PRODUCT DESCRIPTION:

Topotecan is a potent topoisomerase I inhibitor used in the treatment of ovarian cancer, small cell lung cancer (SCLC), and cervical cancer.

It disrupts DNA replication in cancer cells, leading to cell death.

Designed for convenience and safety, the pre-filled syringe format ensures sterile, ready-to-administer dosing with minimal handling risks, especially critical in oncology infusion setups where time and safety are paramount.

Formulation & Presentation:

• Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
• Presentation: Pre-Filled Syringe (customizable as per market demand)
• Available Strengths:
  • 5 MG/ 2.5 ML (Pre-Filled Syringe)
  • 4 MG/ 4 ML (Pre-Filled Syringe)
• Route of Administration: Intravenous (IV) Slow Injection over 30 Minutes/ Infusion after appropriate reconstitution or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as continuous infusion, typically as part of combination chemotherapy regimens

Therapeutic Indications:

• Metastatic Ovarian Cancer after failure of initial or subsequent chemotherapy
• Small Cell Lung Cancer (SCLC) that has relapsed after first-line therapy
• Stage IVB, recurrent, or persistent Cervical Cancer (in combination with cisplatin)
• Investigational use in various solid tumors including breast and colorectal cancer under clinical protocols

Side Effects:

• COMMON:
  • Neutropenia, thrombocytopenia, anemia
  • Nausea, vomiting, diarrhea
  • Fatigue, weakness
  • Alopecia
  • Elevated liver enzymes
• SERIOUS (RARE):
  • Febrile neutropenia with infections
  • Interstitial lung disease
  • Severe diarrhea and dehydration
  • Hypersensitivity reactions
• PRECAUTIONS:
  • Monitor CBC, renal and liver function before and during therapy
  • Dose adjustments required in renal impairment (CrCl < 40 mL/min)
  • Use with caution in patients with bone marrow suppression
  • Contraindicated in pregnancy and lactation (Category D)
  • Administer under trained oncology supervision only