Koselugo

Koselugo Warnings and Precautions

• Left ventricular dysfunction: Cardiac function should be assessed before and periodically during treatment.
• Ocular toxicity: Regular eye exams are recommended, as vision changes and retinal problems can occur.
• Gastrointestinal toxicity: Diarrhea and other GI effects are common and may require dose adjustment.
• Skin toxicity: Rash and other skin reactions can occur and should be monitored.
• Embryo-fetal toxicity: Koselugo can cause fetal harm. Pregnancy status should be verified before starting treatment, and effective contraception used during treatment.
• Drug interactions: Strong or moderate CYP3A4 inducers can reduce Koselugo's effectiveness and should be avoided.

How to Access Koselugo 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 & Availability

What documents are required to import Koselugo to India?

Koselugo (selumetinib) capsules may be imported in the patient's name only, by patients or government hospitals, in line with India's import regulations for unapproved medicines. The following documentation is required:

• A valid prescription from a qualified specialist experienced in treating NF1
• The patient's diagnostic reports confirming neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is Koselugo available in India?

Koselugo (selumetinib capsules) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Koselugo is not commercially marketed in India.

However, patients in India can legally access Koselugo through the Named Patient Program (NPP) — an import provision that allows patients to receive medicines approved in other countries but not yet marketed in India, under a doctor's prescription and proper regulatory documentation.

Koselugo received US FDA approval for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas, ensuring full transparency throughout the process.

Koselugo can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others.

Sourcing & Delivery of Koselugo

Koselugo is sourced directly from authorized channels in the country of origin and shipped to India under GDP-compliant logistics to preserve product integrity from dispatch to delivery.

• Storage maintained at 15°C to 30°C throughout transit
• Real-time shipment tracking and delivery updates
• Delivery coordinated directly with the patient, family, or treating hospital

Availability of Koselugo Across Major Cities in India

Named Patient Program supports access to Koselugo for patients with neurofibromatosis type 1 across major cities in India, coordinating documentation, sourcing, and delivery with treating specialists.

Mumbai

Patients in Mumbai can access Koselugo through NPP with support from treating neurologists and NF1 specialists at the city's leading centers.

Delhi

In Delhi, NPP coordinates with hospitals and specialty genetics clinics to facilitate timely access to Koselugo.

Bangalore

Bangalore's neurology and genetics centers work with NPP to support patients requiring Koselugo.

Chennai

Patients in Chennai can access Koselugo through NPP, with coordination between treating doctors and the program's regulatory and logistics team.

Hyderabad

Hyderabad's neurology and genetic testing centers support diagnosis and access coordination for Koselugo through NPP.

Kolkata

NPP facilitates access to Koselugo for patients in Kolkata under the guidance of treating specialists.

Pune

Patients in Pune can access Koselugo through NPP with prescription-based coordination and delivery support.

Ahmedabad

NPP supports access to Koselugo for patients in Ahmedabad, working directly with treating specialists.

Kochi

Patients in Kochi and across Kerala can access Koselugo through NPP's regulated import pathway.

Chandigarh

NPP coordinates access to Koselugo for patients in Chandigarh and the surrounding region.

Jaipur

Patients in Jaipur can access Koselugo through NPP with support from treating specialists.

Lucknow

NPP facilitates access to Koselugo for patients in Lucknow and across Uttar Pradesh.

Bhubaneswar

Patients in Bhubaneswar can access Koselugo through NPP's coordinated import and delivery process.

Guwahati

NPP supports access to Koselugo for patients in Guwahati and across the Northeast region.

NPP also supports access for patients in other Indian cities not listed above — contact the team to check availability and timelines for your location.