What Is Oxaliplatin (Eloxatin)? FDA Approval, Licensing and Reimbursement in Türkiye

• FDA Approved: Yes (First approval date: 9 August 2002)
• Brand Name: The original brand name is Eloxatin
• Active Ingredient: Oxaliplatin
• Route of Administration: Intravenous (IV) infusion
• Class: Platinum analog, alkylating agent
• Category: Chemotherapy drug
• Manufacturer and Distribution in Türkiye: Eloxatin (Sanofi-Aventis); generic brands in Türkiye: Oxaliplatin Koçak, Deva, Nobel, Sandoz, Onko & Koçsel, Mefar, İdol.
• Cancers for Which It Is Approved:Metastatic colorectal cancer, early-stage colon cancer (as adjuvant treatment), metastatic pancreatic cancer, metastatic gastric and gastroesophageal cancer

What Is Oxaliplatin (Eloxatin)? How Does It Work?

Oxaliplatin is a platinum-analog chemotherapy drug. It binds to DNA, inhibiting DNA synthesis and cell division. It is used with 5-FU and folinic acid.

Mechanism of Action

• Forms crosslinks by binding covalently to DNA.
• Inhibits DNA synthesis, leading to cell death.
• Prevents DNA damage repair and initiates apoptosis.
• May also be effective in cells resistant to cisplatin and carboplatin.

FDA Approval History

• 9 August 2002 – Metastatic colorectal cancer
• 4 November 2004 – Stage III colon cancer (adjuvant)
• 9 December 2011 – Use with the FOLFOX regimen

Licensed Indications in Türkiye

• Adjuvant treatment of stage III colon cancer
• Treatment of metastatic colorectal cancer
• Combination with bevacizumab + 5-FU/FA or capecitabine (1st line)

Reimbursement Information

Reimbursed by SGK for cancer diagnoses without an indication requirement.

Resistance Mechanisms

• Changes in drug transport, such as ABC transporters
• Inactivation by molecules such as glutathione
• Increased DNA repair enzymes, such as ERCC-1
• Resistance to cisplatin and carboplatin does not always coincide with oxaliplatin resistance

Pharmacokinetic Properties

• Absorption: Administered only by the IV route.
• Distribution: Widely distributed in tissues; protein binding up to 98%
• Metabolism: Converted nonenzymatically into active cytotoxic compounds
• Excretion: More than 50% through the kidneys and 2% in feces
• Half-Life: Up to approximately 240 hours

Dose Range

• Standard dose: 85 mg/m² IV every 2 weeks
• Alternative dose: 100–130 mg/m² IV every 3 weeks

Drug Interactions

• Synergistic effect with 5-FU and folinic acid; hematological toxicity may increase
• Caution is required with nephrotoxic and neurotoxic drugs
• Increased bleeding risk with anticoagulants
• Live vaccines are contraindicated
• Calcium-magnesium pretreatment is no longer recommended

Precautions

• Kidney function should be monitored regularly
• Must not be mixed with alkaline solutions
• A neurological examination should be performed at every cycle
• Exposure to cold should be limited
• Be alert for allergic reactions
• ECG monitoring may be considered because of the risk of QT prolongation
• Pregnancy category D; breastfeeding is not recommended

Side Effect Frequencies

• Peripheral neuropathy: 60–90%
• Nausea / vomiting: 40–70%
• Diarrhea: 20–50%
• Stomatitis / oral mucositis: 10–30%
• Leukopenia, neutropenia: 40–50%
• Thrombocytopenia: 20–40%
• Anemia: 30–50%
• Fatigue: 30–60%
• Allergic reactions: 1–3%
• Elevated AST/ALT: 10–20%
• Hyperbilirubinemia: 5–10%
• Pulmonary toxicity: < 1%