Kalydeco® tablets
This product is manufactured by Vertex Pharmaceuticals using the ingredient ivacaftor.
This product is taken orally.
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orally
Why is it prescribed?
Ivacaftor is used for the treatment of cystic fibrosis (CF) in children age 2 months and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
- Each box contains 4 individual blister cards.
- There are 7 days of tablets for each blister card. Each blister card contains 14 tablets: 7 morning doses and 7 evening doses.
- You may cut along the dotted line to separate your doses from the blister card.
- Morning Dose: unpeel the paper backing from a blister card. Do not push the tablet through the paper backing because the tablets could break. Remove one tablet and swallow it whole with food that contains fat.
- Evening Dose: 12 hours after your first dose, unpeel the paper backing from another blister card to remove one tablet and swallow it whole with food that contains fat.
- Do not crush or chew the tablets.
- Kalydeco® should always be taken just before or just after fat-containing food to ensure you get the proper amount in your system.
- If you miss a dose of Kalydeco® and it is within 6 hours of when you usually take it, take your dose 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 when you usually take it. Do not take 2 doses at the same time to make up for your missed dose.
- Store at or below 30°C.
Alternatives
Other products that have the same ingredient as Kalydeco® tablets are •Kalydeco® granules •Orkambi® granules •Orkambi® tablets •Symdeko™ tablets •Trikafta® granules •Trikafta® tablets •
See other products used in the treatment of •cystic fibrosis •
Recommended dose for individuals 6 months of age and older who weigh ≥25 kg: 1 tablet (150mg) twice daily
For dosage in children who weigh <25 kg, see Kalydeco® granules.
Various mutations of the cystic fibrosis gene block the "gates" that allow the flow of salt across the cell membranes. This causes mucus to become thick and clog the lungs. Ivacaftor helps "open the gates" more often allowing more salt to pass through. The thick mucus is reduced and cystic fibrosis symptoms lessen.
Important potential side effects. These are not common but are possible:
- liver problems
- low blood sugar
- allergic reactions
Contact your doctor if any of these side effects persists or are bothersome:
- diarrhea
- nausea
- stomach (abdominal) pain
- common cold
- runny nose
- upper respiratory tract infection
- changes in the type of bacteria in your sputum
- headache
- dizziness
- nasal congestion
- sinus congestion
- sore throat
- rash
- joint pain
- This medication may cause abnormal blood results. Your doctor will decide if you need blood tests.
- Drive and use machinery with caution as you may feel dizzy.
- Do not take this medication if you are allergic to any part of it.
Take this medication with caution if you:
- have kidney or liver problems
- have cataracts
The following medications may interact with ivacaftor:
- antifungals such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole
- some antibiotics such as clarithromycin, erythromycin, rifampin, rifabutin
- some anti-seizure medications such as phenobarbital, carbamazepine, phenytoin
- some medications used to treat anxiety, insomnia, and other conditions such as midazolam, alprazolam, diazepam, triazolam
- digoxin
- medications used after a transplant such as cyclosporine and tacrolimus
- warfarin
- St. John’s wort
- products that contain grapefruit
Use in pregnancy and breastfeeding: Little is known about the safety of this medication when used in pregnancy and breastfeeding. Consult your doctor or pharmacist before use.