Toposar 100 mg/5 ml (IV Infusion)

Indications

• Management of Small Cell Lung Cancer
• Combination therapy with other approved chemotherapeutic agents
• First-line treatment for small cell lung cancer patients

Pharmacology

• Pharmacotherapeutic classification: podophyllotoxin derivatives
• Inhibition of mitosis by blocking microtubular assembly
• Inhibition of cell cycle progression at a premitotic phase
• Biphasic disposition on intravenous administration
• Distribution half-life of about 1.5 hours
• Terminal elimination half-life ranging from 4 to 11 hours
• Total body clearance values ranging from 33 to 48 ml/min
• Linear increase in AUC and Cmax with dose
• Mean volumes of distribution at steady state ranging from 18 to 29 liters

Dosage & Administration

• Dosing range for small cell lung cancer: 35-50 mg/m2/day
• Dose modification based on measured creatinine clearance
• Initial dose modification for impaired renal function
• Subsequent dosing based on patient tolerance and clinical effect

Interaction

• Increased exposure and decreased clearance with high-dose cyclosporine A
• Recommendation for periodic complete blood counts during Toposar treatment
• Monitoring of concentrations and clearance when administered with other medications

Contraindications

• Hypersensitivity to Etoposide or any component of the formulation
• Previous demonstration of hypersensitivity to Etoposide

Side Effects

• Dose-related myelosuppression
• Granulocyte and platelet nadirs occurring after drug administration
• Incidence of fever, infection, and associated deaths
• Nausea, vomiting, and mucositis/esophagitis
• Transient hypotension with rapid intravenous administration
• Anaphylactic-like reactions and possible fatalities
• Reversible alopecia, hypertension, flushing, and rashes
• Occasional reports of abdominal pain, asthenia, and somnolence

Pregnancy & Lactation

• Pregnancy category D
• Lack of adequate and well-controlled studies in pregnant women
• Presence of Etoposide in human milk
• Recommendation to avoid breastfeeding during Etoposide therapy

Precautions & Warnings

• Frequent observation for myelosuppression during and after therapy
• Dose-limiting bone marrow suppression and its significance
• Platelet count and white blood cell count monitoring
• Indication to withhold further therapy based on blood counts
• Possible occurrence of anaphylactic reactions
• Higher rates of anaphylactic-like reactions in children
• Role of infusion concentration in anaphylactic-like reactions
• Need for slow intravenous infusion to prevent hypotension
• Evaluation of drug's need and usefulness against the risk of adverse reactions
• Reversible nature of most adverse reactions if detected early
• Risk of toxicity in patients with low serum albumin

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Refrigeration at 2°C-8°C
• Stability of capsules for 24 months under refrigeration
• Protection from light
• Consideration of proper handling and disposal of anticancer drugs

Related Brands

• Eposide 50 mg (Capsule) - techno-drugs-ltd
• Toposide 100 mg/5 ml (IV Infusion) - healthcare-pharmaceuticals-ltd
• Etopor 100 mg/5 ml (IV Infusion) - eskayef-pharmaceuticals-ltd