DONATAXEL 20mg INJ

Description

Product Overview:

DONATAXEL 20 mg Injection contains Docetaxel, a chemotherapy medication used to treat various types of cancer. Docetaxel is a member of the taxane family, which works by interfering with the normal function of microtubules, crucial components of the cell’s structural framework. By stabilizing microtubules and preventing their disassembly during cell division, Docetaxel inhibits cancer cell proliferation, leading to cell death. It is primarily used in the treatment of breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, and other solid tumors.

Therapeutic Class:

Antineoplastic agent (Chemotherapy drug)

Active Ingredient:

Docetaxel 20 mg per vial

Indications:

DONATAXEL 20 mg Injection is indicated for the treatment of:

• Breast Cancer: As part of adjuvant therapy for early-stage breast cancer and in metastatic breast cancer.
• Non-Small Cell Lung Cancer (NSCLC): Used in combination with other chemotherapy agents or as a single-agent therapy for advanced or metastatic NSCLC.
• Prostate Cancer: For metastatic hormone-refractory prostate cancer.
• Ovarian Cancer: In combination with other drugs for advanced ovarian cancer.
• Head and Neck Cancer: In combination therapy for squamous cell carcinoma of the head and neck.

Mechanism of Action:

Docetaxel works by inhibiting the normal dynamics of microtubules, which are essential for cell division. It binds to microtubules and stabilizes them, preventing their disassembly during cell division. This action disrupts the formation of the mitotic spindle, leading to arrested cell division and cell death, particularly in rapidly dividing cancer cells.

Dosage and Administration:

• Usual dose for adults:
  • Breast Cancer: 75–100 mg/m² every 3 weeks, administered as an intravenous (IV) infusion.
  • Non-Small Cell Lung Cancer (NSCLC): 75–100 mg/m² every 3 weeks, often used in combination with cisplatin.
  • Prostate Cancer: 75 mg/m² every 3 weeks in combination with prednisone.
  • Ovarian Cancer: 75–100 mg/m² every 3 weeks, used in combination with carboplatin.
  • Head and Neck Cancer: 100 mg/m² every 3 weeks, in combination with cisplatin and fluorouracil.
• Administration:
  Administer as an intravenous (IV) infusion over 1 hour. The solution should be diluted to the recommended concentration prior to administration.
• Pre-treatment medications:
  Pre-treatment with corticosteroids (e.g., dexamethasone) is recommended to reduce the risk of hypersensitivity reactions.

Contraindications:

• Hypersensitivity to Docetaxel or other ingredients in the formulation.
• Pregnancy and breastfeeding (Docetaxel may cause fetal harm).
• Severe neutropenia (low white blood cell count) or active infection.
• Severe liver dysfunction.

Warnings and Precautions:

• Bone marrow suppression: Regular monitoring of blood counts is required due to the risk of neutropenia, anemia, and thrombocytopenia.
• Hypersensitivity reactions: Anaphylactic reactions may occur during infusion. Immediate discontinuation and medical intervention may be necessary.
• Liver function: Dose adjustments may be required in patients with hepatic impairment.
• Fluid retention: Docetaxel may cause fluid retention, leading to symptoms like edema, ascites, and pleural effusion. Monitor for signs and symptoms of fluid retention, especially during the first 2–3 days after infusion.
• Pregnancy and Lactation: Not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant.

Adverse Effects:

Common:

• Neutropenia (low white blood cells)
• Anemia
• Nausea and vomiting
• Fatigue
• Hair loss (alopecia)
• Diarrhea
• Peripheral neuropathy

Serious:

• Severe neutropenic fever
• Hepatotoxicity (liver toxicity)
• Severe hypersensitivity reactions (e.g., anaphylaxis)
• Fluid retention (e.g., edema, pleural effusion)
• Cardiotoxicity (rare)

Drug Interactions:

• CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase docetaxel levels and the risk of toxicity.
• CYP3A4 Inducers: Drugs that induce CYP3A4 (e.g., rifampin, phenytoin) may decrease docetaxel efficacy.
• Live vaccines: Use caution with live vaccines, as docetaxel can impair immune response.

Storage:

• Store in a refrigerator at 2°C–8°C (36°F–46°F).
• Do not freeze.
• Protect from light.
• Once diluted, the solution should be used immediately or stored for up to 24 hours at 2°C–8°C (36°F–46°F).