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

Kaftrio

Active Ingredient:
Tezacaftor, Elexacaftor, Ivacaftor
Origin:
EU

Kaftrio (Tezacaftor, Elexacaftor, Ivacaftor)

elexacaftor/tezacaftor/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 treats cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation.

GNH India supplies Kaftrio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. Our global distribution network ensures reliable access to this therapy for eligible patients across Europe, North America, Asia and the Middle East.

Manufacturer / TM Owner

Vertex Pharmaceuticals (Ireland) Limited

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Indications & Clinical Uses

Kaftrio is indicated for cystic fibrosis, a genetic disorder affecting the CFTR protein.

  • Cystic fibrosis (≥12 years, ≥1 F508del mutation): improves lung function and reduces pulmonary exacerbations.
  • Cystic fibrosis (≥12 years, ≥1 F508del mutation): enhances nutritional status and weight gain.
  • Cystic fibrosis (≥12 years, ≥1 F508del mutation): decreases sweat chloride concentration reflecting improved CFTR activity.

How It Works

  • Kaftrio combines a CFTR potentiator (ivacaftor) with two CFTR correctors (elexacaftor and tezacaftor). The correctors facilitate proper folding and trafficking of the defective CFTR protein to the cell surface, while the potentiator increases the channel’s opening probability. Together they raise the quantity and functional activity of CFTR at the epithelial cell membrane, improving chloride transport and reducing mucus buildup in affected tissues.

Side Effects

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

Common Side Effects

  • Headache: mild to moderate pain.
  • Diarrhea: loose stools.
  • Nausea: feeling of sickness.
  • Elevated liver enzymes: mild increase in hepatic transaminases.

Serious or Rare Side Effects

  • Hepatitis: significant liver inflammation.
  • Cataracts: clouding of the eye lens.
  • Severe allergic reaction: including hives, swelling, or anaphylaxis.

Precautions & Warnings

When prescribing Kaftrio, clinicians should observe several precautionary measures to ensure patient safety.

  • Liver function monitoring: assess transaminases before and during therapy.
  • Ophthalmologic evaluation: perform baseline eye exams and monitor for cataracts.
  • Drug interaction review: check for concomitant strong CYP3A inducers or inhibitors.
  • Pregnancy and lactation counseling: discuss unknown safety profile with women of childbearing potential.
  • Adherence education: emphasize importance of taking tablets with a fatty meal.
  • Store at ambient temperature: keep tablets in the original packaging, protect from moisture and heat.

Avoid Interactions

Kaftrio interacts with several medicines; awareness of these interactions helps avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Strong CYP3A inducers (e.g., rifampin, carbamazepine): markedly lower Kaftrio exposure.
  • Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole): substantially raise drug levels.
  • Simvastatin high doses: increased risk of myopathy.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A inhibitors (e.g., erythromycin, clarithromycin): may elevate exposure modestly.
  • Oral contraceptives: Kaftrio can reduce hormonal efficacy, consider alternative contraception.
  • Warfarin: monitor INR as Kaftrio may affect anticoagulant metabolism.

Frequently Asked Questions

Kaftrio is a prescription medication indicated for the treatment of cystic fibrosis in patients aged 12 years and older who carry at least one copy of the F508del mutation in the CFTR gene. It works by improving the function of the defective CFTR protein, which helps to reduce lung disease progression, improve respiratory function, and support better nutritional status.

The combination includes two CFTR correctors (elexacaftor and tezacaftor) that assist the misfolded CFTR protein to reach the cell surface, and a CFTR potentiator (ivacaftor) that enhances the opening of the channel once it is present. By increasing both the quantity and activity of CFTR at the epithelial membrane, the drug restores chloride transport and reduces the thick mucus characteristic of cystic fibrosis.

The prescribed dose of Kaftrio is determined by the treating physician based on the patient’s age, weight, and clinical condition. The medication is supplied as a fixed‑dose tablet containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg, and the prescriber decides the number of tablets and dosing schedule appropriate for each individual.

The safety of Kaftrio in pregnancy and lactation has not been fully established, and it is classified as having an unknown pregnancy category. Healthcare providers should weigh the potential benefits against possible risks, and women who are pregnant, planning to become pregnant, or breastfeeding should discuss treatment options and monitoring plans with their specialist.

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 across international markets, and will ask for trade or institutional credentials. The sales team then replies with pricing, availability, shipping details and any necessary import documentation.

Kaftrio is a triple‑combination CFTR modulator that targets the most common F508del mutation, offering broader coverage than earlier dual‑combination products such as lumacaftor/ivacaftor. Clinical studies have shown greater improvements in lung function and reduced exacerbations, making it a preferred option for eligible patients, while other modulators may be used for different mutation profiles.

Kaftrio tablets should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in their original blister pack, protect them from moisture, heat and direct sunlight. Do not refrigerate or freeze the product, and ensure the packaging remains sealed until the medication is dispensed.

Kaftrio is taken orally as a whole tablet with a fatty meal to enhance absorption. The tablet should be swallowed whole with water and not split, crushed, or chewed. Patients should follow the dosing schedule prescribed by their physician, which typically involves taking the medication at the same times each day to maintain consistent drug levels.

The most serious risks include liver injury, which may manifest as elevated transaminases or hepatitis, and ocular complications such as cataract formation or retinal pigment changes. Severe allergic reactions, including anaphylaxis, have also been reported. Regular monitoring of liver function tests and periodic eye examinations are recommended to detect these adverse events early.

Kaftrio is

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GNH India Pharmaceuticals Limited

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