What is KALYDECO (ivacaftor)?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have one of the following mutations in their CF gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
KALYDECO is not for use in people with CF due to other mutations in the CF gene. KALYDECO is not effective in patients with CF 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.
Important Safety Information
Who should not take KALYDECO?
Do not take KALYDECO if you take certain medicines or herbal supplements such as:
- The antibiotics:
- Rifampin (Rifamate®, Rifater®)
- Rifabutin (Mycobutin®)
- Seizure medications such as:
- Carbamazepine (Tegretol®, Carbatrol®, Equetro®)
- Phenytoin (Dilantin®, Phenytek®)
- St. John's Wort
Talk to your doctor before taking KALYDECO if you take any of these medicines or supplements.
What should I tell my doctor before taking KALYDECO?
Before you 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
- Herbal supplements
The dose of KALYDECO may need to be adjusted when taken with certain medications.
Especially tell your doctor if you take:
- Antifungal medications, such as:
- Ketoconazole (e.g., Nizoral®)
- Itraconazole (e.g., Sporanox®)
- Posaconazole (e.g., Noxafil®)
- Voriconazole (e.g., Vfend®)
- Fluconazole (e.g., Diflucan®)
- Or antibiotics, such as:
- Telithromycin (e.g., Ketek®)
- Clarithromycin (e.g., Biaxin®)
- Erythromycin (e.g., Ery-Tab®)
What should I avoid while taking KALYDECO?
KALYDECO can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how KALYDECO affects you.
You should avoid food containing grapefruit or Seville oranges while you are taking KALYDECO.
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 you start KALYDECO
- Every 3 months during your first year of therapy
- Every year while you are taking 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
- Dark, amber-colored urine
- The most common side effects include:
- Upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose
- Stomach (abdominal) pain
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 , or call 1-800-FDA-1088.
Click here for KALYDECO full Prescribing Information, including Patient Information.