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Kaftrio

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Kaftrio

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Kaftrio
Generic Name (API): Elexacaftor, Tezacaftor, Ivacaftor
Dosage Form & Strength: 75mg/50mg/100mg
Route: Oral
Drug Class:

Manufacturer / Innovator:

Ireland

Regulatory Approval:

  • EMA (Europe)
  • FDA (US) – as Trikafta
  • HC (Canada) – as Trikafta
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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Understanding Kaftrio and Its Medical Uses

Kaftrio (elexacaftor/tezacaftor/ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) modulator combination approved by the European Medicines Agency and the UK MHRA for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene, taken in combination with ivacaftor. It is the EU/UK-marketed equivalent of Trikafta, which is approved in the United States under the same active ingredients.

How Kaftrio Works

Kaftrio contains three CFTR modulators that work together: elexacaftor and tezacaftor help the defective CFTR protein fold and traffic correctly to the cell surface, while ivacaftor (the "potentiator" component, co-packaged separately and taken alongside Kaftrio) helps the CFTR protein at the cell surface open more effectively to allow chloride ion transport. Together, this combination addresses the underlying protein defect in patients with at least one F508del mutation, rather than only managing symptoms.

Approved Patient Population

Kaftrio is indicated for CF patients aged 2 years and older who are homozygous for the F508del mutation, or who are heterozygous for F508del and have a second CFTR mutation that is responsive to elexacaftor/tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

Dosage and Administration

For adults and adolescents 12 years and older, the standard regimen is two Kaftrio 75 mg/50 mg/100 mg (elexacaftor/tezacaftor/ivacaftor) tablets in the morning and one ivacaftor 150 mg tablet in the evening, approximately 12 hours apart, taken with fat-containing food. Dosing for children aged 2 to 11 years is weight-based and uses age-appropriate granule or tablet formulations — a treating physician should confirm the exact regimen based on the patient's age and weight.

Warnings and Precautions for Kaftrio

Important Safety Information — Kaftrio: Cases of liver failure leading to liver transplantation, and liver-related deaths, have been reported in patients treated with elexacaftor/tezacaftor/ivacaftor, generally in patients with pre-existing advanced liver disease. Liver function should be monitored closely, particularly during the first six months of treatment, and treatment should be interrupted if signs of significant liver injury occur.

Hepatic Impairment

Elevations in liver enzymes (ALT, AST) have been observed in clinical trials. Liver function tests are recommended before starting Kaftrio, every three months during the first year of treatment, and periodically thereafter. Kaftrio should be used with caution in patients with moderate hepatic impairment and is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks.

Rash

Rash has been reported, particularly in female patients using hormonal contraceptives containing ethinylestradiol. If a rash occurs, discontinuation of the contraceptive should be considered.

Mood and Behavioural Changes

Cases of mood-related adverse events, including depression and anxiety, have been reported, particularly in adolescent patients. Patients and caregivers should be advised to contact their physician if mood or behavioural changes occur.

Organ Transplant Patients

Kaftrio has not been studied in patients who have undergone organ transplantation. Use in post-transplant patients is not recommended.

Renal Impairment

Kaftrio has not been studied in patients with severe renal impairment or end-stage renal disease; caution is advised, and dose adjustment may be needed.

Drug Interactions

Kaftrio is metabolised by CYP3A. Concomitant use with strong CYP3A inducers should be avoided, and dose adjustment is required with moderate or strong CYP3A inhibitors — a treating physician should review all concomitant medications before initiating therapy.

How to Access Kaftrio in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Kaftrio

Kaftrio is approved and marketed in the European Union and the United Kingdom by Vertex Pharmaceuticals (Europe) Limited. It is not separately marketed in the United States — the identical elexacaftor/tezacaftor/ivacaftor combination is sold there under the brand name Trikafta. Patients seeking either brand can be supported through NPP's regulated import pathway, with documentation requirements varying by source market.

Required Documentation

Patients typically need a valid prescription from a treating pulmonologist or CF specialist confirming CFTR genotype and eligibility, along with supporting clinical records. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant, named-patient import.

Availability

As an EU/UK-approved therapy for a rare genetic disease, Kaftrio is sourced through authorized European distribution channels and imported under GDP-compliant, temperature-monitored logistics to preserve product quality throughout transit.

Sourcing and Delivery of Kaftrio

NPP sources Kaftrio directly from authorized European pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.

Cold Chain and Handling

Kaftrio does not require refrigeration — it should be stored below 30°C in its original blister pack to protect it from moisture, and this condition is maintained throughout transit and storage.

Delivery Timelines

Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile logistics to the patient's city.

Availability of Kaftrio Across Major Cities in India

Patients across India can access Kaftrio through NPP's regulated import pathway, with cystic fibrosis specialists in major cities supporting the treatment process.

Mumbai

Leading hospitals in Mumbai support cystic fibrosis care coordination and documentation for Kaftrio access.

Delhi

Delhi's major hospitals assist patients with prescription support and documentation for Kaftrio.

Bangalore

Bangalore's specialist network offers access coordination for CF patients eligible for Kaftrio.

Chennai

Chennai-based pulmonology specialists coordinate Kaftrio access alongside comprehensive CF care.

Hyderabad

Hyderabad's care institutions support patients pursuing Kaftrio therapy.

Kolkata

Kolkata's specialist centers help coordinate documentation and treatment access for Kaftrio.

Pune

Pune-based specialists assist with prescription support and Kaftrio treatment planning.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Kaftrio.

Kochi

Kochi's specialist units assist patients with the documentation needed for Kaftrio access.

Chandigarh

Chandigarh's care centers support Kaftrio treatment coordination for patients from North India.

Jaipur

Jaipur's specialists help patients navigate the Kaftrio access process.

Lucknow

Lucknow-based centers assist patients pursuing Kaftrio therapy.

Bhubaneswar

Bhubaneswar's institutions support access to Kaftrio for eligible patients.

Guwahati

Guwahati's specialists help coordinate Kaftrio access for patients across the Northeast.

Patients in other cities across India can also access Kaftrio through NPP's nationwide coordination network.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: EMA • UK MHRA

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 15 September 2026

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