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.
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:
To make sure Kalydeco is safe for you, tell your doctor if you have:
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liver disease; or
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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?
Kalydeco is usually taken every 12 hours. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Take with a food that contains fat, such as butter, peanut butter, eggs, cheese pizza. Follow your doctor"s instructions very carefully.
For children 2 to 6 years old who take the oral granules: Mix the granules with 1 teaspoon of liquid or soft food such as pudding, yogurt, applesauce, water, fruit juice, or milk. Mix only 1 dose at a time, and use the mixture within 1 hour after mixing. Then feed the child a high-fat food such as eggs, peanut butter, cheese, yogurt, or whole milk.
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. If you are more than 6 hours late, skip the missed 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. Avoid the use of these products while taking ivacafto.
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:
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severe stomach pain;
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vision problems, eye pain;
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low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
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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:
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dizziness;
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rash;
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headache;
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stomach pain, nausea, diarrhea; or
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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:
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an antibiotic - ciprofloxacin, clarithromycin, erythromycin, telithromycin; or
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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.
