What is the most important information I should know about ivacaftor?
Serious drug interactions can occur when certain medicines are used together with ivacaftor. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.
What is ivacaftor?
Ivacaftor is used to treat cystic fibrosis in adults and children who are at least 2 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 should I discuss with my healthcare provider before taking ivacaftor?
You should not use ivacaftor if you are allergic to it.
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 ivacaftor is safe for you, tell your doctor if you have:
- liver disease; or
- kidney disease.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ivacaftor may pass into breast milk and could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Ivacaftor is not approved for use by anyone younger than 2 years old.
How should I take ivacaftor?
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 ivacaftor 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 ivacaftor 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.
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 ivacaftor?
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 ivacaftor.
What are the possible side effects of ivacaftor?
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;
-
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 side effects may include:
- 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.
What other drugs will affect ivacaftor?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ivacaftor, especially:
-
an antibiotic --ciprofloxacin, 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 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.
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