Trikafta: Uses, Side Effects and Dosage

Serious warnings and precautions box

Liver disorder: TRIKAFTA may worsen your liver function, even if you have no prior liver disease. This can lead to serious liver problems. This includes a liver transplant, and even death.

Your healthcare professional will order some blood tests to check your liver:

• before you start treatment with TRIKAFTA,
• every month during the first 6 months of treatment,
• every 3 months during the next 6 months, and
• every year thereafter while you are taking TRIKAFTA.

If you have had abnormal liver blood test results in the past or have a history of liver problems and you are prescribed TRIKAFTA, your healthcare professional may order blood tests to check your liver more often.

If you have any of these symptoms while taking TRIKAFTA, stop taking it and tell your healthcare professional right away. It may be a sign of liver problems:

• pain or discomfort in the upper right part of your stomach (abdominal) area
• yellowing of your skin or the white part of your eyes
• loss of appetite
• nausea or vomiting
• dark urine
• pale stools
• itchy skin

What TRIKAFTA is used for:

TRIKAFTA is used for the treatment of cystic fibrosis (CF) in patients 2 years of age and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation in the CFTR gene that is responsive to TRIKAFTA.

How TRIKAFTA works:

• The CFTR gene provides instructions to your cells to make the CFTR protein. This protein helps take chloride ions in and out of the cells in many organs of your body.
• People with CF have a lower amount of the CFTR protein and/or reduced function of the CFTR protein.

• TRIKAFTA contains 3 ingredients:

  • elexacaftor and tezacaftor: These are CFTR Correctors. They increase the amount of CFTR protein on the surface of the cell.
  • ivacaftor: This is a CFTR Potentiator. It makes CFTR protein at the cell surface work better by allowing chloride ions to pass through.

The ingredients in TRIKAFTA are:

Medicinal ingredient(s): elexacaftor / tezacaftor / ivacaftor

Non-medicinal ingredients:

• elexacaftor/tezacaftor/ivacaftor granules:

  Colloidal silicon dioxide, croscarmellose sodium, hypromellose, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, sucralose

• ivacaftor granules:

  Colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, sucralose

• elexacaftor/tezacaftor/ivacaftor tablet:

  Tablet core:

  Croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate

  Tablet film coat:

  Hydroxypropyl cellulose, hypromellose, Iron oxide red, iron oxide yellow, talc, titanium dioxide

• ivacaftor tablet:

  Tablet core:

  Colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate

  Tablet film coat:

  Carnauba wax, indigo carmine aluminum lake, PEG 3350, polyvinyl alcohol, talc, titanium dioxide

  Printing ink:

  Ammonium hydroxide, iron oxide black, propylene glycol, shellac

TRIKAFTA comes in the following dosage forms:

Granules:

• 80 mg elexacaftor / 40 mg tezacaftor / 60 mg ivacaftor (in a white and blue packet) and 59.5 mg ivacaftor (in a white and green packet)

• 100 mg elexacaftor / 50 mg tezacaftor / 75 mg ivacaftor (in a white and orange packet)

  • and 75 mg ivacaftor (in a white and pink packet)

Tablets:

• 50 mg elexacaftor / 25 mg tezacaftor / 37.5 mg (light orange and marked with “T50”) and 75 mg ivacaftor (light blue and marked with “V 75”)
• 100 mg elexacaftor / 50 mg tezacaftor / 75 mg ivacaftor (orange and marked with “T100”) and 150 mg ivacaftor (light blue and marked with “V 150”)

Do not use TRIKAFTA if:

• You are allergic to:

  • elexacaftor
  • tezacaftor
  • ivacaftor
  • any of the non-medicinal ingredients (listed in What are the ingredients in TRIKAFTA?)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRIKAFTA. Talk about any health conditions or problems you may have, including if you:

• Have problems with your liver or liver disease (such as cirrhosis).
• Have kidney disease.
• Are a woman and taking hormonal contraceptives.

• Are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your healthcare professional should decide if you will take TRIKAFTA while you are pregnant.

• Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA can pass into your breast milk. You and your healthcare professional should decide if you should take TRIKAFTA while you are breastfeeding.

Other warnings you should know about:

Cataracts: Cloudiness of the eye lens (cataract) with no changes to vision has been seen in some children and adolescents taking TRIKAFTA. Your healthcare professional may perform eye exams before you start treatment and while you are taking TRIKAFTA to look for cataracts.

