Patient leaflet - Alyftrek 50 mg/20 mg/4 mg film-coated tablets
• 1 What Alyftrek is and what it is used for
Alyftrek is a tablet that contains three active substances: deutivacaftor, tezacaftor, and vanzacaftor. The medicine helps the lungs and other organs to work better in some people with cystic fibrosis (CF). CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus.
Alyftrek is for people with CF aged 6 years and over, with at least one F508del mutation or another responsive mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. Alyftrek is intended as a long-term treatment.
Alyftrek works on a protein called CFTR. This protein is damaged in some people with CF, if they have a mutation in the CFTR gene. Vanzacaftor and tezacaftor increase the amount of CFTR protein at the cell surface, while deutivacaftor causes the protein to work better.
Alyftrek helps your breathing by improving your lung function. You may also notice that you do not get ill as often, or that it is easier to maintain a healthy weight.
• 2 What you need to know before you take Alyftrek
Do not take Alyftrek
If you are allergic to deutivacaftor, tezacaftor, vanzacaftor or any of the other
ingredients of this medicine (listed in section 6).
Talk to your doctor and do not take the tablets if this applies to you.
Warnings and precautions
Liver damage and worsening liver function in people with and without
liver disease has been seen in some patients taking elexacaftor/tezacaftor/ ivacaftor, a medicine that has the same or similar ingredients as Alyftrek. The worsening of liver function can be serious and may require transplantation.
Talk to your doctor if you have liver problems, or have had them previously.
Your doctor will do some blood tests to check your liver before and during treatment with Alyftrek, especially if your blood tests showed high liver enzymes in the past. Increased liver enzymes in the blood are common in patients with CF, and those taking Alyftrek.
Tell your doctor right away if you have any signs of liver problems. These are listed in section 4.
Talk to your doctor if you have taken another medicine with tezacaftor or
ivacaftor before and temporarily or permanently stopped because of side effects. Your doctor may want to see you more often.
Talk to your doctor if you have kidney problems, or you have previously had
them.
Your doctor may do eye examinations before and during treatment with
Alyftrek. Cloudiness of the eye lens (cataract) without any effect on vision has occurred in some children and adolescents receiving ivacaftor which is similar to deutivacaftor, a component of Alyftrek.
Children under 6 years of age
Do not give this medicine to children under the age of 6 years because it is not known if Alyftrek is safe and effective in this age group.
Other medicines and Alyftrek
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can affect how Alyftrek works or may make side effects more likely. In particular, tell your doctor if you take any of the medicines listed below. Your doctor may change the dose of one of these medicines if you take any of these.
Antifungal medicines (used for the treatment of fungal infections).
These include fluconazole, itraconazole, ketoconazole, posaconazole and voriconazole.
Antibiotic medicines (used for the treatment of bacterial infections). These
include clarithromycin, erythromycin, rifampicin, rifabutin and telithromycin.
Epilepsy medicines (used to treat seizures, fits, or convulsions). These include
carbamazepine, phenobarbital, and phenytoin.
- Herbal medicines. These include St. John’s wort (Hypericum perforatum).
Immunosuppressants (used after an organ transplantation). These include
ciclosporin, everolimus, sirolimus and tacrolimus.
Cardiac glycosides (used for the treatment of some heart conditions). These
include digoxin.
Anticoagulant medicines (used to prevent blood clots). These include
warfarin.
- Medicines for diabetes. These include glimepiride and glipizide.
- Medicines for lowering blood pressure. These include verapamil.
Alyftrek with food and drink
Avoid food or drinks containing grapefruit during treatment as these may increase the side effects of Alyftrek by increasing the amount of Alyftrek in your body.
Pregnancy and breast-feeding
Ask your doctor for advice before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Pregnancy: Your doctor will help you decide what is best for you and your
child.
Breast-feeding: There is insufficient information to determine if deutivacaftor,
tezacaftor, or vanzacaftor passes into breast milk. Your doctor will consider the benefit of breast-feeding for your baby, and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop the treatment.
Driving and using machines
Alyftrek has no or little influence on the ability to drive and use machines.
Alyftrek contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.
• 3 How to take Alyftrek
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the correct dose for you.
Alyftrek tablets come in two different strengths. Your doctor will determine the correct dose for you.
Recommended dose of Alyftrek for people with CF:
Age Weight Dose per day Tablet strength
6 to less than
12 years of
age
People with CF who weigh less than 40 kg
Three round-shaped Alyftrek tablets, once a day
50 mg/20 mg/4 mg
6 to less than
12 years of
age
People with CF who weigh 40 kg or more
Two capsule-shaped Alyftrek tablets, once a day
125 mg/50 mg/10 mg 12 years of
age or older
Any weight
Take Alyftrek tablets with food that contains fat. Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs. Other fat-containing foods are:
- Cheese, whole milk, whole milk dairy products, yogurt, chocolate
- Meats, oily fish
- Avocados, hummus, soy-based products (tofu)
- Nuts, fat-containing nutritional bars or drinks
Swallow the tablets whole. Do not chew, crush or break the tablets before swallowing.
