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Oxabenz 50/100 Liquid Injection

Generic Name- Oxaliplatin

Drug Class- Antineoplastic agent

Oxaliplatin is a platinum derived chemotherapeutic agent which is used for the treatment of advanced colorectal cancer. It exerts its cytotoxic effects by inhibiting DNA and RNA synthesis and formation of DNA lesions. These cytotoxic effects damages DNA, initiates apoptosis and ultimately cell death.

Product Description

Oxabenz 50/100 (Oxaliplatin for injection) is a liquid injection, which contains preservative free and sterile active drug concentrate.

Indications and Usage

Oxaliplatin used in combination with infusional 5­ fluorouracil/leucovorin, is indicated for:

  • Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor
  • Treatment of advanced colorectal cancer

Dosage and Administration

  • Dosage Regimen for Colorectal Cancer
5-fluorouracil, Leucovorin and Oxaliplatin (FOLFOX4) Regimen
Oxaliplatin 85 mg/m2 IV on day 1 given as a 2-hour infusion in 250 mL of dextrose 5%, concurrent with leucovorin
Leucovorin 200 mg/m2/day given as a 2-hour infusion
5-fluorouracil (5-FU) 400 mg/m2, and a 22-hour continuous infusion of 5-FU, 600 mg/m2, repeated for 2 consecutive days
OR
5-fluorouracil, Leucovorin and Oxaliplatin (modified FOLFOX6) Regimen
Oxaliplatin, 85 mg/m2 IV on day 1 given as a 2-hour infusion in 250 mL of dextrose 5%, concurrent with leucovorin
Leucovorin 400 mg/m2, given as a 2-hour intravenous infusion on day 1
5-fluorouracil 400 mg/m2, on day 1 and a continuous 5-FU, 1,200 mg/m2/day, on day 1 and 2
  • Administer oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks2

Dosage Form and Strengths

  • Supplied as a single use vial containing aqueous solution for intravenous infusion
  • Available as 50mg and 100mg for injection

Clinical Efficacy

  • Effective, safe and well tolerated both as monotherapy and in combination with 5-FU/folinic acid in first- or second-line treatment of patients with metastatic colorectal cancer
  • Shows higher response rate and prolong survival in metastatic colorectal cancer patients, even after 5-FU failure
  • Improves the adjuvant treatment of colon cancer, when added to a regimen of fluorouracil and leucovorin

Adverse Reactions

  • Most common adverse reactions associated with use of oxaliplatin are nausea, diarrhea, vomiting, fatigue, stomatitis, peripheral sensory neuropathy, neutropenia, thrombocytopenia, and increase in transaminases and alkaline phosphatase levels

Contraindications

  • It is contraindicated in patients with a known allergy to oxaliplatin or other platinum compounds

Special Precautions

  • Patients should be routinely monitored for the development of allergic reactions including rash, urticaria, erythema, pruritis, bronchospasm, and hypotension
  • Determine the risk of hepatotoxicity by performing liver function tests
  • Reduce the dose of oxaliplatin to 75 mg/m² (adjuvant setting) or 65 mg/m² (advanced colorectal cancer), in cases of persistent grade 2 neurosensory events that do not resolve, and after recovery from gastrointestinal and hematologic toxicities
  • Consider dose reduction of oxalipatin to 65 mg/m2 for patients with severe renal impairment (creatinine clearance <30 ml/min)
  • Discontinue oxaliplatin, if persistent Grade 3 neurosensory events, neuropathy, interstitial lung disease and pulmonary fibrosis occurs
  • Women of reproductive potential should be advised of potential harm to fetus with oxaliplatin use
  • Pregnant women should not receive oxaliplatin therapy
Oxabenz 50/100 Liquid Injection - ADMAC Life Science