DOCETAXEL ACCORD 20 mg/ml Vial 1 ml

Product Overview

Docetaxel Accord 20 mg/ml is a specialized medication available in a 1 ml vial, containing Docetaxel, a potent cytotoxic agent. It belongs to the taxoid class of drugs, primarily used in chemotherapy for various types of cancer. This medication is prepared as a concentrated solution for infusion, designed for intravenous administration exclusively by healthcare professionals in a clinical setting.

Benefits of Use

Docetaxel Accord 20 mg/ml plays a crucial role in the management of several advanced cancers, either alone or in combination with other therapeutic agents. Its benefits include:

• Effective treatment for breast cancer, including metastatic breast cancer and adjuvant treatment.
• Used in the treatment of non-small cell lung cancer, both locally advanced and metastatic forms.
• Indicated for hormone-refractory prostate cancer.
• An option for gastric adenocarcinoma, particularly advanced stages.
• Utilized in the treatment of head and neck cancer.
• Works by interfering with the division of cancer cells, leading to their death and helping to control tumor growth.

How to Use

Docetaxel Accord 20 mg/ml is a high-alert medication and must only be administered by qualified healthcare professionals experienced in the use of cytotoxic chemotherapy. It is administered intravenously, typically over a period of one hour, every three weeks. The specific dosage and treatment regimen will be determined by your oncologist based on your medical condition, body surface area, and response to therapy. Key aspects of administration include:

1. Premedication: Patients are usually pretreated with oral corticosteroids (e.g., dexamethasone) to reduce the incidence and severity of hypersensitivity reactions and fluid retention.
2. Preparation: The concentrated solution must be diluted in an appropriate infusion solution (e.g., 5% glucose solution or 0.9% sodium chloride solution) before administration.
3. Infusion: The diluted solution is administered as a one-hour intravenous infusion through a central venous line or a peripheral vein, under strict medical supervision.
4. Monitoring: Patients will undergo regular monitoring of blood counts (especially neutrophil counts), liver function, and other vital signs throughout the treatment course.

Caution & Warnings

Due to its potent nature and potential for significant side effects, Docetaxel Accord 20 mg/ml comes with important warnings:

• Hypersensitivity Reactions: Severe hypersensitivity reactions, including anaphylaxis, can occur, especially during the first and second infusions. Premedication is crucial.
• Bone Marrow Suppression: May cause severe myelosuppression (reduction in white blood cells, especially neutrophils), leading to increased risk of infection. Regular blood count monitoring is essential.
• Fluid Retention: Can lead to peripheral edema, pleural effusion, and ascites. Premedication helps mitigate this.
• Neurotoxicity: Peripheral neuropathy (tingling, numbness, pain) can develop and may be severe and persistent.
• Liver Impairment: Patients with severe liver impairment should not receive docetaxel. Dose adjustments may be necessary for moderate impairment.
• Pregnancy and Breastfeeding: Docetaxel is embryotoxic, fetotoxic, and teratogenic. It is contraindicated during pregnancy and breastfeeding. Effective contraception must be used by both male and female patients during and after treatment.
• Drug Interactions: Caution is advised when co-administering with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) as they can increase docetaxel concentrations.
• Administration Safety: Docetaxel is a hazardous drug. Proper handling and disposal procedures must be followed by healthcare personnel.

Ingredients

Each 1 ml vial of Docetaxel Accord 20 mg/ml contains:

• Active Ingredient: Docetaxel 20 mg
• Excipients: Polysorbate 80, Anhydrous Ethanol

Product Details

Form: Solution for infusion (concentrate)

Strength: 20 mg/ml

Package Type: Vial

Package Size: 1 ml

Manufacturer: Accord Healthcare

Storage: Store protected from light. Do not store above 25°C. Do not refrigerate or freeze. Keep out of reach of children.