How to Take KALYDECO®

KALYDECO is for people with cystic fibrosis (CF) age 12 months and older with at least 1 mutation in their CF gene responsive to KALYDECO. It is not known if KALYDECO is safe and effective in younger children.

Take KALYDECO every 12 hours or as directed by your healthcare provider

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  • Taking KALYDECO every 12 hours helps keep enough medicine in the body
  • Remember, taking KALYDECO every 12 hours is not the same as taking it twice a day
  • Your dose may be different—your healthcare provider will tell you how much KALYDECO to take and when to take it

Always take KALYDECO with fat-containing food

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Fat-containing food helps the body absorb KALYDECO better. Click here for examples of fat-containing food.

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Avoid foods or drinks that contain grapefruit or Seville oranges, as these may affect the amount of KALYDECO in the body.

Take KALYDECO, plus all your other CF therapies, exactly as your healthcare provider tells you to take them

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Be sure to talk to your healthcare provider before starting, changing, or stopping any CF therapies or other medications, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Always take KALYDECO with fat-containing foods: learn more about why and get meal and snack ideas

Choose oral granules or tablets

To learn how to take KALYDECO oral granules or tablets, from how they're supplied to step-by-step instructions, choose one below.

KALYDECO is supplied as oral granules for children with CF age 12 months to less than 6 years

Meet Grant and learn how to take KALYDECO oral granules

How to take KALYDECO Oral Granules

How KALYDECO oral granules are packaged

KALYDECO 50 mg and 75 mg oral granules packagingNot actual size.

Each box of KALYDECO oral granules contains 4 wallet cards for a total of 56 unit dose packets—or a 28-day supply of granules.

Each wallet card contains 14 doses. This is enough for a week based on dosing twice a day every 12 hours.

KALYDECO granules are available in 2 different strengths (50-mg and 75-mg packets). Your child's doctor will prescribe the appropriate dose based on your child's weight.

How often should my child take KALYDECO?

  • Take KALYDECO every 12 hours with fat-containing food unless otherwise directed by your healthcare provider
  • Your child's dose may be different. Your child should take KALYDECO exactly as his or her doctor tells you he or she should take it

How to give your child KALYDECO oral granules

STEP 1: Preparation

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  • Hold 1 packet of KALYDECO oral granules with the cut line on top
  • Shake the packet gently to settle the KALYDECO granules
  • Tear or cut the packet open along the cut line
  • Carefully pour all of the KALYDECO granules into 1 teaspoon (5 mL) of soft food or liquid, such as applesauce or other pureed fruits or vegetables, yogurt, water, milk, or juice
    • Food or liquid should be at or below room temperature
  • Then, mix the granules with the 1 teaspoon of food or liquid

STEP 2: Administration

parent giving KALYDECO to a child
  • Within 1 hour of mixing, give KALYDECO to your child
  • Make sure the entire medicine mixture is taken

STEP 3: Fat-containing food before or after the dose

Fat-containing foods to take with KALYDECO
Always take KALYDECO with fat-containing food
  • Make sure to eat fat-containing food just before or after the dose of KALYDECO granules. This helps the body absorb KALYDECO better
  • Examples of fat-containing food include:
    • Eggs
    • Peanut butter
    • Whole-milk cheese pizza
    • Whole milk, cheese, or whole-milk yogurt
  • Your doctor can help you choose healthy fat-containing meals and snacks

What if your child misses a dose of KALYDECO?

If your child misses a dose of KALYDECO and it is within 6 hours of when he or she usually takes it, have your child take 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 he or she usually takes it, have your child skip that dose only and take the next dose with fat-containing food when he or she usually takes it. Do not take 2 doses at the same time to make up for a missed dose.

KALYDECO is supplied as tablets (150 mg) for people 6 years and older.

  • Each KALYDECO box contains 4 individual blister cards. Each blister card contains 14 pills—7 morning doses and 7 evening doses
KALYDECO® (ivacaftor) 150 mg tablets packagingNot actual size.

How often should you take KALYDECO tablets?

  • Take KALYDECO every 12 hours with fat-containing food unless otherwise directed by your healthcare provider
  • Your dose may be different. Take KALYDECO exactly as your doctor tells you to take it

What if you miss a dose of KALYDECO?

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.

What is KALYDECO® (ivacaftor)?

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 12 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 12 months of age.

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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®) or rifabutin (Mycobutin®)
  • seizure medicines such as phenobarbital, carbamazepine (Tegretol®, Carbatrol®, and Equetro®), or phenytoin (Dilantin®, Phenytek®)
  • St. John’s wort (Hypericum perforatum)

Talk to your doctor before taking KALYDECO if you take any of the medicines or supplements listed above.

EXPAND

What is KALYDECO® (ivacaftor)?

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 12 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 12 months 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®) or rifabutin (Mycobutin®)
  • seizure medicines such as phenobarbital, carbamazepine (Tegretol®, Carbatrol®, and Equetro®), or phenytoin (Dilantin®, Phenytek®)
  • St. John’s wort (Hypericum perforatum)

Talk to your doctor before taking KALYDECO if you take any of the medicines or supplements listed above.

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, 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 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 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 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.

Click here for KALYDECO full Prescribing Information, including Patient Information.