Treats cystic fibrosis.

Brand Name(s):

Trikafta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Granule, Tablet, Granule, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablets whole. Do not crush, break, or chew them.
• Oral granules: Mix all the contents of each packet with 1 teaspoon (5 milliliters [mL]) of cool to room temperature soft food (including pureed fruits or vegetables, yogurt, applesauce) or liquid (including water, milk, juice). Take this mixture within 1 hour after mixing.
• Take this medicine with food that contains fat, including food prepared with butter or oils, cheese, eggs, peanut butter, meat, nuts, or whole milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If it is 6 hours or less from the time you normally take your medicine, take a dose as soon as you can. If it is more than 6 hours since the missed morning dose, take the missed dose as soon as you can, but don't take the evening dose. Take the next morning dose at its usual time. If it is more than 6 hours since the missed evening dose, skip the missed dose and take the next morning dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines may affect how elexacaftor/tezacaftor/ivacaftor and ivacaftor works. Tell your doctor if you are using any of the following:
  • Carbamazepine, clarithromycin, cyclosporine, erythromycin, everolimus, fluconazole, glimepiride, glipizide, glyburide, itraconazole, ketoconazole, nateglinide, phenobarbital, phenytoin, posaconazole, repaglinide, rifabutin, rifampin, sirolimus, St John's wort, tacrolimus, telithromycin, voriconazole
  • Blood thinner (including warfarin)
  • Statin medicine
  • Steroid medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or if you have ever been exposed to radiation.
• This medicine may cause the following problems:
  • Serious liver problems
  • Cataracts
• This medicine may cause dizziness. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088