Topoxin 100 mg/5 ml (IV Infusion)

Indications

• Management of Small Cell Lung Cancer in combination with other approved chemotherapeutic agents as first-line treatment

Pharmacology

• Pharmacotherapeutic classification: podophyllotoxin derivatives
• Inhibition of mitosis by blocking microtubular assembly
• Inhibition of cell cycle progression at a premitotic phase (late S and G2)
• Biphasic process with a distribution half-life of about 1.5 hours
• Terminal elimination half-life ranging from 4 to 11 hours
• Total body clearance values range from 33 to 48 ml/min or 16 to 36 ml/min/m^2
• Linear increase in AUC and C_max values with dose
• Mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m^2

Dosage & Administration

• Dose ranges from 35 mg/m^2/day for 4 days to 50 mg/m^2/day for 5 days in combination with other approved chemotherapeutic drugs
• Initial dose modification based on measured creatinine clearance
• Subsequent dosing based on patient tolerance and clinical effect

Interaction

• Increased Topoxin exposure and decreased total body clearance when administered with high-dose cyclosporine a
• Need for periodic complete blood counts during the course of Topoxin treatment
• Laboratory testing prior to each cycle of therapy and at appropriate intervals during and after therapy

Contraindications

• Hypersensitivity to Etoposide or any component of the formulation

Side Effects

• Dose-related myelosuppression
• Granulocyte and platelet nadirs occurring 7 to 16 days after drug administration
• Nausea, vomiting, mucositis, and esophagitis
• Transient hypotension following rapid intravenous administration
• Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, and hypotension
• Reversible alopecia observed in up to 66% of patients
• Other infrequent toxicities such as abdominal pain, aftertaste, constipation, fatigue, and rash

Pregnancy & Lactation

• Pregnancy category D
• Etoposide found in human milk
• Recommendation against breastfeeding while receiving Etoposide

Precautions & Warnings

• Frequent observation for myelosuppression during and after therapy
• Dose limiting bone marrow suppression
• Platelet count, hemoglobin, and white blood cell count monitoring
• Possible occurrence of anaphylactic reaction
• Higher rates of anaphylactic-like reactions reported in children receiving infusions at higher concentrations
• Possible hypotension with rapid intravenous injection
• Need for cautious reinstitution of therapy and consideration of the need for the drug in chemotherapy
• Increased risk for Topoxin associated toxicities 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

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