Basic Information
ONUREG FILM-COATED TABLETS 300 MG
TABLET, FILM COATED
Regulatory Information
SIN16573P
August 19, 2022
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XL01BC07
Company Information
BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Active Ingredients
Strength: 300.0 mg
Detailed Information
Contraindications
**2 CONTRAINDICATIONS** ONUREGTM is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see **DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. ONUREGTM is contraindicated in patients with advanced malignant hepatic tumors.
Indication Information
**1 INDICATIONS** ONUREGTM (azacitidine film-coated tablets) is a nucleoside metabolic inhibitor indicated for: - maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT). Limitations of Use: - ONUREGTM is not interchangeable with, and should not be substituted with or for, azacitidine for injection. See **DOSAGE AND ADMINISTRATION, Administration** and **WARNINGS AND PRECAUTIONS, General** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - The safety and effectiveness of ONUREG for treatment of myelodysplastic syndromes have not been established. Treatment of patients with myelodysplastic syndromes with ONUREG is not recommended outside of controlled trials. See **WARNINGS AND PRECAUTIONS, General** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **1.1 Pediatrics** **Pediatrics (< 18 years of age):** No data are available on administration of ONUREGTM to pediatric or adolescent patients (< 18 years of age). **1.2 Geriatrics** **Geriatrics (≥ 65 years of age):** No dosage adjustment is required for ONUREGTM based on age, see **ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.