Tezacaftor/ivacaftor/ivacaftor (By mouth)

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Introduction

Treats cystic fibrosis.

Brand Name(s)

Symdeko

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

This medicine is generally considered safe for most people. Talk to your doctor if you have concerns.

How to Use This Medicine

Tablet, 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.
  • Take this medicine with food that contains fat, including food prepared with butter or oils, cheese, eggs, meat, nuts, or whole milk. This helps your body absorb the medicine better.
  • 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, skip the missed dose and take your next 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.

  • Do not use this medicine together with carbamazepine, rifabutin, rifampin, phenobarbital, phenytoin, and St John's wort.
  • Some medicines may affect how tezacaftor/ivacaftor and ivacaftor works. Tell your doctor if you are using any of the following:
    • Clarithromycin, cyclosporine, digoxin, erythromycin, everolimus, fluconazole, itraconazole, ketoconazole, posaconazole, sirolimus, tacrolimus, telithromycin, voriconazole
    • Steroid medicine
  • Do not eat grapefruit or Seville oranges or drink grapefruit juice or Seville orange 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:
    • 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

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

  • Headache
  • Nausea

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

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