Kalydeco

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

Kalydeco is used for:

Treating cystic fibrosis (CF) in certain patients.

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

Do NOT use Kalydeco if:

  • you are allergic to any ingredient in Kalydeco
  • you are taking carbamazepine, enzalutamide, a hydantoin (eg, phenytoin), phenobarbital, primidone, a rifamycin (eg, rifabutin, rifampin), or St. John's wort

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

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using Kalydeco:

Some medical conditions may interact with Kalydeco. 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

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

  • Aprepitant, azole antifungals (eg, fluconazole, ketoconazole, voriconazole), cobicistat, diltiazem, fosaprepitant, macrolide antibiotics (eg, clarithromycin, erythromycin), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or verapamil because they may increase the risk of Kalydeco's side effects
  • Carbamazepine, dexamethasone, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, prednisone, primidone, rifamycins (eg, rifabutin, rifampin), or St. John's wort because they may decrease Kalydeco's effectiveness
  • Alprazolam, cyclosporine, diazepam, digoxin, midazolam, tacrolimus, triazolam, or warfarin because the risk of their side effects may be increased by Kalydeco

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kalydeco 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 Kalydeco:

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

  • An extra patient leaflet is available with Kalydeco. Talk to your pharmacist if you have questions about this information.
  • Take Kalydeco by mouth with fat-containing food (eg, eggs, butter, peanut butter, cheese pizza, cheeses, nuts, whole milk, meat).
  • Avoid food or drink containing grapefruit or Seville oranges while you are taking Kalydeco.
  • If you miss a dose of Kalydeco, take it as soon as possible. If it is almost time for your next 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 Kalydeco.

Important safety information:

  • Kalydeco may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Kalydeco 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 Kalydeco. Kalydeco should not be used by patients with certain CF gene mutations. Discuss any questions or concerns with your doctor.
  • Lab tests, including liver function, may be performed while you use Kalydeco. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Kalydeco should be used with extreme caution in CHILDREN younger than 6 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 Kalydeco while you are pregnant. It is not known if Kalydeco is found in breast milk. If you are or will be breast-feeding while you use Kalydeco, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Kalydeco:

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); 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 low blood sugar (eg, increased sweating, weakness, tremors, fainting, drowsiness, severe or persistent dizziness or headache, chills, fast heartbeat, vision changes, increased hunger); 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. Symptoms may include diarrhea; dizziness.

Proper storage of Kalydeco:

Store Kalydeco at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not take Kalydeco after the expiration date on the package. Keep Kalydeco out of the reach of children and away from pets.

General information:

  • If you have any questions about Kalydeco, please talk with your doctor, pharmacist, or other health care provider.
  • Kalydeco is 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 Kalydeco 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 Kalydeco. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Kalydeco. 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 Kalydeco.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

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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