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Doxotero (10mg / 50mg) - Doxorubicin Hydrochloride Injection

Doxotero contains Doxorubicin Hydrochloride, a chemotherapy drug used to treat a variety of cancers. It works by interfering with DNA replication in cancer cells, leading to cell death. It is administered intravenously under medical supervision.

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General Information:
Generic Name: Doxorubicin Hydrochloride
Brand Name: Doxotero
Packing: Single-use glass vial
Strength: 10 mg and 50 mg
Manufacturer: Hetero Healthcare Ltd
Form: Injectable solution
Category: Antineoplastic agent, Anthracycline antibiotic
Product Intro:
Doxotero is an anthracycline class chemotherapy injection used in treating solid tumors and hematological malignancies. It is available in vials for intravenous administration and requires careful dosing due to its potent effect and potential for cardiac toxicity.

Uses (Indications):
  1. Breast cancer
  2. Ovarian cancer
  3. Bladder cancer
  4. Lung cancer
  5. Leukemias (including acute lymphoblastic and myeloid leukemias)
  6. Lymphomas (Hodgkin’s and non-Hodgkin’s)
  7. Soft tissue sarcomas
  8. Neuroblastoma and Wilms tumor (in pediatric patients)

Storage Instructions:
  1. Store in a refrigerator at 2°C to 8°C (do not freeze)
  2. Keep the vial in its original carton to protect from light
  3. Inspect for particles or discoloration before use
  4. Discard unused portions following hospital guidelines for cytotoxic drugs

How It Works (Mechanism of Action):
Doxorubicin intercalates between DNA strands and inhibits the enzyme topoisomerase II, preventing DNA replication and RNA transcription. It also generates free radicals, leading to DNA and cell membrane damage. This ultimately results in apoptosis (cell death) of cancer cells.

Side Effects:
Common Side Effects:
  1. Hair loss (alopecia)
  2. Nausea and vomiting
  3. Fatigue and weakness
  4. Mouth sores (mucositis)
  5. Red-colored urine (harmless but alarming to patients)
  6. Low blood counts (anemia, neutropenia, thrombocytopenia)
Serious Side Effects:
  1. Cardiotoxicity (may lead to heart failure, especially with cumulative doses)
  2. Severe bone marrow suppression
  3. Secondary leukemia (in rare cases after prolonged use)
  4. Severe infusion reactions
  5. Tissue necrosis if extravasation occurs
  6. Liver toxicity in patients with impaired function

Dosage (Typical Recommended Dose):
  1. 60–75 mg/m² IV every 21 days (as a single agent)
  2. 40–60 mg/m² IV on day 1 of a 21-day cycle (in combination therapy)
  3. Cumulative dose should not exceed 450–550 mg/m² to avoid cardiac damage
  4. Dose adjustments may be necessary based on liver function and blood counts

Method of Administration:
  1. Administered as a slow intravenous injection or infusion
  2. Given by trained healthcare professionals in a hospital or infusion center
  3. Should not be given intramuscularly or subcutaneously
  4. Central line preferred for repeated doses to avoid vein irritation
  5. Flush line before and after administration to prevent tissue damage

Precautions:
  1. Perform baseline and periodic cardiac evaluation (e.g., echocardiogram or MUGA scan)
  2. Monitor complete blood counts regularly
  3. Use with caution in patients with liver disease or poor performance status
  4. Not safe during pregnancy or breastfeeding
  5. Avoid live vaccines during treatment
  6. Use PPE (personal protective equipment) during handling by healthcare staff

Drug Interactions:
  1. Cyclophosphamide and trastuzumab – increased cardiotoxicity
  2. Paclitaxel – may increase doxorubicin toxicity if given prior
  3. Hepatotoxic drugs – may worsen liver injury
  4. CYP3A4 inhibitors/inducers – may affect metabolism of doxorubicin
  5. Avoid concurrent use with nephrotoxic or bone marrow suppressive agents unless medically necessary

Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity reactions are rare but possible
  2. Symptoms include hives, shortness of breath, swelling of face or throat
  3. Stop infusion immediately and initiate emergency treatment if any signs of an allergic reaction occur

Overdose Information:
  1. Symptoms include severe mucositis, pancytopenia, and cardiac toxicity
  2. There is no specific antidote for doxorubicin overdose
  3. Hospitalization and supportive treatment including G-CSF, transfusions, and cardiac monitoring are required
  4. Dexrazoxane may be considered for heart protection in some cases

Missed Dose Instructions:
  1. This medication is given under direct medical supervision; missed doses are rare
  2. If missed due to low counts or other medical issues, the oncologist will reschedule
  3. Never self-administer or attempt to adjust dosing without medical advice

Additional Notes:
  1. Red-colored urine after treatment is normal for 1–2 days due to the drug’s color
  2. Wear gloves and avoid contact with bodily fluids for 48 hours after treatment due to drug excretion
  3. Patients should report symptoms like shortness of breath, swelling, or chest pain immediately
  4. Good oral hygiene and soft diet are advised to manage mucositis
  5. Long-term survivors need periodic cardiac monitoring due to risk of delayed heart effects

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