KALYDECO (Ivacaftor) Tablet, Film Coated KALYDECO (Ivacaftor) Granule [Vertex Pharmaceuticals Incorporated]

KALYDECO (kuh-LYE-deh-koh)
(ivacaftor)
Film-Coated Tablets and Dental Granules

Look at this Patient Information before you begin taking KALYDECO and every time you obtain a refill. There might be new information. These details doesn’t replace speaking for your physician regarding your medical problem or perhaps your treatment.

What’s KALYDECO?

KALYDECO is really a prescription drugs used to treat cystic fibrosis (CF) in patients age 24 months and older who’ve a minumum of one mutation within their CF gene that’s attentive to KALYDECO.

Speak to your physician to understand for those who have an indicated CF gene mutation.

It’s not known if KALYDECO is effective and safe in youngsters under 2 years old.

Who shouldn’t take KALYDECO?

Don’t take KALYDECO for certain medicines or herbal medicines for example:

  • the antibiotics rifampin (Rifamate®, Rifater®) or rifabutin (Mycobutin®)
  • seizure medications for example phenobarbital, carbamazepine (Tegretol®, Carbatrol®, Equetro®) or phenytoin (Dilantin®, Phenytek®)
  • St. John’s wort

Speak to your physician before you take KALYDECO for the medicines or supplements in the above list.

What must i tell my physician before you take KALYDECO?

Prior to taking KALYDECO, inform your physician should you:

  • have liver or kidney problems
  • drink grapefruit juice, or eat grapefruit or Seville oranges
  • are pregnant or intend to conceive. It’s not known if KALYDECO will harm your developing fetus. Both you and your physician make the decision for a moment take KALYDECO when you are pregnant.
  • are breastfeeding or intending to breastfeed. It’s not known if KALYDECO passes to your breast milk. Both you and your physician make the decision for a moment take KALYDECO when you are breastfeeding.

KALYDECO may modify the way other medicines work, along with other medicines may affect how KALYDECO works.

Inform your physician about all of the medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal medicines, because the dose of KALYDECO might need to be adjusted when taken with certain medications.

Ask your physician or pharmacist for a summary of these medicines if you’re not sure.

Especially inform your physician for:

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

Be aware of medicines you are taking. Keep a summary of these to show your physician and pharmacist when you are getting a brand new medicine.

How must i take KALYDECO?

  • Take KALYDECO just as your physician informs you to definitely go.
  • Bring your doses of KALYDECO 12 hrs apart.
  • Should you miss a serving of KALYDECO which is within 6 hrs of whenever you usually go, bring your dose of KALYDECO as prescribed with fat-that contains food as quickly as possible.
  • Should you miss a serving of KALYDECO which is greater than 6 hrs following the time you typically go, skip that dose only and go ahead and take next dose whenever you usually go. Do not take 2 doses simultaneously to compensate for your missed dose.

KALYDECO Tablets (ages 6 many older):

  • Always take KALYDECO tablets with food which contains fat. Types of fat-that contains foods include eggs, butter, peanut butter, cheese pizza, and whole-milk milk products for example dairy, cheese, and yogurt.
  • Each KALYDECO box contains 4 individual blister cards.
  • Each blister card contains 14 pills—7 morning doses and seven evening doses.
  • Each morning, unpeel the paper backing from the blister card to get rid of 1 KALYDECO tablet and go with food which contains fat.
  • At night, 12 hrs later, open another blister card to get rid of 1 KALYDECO tablet and go with food which contains fat.
  • You might cut across the dotted line to split up your doses in the blister card.

KALYDECO Dental Granules (ages 2 to under 6 years of age):

  • Contain the packet with cut line on the top.
  • Shake the packet lightly to stay the KALYDECO granules.
  • Tear or cut packet open along cut line.
  • Carefully pour all the KALYDECO granules within the packet into 1 teaspoon of soppy food or liquid. Food or liquid ought to be at or below 70 degrees. A few examples of soppy foods or fluids include puréed vegetables or fruits, yogurt, applesauce, water, milk, or juice.
  • Mix the KALYDECO granules with food or liquid.
  • After mixing, give KALYDECO within one hour. Make certain all prescription medication is taken.
  • Provide a child fat-that contains food right before or simply following the KALYDECO granules dose. Types of fat-that contains foods include eggs, butter, peanut butter, cheese pizza, and whole-milk milk products for example dairy, cheese, and yogurt.

