Kalydeco

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

What is Kalydeco?

Kalydeco (ivacaftor) is used to treat cystic fibrosis in adults and children who are at least 2 years old.

Kalydeco is for use only in patients with a specific gene mutation related to cystic fibrosis.

Before you take Kalydeco, you may need a medical test to make sure you have this gene mutation.

Important information

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

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

Kalydeco 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: Cystic Fibrosis: Living With The Octopus Inside Your Chest

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

To be sure Kalydeco 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 Kalydeco. 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.

Before taking this medicine

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

Some medicines can interact with ivacaftor and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • rifabutin or rifampin;

  • St. John's wort; or

  • seizure medicine such as carbamazepine, phenobarbital, or phenytoin.

To make sure Kalydeco is safe for you, tell your doctor if you have:

  • liver disease; or

  • kidney disease.

Kalydeco is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Ivacaftor may pass into breast milk and could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Kalydeco is not approved for use by anyone younger than 2 years old.

How should I take Kalydeco?

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

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

You will need frequent blood tests to check your liver function during treatment.

A child using this medicine may need frequent eye exams.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take it.

Kalydeco dosing information

Usual Adult Dose for Cystic Fibrosis:

150 mg orally every 12 hours

Uses:
-For the treatment of cystic fibrosis (CF) in patients six years and older with one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R
-For the treatment of CF in patients age 6 years and older who have an R117H mutation in the CFTR gene

Comments:
-This drug should be taken with fat-containing food.

Usual Pediatric Dose for Cystic Fibrosis:

6 years and older:
150 mg orally every 12 hours

Uses:
-For the treatment of cystic fibrosis (CF) in patients six years and older with one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R
-For the treatment of CF in patients age 6 years and older who have an R117H mutation in the CFTR gene

Comments:
-This drug should be taken with fat-containing food.

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.

What should I avoid while taking Kalydeco?

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

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

Kalydeco side effects

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

Call your doctor at once if you have:

  • severe stomach pain;

  • vision problems, eye pain;

  • low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

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

Common Kalydeco side effects may include:

  • abnormal liver function tests;

  • dizziness;

  • rash;

  • headache;

  • stomach pain, nausea, diarrhea; 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 Kalydeco?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Kalydeco, especially:

  • an antibiotic - clarithromycin, erythromycin, telithromycin; or

  • antifungal medicine - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may interact with ivacaftor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Kalydeco.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Kalydeco 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 1996-2015 Cerner Multum, Inc. Version: 2.01. Revision Date: 2015-01-21, 10:47:28 AM.

Hide
(web1)