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HYRNUO

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HYRNUO

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: HYRNUO
Generic Name (API): Sevabertinib
Dosage Form & Strength: 10 mg
Route: Oral
Drug Class: HER2 (ERBB2) tyrosine kinase inhibitor (TKI)

Manufacturer / Innovator:

Germany

Regulatory Approval:

  • US FDA (accelerated approval)
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  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

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  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Hyrnuo Used For?

Hyrnuo (sevabertinib) is an oral, reversible tyrosine kinase inhibitor (TKI). It is indicated for the treatment of adult patients with:

  • Locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test
  • Disease progression after at least one prior systemic therapy

This indication is approved under accelerated approval based on objective response rate and duration of response; continued approval may depend on results from confirmatory trials. It is a prescription oncology medicine and must be used under the supervision of a qualified oncologist, following confirmation of HER2 TKD mutation status.

Recommended Dosage

  • 20 mg (two 10 mg tablets) taken orally twice daily, with food
  • Continued until disease progression or unacceptable toxicity

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Hyrnuo Warnings and Precautions

  • Hepatotoxicity: Can cause severe liver injury. Liver function tests should be monitored at baseline, every 2 weeks for the first month, then monthly thereafter.
  • Interstitial lung disease (ILD) / pneumonitis: Patients should be monitored for new or worsening symptoms such as shortness of breath, cough, or fever; treatment should be discontinued if ILD/pneumonitis is confirmed.
  • Ocular toxicity: Reported in about 14% of patients, including rare cases of temporary vision loss. Prompt evaluation is recommended for new or worsening eye symptoms.
  • Pancreatic enzyme elevation: Increased lipase and amylase are common. Regular monitoring during treatment is recommended.
  • Diarrhea: Very common (reported in the majority of patients) and may require supportive management or dose adjustment.
  • Embryo-fetal toxicity: Hyrnuo can cause fetal harm. Effective contraception is recommended during treatment and for a period after the last dose.

How to Access Hyrnuo 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 Hyrnuo to India?

Hyrnuo (sevabertinib) tablets 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 doctor
  • The patient's diagnostic reports, including confirmation of HER2 tyrosine kinase domain mutation
  • 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 Hyrnuo available in India?

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

However, patients in India can legally access Hyrnuo through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of a specific patient for their personal treatment, under a valid prescription.

Hyrnuo received accelerated US FDA approval on 20 November 2025, ensuring full transparency throughout the process.

Hyrnuo 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 — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) can source Hyrnuo from reliable global channels and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. Hyrnuo tablets should be stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C, and are handled under temperature-controlled shipping conditions throughout transit. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For Hyrnuo cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability of Hyrnuo Across Major Cities in India

Patients across India can access Hyrnuo through regulated import pathways, with delivery arranged to the treating hospital based on a valid oncologist's prescription.

Mumbai

A major oncology hub with institutions like Tata Memorial, Mumbai coordinates access to advanced lung cancer therapies like Hyrnuo for eligible patients.

Delhi

As part of the Delhi NCR region, the city has a strong concentration of cancer centers, making it a key location for accessing targeted lung cancer treatments.

Bangalore

With a growing network of multispecialty oncology hospitals, Bangalore supports access to Hyrnuo through structured import pathways guided by treating specialists.

Chennai

Home to several reputed cancer treatment centers, Chennai facilitates access to Hyrnuo for patients with HER2-mutated NSCLC.

Hyderabad

A growing hub for oncology care, Hyderabad supports coordinated access to Hyrnuo for eligible patients under specialist supervision.

Kolkata

Eastern India's leading cancer centers in Kolkata coordinate Hyrnuo access for patients with advanced lung cancer.

Pune

With an expanding base of oncology clinics, Pune facilitates timely access to Hyrnuo under prescription.

Ahmedabad

Gujarat's leading cancer hospitals support regulated access to Hyrnuo for eligible patients.

Kochi

Kerala's healthcare network, including major cancer centers in Kochi, coordinates access to advanced targeted therapies like Hyrnuo.

Chandigarh

Serving North India, Chandigarh's oncology centers facilitate access to Hyrnuo for patients from Punjab, Haryana, and Himachal Pradesh.

Jaipur

Rajasthan's leading hospitals support patient access to Hyrnuo through the Named Patient Program.

Lucknow

A key referral center for North India, Lucknow facilitates coordinated access to Hyrnuo under oncologist care.

Bhubaneswar

Odisha's growing oncology sector supports patient access to Hyrnuo.

Guwahati

As a referral hub for the North-East, Guwahati facilitates access to Hyrnuo for patients across the region.

Access can also be coordinated for patients in other major Indian cities, subject to a valid prescription and regulatory requirements.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 08 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 08 September 2026

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