Kalydeco

The usual dose for adults and children (over the age of 6 years and weighing more than 25 kg), is 150 mg twice a day (morning and evening about 12 hours apart) with a fat-containing food. Fat-containing food helps get the right amount of medication into your body. Examples include meals or foods prepared with butter or oils, eggs, cheeses, nuts, whole milk, or meats. Meals and snacks recommended in CF guidelines contain the right amounts of fat.

The usual dose for children between the ages of 2 years and 6 years is based on body weight. Oral granules are available for children ages 2 years and older, or individuals who have difficulty swallowing tablets. The granules may be sprinkled on soft foods or liquids (excluding grapefruit juice) and consumed within 1 hour. The granules should be consumed with or immediately after a fat-containing food.

Tablets should be swallowed whole with fluids and not chewed, crushed, or dissolved.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Kalydeco (Ivacaftor) be taken exactly as prescribed by your doctor.

If you miss a dose by less than 6 hours, take the missed dose with fat-containing food, and continue with your regular schedule. If you miss a dose by 6 or more hours, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Kalydeco (Ivacaftor) at room temperature, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Tablet

Each light-blue, capsule-shaped tablet, printed with "V 150" in black ink on one side, contains 150 mg of Kalydeco (Ivacaftor). Nonmedicinal ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, indigo carmine aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Peg 3350, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide. Printing ink: ammonium hydroxide, iron oxide black, propylene glycol, and shellac.

Oral Granules

50 mg
Each packet of white-to-off-white, sweetened, unflavoured granules contains 50 mg of Kalydeco (Ivacaftor). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose and sodium lauryl sulfate.

75 mg
Each packet of white-to-off-white, sweetened, unflavoured granules contains 75 mg of Kalydeco (Ivacaftor). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose and sodium lauryl sulfate.

Do not take Kalydeco (Ivacaftor) if you are allergic to Kalydeco (Ivacaftor) or any ingredients of the medication.

There may be an interaction between Kalydeco (Ivacaftor) and any of the following:

• Aliskiren
• Amiodarone
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• Aprepitant
• Aripiprazole
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• bilastine
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• cetirizine
• Cimetidine
• Cobicistat
• Colchicine
• conivaptan
• Cyclosporine
• dabigatran
• Deferasirox
• Dexamethasone
• Digoxin
• dofetilide
• Dronedarone
• Edoxaban
• Enzalutamide
• Estradiol
• Everolimus
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Hydrocodone
• Hydrocortisone
• ivermectin
• Lomitapide
• Loperamide
• loratidine
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methotrexate
• mifepristone
• Modafinil
• Morphine
• Nadolol
• nefazodone
• Ondansetron
• Paliperidone
• Phenobarbital
• Phenytoin
• Pimozide
• primidone
• Prucalopride
• quinidine
• quinine
• Ranitidine
• rifabutin
• rifampin
• rifapentine
• Riociguat
• Risperidone
• Romidepsin
• St. John's wort
• Sertraline
• Silodosin
• simeprevir
• Sirolimus
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Stiripentol
• Tacrolimus
• Tolvaptan
• tyrosine kinase inhibitors (e.g., imatinib, Lapatinib, Nilotinib)
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Kalydeco (Ivacaftor). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Kalydeco (Ivacaftor).

Cataracts: Cataracts have been reported in children treated with Kalydeco (Ivacaftor). Your doctor may recommend eye examinations before and during treatment with Kalydeco (Ivacaftor).

Dizziness: Kalydeco (Ivacaftor) can cause dizziness. Do not drive or operate machinery until you are certain that Kalydeco (Ivacaftor) does not affect your ability to do these activities safely.

Grapefruit juice: Grapefruit juice can increase the levels of Kalydeco (Ivacaftor) in the body, causing side effects. Avoid consuming food or beverages containing grapefruit or Seville oranges while you are taking Kalydeco (Ivacaftor).

Kidney function: The safety and effectiveness of Kalydeco (Ivacaftor) have not been established for people with decreased kidney function or end-stage Kidney Disease. If you have decreased kidney function or kidney disease, discuss with your doctor how Kalydeco (Ivacaftor) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kalydeco (Ivacaftor), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Kalydeco (Ivacaftor) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Kalydeco (Ivacaftor) may affect your medical condition and how your medical condition may affect the dosing and effectiveness of Kalydeco (Ivacaftor). Your doctor will perform regular tests to check your liver function while you are taking Kalydeco (Ivacaftor).

Pregnancy: The safety and effectiveness of Kalydeco (Ivacaftor) have not been established for women who are pregnant. Kalydeco (Ivacaftor) should not be used during pregnancy unless the benefits outweigh the risks. Talk to your doctor if you become pregnant while taking Kalydeco (Ivacaftor).

Breast-feeding: It is not known whether Kalydeco (Ivacaftor) passes into breast milk. If you are a breast-feeding mother and are taking Kalydeco (Ivacaftor), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Kalydeco (Ivacaftor) have not been established for children less than 2 years old.

Seniors: The safety and effectiveness of Kalydeco (Ivacaftor) have not been established for seniors 65 years of age and older.