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
How to prepare the granules:
• 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.
• Morning Dose: Remove the first dose from the wallet.
• 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 1 teaspoon of soft food or
liquid. Food or liquid should be at or below room temperature. Each packet is for single use
only. Some examples of soft foods or liquids include puréed fruits or vegetables, yogurt,
applesauce, water, milk, breast milk, infant formula, or juice (except for grapefruit juice).
• 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.
• Evening Dose: This dose should be taken 12 hours after your Morning Dose. Follow the
same steps listed above under Morning Dose.
This medication should always be taken with a fat containing food:
Alternatives
Other products that have the same ingredient as Kalydeco® granules are •Kalydeco® tablet •Orkambi® •Symdeko™ tablet •Trikafta® granules •Trikafta® tablet •
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
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 is a "cystic fibrosis transmembrane conductance regulator (CFTC) potentiator". The CFTR protein is a channel at the surface of the cells that allows the movement of particles such as chloride in and out of the cell, contributing to salt and water balance. Ivacaftor helps this CFTR protein channel or "open the gates" more often allowing more salt to pass through. The thick mucus is reduced and cystic fibrosis symptoms lessen.
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
Use with caution if you:
- have kidney or liver problems
- have cataracts
Possible drug interactions:
- ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole
- some antibiotics such as clarithromycin, erythromycin, rifampin, rifabutin
- phenobarbital, carbamazepine, phenytoin
- midazolam, alprazolam, diazepam, triazolam
- digoxin
- cyclosporine, tacrolimus
- warfarin
- St. John’s wort
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.