Kavigale (Sipavibart)

Haiyitan (gumarontinib) is an oral, potent, and highly selective small-molecule inhibitor of the mesenchymal-epithelial transition factor (MET, also called c-MET). It is approved for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 (METex14) skipping mutation.

Gumarontinib works by blocking the activity of the MET receptor tyrosine kinase. In tumors carrying a METex14 skipping mutation, MET signaling becomes abnormally prolonged and drives cancer cell growth, survival, and spread. By selectively inhibiting MET, gumarontinib interrupts this oncogenic signaling, slowing or stopping tumor progression in patients with this specific molecular alteration.

METex14 skipping mutations occur in approximately 3 to 4% of NSCLC cases and represent an actionable driver mutation, often seen in older patients. Identifying these patients through molecular testing is important, since gumarontinib is intended specifically for METex14-positive disease.

It is a prescription medicine and must be used under the supervision of a qualified oncologist.

Recommended Dosage:
In clinical use, Haiyitan is taken as a 300 mg oral dose once daily (administered as the 50 mg tablets at the strength dispensed). In the pivotal trial, gumarontinib was given in continuous 21-day cycles and continued until there is evidence of disease progression, unacceptable toxicity, or withdrawal of consent.
The treating physician determines the appropriate dosing, dose interruptions, and dose reductions based on the patient’s tolerability and the approved product information. Patients should follow their physician’s instructions on how and when to take the tablets and should not adjust the dose on their own.

• Edema, particularly peripheral edema (swelling of the hands, feet, or legs), is the most commonly reported side effect of gumarontinib and other MET inhibitors. Patients should promptly inform their physician about any new or worsening swelling, as treatment adjustments or supportive care may be required.
• Gumarontinib may cause low blood albumin levels (hypoalbuminemia) and changes in liver function tests, including increased bilirubin and elevated ALT or AST levels. Regular blood tests may be recommended by your physician to monitor these laboratory values during treatment.
• Some patients may experience additional side effects such as decreased appetite, headache, nausea, or vomiting while receiving gumarontinib. If any symptoms become persistent, severe, or concerning, patients should consult their treating physician for appropriate medical advice and management.
• Before starting gumarontinib, patients should inform their physician about all prescription medicines, over-the-counter products, vitamins, and herbal supplements they are taking. This helps the healthcare provider identify and manage any potential drug interactions during treatment.
• There is limited information on the use of gumarontinib during pregnancy or while breastfeeding. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits with their treating physician before starting treatment.

What documents are required to import KAVIGALE to India?

KAVIGALE (sipavibart) may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a qualified doctor
• The patient’s diagnostic reports
• 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 an import permit, if applicable.

Is KAVIGALE available in India?

KAVIGALE (sipavibart injections) is a prescription medicine that legally requires a doctor’s prescription to be dispensed. As of current publicly available information, KAVIGALE is not commercially marketed in India.

However, patients in India can legally access KAVIGALE 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 an individual patient, on the prescription of their treating physician.

Indian Pharma Network (IPN) acts as a facilitator under named patient supply, providing input on:

• Availability of Kavigale in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune, etc.) and pathways to access it
• Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE).
  Kavigale price in India under the NPP route
• Sourcing from genuine, reliable channels in the USA, Canada, Europe, and Australia
• Ensuring full transparency throughout the process

KAVIGALE can be made available to patients, doctors, and hospitals in 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.

Indian Pharma Network (IPN) can source KAVIGALE from reliable channels across the world and facilitate supply to patients, doctors, and hospitals, offering worldwide access to this treatment under applicable legal provisions. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the patient’s address from New Delhi, India, after legal requirements are fulfilled.

For Kavigale cost in India and availability, contact IPN at WhatsApp: +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@indianpharmanetwork.in.

Global Approval Status:

Kavigale has been approved by several major regulatory authorities for the pre-exposure prophylaxis of COVID-19 in immunocompromised people:

• Japan: Approved in December 2024 to prevent SARS-CoV-2 infection in adults and adolescents aged 12 years and older weighing at least 40 kg, where vaccination is not recommended or may not achieve a sufficient immune response.
• European Union: Approved in January 2025 for immunocompromised adults and adolescents aged 12 and older weighing at least 40 kg.
• Canada: Approved in March 2025.

Approvals are based on the pivotal SUPERNOVA Phase 3 trial. This randomized, double-blind, comparator-controlled study evaluated Kavigale 300 mg for pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents, in around 3,280 participants randomized to either Kavigale or a comparator. Sipavibart was discovered by RQ Bio and exclusively licensed to AstraZeneca in 2022.

Note: AstraZeneca has indicated that sipavibart is not being pursued in the United States at this time, citing the high prevalence of resistant circulating variants. As of current publicly available information, Kavigale is not approved or commercially marketed in India.

