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Admoxel 20/80/120 Liquid Injection

Generic Name- Docetaxel
Drug Class- Antineoplastic agent
Docetaxel is a clinically well-established semi synthetic taxane, with potential anti-mitotic activity. It is widely used for the treatment of breast, prostate and non-small cell lung cancer. It acts by binding to beta tubulin subunit of microtubules, thereby resulting in disassembly of microtubules. Aberrant microtubules induces cell-cycle arrest, apoptosis and ultimately cell death.

Product Description

Admoxel 20/80/120 (Docetaxel for injection) is a single use vial containing aqueous drug concentrate for intravenous use.

Indications and Usage

Docetaxel is indicated for treatment of:
• Breast Cancer (BC) as single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node positive BC
• Non-Small Cell Lung Cancer (NSCLC) as a single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
• Hormone Refractory Prostate Cancer (HRPC), in combination with prednisone in androgen independent (hormone refractory) metastatic prostate cancer
• Gastric Adenocarcinoma (GC), in combination with cisplatin and fluorouracil for untreated, advanced GC, including the gastro esophageal junction
• Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN), in combination with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN

Dosage and Administration

• Dosage Regimens for Breast Cancer
Docetaxel Monotherapy (for locally advanced or metastatic breast cancer): 60 mg/m2 to 100 mg/m2
Docetaxel, Doxorubicin and Cyclophosphamide (TAC) Regimen: Doxorubicin 50 mg/m2 IV, docetaxel 75 mg/m2 administered 1 hour after doxorubicin and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles

• Dosage Regimens for NSCLC
Docetaxel Monotherapy: 75 mg/m2 IV single agent after platinum therapy failure
Docetaxel and Cisplatin (DC) Regimen: Docetaxel 75 mg/m2 IV over 1 hour followed by cisplatin 75 mg/m2 over 30-60 minutes every 3 weeks

• Dosage Regimen for HRPC
Docetaxel plus Prednisone Regimen: Docetaxel 75 mg/m2 every 3 weeks as a 1 hour IV infusion followed by prednisone 5 mg twice a day continuously

• Dosage Regimen for GC

Docetaxel, Cisplatin and 5-fluorouracil (DCF) Regimen: Docetaxel 75 mg/m2 as a 1 hour IV infusion followed by cisplatin 75 mg/m2, as a 1- 3 hour intravenous infusion (both on day 1 only) followed by fluorouracil 750 mg/m2 per day given as a 24-hour continuous intravenous infusion for 5 days, after cisplatin infusion

• Dosage Regimen for SCCHN:
Docetaxel, cisplatin and 5-fluorouracil (DCF) Regimen: Docetaxel 75 mg/m2 followed by cisplatin 75 mg/m2 intravenously (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hr intravenous infusion (days 1-5), starting at end of cisplatin infusion; for 4 cycles OR 75 mg/m2 followed by cisplatin 100 mg/m2 intravenously (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr intravenous infusion (days 1-4); for 3 cycles
• Premedicate all the patients with oral corticosteroids and adjust dose as needed2

Dosage Form and Strengths
• Supplied as single use vial for intravenous infusion
• Available as 20mg, 80mg and 120mg for injection

Clinical Efficacy

• Prevents progression and increases survival in patients with metastatic NSCLC3
• Shows significant improvements in survival in high-risk patients regardless of prognostic factors such as the expression of estrogen receptor, the degree of nodal involvement, age, menopause status, and schedule of administration when used as adjuvant treatment in BC patients3
• Enhances survival outcomes in patients with metastatic androgen-independent prostate cancer
• Improves disease control when added to a cisplatin doublet induction chemotherapy regimen before concurrent chemo radiotherapy in patients with locally advanced SCCHN4
• Increases the benefits of multimodality therapy for potentially curable gastric cancer5

Adverse Reactions
• The most common adverse reactions which occurs after docetaxel administration are pain, nausea, vomiting, diarrhea, constipation, infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dyspepsia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, mucositis, alopecia, skin reactions, myalgia

Contraindications
• It is contraindicated in patients with a known hypersensitivity to docetaxel or polysorbate and neutrophil counts of <1500 cells/mm3

Special Precautions

• Monitor for signs of delayed myelodysplasia or myeloid leukemia in patients who received docetaxel, doxorubicin and cyclophosphamide
• Dose adjustment should be considered in patients developing severe cutaneous reactions including erythema of the extremities with edema and desquamation
• Docetaxel can cause neurologic reactions including paresthesia, dysesthesia, pain and severe neurosensory symptoms, so consider dose reduction or discontinuation of treatment in these patients
• Discontinue treatment in patients with severe asthenia
• Women of child bearing potential are advised to avoid preganacy as docetaxel can cause fetal harm

Chemotherapy Injection Docataxel 20 / 80 / 120 mg Manufacturer