It's one way of seeing how CF has progressed in the body.
People with CF have higher levels of chloride (a part of salt) in their sweat. A lack of CFTR function causes an imbalance of salt and water, which makes more chloride show up in their sweat.
Sweat chloride is a measure of how much salt is in a person's sweat. Sweat chloride was measured in the ALYFTREK studies because sweat chloride levels may indicate how the CFTR protein is functioning.
The clinical importance of sweat chloride has not been shown in clinical trials.
ALYFTREK is the first-ever CFTR modulator that you take once a day. Your healthcare provider will prescribe either 2 pills or 3 pills of ALYFTREK based on age and weight. You should take this dose at about the same time each day with fat-containing food. You and your healthcare provider should decide the best time to take ALYFTREK.
If it’s within 6 hours of when you usually take your daily dose of ALYFTREK, take the late dose as prescribed with fat-containing food as soon as possible.
If more than 6 hours have passed since you originally planned to take ALYFTREK, skip that dose only. Take the next dose with fat-containing food when you usually take it the following day.
Yes. Following a recommended testing plan can help you and your care team check your liver function throughout the course of treatment. Liver function can be measured through blood tests.
When you start a triple combination CFTR therapy like ALYFTREK, you’ll have one blood test before you begin treatment, a test every month during the first 6 months, a test every 3 months during the next 12 months, and then a test at least once a year after that so your healthcare provider can continue to monitor your liver function.
Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury.
You can get a blood test during your regular CF center visit or at your healthcare provider’s office. You may also be able to get tested at a local lab or at home (if you qualify for visits from a home care company).
Talk to your CF care team about finding the right option for you.
When you start a triple combination therapy, your healthcare provider will carefully check your liver function using a recommended testing plan. They’ll consider a number of factors, including if you’ve had liver problems or high levels of liver enzymes before.
ALYFTREK brochure
Find key facts about treatment, such as:
- How ALYFTREK works
- Study details and results
- Once-daily dosing
Questions for your care team
The ALYFTREK Discussion Guide contains topics you may want to discuss with your care team—whether you're currently taking another CFTR modulator, have taken one in the past, or are now eligible.
Liver monitoring fact sheet
Learn what to expect while you’re taking ALYFTREK, including:
- Why liver function tests are important
- How often you’ll need liver function tests
- Where you can get tested
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ALYFTREK?
Elevated liver enzymes have been observed in patients taking ALYFTREK. Cases of serious liver damage and liver failure leading to transplantation and death have been seen in some people with or without a history of liver problems taking elexacaftor/tezacaftor/ivacaftor (TRIKAFTA®), a medicine which has the same or similar active ingredients as ALYFTREK.
- Your healthcare provider will do blood tests to check your liver:
- before you start ALYFTREK
- every month during your first 6 months of taking ALYFTREK
- then every 3 months during the next 12 months of taking ALYFTREK
- then at least every year while you are taking ALYFTREK
What is ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor)?
ALYFTREK is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Talk to your healthcare provider to learn if you have an indicated CF gene mutation.
It is not known if ALYFTREK is safe and effective in children under 6 years of age.
- Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury
- Stop taking ALYFTREK and call your healthcare provider right away if you have any of the following symptoms of liver problems:
- pain, swelling, or discomfort in the upper right stomach (abdominal) area
- yellowing of your skin or the white part of your eyes
- mental changes
- nausea or vomiting
- dark, amber-colored urine
- loss of appetite
- fluid in your stomach area (ascites)
What should I tell my healthcare provider before taking ALYFTREK?
Before taking ALYFTREK, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had liver problems
- are allergic to ALYFTREK or any ingredients in ALYFTREK. See the Medication Guide for a complete list of ingredients in ALYFTREK
- have taken another medicine with elexacaftor, tezacaftor, or ivacaftor before and temporarily or permanently stopped because of side effects. Your healthcare provider may want to see you more often
- have kidney problems
- are pregnant or plan to become pregnant. It is not known if ALYFTREK will harm your unborn baby. You and your healthcare provider should decide if you will take ALYFTREK while you are pregnant
- are breastfeeding or planning to breastfeed. It is not known if ALYFTREK passes into your breast milk. You and your healthcare provider should decide if you will take ALYFTREK while you are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements.
