elexacaftor, ivacaftor, and tezacaftor

What is the most important information I should know about this medicine?

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.

What is elexacaftor, ivacaftor, and tezacaftor (Trikafta)?

Trikafta is a combination medicine used to treat cystic fibrosis in adults and children at least 12 years old.

Trikafta is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take this medicine, you may need a medical test to make sure you have this gene mutation.

Elexacaftor, ivacaftor, and tezacaftor may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking elexacaftor, ivacaftor, and tezacaftor?

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.

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 elexacaftor, ivacaftor, and tezacaftor?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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.

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.

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

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

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?

What should I avoid while taking elexacaftor, ivacaftor, and tezacaftor?

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

What are the possible side effects of elexacaftor, ivacaftor, and tezacaftor?

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

Common 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 elexacaftor, ivacaftor, and tezacaftor?

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 affect Trikafta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about elexacaftor, ivacaftor, and tezacaftor.