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Kalydeco

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

What is ivacaftor?

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

Ivacaftor is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take ivacaftor, you may need a medical test to make sure you have this gene mutation.

Ivacaftor may also be used for purposes not listed in this medication guide.

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

You should not use ivacaftor if you are allergic to it.

Before you take ivacaftor, tell your doctor if you have liver or kidney disease.

Ivacaftor should be taken with a food that contains fat, such as butter, peanut butter, eggs, cheese pizza. Follow your doctor's instructions very carefully.

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

Grapefruit, grapefruit juice, and Seville oranges may interact with ivacaftor and lead to unwanted effects. Discuss the use of grapefruit and orange products with your doctor.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

There are many other drugs that can interact with ivacaftor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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

You should not use ivacaftor if you are allergic to it.

To make sure you can safely use ivacaftor, tell your doctor if you have any of these other conditions:

  • liver disease; or

  • kidney disease.

FDA pregnancy category B. Ivacaftor is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ivacaftor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ivacaftor?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ivacaftor is usually taken once every 12 hours with a food that contains fat, such as butter, peanut butter, eggs, cheese pizza. Follow your doctor's instructions.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking ivacaftor?

Grapefruit, grapefruit juice, and Seville oranges may interact with ivacaftor and lead to unwanted effects. Discuss the use of grapefruit and orange products with your doctor.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ivacaftor side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain;

  • chest pain, wheezing, feeling short of breath;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery).

Less serious side effects may include:

  • headache;

  • nausea, diarrhea, stomach pain;

  • dizziness;

  • acne or mild rash;

  • joint or muscle pain; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Side effects (in more detail)

What other drugs will affect ivacaftor?

Tell your doctor about all other medicines you use, especially:

  • bosentan (Tracleer);

  • conivaptan (Vaprisol);

  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

  • imatinib (Gleevec);

  • isoniazid (for treating tuberculosis);

  • midazolam (Versed);

  • nefazodone;

  • St. John's wort;

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

  • antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), posaconazole (Noxafil), or voriconazole (Vfend);

  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  • heart or blood pressure medication such as digoxin (Lanoxin, digitalis), nicardipine (Cardene), or quinidine (Quin-G);

  • the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);

  • HIV/AIDS medication such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, Kaletra), or saquinavir (Invirase);

  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf).

  • medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil); or

  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

There may be other drugs that can interact with ivacaftor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about ivacaftor.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02. Revision Date: 2013-11-25, 4:23:30 PM.

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