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 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, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Vertex Pharmaceuticals (Ireland) Limited

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Indications & Clinical Uses

Kaftrio is a CFTR modulator indicated for cystic fibrosis, a genetic disease affecting the respiratory and digestive systems.

  • Cystic fibrosis with one F508del allele: Improves lung function and reduces pulmonary exacerbations.
  • Cystic fibrosis with two F508del alleles: Further enhances sweat‑chloride levels and respiratory outcomes.
  • Cystic fibrosis patients aged 12 years and older: Decreases the frequency of severe respiratory infections and improves overall health status.

How It Works

  • Kaftrio combines two CFTR correctors (tezacaftor and elexacaftor) that improve the folding and trafficking of the defective CFTR protein to the cell surface, with a CFTR potentiator (ivacaftor) that enhances the channel’s opening probability. Together they increase chloride transport across epithelial cells, restoring more normal fluid balance in the lungs and other organs affected by cystic fibrosis.

Side Effects

Common Side Effects

  • Headache: mild to moderate intensity.
  • Diarrhea: occasional loose stools.
  • Abdominal pain: mild discomfort.
  • Rash: skin redness or itching.
  • Nasopharyngitis: cold‑like symptoms.
  • Elevated liver enzymes: mild increase in ALT/AST.

Serious or Rare Side Effects

  • Significant liver injury: jaundice or marked enzyme rise.
  • Cataracts or retinal pigment changes: visual disturbances.
  • Severe allergic reactions: swelling, hives, or anaphylaxis.
  • Pulmonary hemorrhage: coughing up blood.
  • Acute pancreatitis: severe abdominal pain with nausea.
  • Myopathy: muscle weakness or pain.

Precautions & Warnings

Kaftrio requires careful monitoring and patient education before and during therapy.

  • Liver function monitoring: check ALT/AST regularly.
  • Drug interaction awareness: review concomitant medications.
  • Pregnancy and breastfeeding: discuss risks with a healthcare professional.
  • Age considerations: not recommended for children under 12 years.
  • Adherence importance: take tablets exactly as prescribed.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Kaftrio may interact with several drug classes, requiring dose adjustments or avoidance.

Major Interactions (Avoid)

  • Strong CYP3A inducers (e.g., rifampin): may reduce efficacy.
  • Strong CYP3A inhibitors (e.g., ketoconazole): may increase toxicity.
  • Certain macrolide antibiotics (e.g., clarithromycin): risk of elevated drug levels.

Moderate Interactions (Monitor Closely)

  • Warfarin: monitor INR for anticoagulation changes.
  • Oral contraceptives: assess hormonal efficacy.
  • Statins (e.g., simvastatin): watch for increased muscle toxicity.
  • Antifungal azoles (e.g., itraconazole): adjust dosing as needed.
  • Proton pump inhibitors: may affect absorption of ivacaftor.

Frequently Asked Questions

Kaftrio is prescribed for the treatment of cystic fibrosis in patients aged 12 years and older who carry at least one F508del mutation in the CFTR gene. It works by improving the function of the defective protein, helping to restore normal chloride transport in the lungs and other affected organs.

The combination includes two CFTR correctors (tezacaftor and elexacaftor) that assist the misfolded CFTR protein to reach the cell surface, and a CFTR potentiator (ivacaftor) that enhances the opening of the channel. Together they increase chloride flow, improving hydration of airway surfaces and reducing disease symptoms.

The specific dosage and dosing schedule for Kaftrio are determined by the prescribing clinician based on the patient’s age, weight, and genetic profile. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety of Kaftrio in pregnancy and lactation has not been fully established. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider before starting or continuing therapy.

To request Kaftrio, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Kaftrio combines two correctors with a potentiator, offering broader coverage for patients with at least one F508del mutation compared with earlier two‑component regimens. It may provide greater improvements in lung function and sweat‑chloride levels, though individual response varies and treatment choice should be guided by a specialist.

Kaftrio tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect them from moisture. Keep the product out of direct sunlight and away from heat sources to maintain stability.

Kaftrio is taken orally as a tablet, usually with a glass of water. The tablets are swallowed whole and should be taken exactly as prescribed, typically once daily, unless the prescriber advises a different schedule.

Serious risks include significant liver injury, cataracts or retinal pigment changes, severe allergic reactions, pulmonary hemorrhage, and acute pancreatitis. Patients should be monitored regularly for liver function, eye health, and any signs of severe adverse events.

Kaftrio is not recommended for children under 12 years of age, for patients without the F508del mutation, or for individuals taking strong CYP3A inducers or inhibitors without medical supervision. Patients with severe liver disease should also avoid use unless closely monitored by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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