Ivacaftor-Tezacaftor

Name: Ivacaftor-Tezacaftor

What Is Ivacaftor-Tezacaftor?

Ivacaftor and tezacaftor is a combination medicine used to treat cystic fibrosis in adults and children who are at least 12 years old.

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

Ivacaftor and tezacaftor may also be used for purposes not listed in this medication guide.

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.

You should not use this medicine if you are allergic to ivacaftor or tezacaftor.

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

  • St. John's wort;
  • seizure medicine--carbamazepine, phenobarbital, phenytoin; or
  • tuberculosis medicine--rifabutin, rifampin.

Tell your doctor if you have ever had:

  • liver disease; or
  • kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Ivacaftor and tezacaftor is not approved for use by anyone younger than 12 years old.BasicDescription Back to TopIvacaftor-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 problems; 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:

  • stuffy nose;
  • dizziness;
  • nausea; or
  • headache.

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.

Ivacaftor-Tezacaftor Interactions

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Grapefruit and Seville oranges may interact with ivacaftor and tezacaftor and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

Tell your doctor about all your other medicines, especially:

  • an antibiotic--clarithromycin, erythromycin, telithromycin; or
  • antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole.

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

Ivacaftor-Tezacaftor Dosage

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

Ivacaftor and tezacaftor is supplied as two separate daily tablets. A yellow tablet is taken in the morning and a blue tablet is taken 12 hours later. Follow your doctor's dosing instructions very carefully.

To help your body absorb this medicine, take each dose with a food that contains fat, such as whole milk, cheese, yogurt, hummus, peanut butter, eggs, or nuts. Get familiar with the list of foods you should eat while taking this medicine.

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

A child using this medicine may need frequent eye exams.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

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

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