"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
(ivacaftor) Film-Coated Tablets
Read this Patient Information before you start taking KALYDECO and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is KALYDECO?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have one of the following mutations in their CF gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
KALYDECO is not for use in people with CF due to other mutations in the CF gene. KALYDECO is not effective in CF patients with two copies of the F508del mutation (F508del/F508del) in the CF gene.
It is not known if KALYDECO is safe and effective in children under 6 years of age.
Who should not take KALYDECO?
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.
What should I tell my doctor before taking KALYDECO?
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. 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.
- 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 may affect the way other medicines work, and other medicines may affect how KALYDECO works.
Tell your doctor about all the medicines you take, including prescription and nonprescription 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.
How should I take KALYDECO?
- Take KALYDECO exactly as your doctor tells you to take it.
- Always take KALYDECO with food that contains fat. Examples of fat-containing foods include eggs, butter, peanut butter, cheese pizza, etc.
- Your doses of KALYDECO should be taken 12 hours apart.
- Each KALYDECO box contains 4 individual blister cards.
- Each blister card contains 14 pills—7 morning doses and 7 evening doses.
- In the morning, unpeel the paper backing from a blister card to remove 1 KALYDECO pill and take it with food that contains fat.
- In the evening, 12 hours later, open another blister card to remove 1 KALYDECO pill and take it with food that contains fat.
- You may cut along the dotted line to separate your doses from the blister card.
What should I avoid while taking KALYDECO?
- 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.
What are the possible side effects of 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
The most common side effects of KALYDECO include:
- upper respiratory tract infection (common cold),
- sore throat
- nasal or sinus congestion
- runny nose
- stomach (abdominal) pain
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store KALYDECO?
- Store KALYDECO at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not use KALYDECO after the expiration date on the package.
Keep KALYDECO and all medicines out of the reach of children.
General information about KALYDECO
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use KALYDECO for a condition for which it was not prescribed. Do not give KALYDECO to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information summarizes the most important information about KALYDECO. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about KALYDECO that is written for health professionals.
For more information, go to www.kalydeco.com or call 1-877-752-5933.
What are the ingredients in KALYDECO?
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. This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/15/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Kalydeco Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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