ONUREG (Azacitidine) Tablets

ONUREG (oral azacitidine), from Bristol Myers Squibb, is indicated for continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.

Azacitidine is a hypomethylating agent that is incorporated into DNA and RNA, causing hypomethylation and direct cytotoxicity to abnormal hematopoietic cells in the bone marrow, helping maintain remission.

• Severe or fatal myelosuppression, including neutropenia, thrombocytopenia, and anemia, may occur; monitor complete blood counts regularly.
• Gastrointestinal toxicity (nausea, vomiting, diarrhea) is common — antiemetic prophylaxis is recommended.
• Embryo-fetal toxicity — can cause fetal harm; effective contraception is advised during and after treatment.
• ONUREG is not substitutable with injectable azacitidine products due to differing pharmacokinetics.

What documents are required to import ONUREG to India?

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

• A valid prescription from a registered hematologist-oncologist
• Diagnostic report confirming AML remission status post-induction chemotherapy
• 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.

Is ONUREG available in India?

ONUREG is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source ONUREG from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For ONUREG cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — September 2020.

What is ONUREG used for?

ONUREG maintains remission in AML patients after intensive induction chemotherapy who cannot complete further intensive curative therapy.

Who manufactures ONUREG?

ONUREG is developed by Bristol Myers Squibb.

How is ONUREG taken?

As oral tablets, once daily on days 1-14 of each 28-day cycle.

How much does ONUREG cost in India?

Cost depends on monthly quantity and sourcing logistics — share your prescription with IPN for a quote.