Pronunciation: ah-LIF-trek
Generic name: vanzacaftor, tezacaftor, and deutivacaftor tablets
Dosage form: oral tablets (vanzacaftor 4mg/ tezacaftor 20mg/ deutivacaftor 50mg; vanzacaftor 10mg/ tezacaftor 50mg/ deutivacaftor 125mg)
Drug class: CFTR combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 28, 2024.

What is Alyftrek?

Alyftrek is used to treat cystic fibrosis (CF) in people aged 6 years and older with at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

• Alyftrek is a combination tablet containing vanzacaftor, tezacaftor, and deutivacaftor that is taken 1 time a day.
• Your healthcare provider will conduct a blood test to see if you have the F508del mutation or another responsive mutation.

Alyftrek’s mechanism of action is three-fold. Vanzacaftor and tezacaftor bind to different sites on the CFTR protein (which is faulty in cystic fibrosis) and work together to help the CFTR protein reach the surface of cells. Then, deutivacaftor helps these proteins work better once they're there. When all three drugs are combined, you get more working CFTR proteins at the cell surface. This leads to better chloride transport, which can be measured both in lab tests and by checking chloride levels in patients' sweat.

Alyftrek belongs to the drug class called CFTR modulators. Specifically, Alyftrek is a triple combination CFTR modulator.

Alyftrek gained FDA approval on December 20, 2024. There is no Alyftrek generic.

Alyftrek side effects

The most common side effects of Alyftrek are:

• cough
• mouth or throat pain
• pain or swelling of your nose or throat (nasopharyngitis)
• flu (influenza)
• tiredness
• upper respiratory tract infection (common cold) including stuffy and runny nose
• increase in liver enzymes
• rash
• headache
• sinus congestion.

Serious side effects and warnings

Alyftrek contains a Boxed Warning for liver injury and liver failure associated with its use. Talk to your healthcare provider about the following potential serious side effects of Alyftrek.

High 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.

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 o nausea or vomiting
• stomach (abdominal) area
• dark, amber-colored urine
• yellowing of your skin or the white part of your eyes
• loss of appetite
•  mental changes
• have fluid in your stomach area (ascites).

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.

It is not known if Alyftrek is safe and effective in children under 6 years of age.

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 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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

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, vanzacaftor, tezacaftor, deutivacaftor, or any of the other ingredients in Alyftrek. See the end of this guide for a complete list of Alyftrek ingredients
• 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
• are breastfeeding or planning to breastfeed.

Pregnancy

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.

Breastfeeding

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.

How do I take Alyftrek?

Alyftrek tablets are taken 1 time a day. You may have to take up to 3 tablets as a single dose.

• Take Alyftrek tablets whole.
• Take the doses about the same time every day.
• Take Alyftrek exactly as your healthcare provider tells you to take it. Take Alyftrek by mouth only.

Always take Alyftrek tablets with food that contains fat. Examples of fat-containing foods include butter, oil, eggs, peanut butter, nuts, meat, and whole-milk dairy products such as whole milk, cheese, and yogurt.

Alyftrek dosing information

Dosage of Alyftrek tablets for children aged 6 to less than 12 years weighing less than 88 pounds [40 kg]):

• Take 3 tablets at the same time each day of the purple round-shaped tablet.
• This is marked with ‘V4’ and contains the medicines vanzacaftor 4 mg, tezacaftor 20 mg, and deutivacaftor 50 mg.

Dosage of Alyftrek tablets for adults and children aged 6 to less than 12 years weighing 88 pounds [40 kg] or more, or 12 years and older):

• Take 2 tablets at the same time each day of the purple oblong-shaped tablet.
• This is marked with ‘V10’ and contains the medicines vanzacaftor 10 mg, tezacaftor 50 mg, and deutivacaftor 125 mg.

What happens if I miss a dose?

If you miss a dose of Alyftrek and:

• it is 6 hours or less from the time you usually take the dose, take the missed dose with food that contains fat as soon as you can. Then take your next dose at your usual time
• it is more than 6 hours from the time you usually take the dose, do not take the missed dose. Take your dose the next day at your usual time.

Do not take more than your usual dose of Alyftrek to make up for a missed dose. If you are not sure about your dosing, call your healthcare provider.

What should I avoid while taking Alyftrek?

Avoid food or drink that contains grapefruit while you are taking Alyftrek.

What other drugs will affect Alyftrek?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Certain medications, herbal supplements, or vitamins, when used concomitantly with Alyftrek, may reduce the effectiveness of Alyftrek or increase the risk of adverse reactions associated with Alyftrek. Especially tell your healthcare provider if you take:

• Rifampin
• Phenytoin
• HIV medications, such as ritonavir
• Dexamethasone
• Modafinil
• St. Johns Wort
• Heart medications, such as diltiazem,
• Antibiotics, such as clarithromycin or erythromycin
• Antifungals such as itraconazole or ketoconazole.

Avoid food or drink containing grapefruit when using Alyftrek.

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. See the Alyftrek Prescribing Information for a full list of interactions.

How should I store Alyftrek?

Store Alyftrek at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Keep Alyftrek and all medicines out of the reach of children.

What are the ingredients in Alyftrek?

Alyftrek contains the following active and inactive ingredients.

Active ingredients: vanzacaftor, tezacaftor, and deutivacaftor.

Inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat contains Brilliant Blue FCF aluminum lake/FD&C Blue #1, carmine, hydroxypropyl cellulose, hypromellose, iron oxide red, talc, and titanium dioxide.

Alyftrek is available in 2 strengths:

• vanzacaftor 4 mg, tezacaftor 20 mg, and deutivacaftor 50 mg.
• vanzacaftor 10 mg, tezacaftor 50 mg, and deutivacaftor 125 mg

Who makes Alyftrek?

Vertex Pharmaceuticals Incorporated makes Alyftrek.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer