Trikafta

Pronunciation: tri-KAF-tuh
Generic name: elexacaftor, ivacaftor, and tezacaftor
Dosage form: oral tablets, oral granules
Drug class: CFTR combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 11, 2025.

What is Trikafta?

Trikafta is used to treat adults and children aged 2 years and older with cystic fibrosis (CF) with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation responsive to treatment with Trikafta based on clinical and/or laboratory data.

• Your healthcare provider will conduct an FDA-approved CF mutation test to make sure you have either the F508del mutation or at least one other eligible mutation.

Trikafta's mechanism of action is three-fold. The three ingredients in Trikafta (elexacaftor, tezacaftor, and ivacaftor) work together to improve the functioning of the CFTR protein. Elexacaftor and tezacaftor help more CFTR proteins reach the surface. Ivacaftor helps the CFTR proteins stay open for longer at the cell surface, allowing more chloride ions to flow through, which thins the mucus.

Trikafta first gained FDA approval on October 21, 2019. Approval was extended on December 20, 2024, to include non-F508del Trikafta-responsive variants.

Trikafta side effects

The most common Trikafta side effects are:

• headache
• flu with symptoms such as fever, chills, or body aches
• colds with symptoms such as stuffy nose, sinus pain, sneezing, sore throat
• diarrhea
• stomach pain
• rash
• abnormal laboratory tests, such as increases in blood bilirubin, creatine phosphokinase, and liver enzymes.

Serious side effects and warnings

Trikafta carries a Boxed Warning for liver injury and liver failure.

Trikafta can cause serious liver damage and liver failure. Liver failure leading to transplantation and death have 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 it
• then every 3 months during the next 12 months of taking it
• then at least every year while you are taking Trikafta.

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
• nausea or vomiting
• 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).

People with pre-existing advanced liver disease, (such as cirrhosis, portal hypertension, ascites, hepatic encephalopathy) should not take Trikafta unless the benefits outweigh the risks, as cases of liver failure leading to transplantation have been reported. Your healthcare provider will monitor your liver function throughout treatment.

Allergic reactions, including angioedema and anaphylaxis, have been reported with Trikafta. Do not take Trikafta if you have a known hypersensitivity to it or one of its ingredients. Get emergency medical help if you have signs of an allergic reaction to Trikafta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Cataracts have been reported in some children and adolescents treated with medications containing ivacaftor. Your healthcare provider will organize an eye examination before your child starts treatment with Trikafta, and regularly throughout treatment.

It is not known if Trikafta is safe and effective in children under 2 years of age.

This is not a complete list of side effects and others may occur. 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 this medicine

Do not take Trikafta if you have a known hypersensitivity to Trikafta, elexacaftor, ivacaftor, tezacaftor, or one of the inactive ingredients in the tablets or granules. 

Tell your healthcare provider about all your medical conditions including if you:

• have liver disease
• have kidney disease
• are pregnant or plan to become pregnant
• are breastfeeding or planning to breastfeed.

Pregnancy

It is not known if Trikafta will harm your unborn baby. You and your doctor should decide if you should take Trikafta while you are pregnant.

Breastfeeding

It is not known if Trikafta passes into your breast milk. You and your doctor should decide if you should take it while you are breastfeeding.

How should I take Trikafta?

Take Trikafta exactly as your healthcare provider tells you to take it. Follow the instructions of the Trikfta Package Insert.

• Take Trikafta by mouth only.
• Swallow Trikafta tablets whole. If you cannot swallow them whole, talk to your healthcare provider about Trikafta granules.
• Trikafta is taken 2 times a day (a morning dose and an evening dose taken about 12 hours apart).
• Each dose has different ingredients.

Always take Trikafta oral granules or 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. This helps your body to absorb the medicine. Some ways you can add fat to your snack include:

• Pouring on extra virgin olive oil
• Mixing in sliced almonds
• Spreading on butter.

Or take it with a meal such as a bagel with peanut butter, macaroni cheese, a cheese sandwich, or hard-boiled eggs.

Call your doctor at once if you have:

• vision changes or
• liver problems, symptoms may include loss of appetite, stomach pain (upper right side), dark urine, or jaundice (yellowing of the skin or eyes).

How to give Trikafta granules to your child

To prepare Trikafta oral granules:

• Hold the packet with the cut line on top
• Shake the packet gently to settle the Trikafta oral granules
• Tear or cut the packet open along the cut line
• Carefully pour all the Trikafta oral granules in the packet into 1 teaspoon (5 mL) of soft food or liquid in a small container (like an empty bowl). The food or liquid should be at or below room temperature.

