Kalydeco Information and Uses

Kalydeco

Kalydeco Overview

Kalydeco (generic: ivacaftor) is a prescription medication used to treat cystic fibrosis. Kalydeco is for use only in patients who are at least 6 years old, with a specific gene mutation related to cystic fibrosis. It belongs to a group of drugs called cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. It works by improving the function of a protein in the body to decrease the build-up of thick mucus in the lungs and improving other symptoms of cystic fibrosis.

This medication comes in tablet form and is usually taken twice daily, about 12 hours apart, with fatty foods.

Common side effects of Kalydeco include headaches, colds, stomach pain, and diarrhea.

Uses of Kalydeco

Kalydeco is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a certain mutation in their CF gene called the G551D mutation.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Kalydeco

Kalydeco can cause serious side effects. See "Drug Precautions".

The most common side effects of Kalydeco include:

headache
upper respiratory tract infection (common cold), including:
- sore throat
- nasal or sinus congestion
- runny nose
stomach (abdominal) pain
diarrhea
rash
nausea
dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Kalydeco. For more information, ask your doctor or pharmacist.

Kalydeco Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements as the dose of Kalydeco may need to be adjusted when taken with certain medications.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

antifungal medications such as ketoconazole (e.g., Nizoral), itraconazole (e.g., Sporanox), posaconazole (e.g., Noxafil), voriconazole (e.g., Vfend), or fluconazole (e.g., Diflucan)
antibiotics such as telithromycin (e.g., Ketek), clarithromycin (e.g., Biaxin), or erythromycin (e.g., Ery-Tab)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Kalydeco Precautions

Do not take Kalydeco if you take certain medicines or herbal supplements such as:

the antibiotics rifampin (Rifamate, Rifater) or rifabutin (Mycobutin)
seizure medications such as phenobarbital, carbamazepine (Tegretol, Carbatrol, Equetro) or phenytoin (Dilantin, Phenytek)
St. John's Wort

Talk to your doctor before taking Kalydeco if you take any of the medicines or supplements listed above.

Kalydeco can cause dizziness in some people who take it. Do not drive a car, use machinery or do anything that needs you to be alert until you know how Kalydeco affects you.
You should avoid food containing grapefruit or Seville oranges while you are taking Kalydeco.

Kalydeco can cause serious side effects.

High liver enzymes in the blood have been reported in patients receiving Kalydeco. Your doctor will do blood tests to check your liver:

before you start Kalydeco
every 3 months during your first year of taking Kalydeco
every year while you are taking Kalydeco

Call your doctor right away if you have any of the following symptoms of liver problems:

pain or discomfort in the upper right stomach (abdominal) area
yellowing of your skin or the white part of your eyes
loss of appetite
nausea or vomiting
dark, amber-colored urine

Kalydeco Food Interactions

You should avoid food containing grapefruit or Seville oranges while you are taking Kalydeco. Grapefruit and Seville oranges may interact with Kalydeco and cause potentially dangerous effects. Discuss the use of these products with your doctor.

Inform MD

Before you take Kalydeco, tell your doctor if you:

have liver or kidney problems
drink grapefruit juice, or eat grapefruit or Seville oranges
are pregnant or plan to become pregnant.
are breastfeeding or planning to breastfeed.

Kalydeco may affect the way other medicines work, and other medicines may affect how Kalydeco works.

Kalydeco and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Kalydeco will harm your unborn baby. You and your doctor should decide if you will take Kalydeco while you are pregnant.

Kalydeco and Lactation

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Kalydeco passes into your breast milk. You and your doctor should decide if you will take Kalydeco while you are breastfeeding.

Kalydeco Usage

Take Kalydeco exactly as your doctor tells you to take it.
Always take Kalydeco with fatty food. Examples of fat-containing food include eggs, butter, peanut butter, cheese pizza, etc.

Your doses of Kalydeco should be taken 12 hours apart.

Kalydeco Dosage

Take Kalydeco exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of Kalydeco for both adults and pediatric patients age 6 years and older is one 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food. Your doctor may reduce your dose if you have liver disease.

Kalydeco Overdose

If you take too much Kalydeco, call your local Poison Control Center or seek emergency medical attention right away.

Forms of Kalydeco

Kalydeco is available as 150 mg tablets.

Active ingredient: ivacaftor

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

The tablet film coat contains: carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide.

The printing ink contains: ammonium hydroxide, iron oxide black, propylene glycol, and shellac.