Unlike other CFTR modulators that require 2 doses a day, ALYFTREK is taken just once daily.
Unlike other CFTR modulators that require 2 doses a day, ALYFTREK is taken just once daily.
You and your healthcare provider can decide on a time that works best for your routine, giving you:
- One less dose to remember each day
- One less fat-containing food to prepare and eat
- More flexibility—with once-daily dosing, ALYFTREK fits into your day, not the other way round. The key is to take ALYFTREK with fat-containing food about the same time each day—morning, noon, or night
- More time back in your day with one less dose
What's my dose?
Your healthcare provider will determine your dose based on age and weight.
and children aged 6-11 years who weigh 40 kg* or more
Not actual size. (vanzacaftor 10 mg/tezacaftor 50 mg/ | Here’s an illustration comparing the size of these ALYFTREK pills to a typical almond.
Each pill is about 15 mm high x 7 mm wide. |
Not actual size. (vanzacaftor 10 mg/tezacaftor 50 mg/ deutivacaftor 125 mg) |
Here’s an illustration comparing the size of these ALYFTREK pills to a typical almond.
Each pill is about 15 mm high x 7 mm wide. |
who weigh less than 40 kg*
Not actual size. (vanzacaftor 4 mg/tezacaftor 20 mg/ | Here’s an illustration comparing the size of these ALYFTREK pills to a typical pea.
Each pill is about 7 mm high x 7 mm wide. |
Not actual size. (vanzacaftor 4 mg/tezacaftor 20 mg/ deutivacaftor 50 mg) |
Here’s an illustration comparing the size of these ALYFTREK pills to a typical pea.
Each pill is about 7 mm high x 7 mm wide. |
*40 kg is about 88 lb.
Pair your once-daily dose with fat-containing food—morning, noon, or night
Each dose must be taken with fat-containing food to help your body absorb the medicine. Depending on the time you take it, here are some food ideas to consider*:
Morning- Use whole milk in your tea, coffee, or hot chocolate
- Spread butter or peanut butter on your toast, or have scrambled eggs with it
- Add some texture by sprinkling nuts onto whole-milk Greek yogurt
Noon- Try veggies preserved in oil, such as peppers, artichokes, eggplant, or sun-dried tomatoes
- Boost the fat content in salads with crumbled cheese, drizzled oil, or hard-boiled eggs
- Spread cream cheese onto wraps and sandwiches
Evening- Swap out chicken breast for higher-fat cuts of meat, such as chicken thighs
- Toss eggs and peanuts into your favorite stir-fry, and try adding sesame oil
- Top off pastas with olive oil, cheese, or pesto
*Remember to talk to your healthcare provider or dietitian before making any changes to your diet.
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.