Some examples of soft foods or liquids include pureed fruits or vegetables, yogurt, applesauce, water, milk, or juice.

• Mix the Trikafta granules with food or liquid.
• After mixing, give Trikafta within 1 hour with food that contains fat. Make sure all the medicine is taken.

Trikafta dosing instructions

Trikafta is supplied as tablets for adults and children aged 6 years and older and as granules for children aged 2 years to less than 6.

• If you have liver problems, your healthcare provider may tell you to take Trikafta differently.
• If you are not sure about your dosing, call your healthcare provider.

Trikafta granules dosing information (child age 2 to less than 6 years weighing less than 31 pounds [14 kg]):

Morning dose: Give one white and blue packet in the morning.

• Contains the medicines elexacaftor, tezacaftor, and ivacaftor.

Evening dose: Give one white and green packet in the evening.

• This packet only contains ivacaftor.

Trikafta granules dosing information (child age 2 to less than 6 years weighing 31 pounds [14 kg] or more):

Morning dose: Give one white and orange packet in the morning.

• Contains the medicines elexacaftor, tezacaftor, and ivacaftor.

Evening dose: Give one white and pink packet in the evening.

• This packet only contains ivacaftor.

Trikafta tablets dosing information for children age 6 to less than 12 years weighing less than 66 pounds [30 kg]):

Morning dose: Take 2 light orange tablets in the morning.

• The light orange tablet is marked with ‘T50’ and each tablet contains the medicines elexacaftor, tezacaftor and ivacaftor. 

Evening dose: Take 1 light blue tablet in the evening.

• The light blue tablet is marked with ‘V 75’ and contains the medicine ivacaftor. 

Trikafta tablets dosing information for children age 6 to less than 12 years weighing 66 pounds [30 kg] or more, and adults and children age 12 and older):

Morning dose: Take 2 orange tablets in the morning.

• The orange tablet is marked with ‘T100’ and each tablet contains the medicines elexacaftor, tezacaftor and ivacaftor. 

Evening dose: Take 1 light blue tablet in the evening.

• The light blue tablet is marked with ‘V 150’ and contains the medicine ivacaftor. 

What happens if I miss a dose of Trikafta?

If you miss a dose of Trikafta and:

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

Do not take more than your usual dose of Trikafta to make up for a missed dose.

Do not take the morning and evening doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Trikafta?

Avoid driving or hazardous activity until you know how Trikafta will affect you. Your reactions could be impaired.

Grapefruit may interact with Trikafta and lead to unwanted side effects. Avoid the use of grapefruit products.

Talk to your healthcare provider or pharmacist before taking any new medication or supplement.

What other drugs will affect Trikafta?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Especially tell your healthcare provider if you take:

• antibiotics such as rifampin, rifabutin, telithromycin, clarithromycin, or erythromycin.
• seizure medications such as phenobarbital, carbamazepine, or phenytoin
• St. John’s wort
• antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole.

This list is not complete. Other drugs may interact with the components of Trikafta including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. See the Trikafta Prescribing Information for a complete list.

How do I store Trikafta?

Store Trikafta tablets and granules at room temperature 68°F - 77°F (20°C - 25°C).

Keep each tablet in its daily blister strip and the granules in their packet until you are ready to take your dose.

Keep out of reach of children.

Trikafta ingredients

Tablets that contain elexacaftor/tezacaftor/ivacaftor tablets (orange and light orange):

Active ingredients: elexacaftor, tezacaftor and ivacaftor.

Inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium
stearate, microcrystalline cellulose, sodium lauryl sulfate.

The tablet film coat contains hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, talc, and titanium dioxide.

Tablets that contain ivacaftor (light blue):

Active ingredients: ivacaftor.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

The tablet film coat contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium
oxide.

The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac.

Granules that contain elexacaftor/tezacaftor/ivacaftor (white and blue, white and orange):

Active ingredients: elexacaftor, tezacaftor, and ivacaftor.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hypromellose acetate
succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose.

Granules that contain ivacaftor (white and green, white and pink):

Active ingredients: ivacaftor.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose.

Who makes Trikafta?

Vertex Pharmaceuticals Incorporated makes Trikafta.

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Further information

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

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