Andexxa

Boxed Warning — Andexxa: Andexxa is associated with arterial and venous thromboembolic events, ischemic events, cardiac arrest, and sudden death. Resuming anticoagulation as soon as medically appropriate is recommended.

Andexxa Warnings and Precautions

• Confirmed increased thrombosis risk vs. standard care: The ANNEXA-I confirmatory trial found Andexxa was associated with meaningfully higher rates of thrombosis and thrombosis-related death compared to 4F-PCC in intracranial hemorrhage — this is the basis for its December 2025 US market withdrawal.
• Not FDA-approved as of December 2025: Andexxa is no longer available in the US; where it remains conditionally approved (EU, UK, Japan), prescribers should weigh the ANNEXA-I findings alongside local guidance.
• Consider standard of care first: 4-factor prothrombin complex concentrate (4F-PCC) is now generally preferred for reversing Factor Xa inhibitors in life-threatening bleeding.
• Infusion reactions: Can occur during administration.

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

Step 1 – Search & request your medicine: The treating physician submits a request with basic details to initiate the access process, after determining that Andexxa remains the appropriate choice for the specific patient despite the ANNEXA-I safety findings discussed above.

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, cold-chain conditions to maintain product integrity.

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

Note: Given Andexxa's current safety profile relative to standard care, hospitals and physicians are encouraged to discuss 4F-PCC-based reversal protocols with NPP's team alongside any Andexxa request.

Documentation & Availability

What documents are required to import Andexxa to India?

Andexxa (andexanet alfa) injection 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 or hospital order from a qualified physician managing a Factor Xa inhibitor-related bleeding emergency
• Documentation of the clinical rationale for choosing Andexxa over standard-of-care 4F-PCC, given the ANNEXA-I trial findings
• Patient or hospital 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 or institutional order and, if applicable, an import permit.

Is Andexxa available in India?

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

Patients and hospitals in India can access Andexxa through the Named Patient Program (NPP) — an import provision that allows access to medicines approved abroad but not yet marketed in India, under proper regulatory documentation.

Andexxa was voluntarily withdrawn from the US market in December 2025 after safety data showed worse outcomes compared to standard care. It remains conditionally approved in the EU, UK (as Ondexxya), and Japan, and NPP can source it from these markets when a treating physician determines it remains clinically appropriate for a specific patient.

Andexxa can be made available to 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 Andexxa

Andexxa is sourced directly from authorized channels in markets where it remains approved (EU, UK, Japan) and shipped to India under GDP-compliant, cold-chain logistics to preserve product integrity from dispatch to delivery.

• Cold-chain shipping maintained at 2°C to 8°C throughout transit
• Real-time shipment tracking and delivery updates, important given the emergency nature of its use
• Delivery coordinated directly with the treating hospital

Availability of Andexxa Across Major Cities in India

Named Patient Program can coordinate hospital-level access to Andexxa for Factor Xa inhibitor-related bleeding emergencies across major cities in India, when a treating physician determines it is clinically appropriate given the safety findings discussed above.

Mumbai

Hospitals in Mumbai can coordinate emergency-stock access to Andexxa through NPP, in consultation with treating hematologists and emergency physicians.

Delhi

In Delhi, NPP coordinates with hospitals to facilitate access to Andexxa for anticoagulation reversal emergencies.

Bangalore

Bangalore's emergency and critical care centers can work with NPP on Andexxa access when clinically indicated.

Chennai

Hospitals in Chennai can access Andexxa through NPP, with coordination between hospital pharmacy and the program's regulatory and logistics team.

Hyderabad

Hyderabad's critical care centers support access coordination for Andexxa through NPP.

Kolkata

NPP facilitates access to Andexxa for hospitals in Kolkata for anticoagulation reversal emergencies.

Pune

Hospitals in Pune can access Andexxa through NPP with coordination and cold-chain delivery support.

Ahmedabad

NPP supports access to Andexxa for hospitals in Ahmedabad.

Kochi

Hospitals in Kochi and across Kerala can access Andexxa through NPP's regulated import pathway.

Chandigarh

NPP coordinates access to Andexxa for hospitals in Chandigarh and the surrounding region.

Jaipur

Hospitals in Jaipur can access Andexxa through NPP for anticoagulation reversal emergencies.

Lucknow

NPP facilitates access to Andexxa for hospitals in Lucknow and across Uttar Pradesh.

Bhubaneswar

Hospitals in Bhubaneswar can access Andexxa through NPP's coordinated import and delivery process.

Guwahati

NPP supports access to Andexxa for hospitals in Guwahati and across the Northeast region.

NPP also supports hospitals in other Indian cities not listed above — contact the team to check availability and timelines for your location, and to discuss whether 4F-PCC-based reversal is a more appropriate option for your patient.