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Ivacaftor granules

Generic Name: ivacaftor (EYE-va-KAF-tor)
Brand Name: Kalydeco

Ivacaftor granules are used for:

Treating cystic fibrosis (CF) in certain patients.

Ivacaftor granules are a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator. It works by increasing the transfer of chloride into cells.

Do NOT use ivacaftor granules if:

  • you are allergic to any ingredient in ivacaftor granules
  • you are taking carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using ivacaftor granules:

Some medical conditions may interact with ivacaftor granules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems
  • if you have been exposed to radiation

Some MEDICINES MAY INTERACT with ivacaftor granules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone) because the risk of developing cataracts may be increased
  • Clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, or voriconazole because they may increase the risk of ivacaftor granules's side effects
  • Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's wort because they may decrease ivacaftor granules's effectiveness
  • Cyclosporine, digoxin, midazolam, or tacrolimus because the risk of their side effects may be increased by ivacaftor granules

This may not be a complete list of all interactions that may occur. Ask your health care provider if ivacaftor granules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ivacaftor granules:

Use ivacaftor granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ivacaftor granules. Talk to your pharmacist if you have questions about this information.
  • Mix the contents of the packet with 1 teaspoon (5 mL) of soft food or liquid. This includes pureed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Food or liquid should be at or below room temperature.
  • Take ivacaftor granules within 1 hour of mixing.
  • Take ivacaftor granules by mouth just before or just after fat-containing food (eg, eggs; butter; peanut butter; cheese pizza; whole-milk dairy products, such as whole milk, cheese, or yogurt).
  • Avoid food or drink containing grapefruit or Seville oranges while you are taking ivacaftor granules.
  • Take your doses at least 12 hours apart.
  • If you miss a dose of ivacaftor granules, take it as soon as possible. If it is has been 6 hours or more since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ivacaftor granules.

Important safety information:

  • Tell your doctor or dentist that you take ivacaftor granules before you receive any medical or dental care, emergency care, or surgery.
  • Ivacaftor granules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use ivacaftor granules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • If it has not already been done, a test to find out what type of CF gene mutation you have should be performed before you take ivacaftor granules. Ivacaftor granules should not be used by patients with certain CF gene mutations. Discuss any questions or concerns with your doctor.
  • Cataracts have happened in children taking ivacaftor granules. Have an eye exam before starting ivacaftor granules and while taking it. Discuss any questions or concerns with the doctor.
  • Lab tests may be performed while you use ivacaftor granules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ivacaftor granules should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ivacaftor granules while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use ivacaftor granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ivacaftor granules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; diarrhea; dizziness; headache; mild stomach pain; muscle or joint pain; nausea; symptoms of upper respiratory tract infection (eg, cough, runny or stuffy nose, sneezing, sore throat).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); chest pain; symptoms of liver problems (eg, dark urine, loss of appetite, stomach pain or discomfort, unusual nausea or vomiting, yellowing of the skin or eyes); symptoms of high blood sugar (eg, confusion; drowsiness; flushing; fruit-like breath odor; increased thirst, hunger, or urination; rapid breathing); symptoms of low blood sugar (eg, increased sweating, weakness, tremors, fainting, drowsiness, severe or persistent dizziness or headache, chills, fast heartbeat, vision changes, increased hunger); vision changes; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ivacaftor granules:

Store ivacaftor granules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not take ivacaftor granules after the expiration date on the package. Keep ivacaftor granules out of the reach of children and away from pets.

General information:

  • If you have any questions about ivacaftor granules, please talk with your doctor, pharmacist, or other health care provider.
  • Ivacaftor granules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ivacaftor granules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ivacaftor granules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ivacaftor granules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using ivacaftor granules.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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