Product image of Kalydeco (Ivacaftor) supplied by GNH India

Kalydeco

Active Ingredient:
Ivacaftor
Origin:
EU

Kalydeco (Ivacaftor)

Ivacaftor, the active ingredient in Kalydeco, is a CFTR potentiator presented as a 150 mg tablet for oral use. It treats cystic fibrosis in patients aged six years and older who have at least one gating mutation in the CFTR gene, improving chloride transport across cell membranes.

GNH India supplies Kalydeco as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing, quality assurance and regulatory compliance for this specialized cystic fibrosis therapy.

Manufacturer / TM Owner

Vertex Pharmaceuticals (Ireland) Limited

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Kalydeco (ivacaftor) is used in cystic fibrosis therapy targeting the CFTR protein.

  • Cystic fibrosis (patients ≥ 6 years with at least one gating mutation): Improves lung function by enhancing chloride transport.
  • Cystic fibrosis (patients ≥ 6 years with at least one gating mutation): Reduces frequency of pulmonary exacerbations.
  • Cystic fibrosis (patients ≥ 6 years with at least one gating mutation): Improves nutritional status and weight gain.

How It Works

  • Ivacaftor acts as a CFTR potentiator. It binds to the cystic fibrosis transmembrane conductance regulator protein on the cell surface and increases the probability that the channel remains open. By enhancing the gating function of CFTR, ivacaftor facilitates chloride ion transport across epithelial cells, correcting the defective ion flow caused by specific gating mutations and thereby improving hydration of airway surface liquid.

Side Effects

Ivacaftor may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Headache: mild to moderate intensity.
  • Diarrhea: usually transient.
  • Upper respiratory tract infection: symptoms of congestion or sore throat.
  • Nausea: occasional.
  • Abdominal pain: mild discomfort.
  • Elevated liver enzymes: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Liver injury: signs of hepatitis or jaundice.
  • Cataracts: visual disturbances.
  • Severe rash or hypersensitivity: including Stevens‑Johnson syndrome.
  • Pulmonary hemorrhage: rare bleeding in the lungs.

Precautions & Warnings

When prescribing ivacaftor, clinicians should consider several safety precautions.

  • Liver function monitoring: check ALT/AST before starting and periodically during therapy.
  • Drug interactions: review concomitant medications that affect CYP3A4 metabolism.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
  • Respiratory status: monitor for pulmonary exacerbations despite therapy.
  • Vision assessment: periodic eye examinations to detect cataract formation.
  • Store at ambient temperature: keep tablets below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

Ivacaftor interacts with several medicines, primarily through CYP3A4 metabolism.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce ivacaftor exposure.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase ivacaftor levels and risk of toxicity.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may require dose adjustment.
  • Antacids containing aluminum or magnesium: may affect absorption; separate dosing by at least 2 hours.
  • Oral contraceptives: monitor efficacy as ivacaftor may alter hormone levels.
  • Statins metabolized by CYP3A4 (e.g., simvastatin): monitor for increased statin exposure.

Frequently Asked Questions

Kalydeco is indicated for the treatment of cystic fibrosis in patients six years of age and older who have at least one gating mutation in the CFTR gene. By improving the function of the defective protein, it helps enhance lung function, reduce pulmonary exacerbations, and support better nutritional status.

Ivacaftor is a CFTR potentiator. It binds to the cystic fibrosis transmembrane conductance regulator protein on the cell surface and increases the likelihood that the chloride channel remains open. This action restores chloride transport across epithelial cells, improving airway surface liquid hydration and overall lung function in patients with gating mutations.

The dosage of Kalydeco is individualized by the prescribing healthcare professional based on the patient’s age, weight, and specific CFTR mutation profile. The prescriber determines the appropriate regimen and any necessary adjustments, so patients should follow the exact instructions provided by their clinician.

Safety data for ivacaftor in pregnancy and lactation are limited. The product should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers will assess each case and discuss the risk‑benefit profile with the patient.

To request Kalydeco, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After the enquiry, the team will verify trade or institutional credentials and respond with pricing, availability, shipping details and any required import documentation.

Kalydeco (ivacaftor) is a potentiator that works on specific gating mutations, whereas combination products such as lumacaftor/ivacaftor or tezacaftor/ivacaftor target both gating and processing defects. The choice depends on the patient’s genetic profile, disease severity and prior therapy, with Kalydeco often preferred for isolated gating mutations.

Kalydeco tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct light, and store out of reach of children. Do not refrigerate or freeze the tablets.

Kalydeco is taken orally as a tablet. Patients should swallow the tablet whole with a glass of water. It can be taken with or without food, but consistency with respect to meals is recommended to maintain stable drug levels.

The most serious adverse events reported with ivacaftor include liver injury (elevated transaminases or hepatitis), development of cataracts, and severe hypersensitivity reactions such as Stevens‑Johnson syndrome. Patients should be monitored regularly for liver function and visual changes, and any signs of severe rash should prompt immediate medical evaluation.

Kalydeco is contraindicated in patients with known hypersensitivity to ivacaftor or any of the tablet excipients. Caution is advised for individuals with severe liver disease, as they may be at higher risk for hepatic adverse effects. Patients should discuss their full medical history with a healthcare professional before starting therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.