ALYFTREK may affect the way other medicines work, and other medicines may affect how ALYFTREK works. The dose of ALYFTREK may need to be adjusted when taken with certain medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking ALYFTREK?
- Avoid food or drink that contains grapefruit while you are taking ALYFTREK
What are the possible or reasonably likely side effects of ALYFTREK?
ALYFTREK can cause serious side effects, including:
- See “What is the most important information I should know about ALYFTREK?”
- Serious Allergic Reactions can happen to people who are treated with ALYFTREK. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
- rash or hives
- tightness of the chest or throat or difficulty breathing
- light-headedness or dizziness
- Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with ALYFTREK. If you are a child or adolescent, your healthcare provider should perform eye examinations before and during treatment with ALYFTREK to look for cataracts
The most common side effects of ALYFTREK include:
- cough
- pain or swelling of your nose or throat (nasopharyngitis)
- upper respiratory tract infection (common cold) including stuffy and runny nose
- headache
- mouth or throat pain
- flu (influenza)
- tiredness
- increase in liver enzymes
- rash
- sinus congestion
Your healthcare provider should monitor you during treatment with ALYFTREK. You may require additional monitoring if your treatment with a medicine that works like ALYFTREK has been previously stopped or interrupted because of side effects.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of ALYFTREK. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Medication Guide with Important Warning.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TRIKAFTA?
TRIKAFTA can cause serious liver damage and liver failure. Liver failure leading to transplantation and death has been seen in some people with or without a history of liver problems taking TRIKAFTA.
Your healthcare provider will do blood tests to check your liver:
- before you start TRIKAFTA
- then every month during your first 6 months of taking TRIKAFTA
- then every 3 months during the next 12 months of taking TRIKAFTA
- then at least every year while you are taking TRIKAFTA
What is TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)?
TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.
Talk to your healthcare provider to learn if you have an indicated CF gene mutation.
It is not known if TRIKAFTA is safe and effective in children under 2 years of age.
Your healthcare provider may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past or are experiencing signs or symptoms of liver injury.
Stop taking TRIKAFTA and call your healthcare provider right away if you have any of the following symptoms of liver problems:
- pain, swelling, or discomfort in the upper right stomach (abdominal) area
- yellowing of your skin or the white part of your eyes
- mental changes
- nausea or vomiting
- dark, amber-colored urine
- loss of appetite
- fluid in your stomach area (ascites)
What should I tell my healthcare provider before taking TRIKAFTA?
Before taking TRIKAFTA, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had liver problems
- are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the end of the Medication Guide for a complete list of ingredients in TRIKAFTA
- have kidney problems
- are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your healthcare provider should decide if you will take TRIKAFTA while you are pregnant
- are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your healthcare provider should decide if you will take TRIKAFTA while you are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
TRIKAFTA may affect the way other medicines work and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Especially tell your healthcare provider if you take:
- antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
- seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
- St. John’s wort
- antifungal medicines including ketoconazole, itraconazole (such as SPORANOX®), posaconazole (such as NOXAFIL®), voriconazole (such as VFEND®), or fluconazole (such as DIFLUCAN®)
- antibiotics including telithromycin, clarithromycin (such as BIAXIN®), or erythromycin (such as ERY-TAB®)
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking TRIKAFTA?
- Avoid food or drink that contains grapefruit while you are taking TRIKAFTA
What are the possible or reasonably likely side effects of TRIKAFTA?
TRIKAFTA can cause serious side effects, including:
- See “What is the most important information I should know about TRIKAFTA?”
- Serious Allergic Reactions can happen to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
- rash or hives
- tightness of the chest or throat or difficulty breathing
- swelling of the face, lips, and/or tongue, or difficulty swallowing
- light-headedness or dizziness
- Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your healthcare provider should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts
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
- constipation
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of TRIKAFTA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For further information, please see full Prescribing Information, including Medication Guide with Important Warning.