Driving and using machines: You may get dizzy when you take TRIKAFTA. Wait to see how you feel after taking TRIKAFTA before you drive or use machines. For children: children should be supervised after they take TRIKAFTA. Wait to see if your child is dizzy after taking TRIKAFTA before they ride their bikes or do anything else that needs their full attention.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with TRIKAFTA:

• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole and fluconazole).
• Medicines used to treat bacterial infections (such as clarithromycin, erythromycin, rifampin and rifabutin).
• Medicines used to treat seizures (such as phenobarbital, carbamazepine and phenytoin).
• Warfarin (a medicine used to prevent blood clots from forming or growing bigger).
• Medicines used to treat diabetes (such as repaglinide, glimepiride and glipizide).
• Digoxin (a medicine used to treat congestive heart failure or a heart rhythm problem called atrial fibrillation).
• Medicines used after an organ transplant (such as cyclosporine, everolimus, sirolimus and tacrolimus).
• St. John’s wort (Hypericum perforatum).
• Grapefruit, grapefruit juice or products that contain grapefruit. You should avoid food and beverages containing grapefruit while you are taking TRIKAFTA.

Know the medicines you take. Keep a list of them to show your healthcare professional and pharmacist when you get a new medicine.

How to take TRIKAFTA:

• Take TRIKAFTA exactly as your healthcare professional tells you to, even if you feel well. Check with your healthcare professional if you are not sure. Do not change the dose or stop taking TRIKAFTA without first talking to your healthcare professional.

• Always take TRIKAFTA with a fat-containing food. This helps ensure that you get the right amount of medicine in your body. Examples of meals that contain fat are:

  • meals that have been prepared with butter or oils.
  • meals that have eggs, peanut butter, nuts, whole-milk dairy products (such as whole milk, cheese, and yogurt) or meats.
• Take each morning and evening doses approximately 12 hours apart.

TRIKAFTA tablets:

1. 1. To remove the tablet(s) push it through the blister strip.
2. 2.

   Swallow the tablet(s) whole with food that contains fat. Do NOT chew, break or dissolve the tablet(s).

TRIKAFTA granules:

1. 1. Do not remove packet from the wallet until ready to give dose.
2. 2. Shake the packet gently to settle the granules to the bottom of the packet.
3. 3. Tear or cut packet completely open along cut line.
4. 4. Pour all the granules of the packet into 5 mL (1 teaspoon) of soft food or liquid that is between 5°C to 25°C and mix in a small container (like an empty bowl). Look inside the sachet to make sure there are no granules left inside. Some examples of soft foods or liquids include puréed fruits or vegetables, flavoured yogurt or pudding, applesauce, milk, or juice (except grapefruit).
5. 5. After mixing, give within 1 hour. Make sure all medicine is taken. This is very important for it to work properly and be effective.
6. 6. In addition to the granule mixture, fat-containing food must be ingested just before or just after the granules dose. This helps the body better absorb the medicine.

Usual dose:

Your healthcare professional will determine the right dose of TRIKAFTA tablets or TRIKAFTA granules for you. This may depend on your health condition, other medicines you are taking, your weight, your age and how you respond to TRIKAFTA.

The usual dose for TRIKAFTA is as follows:

Take each morning and evening dose approximately 12 hours apart.

Refilling your prescription:

Remember to get a new prescription from your healthcare professional or a refill from your pharmacy 7-10 days before taking your last dose of TRIKAFTA.

Overdose:

If you have taken too much TRIKAFTA, the symptoms of an overdose include:

• nausea
• headache
• feeling dizzy
• diarrhea

If you think you, or a person you are caring for, have taken too much TRIKAFTA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you:

Do NOT take a morning and evening doses together at the same time to make up for a dose that you missed.

Possible side effects from using TRIKAFTA:

These are not all the possible side effects you may have when taking TRIKAFTA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with TRIKAFTA may include:

• upper respiratory tract infection (common cold)
• flu (influenza)
• headache
• blocked nose (nasal congestion)
• runny nose

• swelling of the sinuses

  • diarrhea
  • stomach (abdominal) pain
  • rash, affecting more women than men and women taking hormonal contraceptives
  • changes in blood tests results: increased phosphokinase (sign of muscle breakdown), increased liver enzymes

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at or below 30°C.
• Do not use this medicine after the expiry date (“EXP”) that is stated on the package. The expiry date refers to the last day of that month.
• Keep out of reach and sight of children.

If you want more information about TRIKAFTA:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.vrtx.ca; or by calling 1-877-634-8789.

Date of Authorization: 2026-01-09

© 2026 Vertex Pharmaceuticals Incorporated

TRIKAFTA is a registered trademark of Vertex Pharmaceuticals Incorporated.