Azadine® (Azacitidine) — Hypomethylating Agent for MDS and AML

First-Line Treatment for Myelodysplastic Syndromes and Unfit AML Patients

Azadine® (Azacitidine) is a pyrimidine nucleoside analogue and hypomethylating agent (HMA) used to treat myelodysplastic syndromes (MDS) and Acute Myeloid Leukemia (AML) in patients who are not eligible for intensive chemotherapy. It works by incorporating into DNA and RNA, inhibiting DNA methyltransferase activity and reversing abnormal gene silencing in cancer cells — restoring normal cell differentiation and death pathways.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Azadine (Azacitidine) to hospitals, haematology centres, oncology clinics, and pharmacies across India. Azacitidine is also used in combination with Venclexta (Venetoclax) for newly diagnosed AML — one of the most important combination regimens in modern haematology. Manufactured by leading pharmaceutical companies, Azadine represents a cornerstone treatment in MDS and AML management.

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What is Azadine (Azacitidine)?

Azadine contains Azacitidine, a chemical analogue of the nucleoside Cytidine. Azacitidine is a hypomethylating agent — it works by incorporating into DNA and RNA during cell replication and inhibiting DNA methyltransferase (DNMT) enzymes that add methyl groups to cytosine bases in DNA.

In MDS and AML, abnormal hypermethylation of tumour suppressor gene promoters silences genes that normally control cell growth and differentiation. By inhibiting DNMT, Azacitidine reverses this abnormal methylation, restoring expression of silenced tumour suppressor genes and promoting cancer cell differentiation and apoptosis.

Full prescribing information is available at the FDA label for Azacitidine.

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Clinical Studies and Evidence

AZA-001 Trial (Azacitidine vs Conventional Care in High-Risk MDS) Published in The Lancet Oncology (2009), the AZA-001 trial demonstrated that Azacitidine significantly improved overall survival compared to conventional care regimens in patients with high-risk MDS — median overall survival of 24.5 months vs 15.0 months — establishing Azacitidine as the standard of care for high-risk MDS.

VIALE-A Trial (Azacitidine + Venetoclax for AML) Published in the New England Journal of Medicine (2020), the VIALE-A trial demonstrated that Azacitidine plus Venetoclax (Venclexta) significantly improved overall survival compared to Azacitidine alone in patients with newly diagnosed AML ineligible for intensive chemotherapy — median OS 14.7 months vs 9.6 months. This combination is now the standard of care for unfit AML patients.

AML Studies Multiple studies have demonstrated Azacitidine’s activity as a single agent and in combination in AML patients, with overall response rates of 18-29% as monotherapy and significantly higher rates in combination with Venetoclax.

MRD Negativity Studies Studies have shown Azacitidine maintenance therapy can help maintain minimal residual disease (MRD) negativity after intensive chemotherapy or stem cell transplantation in AML patients, prolonging remission duration.

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Available Strengths

Azadine is available as:

• 100mg powder for solution for injection/infusion (vial)

The recommended dose for MDS is 75mg/m² subcutaneously or intravenously daily for 7 days every 28 days. For AML in combination with Venetoclax the dose is 75mg/m² IV or SC on days 1-7 of each 28-day cycle.

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Indications — What Azadine is Used For

Myelodysplastic Syndromes (MDS)

• Treatment of adult patients with myelodysplastic syndromes including:
  • Refractory anaemia with excess blasts (RAEB)
  • Refractory anaemia with excess blasts in transformation (RAEB-T)
  • Chronic myelomonocytic leukemia (CMML)
  • Intermediate-2 and high-risk MDS by IPSS scoring

Acute Myeloid Leukemia (AML)

• Treatment of adults with newly diagnosed AML who are not eligible for intensive induction chemotherapy
• Used in combination with Venetoclax (Venclexta) as standard of care for unfit AML patients

For detailed indication information refer to NCI Azacitidine Drug Information.

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Key Benefits of Azadine

Proven Overall Survival Benefit in MDS The AZA-001 trial demonstrated a significant overall survival benefit of 9.5 months compared to conventional care in high-risk MDS — the first treatment to demonstrate an OS benefit in this disease.

Cornerstone of AML Combination Therapy In combination with Venclexta (Venetoclax), Azacitidine forms the standard of care for newly diagnosed unfit AML patients — achieving median OS of 14.7 months vs 9.6 months for Azacitidine alone.

Applicable Regardless of Cytogenetics Azacitidine demonstrates activity across different cytogenetic risk groups in MDS and AML including high-risk features such as complex karyotype and TP53 mutations.

Outpatient Administration Option Subcutaneous administration allows Azacitidine to be given in an outpatient setting, reducing the need for prolonged hospitalisation.

Delays Transformation to AML In lower-risk MDS patients, Azacitidine delays transformation to AML and reduces transfusion dependence, improving quality of life.

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How Azadine Works

MDS and AML are characterised by abnormal epigenetic changes — particularly hypermethylation of CpG islands in the promoter regions of tumour suppressor genes. This hypermethylation silences genes that normally control cell differentiation and apoptosis.

Azadine works through two complementary mechanisms:

Hypomethylation (Primary Mechanism):

• Azacitidine is incorporated into DNA during replication in place of cytosine
• Incorporated Azacitidine covalently traps and inactivates DNMT enzymes
• This prevents methylation of newly synthesised DNA strands
• Over successive cell divisions, global DNA methylation decreases
• Silenced tumour suppressor genes are re-expressed
• Normal differentiation and apoptosis pathways are restored

Direct Cytotoxicity (Secondary Mechanism):

• At higher concentrations Azacitidine incorporates into RNA disrupting protein synthesis
• This causes direct cytotoxic effects on rapidly dividing cancer cells

For a detailed mechanism overview refer to the American Society of Hematology educational resources.