Take at approximately the same time each day. The tablets are for oral use.
Avoid food and drink containing grapefruit while you are taking Alyftrek. See Alyftrek with food and drink in section 2 for more details.
You must keep using all your other medicines, unless your doctor tells you to stop.
If you have moderate liver problems, this medicine is not recommended but your doctor will decide if it is appropriate for you to take this medicine.
If you have severe liver problems, you should not be taking this medicine. See also Warnings and precautions in section 2.
If you take more Alyftrek than you should
Contact your doctor or pharmacist for advice. If possible, take your medicine and this leaflet with you. You may get side effects, including those mentioned in section 4 below.
If you forget to take Alyftrek
If you forget a dose, work out how long it is since the dose you missed.
- If less than 6 hours have passed since you missed a dose, take the forgotten tablets as soon as possible. Then go back to your usual schedule.
- If more than 6 hours have passed since the missed dose, skip the missed dose, and continue on the original schedule the next day.
Do not take a double dose to make up for any missed tablets.
If you stop taking Alyftrek
Your doctor will tell you how long you need to keep taking Alyftrek. It is important to take this medicine regularly. Do not make changes unless your doctor tells you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
• 4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Possible signs of liver problems
Increased liver enzymes in the blood are common in people with CF, and those taking Alyftrek. These may be signs of liver problems:
- Pain or discomfort in the upper right area of the stomach (abdominal) area
- Yellowing of the skin or the white part of the eyes
- Loss of appetite
- Nausea or vomiting
- Dark urine
Tell your doctor straight away if you have any of these symptoms.
Other side effects with Alyftrek
Very common side effects
(may affect more than 1 in 10 people)
- Headache
- Diarrhoea
Common side effects
(may affect up to 1 in 10 people)
- Rash
- Increase in liver enzymes (signs of stress on the liver)
- Increase creatine phosphokinase (sign of muscle breakdown) seen in blood tests
Additional side effects in adolescents
Side effects in adolescents are similar to those observed in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
• 5 How to store Alyftrek
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
• 6 Contents of the pack and other information
What Alyftrek contains
- The active substances are deutivacaftor, tezacaftor and vanzacaftor.
Alyftrek 50 mg/20 mg/4 mg film-coated tablets
Each film-coated tablet contains 50 mg of deutivacaftor, 20 mg of tezacaftor and vanzacaftor calcium dihydrate equivalent to 4 mg of vanzacaftor.
Alyftrek 125 mg/50 mg/10 mg film-coated tablets
Each film-coated tablet contains 125 mg of deutivacaftor, 50 mg of tezacaftor and vanzacaftor calcium dihydrate equivalent to 10 mg of vanzacaftor.
The other ingredients are:
- Tablet core: croscarmellose sodium (E468), hypromellose (E464), hypromellose acetate succinate, magnesium stearate (E470b), microcrystalline cellulose (E460(i)) and sodium laurilsulfate (E487).
- Tablet film coat: Carmine (E120), Brilliant Blue FCF aluminum lake (E133), hydroxypropyl cellulose (E463), hypromellose (E464), iron oxide red (E172), talc (E553b) and titanium dioxide (E171).
See the end of section 2 for important information about the contents of Alyftrek.
What Alyftrek looks like and contents of the pack
Alyftrek 50 mg/20 mg/4 mg film-coated tablets are purple, round-shaped tablet debossed with “V4” on one side and plain on the other.
Alyftrek 125 mg/50 mg/10 mg film-coated tablets are purple, capsule-shaped tablet debossed with “V10” on one side and plain on the other.
Marketing Authorisation Holder
Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street
London, W2 6BD
United Kingdom
Tel: +44 20 3204 5100
Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland
This leaflet was last revised in July 2026.
Other sources of information
Detailed information on this medicine is available on the website of Medicines and Healthcare products Regulatory Agency: http://www.mhra.gov.uk.
Alyftrek 50 mg/20 mg/4 mg
film-coated tablets
Alyftrek 125 mg/50 mg/10 mg
film-coated tablets
deutivacaftor/tezacaftor/vanzacaftor
Alyftrek 50 mg/20 mg/4 mg film-coated tablets
Alyftrek 125 mg/50 mg/10 mg film-coated tablets
deutivacaftor/tezacaftor/vanzacaftor
PXXXXX/X
PXXXXX/X
FPO
FPO
Packaging Site: Almac
LFT-0038-00
Overall dimensions
645mm x 420mm
Folded dimensions (if needed) 50mm x 44mm
CMO Drawing
CDS-PX000408
CMO Code
2024_0255_A_WST_GX_645x420
Revision Date
06 May 2024
07 Jul 2026
Alyftrek UK 125-50-10_50-20-4 Leaflet (Dundalk) Mock-up
Leaflet 03
PXXXXX/X 7 pt
FPO 955909
N/A
29 Business Park Drive, Suite A | Branford, CT 06405 | 203.433.4054