OXALIPLATIN 5 mg/ml (Seacross) Concentrate for Solution for Infusion

What is OXALIPLATIN 5 mg/ml (Seacross)

OXALIPLATIN 5 mg/ml (Seacross) is a platinum-based cytotoxic chemotherapy agent used in the treatment of advanced colorectal cancer. It contains the active substance Oxaliplatin, which belongs to the class of alkylating agents and is administered intravenously after dilution.

• Generic Name: Oxaliplatin
• Concentration: 5 mg/ml
• Form: Concentrate for solution for infusion
• Packaging: 20 ml glass vial (contains 100 mg Oxaliplatin)
• Therapeutic Use:
  • Adjuvant therapy for Stage III colon cancer following surgery
  • Treatment of metastatic colorectal cancer in combination with other agents such as 5-FU and leucovorin

This formulation is ready for further dilution in 5% glucose solution before administration. It is not to be used without dilution and should never be mixed with saline solutions.

How to use OXALIPLATIN 5 mg/ml (Seacross)

OXALIPLATIN 5 mg/ml must be administered by trained healthcare professionals in a clinical setting. Proper preparation, dilution, and administration protocols are essential to ensure efficacy and safety.

• Preparation:
  • Withdraw the required volume of concentrate and dilute in 250–500 ml of 5% glucose solution.
  • Ensure the solution is clear and free from particulates before infusion.
• Administration:
  • Administer via intravenous infusion over 2 to 6 hours.
  • Oxaliplatin must be given before fluoropyrimidines like 5-FU when part of combination therapy.
• Do Not:
  • Mix with or dilute using sodium chloride (saline) due to precipitation risk.
  • Administer as a direct injection or bolus.

Use aseptic technique throughout preparation. Infusion should occur under close medical supervision with emergency support available in case of hypersensitivity or other reactions.

Mode of Action OXALIPLATIN 5 mg/ml (Seacross)

Oxaliplatin functions as a DNA cross-linking agent that interferes with the replication and transcription of DNA, ultimately triggering cell death in rapidly dividing cancer cells.

• DNA Binding: Forms platinum-DNA adducts by covalently binding to DNA bases, mainly guanine.
• Inhibition of DNA Synthesis: The resulting cross-links prevent DNA strand separation, halting DNA replication and transcription.
• Apoptosis Induction: DNA damage activates signaling pathways that lead to programmed cell death.
• Cytotoxic Selectivity: Targets rapidly dividing tumor cells more aggressively than normal cells.
• DACH Carrier Ligand: Provides improved stability and lower resistance compared to older platinum drugs.

This unique mechanism enhances oxaliplatin's effectiveness, especially in combination with 5-FU and leucovorin for colorectal cancer treatment.

OXALIPLATIN 5 mg/ml (Seacross) Interactions OXALIPLATIN 5 mg/ml (Seacross)

Drug interactions may enhance or impair oxaliplatin’s therapeutic effects or increase the risk of adverse events. A comprehensive medication review is necessary before starting therapy.

• With 5-Fluorouracil (5-FU): Synergistic effect; increased risk of gastrointestinal and hematologic toxicity.
• With Nephrotoxic Drugs: Use caution with aminoglycosides or NSAIDs, as they may enhance renal toxicity.
• With Live Vaccines: Avoid due to risk of infection in immunosuppressed patients.
• With Anticoagulants: Monitor INR closely if the patient is on warfarin or similar agents due to increased bleeding risk.
• With Other Cytotoxic Drugs: May increase cumulative toxicity, especially neuropathy or myelosuppression.

Patients should report any changes in medication or supplements during chemotherapy, including over-the-counter drugs or herbal products.

Dosage of OXALIPLATIN 5 mg/ml (Seacross)

The dose of oxaliplatin is determined based on body surface area (BSA) and treatment regimen. Dosage adjustments may be required based on toxicity or renal function.

• Standard Adult Dose: 85 mg/m² IV every 2 weeks in combination with leucovorin and 5-FU (FOLFOX regimen).
• Adjuvant Therapy: Same dose, typically for 6 months following colon surgery.
• Renal Impairment: Dose reduction or increased monitoring required in moderate renal impairment; contraindicated in severe cases.
• Premedication: Antiemetics such as ondansetron are recommended prior to infusion to minimize nausea and vomiting.

Dose modifications or discontinuation may be necessary if the patient develops severe side effects such as persistent neuropathy, hematologic toxicity, or hypersensitivity.

Possible side effects of OXALIPLATIN 5 mg/ml (Seacross)

Like all cytotoxic chemotherapy agents, oxaliplatin has a significant side effect profile. Patients must be monitored regularly to manage and mitigate adverse effects.

• Very Common:
  • Peripheral sensory neuropathy (especially cold-induced)
  • Nausea, vomiting, diarrhea
  • Fatigue and malaise
  • Myelosuppression (anemia, neutropenia, thrombocytopenia)
• Common:
  • Stomatitis, anorexia, dehydration
  • Hypokalemia, hypocalcemia
  • Increased liver enzymes
• Serious or Rare:
  • Severe hypersensitivity reactions including anaphylaxis
  • Respiratory complications (e.g., pulmonary fibrosis)
  • Persistent and disabling neuropathy after prolonged use

All adverse effects should be reported immediately. In some cases, dose delay, reduction, or discontinuation may be required to ensure patient safety.

OXALIPLATIN 5 mg/ml (Seacross) Contraindications OXALIPLATIN 5 mg/ml (Seacross)

There are specific situations where oxaliplatin should not be used due to serious safety concerns.

• Known hypersensitivity: To oxaliplatin or other platinum compounds.
• Severe renal impairment (CrCl < 30 ml/min): Due to increased risk of toxicity and drug accumulation.
• Pregnancy: Teratogenic risk; avoid unless absolutely necessary under oncologic guidance.
• Lactation: Contraindicated during breastfeeding.
• Pre-existing severe neuropathy: May worsen with treatment, leading to irreversible damage.

Physicians must conduct a comprehensive medical evaluation to identify contraindications before initiating therapy.

Storage of OXALIPLATIN 5 mg/ml (Seacross)

Proper storage of oxaliplatin concentrate is essential to preserve its stability and prevent degradation.

• Before Dilution:
  • Store below 25°C, away from direct sunlight.
  • Do not freeze the concentrate.
• After Dilution:
  • Use immediately if possible.
  • If storage is required, keep at 2–8°C and use within 24 hours.
• Handling Guidelines:
  • Use gloves and protective clothing during handling.
  • Dispose of unused medication and materials as cytotoxic waste according to local protocols.

Always inspect the solution visually for particulates or discoloration before use. Do not use if any abnormalities are observed.