Tirabrutinib Tablets

Tirabrutinib (marketed as Velexbru), from Ono Pharmaceutical, is indicated for the treatment of relapsed or refractory primary central nervous system lymphoma (PCNSL), and chronic lymphocytic leukemia/small lymphocytic lymphoma and Waldenstrom’s macroglobulinemia, in markets where it is approved.

Tirabrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor. By blocking BTK, it interrupts B-cell receptor signaling that drives the proliferation of malignant B-lymphocytes in these conditions.

• Hemorrhage risk — BTK inhibitors carry a class risk of bleeding events; use caution with concomitant anticoagulants/antiplatelets.
• Infections, including opportunistic infections, may occur.
• Cytopenias (low blood counts) have been reported; regular monitoring is recommended.
• Since this product is not FDA-approved, treatment should only be undertaken under close specialist supervision with full awareness of its regulatory status.

What documents are required to import Tirabrutinib to India?

As a product not FDA-approved, it may only be imported in the patient’s name based on a treating specialist’s recommendation, referencing its approval status in its country of origin. Required documents include:

• A valid prescription from a registered hematologist-oncologist/neuro-oncologist
• Diagnostic report confirming the applicable diagnosis
• 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 and confirmation of sourcing feasibility.

Is Tirabrutinib available in India?

It is not commercially marketed in India or the United States. Availability through the Named Patient Program (NPP) depends on sourcing feasibility from markets where it holds regulatory approval.

Indian Pharma Network (IPN) will assess sourcing feasibility for Tirabrutinib on a case-by-case basis, given its current regulatory status, and facilitate supply where legally and logistically possible.

For enquiries, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• Japan: Approved by the PMDA (marketed as Velexbru).
• United States: Not FDA-approved.

What is Tirabrutinib used for?

It is used (where approved) for relapsed/refractory primary CNS lymphoma, CLL/SLL, and Waldenstrom’s macroglobulinemia.

Who manufactures Tirabrutinib?

Tirabrutinib is developed by Ono Pharmaceutical, marketed as Velexbru.

Is Tirabrutinib FDA-approved?

No — it is approved by Japan’s PMDA and is not currently FDA-approved.

How much does Tirabrutinib cost in India?

Cost and sourcing feasibility depend on the patient’s specific case — contact IPN to discuss.