2 of the 3 components of ALYFTREK are unique compared to those in other CFTR modulators.
2 of the 3 components of ALYFTREK are unique compared to those in other CFTR modulators.
Jump to: How the 3 components work
Jump to: How the 3 components work
How the 3 components of ALYFTREK work
How the 3 components of ALYFTREK work
Illustration does not represent actual tablet.
Deutivacaftor
This unique component helps CFTR proteins stay open longer.
Vanzacaftor
This unique component helps CFTR proteins reach the cell surface.
Tezacaftor
This established component from other CFTR modulators works with vanzacaftor to help more CFTR proteins reach the cell surface.
Illustration does not represent actual tablet.
Deutivacaftor
This unique component helps CFTR proteins stay open longer.
Vanzacaftor
This unique component helps CFTR proteins reach the cell surface.
Tezacaftor
This established component from other CFTR modulators works with vanzacaftor to help more CFTR proteins reach the cell surface.
ALYFTREK works in multiple ways to help improve CFTR function
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. That means some CFTR proteins don’t reach the surface of the cell, and the ones that do may not open correctly. The 3 components of ALYFTREK help more proteins reach the cell surface and stay open longer.
At the cell surface
At the cell surface
At the cell surface
At the cell surface
At the cell surface
At the cell surface
What may not be working?
If CFTR proteins don't open correctly, chloride ions may not move in and out of cells the way they should. This may cause the buildup of thick mucus in organs, like the lungs.
Illustrations are artistic representations.
How ALYFTREK works
Deutivacaftor helps the CFTR proteins stay open longer. This allows chloride ions and water to flow more easily so mucus can clear from organs, like the lungs.
Illustrations are artistic representations.
BELOW the cell surface
BELOW the cell surface
BELOW the cell surface
BELOW the cell surface
BELOW the cell surface
BELOW the cell surface
What may not be working?
If CFTR proteins don't reach the cell surface, they can't help chloride ions move in and out.
Illustrations are artistic representations.
How ALYFTREK works
Vanzacaftor and tezacaftor bind to different places on the CFTR protein. They help the proteins form and move through the cell, so more proteins reach the cell surface to do their job.
Illustrations are artistic representations.
ALYFTREK is a triple combination therapy that helps improve CFTR function at and below the cell surface.
What is known about how ALYFTREK works was learned from studies conducted in a laboratory. Keep in mind that results from laboratory studies do not always match how these medicines work in a person. If you have questions about your treatment, speak with your healthcare provider.
What is known about how ALYFTREK works was learned from studies conducted in a laboratory. Keep in mind that results from laboratory studies do not always match how these medicines work in a person. If you have questions about your treatment, speak with your healthcare provider.
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.
