Trikafta

Generic name: elexacaftor, ivacaftor, and tezacaftor [ e-LEX-a-KAF-tor, EYE-va-KAF-tor, and-TEXZ-a-KAF-for ]
Drug class: CFTR combinations

Medically reviewed by Judith Stewart, BPharm. Last updated on Aug 4, 2021.

What is Trikafta?

Trikafta contains a combination of elexacaftor, ivacaftor, and tezacaftor.

Trikafta is a prescription medicine used to treat cystic fibrosis in adults and children at least 6 years old.

Trikafta is for use only in patients who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with Trikafta.

Before you take this medicine, you may need a medical test to make sure you have this gene mutation.

Warnings

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

Trikafta may affect the way other medicines work, and other medicines may affect how Trikafta works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Some medicines can cause unwanted or dangerous effects when used with Trikafta. Your doctor may change your treatment plan if you also use:

• rifabutin or rifampin;

• St. John's wort; or

• seizure medicine such as carbamazepine, phenobarbital, or phenytoin.

To make sure Trikafta is safe for you, tell your doctor if you have ever had::

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Trikafta?

Take Trikafta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Trikafta is supplied as two separate daily tablets. The usual dose is 2 orange tablets in the morning and 1 blue tablet in the evening, 12 hours later. Follow your doctor's dosing instructions very carefully.

Swallow the Trikafta tablet whole and do not crush, chew, or break it.

Doses are based on weight and may change if your child gains or loses weight.

Your doctor may change your dose if you also take certain other medications. Your doctor may tell you to take the orange tablets and the blue tablet on separate days. Do not change your dose or dosing schedule without your doctor's advice.

Always take Trikafta with food that contains fat, such as butter, peanut butter, eggs, nuts, meat, whole milk, cheese, or yogurt. Follow your doctor's dosing instructions very carefully.

You will need frequent blood tests to check your liver function.

A child using Trikafta may need frequent eye exams to check for cataracts.

Store at room temperature away from moisture and heat. Keep each tablet in its daily blister strip until you are ready to take your dose.

Dosing information

Usual Adult Dose of Trikafta for Cystic Fibrosis:

Co-Packaged Blister Pack contains fixed dose combination tablets with ivacaftor tablets:
-Fixed dose combination tablet contains elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg
-Single-ingredient tablet contains ivacaftor 150 mg

Morning dose: Two elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg fixed dose tablets orally each morning
Evening dose: One ivacaftor 150 mg tablet orally each evening
-Doses should be taken approximately 12 hours apart

Comments:
-Tablets should be taken with fat-containing food.
-If genotype is unknown, an FDA-cleared cystic fibrosis (CF) mutation test should be used to confirm the presence of at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive based on in vitro data.

Use: For the treatment of CF in patients who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive based on in vitro data.

Usual Pediatric Dose of Trikafta for Cystic Fibrosis:

Co-Packaged Blister Pack contains fixed dose combination tablets with ivacaftor tablets:
-Fixed dose combination tablet contains elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg
-Single-ingredient tablet contains ivacaftor 150 mg

12 years or older:
Morning dose: Two elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg fixed dose tablets orally each morning
Evening dose: One ivacaftor 150 mg tablet orally each evening
-Doses should be taken approximately 12 hours apart

6 to 11 years (weighing 30 kgs or more):
Morning dose: Two elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg fixed dose tablets orally each morning
Evening dose: One ivacaftor 150 mg tablet orally each evening
-Doses should be taken approximately 12 hours apart

6 to 11 years (weighing less than 30 kgs):
Morning dose: Two elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg fixed dose tablets orally each morning
Evening dose: One ivacaftor 75 mg tablet orally each evening
-Doses should be taken approximately 12 hours apart

Comments:
-Tablets should be taken with fat-containing food.
-If genotype is unknown, an FDA-cleared cystic fibrosis (CF) mutation test should be used to confirm the presence of at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive based on in vitro data.

Use: For the treatment of CF in patients who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive based on in vitro data.

What happens if I miss a dose?

Take the medicine as soon as you can, but do not take two doses at one time.

If you are more than 6 hours late in taking the orange tablets, take them as soon as you can but skip taking the blue tablet for that day.

If you are more than 6 hours late in taking the blue tablet, skip that missed dose and take the orange tablets at the regular time the next day.

Be sure to take a missed dose with a food that contains fat.

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 elexacaftor, ivacaftor and tezacaftor and lead to unwanted side effects. Avoid the use of grapefruit products.

Elexacaftor, ivacaftor, and tezacaftor side effects

Get emergency medical help if you have signs of an allergic reaction to Trikafta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision changes; or

• liver problems - loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common Trikafta side effects may include:

• headache;

• diarrhea, stomach pain;

• rash;

• abnormal lab tests;

• flu symptoms such as fever, chills, body aches; or

• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

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 FDA at 1-800-FDA-1088.

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.

Tell your doctor about all your other medicines, especially:

• an antibiotic - clarithromycin, erythromycin, telithromycin; or

• antifungal medicine - fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may interact with elexacaftor, ivacaftor and tezacaftor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Trikafta only for the indication prescribed.

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

Medical Disclaimer

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