ivacaftor and tezacaftor

Pronunciation: EYE va KAF tor and TEZ a KAF tor

Brand: Symdeko

Symdeko

slide 1 of 1, Symdeko,

150 mg-100 mg and ivacaftor 150 mg

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What is the most important information I should know about ivacaftor and tezacaftor?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is ivacaftor and tezacaftor?

Ivacaftor and tezacaftor is a combination medicine used to treat cystic fibrosis in adults and children who are at least 6 years old.

Ivacaftor and tezacaftor 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.

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

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.

Tell your doctor if you are pregnant or breastfeeding.

Ivacaftor and tezacaftor is not approved for use by anyone younger than 6 years old.

How should I take ivacaftor and tezacaftor?

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.

Always take this medicine with food that contains fat, such as butter, peanut butter, whole milk, cheese, yogurt, or cheese pizza. Follow your doctor's dosing instructions very carefully.

You will need frequent blood tests to check your liver function. Your blood pressure may also need to be checked often.

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.

What happens if I miss a dose?

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.

If you miss doses or stop taking ivacaftor and tezacaftor for more than 1 week, call your doctor before you start taking the medicine again. You may need a different dose.

What happens if I overdose?

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

What should I avoid while taking ivacaftor and tezacaftor?

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.

What are the possible side effects of ivacaftor and tezacaftor?

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.

What other drugs will affect ivacaftor and tezacaftor?

Your doctor may adjust your ivacaftor and tezacaftor dose if you also use 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.

Where can I get more information?

Your pharmacist can provide more information about ivacaftor and tezacaftor.

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