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KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 4 months and older who have at least one mutation in their CF 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 4 months of age.
| 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 | V754M | R933G |
| V1293G | R1070Q | W1282R |
| R1070W* | Y1014C | R1162L |
| 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.
Do not take KALYDECO if you take certain medicines or herbal supplements, such as: the antibiotics rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®); seizure medications such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®) or phenytoin (DILANTIN®, PHENYTEK®); or St. John's wort.
Talk to your doctor before taking KALYDECO if you take any of these medicines or supplements.
No, KALYDECO is not a cure for CF.
KALYDECO affects the CFTR protein "gating" in people with at least one mutation in their CF gene that is responsive to KALYDECO. KALYDECO helps the "gates" of the CFTR proteins stay open longer, allowing more chloride ions to move into and out of the cells. The movement of chloride ions may help keep a balance of salt and water in the lungs. KALYDECO does not increase the amount of CFTR proteins at the cell surface.
What is known about how KALYDECO works was learned from studies conducted in a laboratory. Keep in mind that results from laboratory studies do not always match how these medicines work in a person. If you have any questions about your treatment, please speak with your healthcare provider.
KALYDECO is not indicated for people with 2 copies of the F508del mutation.
Before you take KALYDECO, tell your doctor if you:
- have liver or kidney problems
- drink grapefruit juice or eat grapefruit
- 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 such as ketoconazole (e.g., NIZORAL®), itraconazole (e.g., SPORANOX®), posaconazole (e.g., NOXAFIL®), voriconazole (e.g., VFEND®), or fluconazole (e.g., DIFLUCAN®); or antibiotics such as telithromycin (e.g., KETEK®), clarithromycin (e.g., BIAXIN®), or erythromycin (e.g., ERY-TAB®).
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine or stop taking a medicine.
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 while you are taking 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 taking KALYDECO, and every year while you are taking KALYDECO
- For patients 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; or dark, amber-colored urine
- Abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving KALYDECO. Your doctor should perform eye examinations prior to and during treatment with KALYDECO to look for cataracts
- The most common side effects of KALYDECO include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and 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.
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 taking KALYDECO, and every year while you are taking KALYDECO
- For patients 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; or dark, amber-colored urine
Take KALYDECO orally every 12 hours with fat-containing food unless otherwise directed by your healthcare provider.
KALYDECO should be taken with fat-containing food because fat-containing food helps the body absorb KALYDECO better.
If you have questions about KALYDECO, please talk to your doctor. You can also find information about KALYDECO in the full Prescribing Information, including Patient Information.
Prescriptions for KALYDECO can only be filled at authorized specialty pharmacies. If you'd like to see a list of specialty pharmacies and specialty distributors, click here. Based on your health plan, there may be restrictions on which pharmacies you can use.
You may cut along the dotted line to separate your doses from the blister card.
KALYDECO should be stored at 68°F to 77°F (20°C to 25°C).
Do not use KALYDECO after the expiration date on the package.
Keep KALYDECO and all medicines out of the reach of children.
For people 6 years and older, KALYDECO tablets are supplied as light blue, film-coated, capsule-shaped tablets containing 150-mg of ivacaftor. Each tablet is printed with the characters "V 150" on one side and plain on the other.
Not actual size.
If you miss a dose of KALYDECO and it is within 6 hours of when you usually take it, take the dose of KALYDECO as prescribed with fat-containing food as soon as possible.
If you miss a dose and it is more than 6 hours after the time you usually take it, skip that dose only and take the next dose with fat-containing food when you usually take it.
Do not take 2 doses at the same time to make up for a missed dose.
If you have questions about KALYDECO, please talk to your healthcare provider. You can also find information about KALYDECO in the full Prescribing Information, including Patient Information.
The granules should be taken within 1 hour of mixing with soft food or liquid. Make sure all medicine is taken.
KALYDECO should be stored at room temperature between 68°F to 77°F (20°C to 25°C).
Do not use KALYDECO after the expiration date on the package.
Keep KALYDECO and all medicines out of the reach of children.
KALYDECO is supplied as oral granules (25-mg, 50-mg, or 75-mg packets) for people age 4 months to less than 6 years.
Not actual size.
The recommended dose of KALYDECO oral granules for children age 4 months to less than 6 months old who weigh more than 11 pounds (5 kg) is one 25-mg packet mixed with 1 teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 50 mg.
The recommended dose of KALYDECO oral granules for children age 6 months to less than 6 years old is based on weight.
