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Kalydeco

Kalydeco

(ivacaftor)

Kalydeco (Ivacaftor) belongs to the class of medications called Cystic Fibrosis transmembrane conductance regulator (CFTR) potentiators. It is used to treat cystic fibrosis (CF) in adults and children over the age of 2 who have one of several possible mutations (a change) in their CFTR gene.

Available form

Dosage

Tablet

150MG

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Kalydeco information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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.

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.

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