Donataxel Injection 80mg

Donataxel Injection 80mg by Bioprofarma Bagó contains Docetaxel, a taxane chemotherapy medicine that treats breast, lung, prostate, gastric, and head and neck cancers. The 80mg vial supplies the standard adult dose for most chemotherapy regimens.

Donataxel 80mg Ingredients and Usage

Donataxel 80mg Injection contains Docetaxel anhydrous as its active ingredient, with citric acid and polysorbate 80 in the vehicle. Docetaxel belongs to the taxane class of antineoplastic medicines, semi synthetically derived from the European yew tree. Oncologists prescribe Donataxel 80mg as the standard adult dose for several solid tumour types.

Donataxel 80mg treats operable and metastatic breast cancer, often combined with doxorubicin and cyclophosphamide as adjuvant therapy after surgery. It also treats non small cell lung cancer (NSCLC), either alone after prior chemotherapy failure or with cisplatin in newly diagnosed patients.

Oncologists also prescribe Donataxel 80mg for hormone refractory metastatic prostate cancer with prednisone, gastric adenocarcinoma with cisplatin and 5 FU, and squamous cell carcinoma of the head and neck. The 80mg vial covers most adult body surface area requirements at the standard 75 to 100 mg per square metre dose.

How Does Donataxel 80mg Work?

Donataxel 80mg targets the microtubule network inside dividing cancer cells. Docetaxel binds with high affinity to the beta tubulin subunit of microtubules and promotes their assembly. This binding stabilises the microtubule structure and prevents its normal depolymerisation.

Microtubules must assemble and disassemble dynamically for a cell to divide successfully. By freezing this process, Donataxel arrests cancer cells in the G2 and M phases of the cell cycle.

Trapped cells cannot complete mitosis and eventually undergo apoptosis, or programmed cell death. The selective effect on rapidly dividing cells makes docetaxel effective against many solid tumours.

Donataxel 80mg Side Effects

Donataxel 80mg can cause significant side effects, especially at the standard adult dose. The oncology team monitors blood counts, liver function, and clinical signs before every chemotherapy cycle.

• Neutropenia (low white blood cell count), which is dose limiting and may lead to febrile neutropenia or sepsis

• Anaemia and thrombocytopenia

• Hypersensitivity reactions including rash, flushing, low blood pressure, or bronchospasm

• Fluid retention causing peripheral oedema, pleural effusion, or ascites

• Hair loss (alopecia), which is usually reversible after treatment ends

• Skin reactions, nail changes, and hand foot syndrome

• Peripheral sensory neuropathy with numbness, tingling, or burning sensations

• Fatigue, weakness (asthenia), and muscle pain

• Mouth sores (stomatitis) and mucositis

• Nausea, vomiting, and diarrhoea

• Excessive tearing (epiphora) due to tear duct narrowing

• Raised liver enzymes including AST, ALT, and bilirubin

• Cardiac arrhythmias and rare reports of heart failure

• Serious: anaphylaxis, severe hepatotoxicity, and tissue damage from extravasation

Warnings

• Donataxel 80mg carries boxed warnings for toxic deaths, hepatotoxicity, severe neutropenia, hypersensitivity reactions, and fluid retention.

• Only specialised oncology units should administer Donataxel under the supervision of a qualified chemotherapy physician.

• Patients must take oral dexamethasone 16mg daily for 3 days starting the day before infusion to reduce fluid retention and hypersensitivity risk.

• For prostate cancer regimens, give dexamethasone 8mg at 12 hours, 3 hours, and 1 hour before each Donataxel infusion.

• Do not give Donataxel if the neutrophil count is below 1500 cells per mm³ at the start of a cycle.

• Donataxel is contraindicated in patients with severe hepatic impairment due to raised toxicity risk.

• Patients with a history of severe hypersensitivity to docetaxel, polysorbate 80, or any other ingredient must not receive Donataxel.

• Strong CYP3A4 inhibitors such as ketoconazole, erythromycin, ritonavir, and ciclosporin can raise docetaxel blood levels and worsen toxicity.

• Extravasation during infusion can cause severe tissue irritation, necrosis, or thrombophlebitis at the injection site.

• Donataxel causes fetal harm and is contraindicated during pregnancy and breastfeeding.

• Women of childbearing potential and male partners must use effective contraception during treatment and for several months after the final dose.

• Avoid live vaccines during Donataxel therapy due to the risk of severe infection in immunocompromised patients.

• Granulocyte colony stimulating factor (G CSF) may be used prophylactically in patients at high risk of febrile neutropenia.

• Stop Donataxel and seek emergency care for signs of anaphylaxis, severe shortness of breath, or fever above 38°C with low white cell count.

Donataxel 80mg Storage Conditions

Store Donataxel 80mg vials in a refrigerator between 2°C and 8°C in the original carton to protect the concentrate from light. Do not freeze the product, and use the prepared infusion solution within 6 hours at room temperature or 24 hours when refrigerated. Always store Donataxel 80mg out of the reach and sight of children at the dispensing pharmacy or hospital cytotoxic storage facility.