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Azadine + Venclexta — The Standard of Care Combination

The combination of Azadine (Azacitidine) plus Venclexta (Venetoclax) is now the internationally recognised standard of care for newly diagnosed AML patients ineligible for intensive chemotherapy:

Both medicines are available from A.K. Pharma:

• Azadine (Azacitidine) — medicine distributor in Delhi
• Venclexta (Venetoclax) — medicine distributor in Delhi

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Dosage and Administration

MDS — Recommended Dosing:

• 75mg/m² subcutaneously (SC) or intravenously (IV) once daily for 7 consecutive days
• Repeat every 28 days (7 days on, 21 days off)
• Minimum 6 treatment cycles recommended — continue as long as patient benefits

AML in Combination with Venetoclax:

• Azacitidine 75mg/m² IV or SC on days 1-7 of each 28-day cycle
• Venetoclax 400mg orally once daily on days 1-28 (after ramp-up)

Administration Routes:

• Subcutaneous injection — preferred for outpatient administration
• Intravenous infusion over 10-40 minutes — for inpatient administration

Full dosing guidelines available at Drugs.com Azacitidine Dosage.

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Who Should Use Azadine

Azadine is prescribed for:

• Adults with intermediate-2 or high-risk MDS requiring disease-modifying therapy
• Adults with CMML requiring systemic treatment
• Adults with newly diagnosed AML ineligible for intensive induction chemotherapy
• AML patients being considered for Azacitidine plus Venetoclax combination therapy

Azadine is prescribed by haematologists and oncologists. A.K. Pharma supplies Azadine to haematology centres, hospitals, and pharmacies across Delhi and India.

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Possible Side Effects

Common side effects include injection site reactions, nausea, vomiting, diarrhoea, constipation, anaemia, thrombocytopenia, neutropenia, fatigue, and pyrexia.

Serious side effects include:

• Severe cytopenias — anaemia, neutropenia, thrombocytopenia requiring dose delay or modification
• Serious infections including pneumonia and sepsis — increased risk due to neutropenia
• Hepatotoxicity — monitor liver function in patients with hepatic impairment
• Renal toxicity — monitor renal function particularly in patients on diuretics
• Tumour lysis syndrome — particularly when used in combination with Venetoclax

Full side effect information available at FDA Azacitidine Safety Information.

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Precautions

• Monitor complete blood count before each cycle and as clinically indicated
• Dose delay or reduction required for significant cytopenias
• Monitor renal and hepatic function before initiating and periodically during treatment
• Use with caution in patients with renal impairment — dose modification may be required
• Not recommended in patients with advanced malignant hepatic tumours
• Effective contraception required during treatment and for 6 months after last dose for women and 3 months for men
• Not recommended during pregnancy or breastfeeding

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Storage and Handling

• Store unreconstituted vials at room temperature below 25°C
• After reconstitution with water for injection: store at room temperature and use within 1 hour
• After reconstitution with cold (2°C-8°C) diluent for SC injection: may be stored at 2°C-8°C for up to 8 hours
• Keep out of reach of children

As a responsible medicine distributor in Delhi, A.K. Pharma stores all medicines including Azadine under manufacturer-recommended conditions ensuring product integrity for every supply.

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Manufacturer Information

Azadine (Azacitidine) is manufactured by leading pharmaceutical companies producing the generic Azacitidine formulation. The originator Azacitidine (Vidaza) received FDA approval in May 2004 for MDS. A.K. Pharma supplies only genuine Azadine sourced from authorized distributors.

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Related Cancer and Haematology Medicines Available at A.K. Pharma

• Venclexta (Venetoclax) — BCL-2 inhibitor — used in combination with Azadine for AML
• Blincyto (Blinatumomab) — BiTE antibody for ALL
• Tibsovo (Ivosidenib) — IDH1 inhibitor for AML
• Acabrunat (Acalabrutinib) — BTK inhibitor for CLL
• Browse all Cancer Medicines available at A.K. Pharma

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Frequently Asked Questions

Q. What is Azadine used for? Azadine (Azacitidine) is used to treat myelodysplastic syndromes (MDS) and Acute Myeloid Leukemia (AML) in patients not eligible for intensive chemotherapy. More information available at Cancer.gov.

Q. What is the generic name of Azadine? The generic name of Azadine is Azacitidine. It belongs to the hypomethylating agent class of cancer medicines.

Q. Can Azadine be combined with Venetoclax? Yes. The combination of Azadine (Azacitidine) plus Venclexta (Venetoclax) is the standard of care for newly diagnosed AML patients ineligible for intensive chemotherapy, achieving significantly better outcomes than Azacitidine alone.

Q. Is Azadine available in India? Azadine can be supplied to hospitals, haematology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Azadine in India? Azadine price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Azadine from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Azadine in bulk? Yes. A.K. Pharma supplies Azadine in bulk to haematology centres, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.

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Why Order Azadine from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Azadine sourced from authorized distributors
• Reliable supply to haematology centres, hospitals, and pharmacies across India
• Bulk supply available with competitive pricing
• Prompt response to all quote requests
• Serving haematologists and oncologists across Delhi NCR and India

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Contact A.K. Pharma for Azadine Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in