1. Product Overview: Azarest® is a hypomethylating antineoplastic agent containing Azacitidine, used in the treatment of myelodysplastic syndromes (MDS) and certain acute myeloid leukemia (AML) cases.

2. Composition: Azacitidine INN 300 mg | Dosage Form: Powder for Injection / Lyophilized vial

3. Pharmacological Class: DNA Methyltransferase Inhibitor (Hypomethylating Agent)

4. Mechanism of Action: Azacitidine incorporates into DNA and RNA, inhibiting DNA methyltransferase activity, leading to hypomethylation and reactivation of suppressed genes, which helps control abnormal cell growth.

5. Indications: Myelodysplastic syndromes (MDS) | Acute myeloid leukemia (AML) in selected cases | Other hematological malignancies as prescribed

6. Dosage & Administration: As directed by oncology specialist only | Administered by subcutaneous or intravenous route | Dose and cycle depend on body surface area and clinical condition

7. Clinical Benefits: Slows progression of bone marrow disorders | Improves blood cell production | Reduces transfusion dependence | May improve survival in selected patients

8. Contraindications: Hypersensitivity to Azacitidine or any component of the formulation

9. Precautions: Risk of bone marrow suppression | Regular blood count monitoring required | Use cautiously in liver and kidney impairment | Infection risk due to low blood counts

10. Drug Interactions: May enhance bone marrow suppression when used with other cytotoxic agents

11. Special Populations: Not recommended during pregnancy unless clearly necessary | Avoid breastfeeding during treatment | Elderly use under strict monitoring

12. Adverse Effects: Nausea | Vomiting | Fatigue | Anemia | Neutropenia | Injection site reactions

13. Storage Conditions: Store below 30°C | Protect from light | Reconstituted solution should be used as per medical guidelines | Keep out of reach of children

14. Packaging: Single-dose vial

15. Manufacturer: Everest Pharmaceutical Ltd.