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Kalydeco

Generic Name: ivacaftor (EYE va KAF tor)
Brand Names: Kalydeco
Kalydeco (ivacaftor) is used to treat cystic fibrosis in adults and children who are at least 6 months old. Includes Kalydeco side effects, interactions and indications.
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Drug Information:
Kalydeco (ivacaftor) is used to treat cystic fibrosis in adults and children who are at least 6 months old and weigh at least 11 pounds (5 kilograms). Kalydeco is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take Kalydeco, you may need a medical test to make sure you have this gene mutation. You should not use Kalydeco if you are allergic to ivacaftor. Before you take Kalydeco, tell your doctor if you have liver or kidney disease. Kalydeco should be taken with a food that contains fat, such as butter, peanut butter, eggs, cheese pizza, or whole-milk dairy products such as whole milk, cheese, and yogurt. Follow your doctor's instructions very carefully. Learn more

Kalydeco Side Effects

Kalydeco Side Effects

Note: This document contains side effect information about ivacaftor. Some of the dosage forms listed on this page may not apply to the brand name Kalydeco.

In Summary

Common side effects of Kalydeco include: dizziness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ivacaftor: oral granule, oral tablet

Along with its needed effects, ivacaftor (the active ingredient contained in Kalydeco) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ivacaftor:

More common

  • Body aches or pain
  • chest pain
  • chills
  • cough
  • difficulty with breathing or troubled breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common

  • Dark urine
  • fever with or without chills
  • light-colored stools
  • loss of appetite
  • nausea
  • stomach pain
  • vomiting
  • yellow eyes or skin

Some side effects of ivacaftor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Blemishes on the skin
  • diarrhea
  • difficulty with moving
  • dizziness
  • muscle aches, pain, or stiffness
  • pain in the joints
  • pimples
  • rash

For Healthcare Professionals

Applies to ivacaftor: oral granule for reconstitution, oral tablet

Dermatologic

Very common (10% or more): Rash (up to 13%)

Common (1% to 10%): Acne

Gastrointestinal

Very common (10% or more): Oropharyngeal pain (22%), abdominal pain (16%), diarrhea (13%), nausea (12%)

Hepatic

Very Common (10% or more): Transaminase elevations (up to 27.8%)

Common (1% to 10%): Increased aspartate aminotransferase, increased hepatic enzymes, transaminase elevations

Maximum transaminase (ALT or AST) levels of greater than 8 times upper limit of normal (ULN), greater than 5 times ULN, and greater than 3 times ULN were reported in 2%, 3%, and 6% of patients treated with ivacaftor, respectively.

In patients aged 12 months to less than 24 months (N=19), the incidence transaminase elevations (ALT or AST) greater than 3, greater than 5, and greater than 8 times the upper limit of normal (x ULN) was 27.8% (5/18), 11.1% (2/18) and 11.1% (2/18), respectively. In patients aged 6 months to less than 12 months (N=11) one patient (9.1%) had elevated ALT of greater than 3 to less than or equal to 5 x ULN. No patients had elevations in total bilirubin, or discontinued ivacaftor treatment due to transaminase elevations.

Metabolic

Common (1% to 10%): Increased blood glucose

Musculoskeletal

Common (1% to 10%): Arthralgia, musculoskeletal chest pain, myalgia

Nervous system

Very common (10% or more): Headache (24%)

Common (1% to 10%): Dizziness, sinus headache

Other

Very common (10% or more): Pyrexia (14.7%)

Common (1% to 10%): Bacteria in sputum, ear discomfort, ear pain, tinnitus, tympanic membrane hyperemia, ear congestion

Respiratory

Very common (10% or more): Upper respiratory tract infection (22%), nasal congestion (20%), nasopharyngitis (15%), cystic fibrosis lung (38.5%), cough (36.7%), productive cough (12.8%), rales (10%)

Common (1% to 10%): Rhinitis, pharyngeal erythema, pleuritic pain, sinus congestion, wheezing

Endocrine

Common (1% to 10%): Breast mass

Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain

Ocular

Postmarketing reports: Non-congenital lens opacities/cataracts (in pediatric patients up to 12 years of age)

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Kalydeco