Kalydeco® granules

Kalydeco® granules

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 wallets.
  • There are 7 days of granules in each wallet. Each wallet contains 14 packets of granules (7 morning doses and 7 evening doses).
  • Finish all doses from one wallet before starting a new one.
  • How to prepare the granules:
    • Remove the first dose from the wallet. Each packet is for single use only.
    • Hold the packet with cut line on top.
    • Shake the packet gently to settle the granules.
    • Tear or cut packet open along cut line.
    • Carefully pour all of the granules in the packet into 5 mL (1 teaspoonful) of soft food (e.g., puréed fruits or vegetables, yogurt, applesauce) or liquid (e.g., water, milk, breastmilk, infant formula, juice [except for grapefruit juice]). Food or liquid should be at or below room temperature.
    • Mix the granules with food or liquid.
    • After mixing, give the medication within 1 hour. Make sure all medicine is taken. This is very important for it to work properly and be effective.
    • If mixed with food, the granules must not be stored for future use.
  • Take the evening dose 12 hours after your morning dose. 
  • This medication should always be taken with a fat-containing food.
  • If you miss a dose 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® granules are •Kalydeco® tablets •Orkambi® granules •Orkambi® tablets •Symdeko™ tablets •Trikafta® granules •Trikafta® tablets •

See other products used in the treatment of •cystic fibrosis •

The recommended dosage is based on weight and age:

  • 2 months to less than 4 months of age and weight of ≥3 kg: 1 packet (13.4 mg) twice daily
  • 4 months to less than 6 months of age and weight of ≥5 kg: 1 packet (25 mg) twice daily
  • 6 months and older and weight of:
    • ≥5 kg to <7 kg: 1 packet (25 mg) twice daily
    • ≥7 kg to <14 kg: 1 packet (50 mg) twice daily
    • ≥14 kg to <25 kg: 1 packet (75 mg) twice daily
  • For individuals 6 months and older who weigh ≥ 25 kg, see Kalydeco® tablets.

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.