PRODUCT DESCRIPTION:

Paclitaxel is a microtubule-stabilizing agent derived from the bark of the Pacific yew tree (Taxus brevifolia). It is widely used as a chemotherapeutic agent in the treatment of various solid tumors, including ovarian, breast, lung, and pancreatic cancers.

Paclitaxel works by inhibiting cell division, effectively arresting cancer cell proliferation.

The pre-filled syringe formulation ensures precise dosing, minimizes contamination risks, and enhances clinical efficiency in oncology settings.

Formulation & Presentation:

• Dosage Form: Sterile Injectable
• Presentation: Pre-Filled Syringe (customizable as per market demand)
• Available Strengths:
  • 30 MG/ 5 ML (Pre-Filled Syringe)
  • 100 MG/ 16.7 ML (Pre-Filled Syringe)
  • 260 MG/ 43.4 (Pre-Filled Syringe)
  • 300 MG/ 50 ML (Pre-Filled Syringe)
• Route of Administration: Intravenous (IV) Slow Injection/ 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:

• Advanced colorectal cancer
• Stage III colon cancer (adjuvant setting post-surgery)
• Off-label uses in gastric and pancreatic cancers under protocol guidance

Side Effects:

• COMMON:
  • Hair loss (Alopecia)
  • Nausea & vomiting
  • Diarrhea
  • Fatigue
  • Peripheral neuropathy
  • Low blood cell counts (anemia, neutropenia)
• SERIOUS (RARE):
  • Severe hypersensitivity reactions (e.g., anaphylaxis)
  • Cardiac arrhythmias or bradycardia
  • Pulmonary toxicity
  • Myelosuppression leading to life-threatening infections
  • Hepatic dysfunction
• PRECAUTIONS:
  • Use with caution in patients with hepatic impairment.
  • Pre-medication with corticosteroids and antihistamines is recommended to reduce the risk of hypersensitivity reactions.
  • Monitor CBC, liver function tests, and ECG periodically.
  • Pregnancy Category D: Not recommended during pregnancy unless clearly necessary.
  • Ensure administration by trained oncology professionals only.