Product image of Kaftrio (Tezacaftor, Elexacaftor, Ivacaftor) supplied by GNH India

Kaftrio

Active Ingredient:
Tezacaftor, Elexacaftor, Ivacaftor
Origin:
EU

Kaftrio (Tezacaftor, Elexacaftor, Ivacaftor)

Tezacaftor/elexacaftor/ivacaftor, the active ingredient in Kaftrio, is a CFTR modulator presented as a elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg oral tablet for oral use. It is indicated for the treatment of cystic fibrosis in patients aged 12 years and older who carry at least one F508del mutation, improving the function of the defective CFTR protein.

GNH India supplies Kaftrio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution channels aligned to EU regulatory standards.

Manufacturer / TM Owner

Vertex Pharmaceuticals (Ireland) Limited

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Indications & Clinical Uses

Kaftrio is a CFTR modulator used in the management of cystic fibrosis, a genetic disorder affecting chloride transport.

  • Cystic fibrosis (patients ≥12 years with at least one F508del mutation): improves lung function and reduces pulmonary exacerbations.
  • Cystic fibrosis (patients ≥12 years with two F508del mutations): provides greater clinical benefit compared with single‑mutation therapy.
  • Cystic fibrosis (patients ≥12 years with one F508del and a minimal‑function mutation): expands treatment options for this genotype subgroup.

How It Works

  • Kaftrio combines a CFTR potentiator (ivacaftor) with two CFTR correctors (tezacaftor and elexacaftor). The correctors facilitate proper folding and trafficking of the mutant CFTR protein to the cell surface, while the potentiator enhances channel gating, together increasing the quantity and function of chloride transport across epithelial cells.

Side Effects

Kaftrio may cause a range of adverse reactions.

Common Side Effects

  • Headache: mild to moderate intensity.
  • Diarrhea: may be watery and intermittent.
  • Nausea: often transient after dosing.
  • Abdominal pain: cramp‑like discomfort.
  • Rash: skin erythema or pruritus.
  • Elevated liver enzymes: mild transaminase increase.

Serious or Rare Side Effects

  • Hepatitis: significant liver injury requiring monitoring.
  • Cataracts or retinal changes: visual disturbances reported.
  • Severe allergic reactions: anaphylaxis or angioedema.
  • Dyspnea: worsening respiratory symptoms.
  • Elevated bilirubin: possible jaundice.

Precautions & Warnings

Before initiating Kaftrio, several safety considerations should be observed.

  • Liver monitoring: obtain baseline liver function tests and repeat periodically.
  • Drug interactions: review concomitant CYP3A4 substrates and inhibitors.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk.
  • Respiratory status: monitor for any worsening of pulmonary symptoms.
  • Adherence: take tablets with a fat‑containing meal to enhance absorption.
  • Store at ambient temperature: keep below 25 °C, in the original pack, and protect from moisture.

Avoid Interactions

Kaftrio interacts with several medications that affect its metabolism and absorption.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce drug exposure.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase exposure and risk of toxicity.
  • High‑dose statins (e.g., simvastatin >20 mg): increased risk of myopathy.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise plasma levels.
  • Antacids containing aluminum or magnesium: may decrease absorption if taken concurrently.
  • Oral contraceptives: potential reduction in efficacy; consider alternative contraception.

Frequently Asked Questions

Kaftrio is prescribed for the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. By improving the quantity and function of the CFTR protein, it helps to enhance lung function, reduce pulmonary exacerbations, and support overall disease management.

The combination contains two CFTR correctors (tezacaftor and elexacaftor) that assist the misfolded CFTR protein to reach the cell surface, and a CFTR potentiator (ivacaftor) that increases the channel’s opening probability. Together they restore chloride transport across epithelial cells, addressing the underlying defect in cystic fibrosis.

The specific dosing regimen for Kaftrio is determined by the prescribing clinician based on the patient’s age, weight, genotype, and clinical status. Typically, the medication is taken as an oral tablet twice daily with a fat‑containing meal, but the exact schedule should follow the prescriber’s instructions.

Limited clinical data are available on the use of Kaftrio in pregnant or lactating individuals. It should only be used when the potential therapeutic benefit justifies any potential risk to the fetus or infant, and the decision should be made in consultation with a healthcare professional.

To request Kaftrio, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide. After the enquiry, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details, and any necessary import documentation.

Kaftrio contains the same three active components as other triple‑combination therapies such as Trikafta, offering comparable efficacy in patients with at least one F508del mutation. Differences may lie in formulation, regulatory approvals, and regional availability, but the core mechanism of correcting and potentiating CFTR function is shared.

Kaftrio tablets should be stored at ambient temperature, below 25 °C, in their original packaging. Keep the product away from moisture, direct sunlight, and excessive heat to maintain stability throughout its shelf life.

Kaftrio is taken orally as a tablet. The label advises swallowing the tablet whole with a meal that contains fat, which enhances absorption of the active ingredients. Doses are usually spaced about 12 hours apart, but patients should follow the exact schedule prescribed by their clinician.

Serious adverse events include significant liver injury (hepatitis), development of cataracts or other retinal changes, and severe allergic reactions such as anaphylaxis. Patients should be monitored regularly for liver function abnormalities and any visual disturbances, and they should seek immediate medical attention if signs of an allergic reaction appear.

Kaftrio is contraindicated in individuals with a known hypersensitivity to any of its components. Patients with severe hepatic impairment should avoid the medication, and those who are unable to take oral tablets with a fatty meal may not achieve adequate drug exposure. Clinicians should assess each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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