What must i avoid while taking KALYDECO?

  • KALYDECO may cause dizziness in certain individuals who go. Don’t drive a vehicle, use machinery or do anything whatsoever that requires you to definitely be alert until you are aware how KALYDECO affects you.
  • You need to avoid food that contains grapefruit or Seville oranges when you are taking KALYDECO.

Do you know the possible negative effects of KALYDECO?

KALYDECO may cause serious negative effects.

High liver enzymes within the bloodstream happen to be reported in patients receiving KALYDECO. Your physician is going to do bloodstream tests to check on your liver:

  • before you begin KALYDECO
  • every 3 several weeks on your newbie of taking KALYDECO
  • each year when you are taking KALYDECO

For patients who’ve had high liver enzymes previously, the physician may do bloodstream tests to determine the liver more frequently.

Call your physician immediately for those who have the following signs and symptoms of liver problems:

  • discomfort or discomfort within the upper right stomach (abdominal) area
  • yellowing of the epidermis or even the white-colored a part of your vision
  • appetite loss
  • queasiness
  • dark, amber-colored urine

Abnormality from the eye lens (cataract) continues to be noted in certain children and adolescents receiving KALYDECO.

Your physician should perform eye examinations just before and through treatment with KALYDECO to consider cataracts.

The most typical negative effects of KALYDECO include:

  • headache
  • upper respiratory system infection (common cold), including:
    • a sore throat
    • nasal or sinus congestion
    • runny nose
  • stomach (abdominal) discomfort
  • diarrhea
  • rash
  • nausea
  • dizziness

Inform your physician for those who have any side-effect that bothers you or that doesn’t disappear.

These aren’t all of the possible negative effects of KALYDECO. To learn more, ask your physician or pharmacist.

Call your physician for medical health advice about negative effects. You might report negative effects to Food and drug administration at 1-800-Food and drug administration-1088.

How must i store KALYDECO?

  • Store KALYDECO at 70 degrees between 68°F to 77°F (20°C to 25°C).
  • Don’t use KALYDECO following the expiration date around the package.

Keep KALYDECO and all sorts of medicines from the achieve of kids.

General details about the effective and safe utilization of KALYDECO

Medicines are occasionally prescribed for purposes apart from individuals indexed by someone Information leaflet. Don’t use KALYDECO for any condition that it wasn’t prescribed. Tendency to slack KALYDECO with other people, even should they have exactly the same signs and symptoms you’ve. It might harm them.

This Patient Information summarizes the most crucial details about KALYDECO. If you’d like more details, engage with your physician. You are able to ask your friendly phamacist or physician for details about KALYDECO that’s written for health care professionals.

To learn more, visit world wide web.kalydeco.com or call 1-877-752-5933.

Do you know the ingredients in KALYDECO?

Active component: ivacaftor

Inactive ingredients:

KALYDECO Tablets are light blue, film-coated, capsule-formed tablets for dental administration and retain the following inactive ingredients: colloidal plastic dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

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

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

KALYDECO Dental Granules are white-colored to off-white-colored granules for dental administration (sweetened but unflavored) and retain the following inactive ingredients: colloidal plastic dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose, and sodium lauryl sulfate.

This Patient Information continues to be authorized by the U.S. Fda.

Manufactured for:
Vertex Pharmaceuticals Incorporated
50 Northern Avenue
Boston, MA 02210

Approved This summer 2017

KALYDECO, VERTEX, and also the VERTEX triangular emblem are registered trademarks of Vertex Pharmaceuticals Incorporated.
Other trademarks referenced herein belong to their particular proprietors.
©2017 Vertex Pharmaceuticals Incorporated
ALL Legal rights RESERVED
69264-10

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