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Azadine 100mg - Azacitidine Injection

Azadine 100mg is a chemotherapy injection used to treat myelodysplastic syndromes (MDS) and certain types of leukemia, particularly in adults who are not candidates for intensive treatment. It works by correcting abnormal cell growth in the bone marrow and promoting healthy blood cell development.

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General Information:
Generic Name: Azacitidine
Brand Name: Azadine 100mg
Packing: Single-use vial
Strength: 100 mg per vial
Manufacturer: Intas Pharmaceuticals Ltd.
Form: Lyophilized Powder for Injection
Category: Antineoplastic Agent / DNA Methyltransferase Inhibitor
Product Introduction:
Azadine 100mg contains Azacitidine, a hypomethylating agent and cytotoxic drug. It helps restore normal blood formation by reducing the number of cancerous cells and correcting epigenetic abnormalities in the DNA. It is commonly administered in cycles and may help delay disease progression or improve survival in patients with bone marrow disorders.

Uses:
Azadine 100mg is used for:
  1. Myelodysplastic Syndromes (MDS) – all subtypes
  2. Chronic Myelomonocytic Leukemia (CMML)
  3. Acute Myeloid Leukemia (AML) in elderly or unfit patients
  4. Prevention of disease progression from MDS to AML
  5. Improving anemia, neutropenia, and thrombocytopenia in bone marrow failure
  6. Used off-label in combination with other agents for higher-risk leukemias

Storage Instructions:
  1. Store refrigerated at 2°C to 8°C
  2. Protect from light and moisture
  3. Reconstituted solution should be used immediately or within prescribed time frame
  4. Do not freeze
  5. Keep out of reach of children

How It Works (Mechanism of Action):
Azacitidine is a nucleoside analog that inhibits DNA methyltransferase. It incorporates into RNA and DNA, leading to hypomethylation of DNA, which reactivates tumor suppressor genes and induces cell differentiation or apoptosis in abnormal hematopoietic cells. It slows or stops the growth of abnormal cells and allows healthy blood cells to grow.

Side Effects:
Common side effects include:
  1. Injection site reactions (pain, redness, swelling)
  2. Fatigue
  3. Nausea, vomiting, constipation
  4. Low blood counts (anemia, leukopenia, thrombocytopenia)
  5. Fever or infections
Serious side effects may include:
  1. Severe bone marrow suppression
  2. Sepsis or other life-threatening infections
  3. Liver toxicity
  4. Kidney impairment
  5. Severe allergic reactions (rare)

Dosage (Typical Recommended Dose):
  1. 75 mg/m² once daily for 7 days in a 28-day cycle
  2. Treatment is typically continued for at least 6 cycles to assess effectiveness
  3. Dosage adjustments may be necessary based on tolerability and response

Method of Administration:
  1. Can be given subcutaneously (SC) or intravenously (IV)
  2. Reconstitution is done with sterile water before use
  3. Administered by trained healthcare professionals
  4. Patient may require supportive care (e.g., antiemetics, antibiotics) during therapy

Precautions:
  1. Close monitoring of complete blood counts is essential
  2. Use caution in patients with renal or hepatic dysfunction
  3. Not recommended during pregnancy or breastfeeding
  4. Use effective contraception during and after treatment
  5. Avoid contact with sick individuals due to immunosuppression

Drug Interactions:
  1. Limited interaction with CYP450 enzymes, but use caution with:
    1. Other myelosuppressive agents
    2. Nephrotoxic or hepatotoxic drugs
  2. Consult a doctor before combining with any prescription, OTC, or herbal medicines

Allergies:
  1. Do not use if allergic to Azacitidine or mannitol (excipient)
  2. Discontinue immediately if signs of hypersensitivity occur, such as rash, swelling, difficulty breathing

Overdose Information:
  1. Overdose may cause excessive bone marrow suppression, infections, or bleeding
  2. No specific antidote – treatment is supportive and symptomatic
  3. Hospitalization may be necessary for close monitoring and supportive care

Missed Dose Instructions:
  1. If a dose is missed, contact the healthcare provider to reschedule
  2. Do not self-administer extra doses
  3. Always follow physician instructions for subsequent dosing

Additional Notes:
  1. Treatment with Azadine often requires long-term commitment and monitoring
  2. Periodic bone marrow biopsies may be needed to assess response
  3. Patients may need growth factors or transfusions as supportive treatment
  4. Discuss all side effects and new symptoms with your healthcare provider promptly
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