Zuvitere

Docetaxel is an antineoplastic agent belonging to the taxane family.

It is prepared by semisynthesis from a precursor extracted from renewable yew-tree needle biomass.

Docetaxel is a white to almost white powder. It is highly lipophilic and practically insoluble in water.

Zuvitere is indicated for the treatment of

• Locally advanced or metastatic breast cancer that has progressed during anthracycline-based treatment or relapsed after anthracycline-based adjuvant therapy.

• Advanced or metastatic non-small cell lung cancer following failure of platinum-containing chemotherapy.

Docetaxel has demonstrated clinical efficacy as monotherapy in both chemotherapy-naive and treatment-resistant non-small cell lung cancer.

It is commonly administered on a 3-week schedule at a dose of 75 mg/m², according to the selected treatment protocol and patient condition.

Hematologic Effects

Frequent peripheral blood cell counts are recommended during treatment.

Patients should not receive subsequent treatment cycles until neutrophils recover to more than 1,500 cells/mm³ and platelets recover to more than 100,000 cells/mm³.

A dose reduction may be required following severe neutropenia, febrile neutropenia or serious infection.

Hypersensitivity Reactions

Reactions may occur within minutes after initiation of the infusion. Patients should be observed closely and appropriately premedicated with corticosteroids.

Cutaneous Effects

Localized erythema, edema and desquamation may occur. Severe skin toxicity may require dose adjustment.

Fluid Retention

Severe fluid retention may occur. Corticosteroid premedication may reduce its incidence and severity.

Neurologic Effects

Severe sensory or motor neuropathy may require dose reduction or discontinuation.

Breast Cancer

For patients with locally advanced or metastatic breast cancer after progression during anthracycline-based therapy or relapse during anthracycline-based adjuvant therapy, the recommended dose is 60–100 mg/m² administered intravenously over 1 hour every 3 weeks.

Non-Small Cell Lung Cancer

For patients with advanced or metastatic non-small cell lung cancer after failure of prior platinum-containing therapy, the recommended dose is 75–100 mg/m² administered intravenously over 1 hour every 3 weeks.

Premedication

Patients should receive an oral corticosteroid such as dexamethasone 16 mg per day, for example 8 mg twice daily, beginning 1 day before docetaxel administration, according to the treating physician's protocol.

Dose Adjustment

For patients initially receiving 100 mg/m² who develop febrile neutropenia, neutrophils below 500 cells/mm³, severe skin reactions or severe peripheral neuropathy, reduce the dose to 75 mg/m².

If these reactions continue, reduce the dose further to 55 mg/m² or discontinue treatment.

Preparation

Docetaxel concentrate must be diluted before administration.

Withdraw the prescribed quantity of premix solution and dilute it in sodium chloride intravenous infusion or dextrose intravenous infusion.

The final docetaxel concentration should not exceed 0.9 mg/mL.

Mix the infusion solution by gentle manual rotation and inspect it for particulate matter or discoloration.

Administer intravenously as a 1-hour infusion.

Avoid contact of undiluted concentrate with plasticized PVC equipment.