Ivacaftor oral granules

What is this medication?

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.

COMMON BRAND NAME(S): Kalydeco

What should I tell my care team before I take this medication?

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 breast-feeding

How should I use this medication?

Take this medication by mouth just before or just after eating fat-containing food such as eggs, peanut butter, cheese pizza, or whole-milk dairy products. Take it as directed on the prescription label at the same time every day. Open the packet and put the contents in 1 teaspoonful of soft food or liquid, such as yogurt, applesauce, water, breast milk, infant formula, milk, or juice. Take the dose right away after mixing. Keep taking this medication unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 4 months for selected conditions, precautions do apply.

Overdosage: If you think you have 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 medication?

Do not take this medication with any of the following:

• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Grapefruit juice
• Rifabutin
• Rifampin
• Seville oranges
• St. John's Wort

This medication may also interact with the following:

• Certain antibiotics, such as clarithromycin, erythromycin, telithromycin
• Certain medications for anxiety or sleep
• Certain medications for fungal infections, such as 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 medication?

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 ride a bicycle, drive, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly. This reduces the risk of dizzy or fainting spells. Avoid cough and cold medicines, alcohol, and activities that may make you drowsy or dizzy.

What side effects may I notice from receiving this medication?

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 of 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 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 medication?

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.