Children who weigh 11 pounds to less than 15 pounds (5 kg to less than 7 kg) should take one 25-mg packet mixed with 1 teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 50 mg.
Children who weigh 15 pounds to less than 31 pounds (7 kg to less than 14 kg) should take one 50-mg packet mixed with 1 teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 100 mg.
Children who weigh 31 pounds (14 kg) or more should take one 75-mg packet mixed with one teaspoon (5 mL) of food or liquid every 12 hours for a total daily dose of 150 mg.
Give your child fat-containing food just before or just after the dose of KALYDECO granules. This helps the body absorb KALYDECO better.
Your child's dose may be different. Your doctor should tell you how much KALYDECO your child should take and when to take it.
Yes, KALYDECO oral granules can be mixed with 1 teaspoon (5 mL) of breast milk or prepared infant formula at or below room temperature. Be sure that the entire mixture is taken by the child within 1 hour. Remember your child should always take KALYDECO with a fat-containing food.
If your child misses a dose of KALYDECO and it is within 6 hours of when your child usually takes it, give the dose of KALYDECO as prescribed with fat-containing food as soon as possible.
If your child misses a dose and it is more than 6 hours after the time your child usually takes it, skip that dose only and give the next dose with fat-containing food when your child usually takes it.
Do not give 2 doses at the same time to make up for a missed dose.
Yes, you can mix KALYDECO granules with fat-containing food, for example, 1 teaspoon (5 mL) of whole-milk yogurt or milk, to give to your child. But your child should still eat fat-containing food just before or after taking the spoonful of the mixture.
Yes, breast milk and prepared infant formula qualify as fat-containing food.
The granules should be mixed with soft food or liquid at room temperature or below. The granules should not be mixed in items that are frozen or hot.
The entire contents of each packet should be mixed with 1 teaspoon (5 mL) of age-appropriate soft food or liquid. The mixture should be taken within 1 hour of being mixed. Make sure all medicine is taken.
In the clinical study, instruction was provided to give the dose of KALYDECO oral granules mixed into 1 teaspoon of an age-appropriate soft food or liquid, either orally with a syringe or with a spoon, every 12 hours along with a fat-containing food.
Direction was given to ensure the full contents of the syringe were administered.
KALYDECO granules should not be given with a bottle.
The granule formulation is sweetened but unflavored.
You should contact your child’s healthcare provider to discuss this. Your pharmacist may also be a good resource.
You should give your child KALYDECO oral granules every 12 hours or as prescribed by your child’s healthcare provider.
If your child misses a dose of KALYDECO and it is within 6 hours of when that dose is usually taken, give your child that dose of KALYDECO as prescribed with fat-containing food as soon as possible.
If more than 6 hours have passed, skip that dose only and give your child the next dose when you usually take it.
Do not give your child 2 doses at the same time to make up for a missed dose.
No, granules should be kept in the foil packet until they are ready to be used.
The packets are child-resistant.
KALYDECO granules (25-mg, 50-mg, or 75-mg) are for use in children who are 4 months to less than 6 years of age, while KALYDECO tablets (150-mg) are for use in children age 6 years and older. You and your child's healthcare provider should discuss when to transition your child to KALYDECO tablets.
Yes, you will need a new prescription when your child changes to a new strength or dosage form.
If you have questions about KALYDECO, please talk to your doctor. You can also find information about KALYDECO in the full Prescribing Information, including Patient Information.
Important Safety Information
Do not take KALYDECO if you take certain medicines or herbal supplements, such as:
- the antibiotics rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®)
- seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, and EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®)
- St. John’s wort
Talk to your doctor before taking KALYDECO if you take any of the medicines or supplements listed above.
What is KALYDECO® (ivacaftor)?
What is KALYDECO®
(ivacaftor)?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 4 months and older who have at least one mutation in their CF 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 4 months of age.
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
- 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 such as ketoconazole (e.g., NIZORAL®), itraconazole (e.g., SPORANOX®), posaconazole (e.g., NOXAFIL®), voriconazole (e.g., VFEND®), or fluconazole (e.g., DIFLUCAN®)
- antibiotics such as telithromycin (e.g., KETEK®), clarithromycin (e.g., BIAXIN®), or 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 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 taking KALYDECO
- every year while you are taking KALYDECO
For patients who have had high liver enzymes in the past, the 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) has been noted in some children and adolescents receiving KALYDECO. Your doctor should perform eye examinations prior to 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.
Call your doctor for medical advice about side effects. You are encouraged to 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.