What is KALYDECO?

KALYDECO is a prescription medicine used for the treatment of cystic
fibrosis (CF) in patients age 6 years and older who have a certain mutation in
their CF gene called the G551D mutation.

KALYDECO is not for use in people with CF due to other mutations in the CF gene. It is not effective in
CF patients with two copies of the F508del mutation (F508del/F508del) in the CF gene.

It is not known if KALYDECO is safe and effective in children under 6 years of age.

Who should not take KALYDECO?

KALYDECO should not be used with certain medicines or herbal supplements such as antibiotics (rifampin, rifabutin), seizure medications (phenobarbital, carbamazepine, or phenytoin), or St. John's wort.

What should I tell my doctor before taking KALYDECO?

Before you start to take KALYDECO, tell your doctor if you:

• have liver or kidney problems
• drink grapefruit juice, or eat grapefruit or Seville oranges
• are pregnant or plan to become pregnant. It is not known if KALYDECO will harm your unborn baby. You and your doctor should decide if you will take KALYDECO while you are pregnant
• are breastfeeding or planning to breastfeed. It is not known if KALYDECO passes into your breast milk. You and your doctor should decide if you will take KALYDECO while you are breastfeeding

KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements as the dose of KALYDECO may need to be adjusted when taken with certain medications. Especially tell your doctor if you take antifungal medications (ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole), or antibiotics (telithromycin, clarithromycin, or erythromycin).

What are the possible side effects of KALYDECO?

KALYDECO can cause serious side effects. High liver enzymes in the blood have been reported in patients receiving KALYDECO. Your doctor will do blood tests to check your liver before and after starting KALYDECO.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area, yellowing of your skin or the white part of your eyes, loss of appetite, nausea or vomiting, or dark, amber-colored urine.

The most common side effects of KALYDECO include:

• headache
• upper respiratory tract infection (common cold), including:
• sore throat
• nasal or sinus congestion
• runny nose
• stomach (abdominal) pain
• diarrhea
• rash
• nausea
• dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of KALYDECO. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

KALYDECO is pronounced kuh-LYE-deh-koh.