How to Take KALYDECO®

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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
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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
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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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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.

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Choose tablets or oral granules.

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

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

KALYDECO 150 mg tablets packagingTablets depicted here are not actual size.

How should you take KALYDECO Tablets?

  • Take KALYDECO exactly as your doctor tells you to take it
  • Take your doses of KALYDECO 12 hours apart
  • Each KALYDECO box contains 4 individual blister cards. Each blister card contains 14 pills—7 morning doses and 7 evening doses

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.

KALYDECO is supplied as oral granules for children with CF age 2 to less than 6 years

KALYDECO 50 mg and 75 mg oral granules packagingGranules depicted here are not 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 formulations (50-mg and 75-mg packets). Your child's doctor will prescribe the appropriate dose based on your child's weight.

How should my child take KALYDECO?

  • Your child should take KALYDECO exactly as his or her doctor tells you he or she should take it
  • Your child should take his or her doses of KALYDECO 12 hours apart

Meet Grant and learn how to take KALYDECO oral granules

The following video shows how to prepare and administer KALYDECO granules.

How to Take KALYDECO Oral Granules

How to take KALYDECO oral granules

Step 1

Carefully pour all of the KALYDECO granules in the packet into 1 teaspoon (5 mL) of soft food or liquid, and mix.

Examples of soft foods or liquids that you can mix with KALYDECO granules include:

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  • Applesauce, or other puréed fruits
    or vegetables,
  • Yogurt
or
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  • Water
  • Milk
  • Juice

Food or liquid should be at or below room temperature. After mixing, give KALYDECO within 1 hour. Make sure all of the medicine mixture is taken.

Step 2

Give your child fat-containing food just before or after the dose of KALYDECO granules. Click here to see some suggestions.

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Examples of fat-containing foods include:

  • Eggs
  • Peanut butter
  • Whole-milk cheese pizza
  • Whole milk, cheese, or whole-milk yogurt

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.

What is KALYDECO® (ivacaftor)?

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years 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 2 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®) 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.

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 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.

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®); or 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, and 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; 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 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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