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Kalydeco is a medicine used to treat cystic fibrosis (an inherited disease that causes your mucus to be thick and sticky, and may result in difficulty breathing). Kalydeco is available as tablets and oral granules.
How does this medication work?
Kalydeco works by improving the function of a protein in the body to decrease the build-up of thick mucus in the lungs, thereby improving your symptoms.
What are the beneficial effects of this medication and when should I begin to have results?
What: In studies, people who took Kalydeco had improvement in lung function through 24 weeks of treatment.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Kalydeco exactly as your healthcare provider has prescribed.
How do I know it is working?
You may feel an improvement in your symptoms once you begin taking Kalydeco. This is a good indicator that your medication is working. Your healthcare provider may ask you questions to assess how well your symptoms are controlled.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
More common side effects may include: headache, nose and throat pain, upper respiratory infection, nasal stuffiness, abdominal (stomach area) pain, common cold, diarrhea, rash, nausea, dizziness.
Less common side effects may include:
Kalydeco may cause you to have high liver enzymes in the blood or abnormality of the eye lens (cataracts) in some children.
Do not take Kalydeco if you are allergic to it or any of its ingredients.
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Kalydeco. Also, talk to your healthcare provider about your complete medical history, especially if you have kidney or liver problems, vision problems, drink grapefruit juice or eat grapefruit or Seville oranges, or if you are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults and children ≥6 years: The recommended dose is one 150-milligram tablet every 12 hours.
Children 2-5 years: Your healthcare provider will prescribe the appropriate dose for your child based on his/her weight.
If you have liver impairment or are taking certain other medicines, your healthcare provider may adjust your dose appropriately.
Take Kalydeco exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Kalydeco without first talking with your healthcare provider.
Take Kalydeco tablets with fat-containing foods (such as eggs, butter, peanut butter, or cheese pizza).
Take Kalydeco oral granules just before or just after consuming food that contains fat.
The entire contents of each packet of oral granules should be mixed with 1 teaspoon (5 milliliters) of age-appropriate soft food or liquid and completely consumed within 1 hour. The food or liquid should be at or below room temperature.
Do not eat foods containing grapefruit or Seville oranges.
Do not drive a car, operate heavy machinery, or do other activities requiring mental alertness until you know how Kalydeco affects you.
If Kalydeco is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Kalydeco may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.
The effects of Kalydeco during pregnancy are unknown. Kalydeco may be found in your breast milk if you take it while breastfeeding. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
If you miss a dose of Kalydeco and it has been within 6 hours of the time it is usually taken, take it as soon as you remember. If more than 6 hours have passed, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.
Store at room temperature.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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