Take KALYDECO every 12 hours or as directed by your healthcare provider
- 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
- Fat-containing food helps the body absorb KALYDECO better
See examples of fat-containing foods.
- Avoid foods or drinks that contain grapefruit, as these may affect the amount of KALYDECO in the body
Take KALYDECO, plus all your other cystic fibrosis (CF) therapies, exactly as your healthcare provider tells you to take them
- 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
Before you start taking KALYDECO, be sure KALYDECO is right for you.
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 4 months to less than 6 years old
Meet Grant and learn how to take KALYDECO oral granules
View Important Safety Information and full Prescribing Information, including Patient Information, for KALYDECO.
How KALYDECO oral granules are packaged
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 3 different strengths (25-mg, 50-mg and 75-mg packets). Your child's doctor will prescribe the appropriate dose based on your child's weight.
KALYDECO oral granules recommended doses
| IF YOUR CHILD IS: | AND WEIGHS: | THE RECOMMENDED DOSE IS: |
|---|---|---|
| 4 months to less than 6 months old | 11 pounds or more (5 kg or more) |
One 25-mg packet every 12 hours Total daily dose: 50 mg |
| 6 months to less than 6 years old | 11 pounds to less than 15 pounds (5 kg to <7 kg) |
One 25-mg packet every 12 hours Total daily dose: 50 mg |
| 15 pounds to less than 31 pounds (7 kg to <14 kg) |
One 50-mg packet every 12 hours Total daily dose: 100 mg |
|
| 31 pounds or more (14 kg or more) |
One 75-mg packet every 12 hours Total daily dose: 150 mg |
| IF YOUR CHILD IS: | |||
| 4 months to less than 6 months old | 6 months to less than 6 years old | ||
| AND WEIGHS: | |||
| 11 pounds or more (5 kg or more) | 11 pounds to less than 15 pounds (5 kg to <7 kg) | 15 pounds to less than 31 pounds (7 kg to <14 kg) | 31 pounds or more (14 kg or more) |
| THE RECOMMENDED DOSE IS: | |||
| One 25-mg packet every 12 hours Total daily dose: 50 mg | One 25-mg packet every 12 hours Total daily dose: 50 mg | One 50-mg packet every 12 hours Total daily dose: 100 mg | One 75-mg packet every 12 hours Total daily dose: 150 mg |
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
- 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 age-appropriate soft food or liquid and mix. Food should be at or below room temperature
- Here are examples of foods and liquids you can mix KALYDECO granules into. Remember, every child is different, so be sure to talk to your healthcare provider about what the best options are for your child
- Breast milk
- Infant formula
- Puréed fruits or vegetables
- Yogurt
- Applesauce
- Water
- Milk
- Juice
- Then, mix the granules with the 1 teaspoon of food or liquid
Step 2: Administration
- 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
Always take KALYDECO with fat-containing food
- Make sure to give your child age-appropriate fat-containing food just before or after the dose of KALYDECO granules. This helps the body absorb KALYDECO better
- Here are suggestions for fat-containing foods to give your child:
- Breast milk
- Infant formula
- Whole milk
- Whole-milk yogurt
- Eggs
- Whole-milk cheese
- Butter
- Peanut butter
- Cheese pizza
- Talk to your healthcare provider about fat-containing foods appropriate for your child when taking KALYDECO granules
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
Not 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.
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.