Unecritinib

Warnings and Precautions

Who should not take it: the Chinese label says it must not be used in pregnancy or while breastfeeding, by people with severe liver or kidney impairment, or by anyone allergic to unecritinib or the capsule ingredients.

• Liver: in the pivotal study (113 patients), AST went up in 75.2% and ALT in 73.5%, but severe rises were uncommon (7.1% and 3.5%). Liver tests are checked before and during treatment.
• Blood counts: low neutrophils were seen in 57.5% and were severe in 28.3%, so regular blood counts are needed. No one stopped treatment because of this in the study.
• Stomach and bowel: vomiting (63.72%), diarrhoea (44.25%), nausea (38.05%) and constipation (31.86%) were common in the pivotal study, though none were severe. They usually start in the first days of treatment.
• Heart: a slow heartbeat (sinus bradycardia) occurred in 54.0%, with no severe cases. QT prolongation on the ECG was seen in 15.0% and was severe in 5.3%, so ECGs and blood salts are monitored.
• Eyes: blurred vision, floaters or other visual changes affected 16.8%, none severe. Be careful when driving if this happens.
• Lungs: lung inflammation (pneumonitis) was rare (1.8%, all mild), but sudden breathlessness, cough or fever should be reported straight away.
• Other medicines: strong drugs that affect the CYP3A4 liver enzyme should be avoided where possible. Give your doctor a full list of what you take.

Overall: in the pooled safety data on the label (304 patients at the full dose), 31.25% had to pause treatment because of a side effect and 8.22% stopped for good. Oedema (20.7%), anaemia (23.7%), tiredness (17.4%), taste changes (10.5%) and dizziness (10.2%) were also reported. There were no treatment-related deaths in the published phase 1/2 study. It has not been studied in children under 18.

How to Access Unecritinib 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 Unecritinib to India?

The capsules can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

• A valid prescription from a qualified medical oncologist
• Diagnostic reports confirming non-small cell lung cancer, including the ROS1 test result (for example NGS or FISH) and details of earlier treatment
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Unecritinib available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. We can also help with other imported ROS1 medicines, such as Ibtrozi and Augtyro, if your oncologist prefers one of them.

It 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) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. The 100 mg capsules come in blister strips of seven; the box we have seen holds 28 capsules. The label says to keep them sealed, protected from light and at no more than 25°C, so they travel in their original packs under temperature-controlled shipping. At six capsules a day, we plan supply ahead so there is no break in treatment. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

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

Availability Across Major Cities in India

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

Delhi

Lung cancer specialists in Delhi see patients from across North India, and our New Delhi dispatch point keeps delivery times short.

Mumbai

Oncologists in Mumbai can request the medicine for a named patient once the ROS1 report is available.

Bangalore

Patients in Bangalore can receive the capsules at home or at their cancer centre after the paperwork is checked.

Chennai

Cancer centres in Chennai offer the molecular testing needed to confirm a ROS1 fusion before treatment starts.

Hyderabad

Medical oncologists in Hyderabad can send us the prescription and biomarker report to begin the import.

Kolkata

For Kolkata and the eastern states, deliveries are timed so a new supply arrives before the old one runs out.

Pune

Patients in Pune can use the same documented import route, with updates at each step.

Ahmedabad

Oncologists in Ahmedabad can arrange access for patients with this uncommon type of lung cancer.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or treating hospital.

Jaipur

Patients in Rajasthan can have the capsules sent to them directly once the import in their name is cleared.

Lucknow

We coordinate delivery to public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can have their supply delivered to their home or hospital in Kochi and nearby cities.

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