What is the generic name for the brand drug Kavigale?

Sipavibart is the generic name for the brand drug Kavigale.

What is Kavigale used for?

Kavigale (sipavibart) is used for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised adults and adolescents aged 12 and older weighing at least 40 kg, who may not be adequately protected by vaccination.

Who manufactures Kavigale?

Kavigale is developed and manufactured by AstraZeneca. The antibody, sipavibart, was originally discovered by RQ Bio and licensed to AstraZeneca in 2022.

What type of medicine is sipavibart?

Sipavibart is a long-acting recombinant human IgG1 monoclonal antibody that neutralizes SARS-CoV-2 by binding to its spike protein — a form of passive immunization.

Is Kavigale approved by the FDA?

As of current publicly available information, Kavigale is not approved in the United States. AstraZeneca has cited the prevalence of resistant circulating variants as the reason for not pursuing US authorization at this time.

Where is Kavigale approved?

Kavigale is approved in Japan (December 2024), the European Union (January 2025), and Canada (March 2025) for the prevention of COVID-19 in immunocompromised people.

What strength and dosage form is available?

Kavigale is available as a 300 mg solution for injection/infusion, supplied for intravenous administration under the supervision of a qualified healthcare professional.

What are the most common side effects of Kavigale?

The most commonly reported side effects are infusion-related reactions, fatigue, nausea, headache, fever, diarrhea, and decreased appetite.

How does Kavigale import in India work?

Kavigale import in India is possible through the Named Patient Program (NPP) — on behalf of an individual patient with a valid doctor’s prescription. Indian Pharma Network (IPN) helps manage the process, including documentation, approvals, and delivery, so the medicine reaches the patient safely and legally.

Who is a reliable Kavigale supplier in India?

Indian Pharma Network (IPN) facilitates compliant access to Kavigale in India through global sourcing channels and structured documentation support for eligible patients in accordance with applicable regulatory provisions.

How much does Kavigale cost in India?

Kavigale is not yet approved or marketed in India, but patients can legally access it through the Named Patient Program. Prices may vary over time due to market and regulatory factors. For the latest Kavigale cost in India, call +91 96548 60915 or WhatsApp +91 98104 69557 or email info@indianpharmanetwork.in.

Can Kavigale be accessed in SAARC countries?

Yes. In addition to Gulf countries, Kavigale can be accessed through import provisions such as the Named Patient Program in SAARC countries (India, Afghanistan, Maldives, Nepal, Bangladesh, Bhutan, Pakistan, and Sri Lanka). IPN can help facilitate compliant supply where permitted by local regulations.

Is it safe to buy Kavigale® injections online in India?

Yes, one can buy Kavigale in India from the Indian Pharma Network (IPN), as this medicinal product is not yet registered or available in the country. We can help facilitate the import of Kavigale® injections through legal channels.

Can Kavigale be delivered to my treating hospital?

Yes. IPN can facilitate delivery of Kavigale to the patient’s treating hospital across major Indian cities, under the Named Patient Program, with a valid doctor’s prescription and import permit where applicable. Leading hospitals include AIIMS Delhi, Sir Ganga Ram Hospital, Medanta – The Medicity, Apollo Hospitals Chennai, Christian Medical College (CMC), PGIMER, Kidwai Memorial Institute of Oncology, Adyar Cancer Institute, Amrita Hospital, Artemis Hospital, Safdarjung Hospital, Kauvery Hospital, Sri Ramachandra Medical Centre, Cytecare Cancer Hospital, MIOT International, SCTIMST, NIMS Hospital, KIMS Hospitals, AIG Hospitals, Bombay Hospital, Lilavati Hospital, Care Hospitals, Narayana Health City, Jaslok Hospital, Yashoda Hospitals, Fortis Memorial Research Institute, Kokilaben Dhirubhai Ambani Hospital, P. D. Hinduja Hospital, Manipal Hospitals, Aster Medcity, Indraprastha Apollo Hospital, King George’s Medical University (KGMU), Shalby Hospitals, Tata Memorial Centre, HCG Cancer Center, Basavatarakam Indo-American Cancer Hospital, Cancer Institute (WIA), Max Healthcare, and Rajiv Gandhi Cancer Institute & Research Centre.

What are the storage conditions for Kavigale injections?

Kavigale® (tasurgratinib) injections should be stored at room temperature, typically between 15°C and 30°C, protected from excessive moisture and kept in the original packaging

Disclaimer: Kavigale (sipavibart injection) is a prescription medicine and should only be used under the supervision of a qualified healthcare professional. Product availability, import requirements, and access pathways vary by country-specific regulations. The effectiveness of antibody therapies against COVID-19 may vary with circulating SARS-CoV-2 variants. This page is for informational purposes and does not constitute medical advice.