Docetax 20 mg/vial (IV Infusion)

Indications

• Breast Cancer (BC)
• Locally Advanced or Metastatic BC
• Adjuvant Treatment of Operable Node-Positive BC
• Non-small Cell Lung Cancer (NSCLC)
• Castration-Resistant Prostate Cancer (CRPC)
• Gastric Adenocarcinoma (GC)
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Pharmacology

• Antineoplastic Agent
• Disrupts Microtubular Network
• Promotes Assembly of Tubulin
• Inhibits Mitosis in Cells
• Cytotoxic Against Tumor Cell Lines

Dosage & Administration

• Administered in a Facility Equipped for Complications
• Administered Intravenously (IV) over 1 hr every 3 weeks
• Various Dosage Regimens for Different Indications
• Use of 21 Gauge Needle

Interaction

• CYP3A4 Substrate
• Metabolism may be Modified by Concomitant Administration of Compounds

Contraindications

• Neutrophil Counts of <1500 cells/mm3
• History of Severe Hypersensitivity Reactions to Docetaxel or Polysorbate 80

Side Effects

• Infections
• Neutropenia
• Anemia
• Hypersensitivity
• Thrombocytopenia
• Neuropathy
• Dysgeusia
• Dyspnea
• Constipation
• Anorexia
• Nail Disorders
• Fluid Retention
• Asthenia
• Pain
• Nausea
• Diarrhea
• Vomiting
• Alopecia
• Skin Reactions
• Myalgia

Pregnancy & Lactation

• Can Cause Fetal Harm
• No Information on Presence in Human Milk
• No Lactation Studies in Animals

Precautions & Warnings

• Administered Under Supervision of Experienced Physician
• Higher Risk in Patients with Hepatic Impairment
• Not Recommended for Neutrophil Counts <1500 cells/mm3
• Fatal Cases of Enterocolitis Reported
• Severe Hypersensitivity Reactions
• Treatment-related Acute Myeloid Leukemia
• No Carcinogenic Potential Studies Conducted

Overdose Effects

• No Known Antidote
• Complications: Bone Marrow Suppression, Neurotoxicity, Mucositis
• Therapeutic G-CSF Recommended

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Store Between 2°C and 25°C
• Protected from Light
• Freezing Does Not Adversely Affect the Product

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