Check Your Eligibility
KALYDECO is for people with cystic fibrosis (CF) age 1 month and older with at least one CF gene mutation that is responsive to KALYDECO. Enter your or your loved one's mutations to see if at least one of them is eligible. You can also use the chart below to determine if you are eligible for KALYDECO.
If you don’t know your or your loved one's CF gene mutations, it’s important to work with your healthcare provider to identify them. Knowing your mutations can help determine if KALYDECO could be right for you.
*Use of KALYDECO in patients aged 1 month to less than 6 months born from a pregnancy lasting (gestational age) less than 37 weeks has not been evaluated.
Based on the information you entered, you may be eligible for KALYDECO.
Talk with your healthcare provider to see if KALYDECO is right for you.
Here is some information about KALYDECO that may be helpful:Neither CF gene mutation you entered is eligible for KALYDECO.
Talk with your healthcare provider to discuss your CF care plan and treatment options that may be right for you.
We’re sorry, we do not recognize 1 or both of the mutations you entered.
Talk to your healthcare provider to discuss your CF care plan. They can help determine what treatment option is right for you at this time.
You can view the full list of eligible KALYDECO mutations here.
See which mutations KALYDECO is indicated for
KALYDECO is for the treatment of CF in people age 1 month and older who have one of the following 97 CF gene mutations. If you don't see your mutation in this chart, try using the tool above or talk to your healthcare provider.
Talk to your doctor to learn if you have an indicated CF gene mutation
It is not known if KALYDECO is safe and effective in children under 1 month of age.
Keep in mind that not all mutations were evaluated in clinical studies, and those that were evaluated were not studied in all age groups. However, KALYDECO is approved for people age 1 month and older with any of the 97 indicated mutations listed above.
Important Safety Information
Before taking KALYDECO, tell your doctor about all of your medical conditions, including if you:
- have liver or kidney problems
- 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.
What is KALYDECO® (ivacaftor)?
What is KALYDECO®
(ivacaftor)?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 1 month and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR gene) that is responsive to KALYDECO.
Talk to your doctor to learn if you have an indicated CF gene mutation.
It is not known if KALYDECO is safe and effective in children under 1 month of age.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Especially tell your doctor if you take:
- the antibiotics rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
- seizure medications such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®) or phenytoin (DILANTIN®, PHENYTEK®)
- St. John’s wort
- antifungal medications such as ketoconazole, itraconazole (SPORANOX®), posaconazole (NOXAFIL®), voriconazole (VFEND®), or fluconazole (DIFLUCAN®)
- antibiotics such as telithromycin, clarithromycin (BIAXIN®), or erythromycin (ERY-TAB®)
What should I avoid while taking KALYDECO?
- KALYDECO can cause dizziness in some people who take it. If you experience dizziness, do not drive or operate machines until symptoms improve.
- You should avoid food or drink containing grapefruit while you are taking KALYDECO
What are the possible side effects of KALYDECO?
KALYDECO can cause serious side effects, including:
High liver enzymes in the blood, which have happened in people receiving KALYDECO. Your doctor will do blood tests to check your liver:
- before you start KALYDECO
- every 3 months during your first year of taking KALYDECO
- every year while you are taking KALYDECO
For people who have had high liver enzymes in the past, your doctor may do blood tests to check the liver more often.
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
Abnormality of the eye lens (cataract), which has happened in some children and adolescents receiving KALYDECO. Your doctor should perform eye examinations before and during treatment with KALYDECO to look for cataracts.
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.
Use of KALYDECO in children aged 1 month to less than 6 months born from a pregnancy lasting (gestational age) less than 37 weeks has not been evaluated.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For further information, please see full Prescribing Information, including Patient Information.
People with CF pictured may or may not be taking KALYDECO.