Pregnancy & Lactation: Risk data not available
What is Elexacaftor, Ivacaftor, And Tezacaftor?
Trikafta is a combination medicine used to treat cystic fibrosis in adults and children at least 6 years old.
Trikafta is for use only in patients with a specific gene mutation related to cystic fibrosis. 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.
Warnings
Some drugs should not be used with Trikafta. Your treatment plan may change 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 use Elexacaftor, Ivacaftor, And Tezacaftor
Use Elexacaftor, Ivacaftor, And Tezacaftor (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Swallow the 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 dose may change 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 this medicine 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 this medicine 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.
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.
Elexacaftor, Ivacaftor, And Tezacaftor side effects
Get emergency medical help if you have signs of an allergic reaction: 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 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?
Avoid driving or hazardous activity until you know how this medicine 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.