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Ivacaftor (By mouth)

Ivacaftor (eye-va-KAF-tor)

Treats cystic fibrosis (CF).

Brand Name(s):

Kalydeco

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to ivacaftor.

How to Use This Medicine:

Tablet

  • Take your medicine as directed.
  • Take this medicine with food that contains fat, such as butter, cheese pizza, eggs, or peanut butter. This helps your body absorb the medicine.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. 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 foods and medicines can affect how ivacaftor works. Tell your doctor if you are also using any of the following:
    • Cyclosporine, digoxin, midazolam, St John's wort, or tacrolimus
    • Medicine to treat an infection (clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole), medicine to treat tuberculosis (rifampin, rifabutin), or medicine to treat seizures (carbamazepine, phenobarbital, phenytoin)
  • Do not eat or drink anything that contains grapefruit or Seville oranges.

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or liver disease.
  • This medicine may make you dizzy. Do not drive or do anything that could be dangerous until 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
  • 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 or dizziness
  • Joint or muscle pain
  • Mild nausea, stomach pain, or diarrhea
  • Rash
  • Stuffy or runny nose, sore throat

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


Last Updated: 11/4/2014
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