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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:

You should not use this medicine if you have 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.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

If a dose is missed:

  • 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.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you are also using medicine to treat an infection (such as clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Biaxin®, Diflucan®, Ery-tab®, Ketek®, Nizoral®, Noxafil®, Sporanox®, or Vfend®), medicine to treat tuberculosis (such as rifampin, rifabutin, Mycobutin®, Rifadin®, or Rifamate®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, or Tegretol®), or St John's wort. Tell your doctor if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), digoxin (Lanoxin®), midazolam (Versed®), or tacrolimus (Prograf®).
  • Do not eat or drink anything that contains grapefruit or Seville oranges.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease or liver disease.
  • Check with your doctor right away if you have pain or tenderness in your upper right side, pale stools, dark urine, loss of appetite, nausea, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • This medicine may make you dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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-colored urine or pale stools
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach
  • Yellowing of your skin or the whites of your 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: 4/4/2014

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