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Kalydeco (Granules)

Generic Name: Ivacaftor Granules (eye va KAF tor)
Brand Name: Kalydeco

Uses of Kalydeco:

  • It is used to treat cystic fibrosis.

What do I need to tell my doctor BEFORE I take Kalydeco?

  • If you have an allergy to Kalydeco (ivacaftor granules) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's wort.

This is not a list of all drugs or health problems that interact with Kalydeco.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Kalydeco?

  • Tell all of your health care providers that you take Kalydeco. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid grapefruit and grapefruit juice.
  • Avoid Seville oranges.
  • Cataracts have happened in children taking Kalydeco. Have an eye exam before starting this medicine and while taking it. Talk with your doctor
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Kalydeco with your other drugs.
  • Do not give to a child younger than 2 years of age.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Kalydeco) best taken?

Use Kalydeco as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • Mix the contents of the packet with 1 teaspoon (5 mL) of soft food or liquid. This includes pureed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Food or liquid needs to be at or below room temperature.
  • Take Kalydeco within 1 hour of mixing.
  • Take this medicine just before or just after fatty foods. This includes eggs; butter; peanut butter; cheese pizza; or whole-milk dairy products like whole-milk, cheese, or yogurt.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it has been 6 hours or more since the missed dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Change in eyesight.
  • Chest pain.

What are some other side effects of Kalydeco?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Dizziness.
  • Sore throat.
  • Nose and throat irritation.
  • Runny nose.
  • Stuffy nose.
  • Loose stools (diarrhea).
  • Belly pain.
  • Upset stomach.
  • Pimples (acne).
  • Muscle or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Kalydeco?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Kalydeco (ivacaftor granules), please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kalydeco. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Kalydeco.

Review Date: September 6, 2017

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