Ivacaftor

Generic name: Ivacaftor
Brand names: Kalydeco
Drug class: CFTR potentiators

Usage of Ivacaftor

Ivacaftor is used to treat cystic fibrosis in adults and children who are at least 1 month old and weigh at least 6 pounds (3 kilograms).

Ivacaftor tablet can be used in children aged 6 years and older. Ivacaftor granules can be used in children aged 1 month to under 6 years old.

Your doctor will make sure you have the specific gene mutation related to cystic fibrosis to be treated with ivacaftor.

Ivacaftor may also be used for purposes not listed in this medication guide.

Ivacaftor side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Ivacaftor may cause serious side effects. Call your doctor at once if you have:

blurred vision, eye pain or redness, seeing halos around lights;

low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of ivacaftor may include:

muscle or joint pain;

dizziness;

rash, acne;

headache;

mouth pain;

stomach pain, nausea, diarrhea; or

cold symptoms such as stuffy nose, sneezing, runny nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Ivacaftor

You should not be treated with ivacaftor if you are allergic to it, or if you have or have ever had:

liver or kidney disease.

It is not known if ivacaftor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using ivacaftor.

Relate drugs

How to use Ivacaftor

Usual Adult Dose for Cystic Fibrosis:

150 mg orally every 12 hours with fat containing food Comments:-Examples of fat-containing food include: eggs, butter, peanut butter, cheese pizza, and whole milk dairy products. -If the patient's genotype is unknown, an approved CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.Uses: -For the treatment of cystic fibrosis in patients having one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.

Usual Pediatric Dose for Cystic Fibrosis:

Oral Granules: Age: 4 months to less than 6 months: Weight: 5 kg or greater: 25 mg orally every 12 hours-Use is not recommended in the presence of hepatic impairment or in those taking concomitant moderate or strong CYP450 3A inhibitorsAge: 6 months or older: Weight: 5 to less than 7 kg: 25 mg orally every 12 hoursWeight: 7 to less than 14 kg: 50 mg orally every 12 hoursWeight: 14 kg or greater: 75 mg orally every 12 hours Oral Tablet: Age: 6 years and older: 150 mg orally every 12 hours Comments:-Doses should be taken just before or after fat-containing food; examples of fat-containing food include: eggs, butter, peanut butter, cheese pizza, and whole milk dairy products. -Dose adjustments are recommended for patients 6 months or older with hepatic impairment and/or taking concomitant moderate or strong CYP450 3A inhibitors. -If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.Uses: -For the treatment of cystic fibrosis in patients 4 months or older having one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What other drugs will affect Ivacaftor

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

St. John's wort;

seizure medicine such as Carbamazepine, phenobarbital, or phenytoin;

an antibiotic--clarithromycin, erythromycin, telithromycin, rifabutin, rifampin; or

antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may affect ivacaftor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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