PRODUCT DESCRIPTION:

Temoporfin is a second-generation photosensitizing agent used in photodynamic therapy (PDT) for certain types of advanced cancers.

Upon activation by red light at a specific wavelength (652 nm), Temoporfin produces cytotoxic singlet oxygen species that selectively destroy tumor tissues.

Its longer tissue retention and deeper light penetration make it a superior alternative to first-generation photosensitizers. Delivered in a ready-to-use pre-filled syringe, it ensures sterility, precise dosing, and simplified clinical workflow.

Formulation & Presentation:

• Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
• Presentation: Pre-Filled Syringe (customizable as per market demand)
• Available Strengths:
  • 1 MG/ 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 followed by Laser Light Activation at Tumor Site. 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:

• Palliative treatment of advanced head and neck squamous cell carcinoma (HNSCC) in patients unsuitable for other therapies
• Investigational or off-label use in cholangiocarcinoma, esophageal carcinoma, and other accessible tumors amenable to photodynamic therapy
• Research protocols in minimally invasive oncology and light-activated cytotoxic therapy

Side Effects:

• COMMON:
  • Photosensitivity (up to several weeks post-treatment)
  • Localized pain, swelling, or inflammation at light-exposed sites
  • Nausea
  • Skin discoloration
• SERIOUS (RARE):
  • Severe phototoxic skin reactions if exposed to sunlight or strong indoor light
  • Airway edema or respiratory distress (when used in respiratory tract tumors)
  • Hepatotoxicity or injection-site reactions
  • Visual disturbances (transient)
• PRECAUTIONS:
  • Strict light protection required for at least 15 days post-injection to avoid phototoxicity
  • Use protective clothing, sunglasses, and low-light environments after administration
  • Dose adjustment may be necessary in hepatic dysfunction
  • Trained personnel and appropriate light-delivery systems must be available
  • Not recommended during pregnancy or lactation