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Admatop 2.5 Injection

Generic Name– Topotecan
Drug Class– Antineoplastic agent

Description- Topotecan is a semi-synthetic derivative of camptothecin which has demonstrated anti-tumor activity in a wide range of cancers. It is approved by FDA for second-line therapy in ovarian and small cell lung cancer (SCLC). It acts by inhibiting replication of rapidly dividing cells by blocking the activity of enzyme topoisomerase I.

Product Description

Admatop 2.5 (Topotecan for injection) is a liquid injection, for intravenous use.

Indications and Usage

Topotecan is indicated for the treatment of:
• Small cell lung cancer sensitive disease after failure of first line chemotherapy
• Stage IV-B, recurrent,or persistent cervical cancer which is not amenable to curative treatment with surgery and/or radiation therapy, when used in combination therapy with cisplatin

Dosage and Administration

• Dosage Regimen for SCLC
Topotecan Monotherapy
Topotecan-1.5 mg/m2 IV, over 30 minutes daily for 5 consecutive days, starting on day one of a 21-day course

• Dosage Regimen for Cervical Cancer
TC (Topotecan plus Cisplatin) Regimen
Topotecan-0.75 mg/m2 IV, over 30 minutes on days 1, 2, and 3
Cisplatin-50 mg/m2 IV, on day 1 repeated every 21 days

Dosage Forms and Strengths
• Supplied as a single use vial containing liquid solution for intravenous infusion
• Available as 2.5mg for injection

Clinical Efficacy

• Offers effective control of symptoms in patients with relapsed SCLC1
• Produce partial responses with better tolerability in patients with limited and extensive-stage SCLC3
• Shows higher response rates with improvement in durable remission, when used in combination with systemic cisplatin chemotherapy and radiation4
• Improves overall survival rates and quality of life in patients with advanced and previously treated recurrent/metastatic cervical cancer

Adverse Reactions
• The most common adverse events which occurs following administration with topotecan in lung cancer patients are nausea, vomiting, diarrhea, constipation, fatigue, pyrexia, alopecia, neutropenia, thrombocytopenia, leucopenia and anemia
• The most common adverse events which occurs following administration of combination of topotecan and cisplatin in cervical cancer patients are pain, nausea, vomiting, infections, neutropenia, leucopenia, thrombocytopenia and anemia

Contraindications
• It is contraindicated in patients with a severe bone marrow suppression and a known hypersensitivity to topotecan or other ingredients present in formulation

Special Precautions

• Peripheral blood counts should be monitored and topotecan should be administered only to patients with adequate bone marrow
• Avoid use of topotecan in patients with baseline neutrophil counts less than 1,500 cells/mm3
• Monitor patients for symptoms of interstitial lung disease and discontinue use if the
diagnosis is confirmed
• Do not initiate G-CSF until 24 hours after completion of treatment, as concomitant use can prolong duration of neutropenia
• Advise women of reproductive potential to use effective contraceptives to avoid pregnancy
• Discontinue use of topotecan while breast feeding or nursing

Admatop 2.5 Injection - ADMAC Life Science