Who KALYDECO® Is For

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.

1 month and older

Learn how to enter 2 or more mutations

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.

View Eligible Mutations

 
711+3A→G* F311del I148T R75Q S589N
2789+5G→A* F311L I175V R117C* S737F
3272-26A→G* F508C I807M R117G S945L*
3849+10kbC→T* F508C;S1251N† I1027T R117H* S977F*
A120T F1052V I1139V R117L S1159F
A234D F1074L K1060T R117P S1159P
A349V G178E L206W* R170H S1251N*
A455E* G178R* L320V R347H* S1255P*
A1067T G194R L967S R347L T338I
D110E G314E L997F R352Q* T1053I
D110H G551D* L1480P R553Q V232D
D192G G551S* M152V R668C V562I
D579G* G576A M952I R792G V754M
D924N G970D M952T R933G V1293G
D1152H* G1069R P67L* R1070Q W1282R
D1270N G1244E* Q237E R1070W* Y1014C
E56K G1249R Q237H R1162L Y1032C
E193K G1349D* Q359R R1283M  
E822K H939R Q1291R S549N*  
E831X* H1375P R74W S549R*  
711+3A→G* F311del I148T
2789+5G→A* F311L I175V
3272-26A→G* F508C I807M
3849+10kbC→T* F508C;S1251N† I1027T
A120T F1052V I1139V
A234D F1074L K1060T
A349V G178E L206W*
A455E* G178R* L320V
A1067T G194R L967S
D110E G314E L997F
D110H G551D* L1480P
D192G G551S* M152V
D579G* G576A M952I
D924N G970D M952T
D1152H* G1069R P67L*
D1270N G1244E* Q237E
E56K G1249R Q237H
E193K G1349D* Q359R
E822K H939R Q1291R
E831X* H1375P R74W
R75Q S589N R117C*
S737F R117G S945L*
R117H* S977F* R117L
S1159F R117P S1159P
R170H S1251N* R347H*
S1255P* R347L T338I
R352Q* T1053I R553Q
V232D R668C V562I
R792G R933G V754M
V1293G R1070Q W1282R
R1070W* R1162L Y1014C
Y1032C R1283M  
S549N* S549R*  

*Clinical data exists for these mutations. See clinical studies.

Complex/compound mutations. Most people with CF have 2 CF mutations, 1 on each copy of the CF gene. However, in rare instances, 1 copy of the CF gene can have more than 1 mutation. This is called a compound, or complex, mutation.

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 allergic to KALYDECO or any ingredients in KALYDECO. See the Patient Information for a list of ingredients
  • 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)?

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 medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
  • St. John’s wort
  • antifungal medicines 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
  • 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
  • Serious allergic reactions have happened to people who are treated with KALYDECO. Call your healthcare provider or go to the emergency room right away if you have symptoms of an allergic reaction. Symptoms of an allergic reaction may include:

 

  • rash or hives
  • tightness of the chest or throat or difficulty breathing
  • light-headedness or dizziness
  • 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.