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Mylodec 50mg - Decitabine For Injection

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Mylodec 50mg - Decitabine For Injection

Mylodec 50mg contains Decitabine, a hypomethylating agent used to treat myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). It works by modifying DNA methylation, which helps in restoring normal function in bone marrow cells.

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Description Product Details
General Information:
Generic Name: Decitabine
Brand Name: Mylodec
Packing: Vial (For Injection)
Strength: 50 mg
Manufacturer: [Manufacturer Name]
Form: Lyophilized Powder for Injection
Category: Hypomethylating Agent / Chemotherapy
Product Introduction:
Mylodec 50mg is an anti-cancer chemotherapy drug used primarily to treat myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). It is a DNA methyltransferase inhibitor that helps in reactivating tumor suppressor genes, leading to cell cycle arrest and apoptosis in cancerous blood cells.
Uses of Mylodec 50mg Injection:
Mylodec 50mg is used in the treatment of:
  1. Myelodysplastic Syndromes (MDS) – Includes different types such as refractory anemia and chronic myelomonocytic leukemia (CMML).
  2. Acute Myeloid Leukemia (AML) – Particularly in elderly patients who are ineligible for intensive chemotherapy.
  3. Chronic Myelomonocytic Leukemia (CMML) – A rare type of leukemia affecting white blood cells.
  4. Off-Label Uses – Research indicates potential use in solid tumors and other blood cancers.
Storage Instructions:
  1. Store at 2°C – 8°C (Refrigerated).
  2. Protect from light and keep in the original vial until use.
  3. Do not freeze the reconstituted solution.
  4. Discard any unused portion after reconstitution.
  5. Keep out of reach of children and pets.
How Mylodec 50mg Works (Mechanism of Action):
Decitabine works as a DNA methyltransferase inhibitor, meaning it reduces the abnormal methylation of DNA. This results in:
  1. Reactivation of tumor suppressor genes
  2. Inhibition of cancer cell proliferation
  3. Induction of cell differentiation and apoptosis (programmed cell death)
Decitabine incorporates into the DNA during replication and prevents DNA methylation, which is a key process in cancer cell survival.
Side Effects:
Common Side Effects:
  1. Nausea and vomiting
  2. Fatigue and weakness
  3. Fever and chills
  4. Loss of appetite
  5. Low blood cell counts (Anemia, Neutropenia, Thrombocytopenia)
Severe Side Effects (Rare but Serious):
  1. Severe infections due to low white blood cell count
  2. Internal bleeding (GI bleeding, nosebleeds, brain hemorrhage)
  3. Liver and kidney toxicity
  4. Heart problems (Chest pain, abnormal heartbeat)
  5. Lung infections or pneumonia
  6. Severe allergic reactions
Seek immediate medical attention if severe side effects occur.
Dosage (Typical Recommended Dose):
For Myelodysplastic Syndromes (MDS):
  1. 20 mg/m² IV infusion over one hour for 5 consecutive days every 4 weeks.
For Acute Myeloid Leukemia (AML):
  1. 15-20 mg/m² IV infusion for 5–10 days every 4 weeks.
Important:
  1. Dose adjustments are required based on blood cell counts and liver/kidney function.
  2. Do not stop or adjust the dose without consulting a doctor.
Method of Administration:
  1. Administered as an IV infusion under medical supervision.
  2. Infusion duration: 1-2 hours, depending on dosage.
  3. Pre-medication (anti-nausea drugs) may be given before administration.
  4. Monitor blood counts regularly before and after infusion.
Precautions:
  1. Regular blood tests are required to monitor blood cell levels.
  2. Risk of infections – Avoid crowded places and sick individuals.
  3. Caution in patients with liver or kidney disease.
  4. Avoid pregnancy & breastfeeding – Can cause birth defects.
  5. Do not receive live vaccines while on this medication.
Drug Interactions:
Mylodec 50mg may interact with:
  1. Blood Thinners (Warfarin, Heparin, Aspirin) – Increases bleeding risk.
  2. Antibiotics & Antifungals – May alter drug metabolism.
  3. Immunosuppressants & Chemotherapy Drugs – Can increase toxicity.
  4. Live Vaccines (MMR, Chickenpox, Polio) – Avoid, as it can cause severe infections.
Inform your doctor about all medications you are taking.
Allergies (Warnings for Allergic Reactions):
  1. Do not use if allergic to Decitabine or any inactive ingredients.
  2. Symptoms of an allergic reaction: rash, swelling, difficulty breathing, dizziness.
  3. Seek emergency medical help if severe allergic reactions occur.
Overdose Information:
Symptoms of overdose:
  1. Severe drop in blood cell counts
  2. Uncontrolled bleeding or bruising
  3. Severe fatigue or weakness
  4. Organ failure (Liver or kidney damage)
What to do in case of overdose?
  1. Seek immediate medical attention.
  2. Supportive care includes blood transfusions and infection management.
Missed Dose Instructions:
  1. If a dose is missed, the doctor will reschedule it based on blood count levels.
  2. Do not double the dose to make up for the missed one.
Additional Notes:
  1. Frequent monitoring of blood counts is essential.
  2. Patients may need blood transfusions to manage low blood cell counts.
  3. Avoid alcohol consumption during treatment.
  4. Long-term treatment may require heart and lung function tests.
  5. Patients should maintain good hygiene to avoid infections.

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