Antineoplastic – Pyrimidine Analog Antimetabolite

MARCA: ADRUCIL

Product Description:

Fluorouracil (5-FU) is a cytotoxic antimetabolite that interferes with DNA and RNA synthesis by inhibiting thymidylate synthase. It is primarily used in the treatment of solid tumors, especially of the gastrointestinal tract, breast, and skin. It may be administered systemically or topically, depending on the indication.

Presentations:

• Strength: 250 mg per vial
• Form: Injectable solution
• Concentration: Typically 25 mg/mL in 10 mL vials
• Route of Administration: Intravenous (IV) or intra-arterial; topical form also available (cream 5%)
• Packaging:
  • Single-dose vials (glass or plastic)
  • Carton boxes containing 1, 5, or 10 vials
  • Spanish-language and Cofepris-labeling available upon request

Uses / Indications:

• Oncology – Systemic Therapy:
  • Colorectal cancer (adjuvant or metastatic)
  • Gastric cancer (including in combination regimens)
  • Pancreatic cancer
  • Breast cancer (early, metastatic, or HER2-positive in FEC or CMF regimens)
  • Head and neck cancers (squamous cell, nasopharyngeal)
  • Anal and esophageal cancers
  • Advanced prostate or bladder carcinoma (off-label combinations)



• Topical Therapy:
  • Actinic keratosis
  • Superficial basal cell carcinoma
  • Precancerous skin lesions

Combination Regimens:

Frequently included in standard protocols such as: FOLFOX, FOLFIRI, FOLFIRINOX, CMF, FEC-75, and in combination with monoclonal antibodies such as cetuximab, bevacizumab, or panitumumab in metastatic colorectal cancer. Also used with leucovorin to potentiate antitumor activity through thymidylate synthase inhibition.

Important Notes:

• Listed on the WHO Model List of Essential Medicines
• Store below 25–30°C; protect from light
• Administer only by trained oncology personnel
• Certificate of Analysis (CoA), GMP Certification, and Batch Traceability available upon request