Ivacaftor Oral tablet

What is this medicine?

IVACAFTOR (EYE va KAF tor) is used to treat cystic fibrosis (CF) in patients who have certain mutations in their CF gene.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease

• liver disease

• an unusual or allergic reaction to ivacaftor, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with fat-containing food such as eggs, peanut butter, or cheese pizza. Follow the directions on the prescription label. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years of age for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 6 hours, then do not take

the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• grapefruit juice

• rifabutin

• rifampin

• Seville oranges

• St. John's Wort

This medicine may also interact with the following medications:

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• certain medicines for anxiety or sleep

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole

• cyclosporine

• digoxin

• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Your vision and blood may be tested before and during use of this medicine.

Tell your doctor or health care professional right away if you have any change in your eyesight.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To avoid dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older person. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• dark urine

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite

• right upper belly pain

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• dizziness

• headache

• joint pain

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 to 30 degrees C (59 to 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.