Description
Oxabenz 50/100 (Oxaliplatin for injection) is a liquid injection, which contains preservative free and sterile active drug concentrate.
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.
Dosage and Administration
The recommended dosing regimen of oxaliplatin is as follow:
- Oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2-4 minutes, followed by 5 fluorouracil 600 mg/m2 IV, as a 22-hour continuous infusion on day 1
- Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 IV bolus given over 2-4 minutes, followed by 5-fluorouracil 600 mg/m2 IV as a 22-hour continuous infusion on day 2
- Administer oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks
Dosage Form and Strengths
- Supplied as a single use vial containing aqueous solution for intravenous infusion
- Available as 50mg and 100mg for injection
Indications & 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
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 rates 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
Safety Information
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
