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 months old and weigh at least 11 pounds (5 kilograms).
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.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
Before taking this medicine
You should not use ivacaftor if you are allergic to it.
Some medicines can cause unwanted or dangerous effects when used with ivacaftor. Your doctor may change your treatment plan if you also use:
rifabutin or rifampin;
St. John's wort; or
Tell your doctor if you have ever had:
liver disease; or
It is not known whether ivacaftor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Ivacaftor is not approved for use by anyone younger than 12 months old.
How should I take ivacaftor?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take ivacaftor with food that contains fat, such as butter, peanut butter, eggs, cheese, whole milk, yogurt, or cheese pizza. Follow your doctor's instructions very carefully.
To use ivacaftor oral granules: Mix the granules with 1 teaspoon of liquid or soft food such as water, juice, milk, pudding, yogurt, or applesauce. Mix only 1 dose at a time, and use the mixture within 1 hour after mixing. Feed the child a high-fat food just before or just after giving the granule mixture.
Take your doses at regular intervals, 12 hours apart.
Ivacaftor doses are based on age and weight in children. Children from 6 months to 5 years old should take oral granules. Children 6 and older should take tablets.
You will need frequent blood tests to check your liver function.
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.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.
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 ivacaftor?
Avoid driving or hazardous activity until you know how ivacaftor will affect you. Your reactions could be impaired.
Grapefruit and Seville oranges may interact with ivacaftor and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.
Ivacaftor side effects
Get emergency medical help if you have signs of an allergic reaction: 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;
Common side effects may include:
stomach pain, nausea, diarrhea; or
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.
Ivacaftor dosing information
Usual Adult Dose for Cystic Fibrosis:
150 mg orally every 12 hours
-This drug should be taken with fat-containing food, examples include: eggs, butter, peanut butter, cheese pizza, and whole milk dairy products.
-If the patient's genotype is unknown, an approved CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
-For the treatment of cystic fibrosis in patients having one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
Usual Pediatric Dose for Cystic Fibrosis:
Age: 6 months to less than 6 years:
Weight: 5 kg to less than 7 kg: 25 mg orally every 12 hours
Weight: 7 kg to less than 14 kg: 50 mg orally every 12 hours
Weight: 14 kg or greater: 75 mg orally every 12 hours
Age: 6 years and older:
150 mg orally every 12 hours
-The oral granules should be mixed with 5 mL of age-appropriate soft food or liquid and completely consumed; food or liquid should be at room temperature. See Administration Advice for further guidance.
-The oral tablet should be taken with fat-containing food, examples include: eggs, butter, peanut butter, cheese pizza, and whole milk dairy products.
-If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
-For the treatment of cystic fibrosis in patients 6 months or older having one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
What other drugs will affect ivacaftor?
Tell your doctor about all your other medicines, especially:
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.
Copyright 1996-2018 Cerner Multum, Inc. Version: 4.03.
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More about ivacaftor
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 1 Review
- Drug class: CFTR potentiators
Other brands: Kalydeco