OXALIPLATIN "EBEWE" 50mg/10ml Infusion/Concentrate for

What is OXALIPLATIN "EBEWE" 50mg/10ml

OXALIPLATIN "EBEWE" 50mg/10ml is a platinum-based cytotoxic agent used in cancer chemotherapy. It contains Oxaliplatin as the active ingredient and is formulated as a concentrate for solution for infusion. It is most commonly prescribed for colorectal cancer, either as part of combination therapy or as monotherapy in certain clinical situations.

• Generic Name: Oxaliplatin
• Pharmaceutical Form: Concentrate for solution for infusion
• Strength: 50 mg of Oxaliplatin in 10 ml vial (5 mg/ml concentration)
• Indication: First-line and adjuvant treatment of metastatic colorectal cancer, typically in combination with 5-FU and leucovorin
• Mechanism: DNA damage leading to inhibition of replication and apoptosis of cancer cells

This medicine plays a vital role in modern oncologic protocols and is part of the widely used FOLFOX chemotherapy regimen.

How to use OXALIPLATIN "EBEWE" 50mg/10ml

OXALIPLATIN "EBEWE" 50mg/10ml must only be administered under the supervision of a qualified oncologist in a hospital or clinical setting.

• Preparation:
  • Inspect visually for particulates or discoloration prior to use.
  • Must be diluted with 5% glucose solution (D5W); never use sodium chloride due to precipitation risks.
  • Final infusion concentration should typically be between 0.2 mg/ml and 0.7 mg/ml.
• Route: Intravenous infusion only
• Infusion Duration: Over 2–6 hours depending on protocol and tolerability
• Frequency: Every 2 weeks as part of a chemotherapy cycle (e.g., FOLFOX regimen)
• Supportive Measures: Pre-medicate with antiemetics to prevent nausea and vomiting

Proper handling and disposal procedures must be followed due to its cytotoxic nature. Healthcare providers should wear gloves and protective clothing.

Mode of Action OXALIPLATIN "EBEWE" 50mg/10ml

Oxaliplatin is a third-generation platinum compound that works through DNA damage mechanisms, effectively impairing cancer cell replication and triggering apoptosis.

• DNA Adduct Formation: Binds to guanine residues in DNA, forming intrastrand and interstrand crosslinks
• Cell Cycle Disruption: Interferes with DNA transcription and replication, especially during the S and G2 phases
• Induction of Apoptosis: Triggers programmed cell death in rapidly proliferating tumor cells
• DACH Ligand Advantage: The diaminocyclohexane (DACH) moiety contributes to improved cytotoxicity and reduced cross-resistance compared to earlier platinum drugs

Oxaliplatin's synergy with 5-fluorouracil significantly boosts its anti-tumor efficacy, making it a cornerstone in colorectal cancer treatment.

OXALIPLATIN "EBEWE" 50mg/10ml Interactions OXALIPLATIN "EBEWE" 50mg/10ml

Oxaliplatin may interact with a variety of medications and substances. Patients should inform their doctor about all concurrent treatments, including over-the-counter drugs and supplements.

• Nephrotoxic Drugs: Concurrent use with aminoglycosides or NSAIDs may increase kidney toxicity
• Live Vaccines: Increased risk of severe infections due to immunosuppression
• Anticoagulants: Use with caution, especially in patients at risk of bleeding or with mucositis
• Other Chemotherapeutics: Combination with 5-FU and leucovorin is common but requires careful monitoring for cumulative toxicities
• Calcium/Magnesium Infusions: Previously used to prevent neuropathy, though their effectiveness remains debated

Interactions may alter therapeutic outcomes or increase toxicity. Regular blood work and clinical monitoring are essential during treatment.

Dosage of OXALIPLATIN "EBEWE" 50mg/10ml

Dosage is based on body surface area (BSA), and Oxaliplatin is not typically used alone but as part of combination chemotherapy regimens.

• Standard Adult Dose: 85 mg/m² administered every 2 weeks
• Combination Use: Often administered in conjunction with 5-FU and leucovorin (FOLFOX regimen)
• Renal Adjustment: No dose adjustment required for mild-to-moderate renal impairment; avoid in severe renal dysfunction unless benefits outweigh risks
• Neurotoxicity: Dose may need to be reduced or withheld in patients developing significant peripheral neuropathy
• Myelosuppression: Treatment should be delayed in patients with grade 3/4 neutropenia or thrombocytopenia

Dosing must always be tailored by an oncologist based on individual tolerance, renal function, and therapeutic goals.

Possible side effects of OXALIPLATIN "EBEWE" 50mg/10ml

Like most chemotherapy agents, Oxaliplatin has a broad side effect profile. Some side effects are common and manageable, while others can be severe or persistent.

• Common Side Effects:
  • Peripheral neuropathy (cold-induced or chronic)
  • Nausea, vomiting, diarrhea
  • Fatigue and malaise
  • Stomatitis (mouth sores)
• Hematologic Effects:
  • Neutropenia, thrombocytopenia, and anemia
• Severe Reactions:
  • Hypersensitivity (rash, bronchospasm, anaphylaxis)
  • Respiratory symptoms (rare interstitial lung disease)
  • Hepatotoxicity (transaminase elevation)

Long-term or cumulative doses may lead to chronic peripheral neuropathy, which can impact quality of life. Regular monitoring is crucial.

OXALIPLATIN "EBEWE" 50mg/10ml Contraindications OXALIPLATIN "EBEWE" 50mg/10ml

Certain conditions or situations make the use of Oxaliplatin inappropriate due to heightened risks.

• Hypersensitivity: Known allergy to Oxaliplatin or other platinum compounds
• Severe Renal Impairment: Increases systemic toxicity; avoid unless benefits outweigh risks
• Pregnancy: Teratogenic and not recommended unless in life-threatening cases
• Breastfeeding: Should be discontinued during treatment
• Severe Peripheral Neuropathy: Pre-existing neuropathy may worsen, leading to permanent damage

Patients should undergo full assessment before initiation, including renal function, blood counts, and neurologic status.

Storage of OXALIPLATIN "EBEWE" 50mg/10ml

Proper storage is critical to maintain the medication's stability, potency, and safety.

• Storage Conditions:
  • Keep the vial refrigerated at 2°C–8°C
  • Do not freeze the solution
  • Protect from light by storing in the original carton
• After Opening: Use immediately after dilution. If needed, the diluted solution may be stored for up to 24 hours at 2–8°C
• Disposal: Handle as cytotoxic waste. Dispose in accordance with local regulations for hazardous materials

Healthcare providers must use appropriate protective equipment when handling and administering Oxaliplatin to avoid contamination and exposure.