OXALIPLATIN "EBEWE" 100mg/20ml Infusion/Concentrate for

What is OXALIPLATIN "EBEWE" 100mg/20ml

OXALIPLATIN "EBEWE" 100mg/20ml is a prescription-only chemotherapy medication used in the treatment of colorectal cancer, particularly in advanced stages or as an adjuvant therapy following surgery. It contains the active substance Oxaliplatin, a platinum-based antineoplastic agent that disrupts cancer cell growth. This medicine is administered intravenously as part of a combination chemotherapy regimen, typically including 5-fluorouracil (5-FU) and leucovorin.

• Pharmaceutical Form: Concentrate for solution for infusion
• Presentation: 100mg of Oxaliplatin in 20ml glass vial
• Indications: Treatment of metastatic colorectal cancer and adjuvant treatment of stage III colon cancer
• Administration Setting: Hospital or clinical setting under supervision of oncology professionals

How to use OXALIPLATIN "EBEWE" 100mg/20ml

OXALIPLATIN "EBEWE" must be prepared and administered by trained medical professionals. It is not for self-administration. Proper dilution and compatibility protocols must be followed to ensure safe and effective use.

• Preparation: The concentrate must be diluted with 5% glucose solution before infusion. Do not use saline or chloride-containing solutions.
• Administration: Intravenous infusion over 2 to 6 hours depending on regimen. Commonly used with 5-FU and leucovorin (FOLFOX regimen).
• Cycle Frequency: Usually administered once every 2 weeks in 14-day cycles.
• Monitoring: Continuous monitoring during administration is essential due to risk of allergic reactions and neuropathy.
• Avoid Cold Exposure: Patients are advised to avoid cold drinks, foods, and environments after administration, as cold can trigger or worsen nerve-related side effects.

Mode of Action OXALIPLATIN "EBEWE" 100mg/20ml

Oxaliplatin acts as a cytotoxic agent through its platinum-based compound, which interferes with the replication of DNA in cancer cells. Its mechanism is characterized by:

• Platinum-DNA Adduct Formation: Oxaliplatin forms platinum complexes that bind to DNA, causing intra- and inter-strand crosslinks.
• Inhibition of DNA Synthesis: These crosslinks inhibit DNA replication and transcription, leading to cell cycle arrest in the G2 phase.
• Apoptosis Induction: The disruption in genetic function results in programmed cell death (apoptosis) of cancerous cells.
• Synergistic Effects: When combined with 5-FU and leucovorin, the drug’s cytotoxic activity is enhanced, improving overall treatment efficacy.

OXALIPLATIN "EBEWE" 100mg/20ml Interactions OXALIPLATIN "EBEWE" 100mg/20ml

OXALIPLATIN "EBEWE" can interact with a range of medications and substances, potentially altering its efficacy or increasing side effect risks.

• Nephrotoxic Agents: Concomitant use with aminoglycosides, amphotericin B, or NSAIDs may increase nephrotoxicity.
• Other Cytotoxics: Care must be taken when combining with other chemotherapy agents due to compounded toxicity profiles.
• Live Vaccines: Avoid administration of live vaccines due to immunosuppression caused by oxaliplatin.
• Anticoagulants: Monitor coagulation parameters if combined with warfarin or other blood thinners.
• No Known CYP450 Interactions: Unlike many other drugs, oxaliplatin is not metabolized by cytochrome P450 enzymes.

Dosage of OXALIPLATIN "EBEWE" 100mg/20ml

Dosage is individualized and determined by body surface area (BSA), renal function, and concurrent therapies. The typical dosage guidelines are:

• Standard Dose: 85 mg/m² administered once every 2 weeks in combination with 5-FU and leucovorin (FOLFOX regimen).
• Adjustments: Dose reduction may be necessary in cases of hematologic toxicity, neuropathy, or renal impairment.
• Route: Intravenous infusion only.
• Maximum Duration: Typically not used beyond 6 months due to risk of cumulative neurotoxicity.
• Renal Function Monitoring: Essential before each dose; oxaliplatin should be used cautiously in patients with renal insufficiency.

Possible side effects of OXALIPLATIN "EBEWE" 100mg/20ml

Like other chemotherapy agents, oxaliplatin may cause a range of side effects. Some are mild and manageable, while others may require dose adjustment or discontinuation.

• Very Common:
  • Peripheral sensory neuropathy (numbness, tingling, cold sensitivity)
  • Nausea, vomiting, diarrhea
  • Fatigue and weakness
  • Myelosuppression (low WBC, RBC, or platelets)
• Common:
  • Mouth sores (mucositis)
  • Fever, infections
  • Increased liver enzymes
• Rare:
  • Allergic reactions (rash, anaphylaxis)
  • Severe pulmonary toxicity (interstitial lung disease)
  • Hearing loss

OXALIPLATIN "EBEWE" 100mg/20ml Contraindications OXALIPLATIN "EBEWE" 100mg/20ml

OXALIPLATIN "EBEWE" should not be used in certain clinical conditions due to the risk of serious adverse outcomes.

• Hypersensitivity: Known allergy to oxaliplatin or other platinum-containing compounds
• Severe Myelosuppression: Especially with neutropenia or thrombocytopenia
• Peripheral Neuropathy: Severe pre-existing neuropathy from prior treatment
• Pregnancy and Breastfeeding: Contraindicated due to potential harm to the fetus or infant
• Severe Renal Impairment: Use is contraindicated or requires extreme caution with dosage adjustments

Storage of OXALIPLATIN "EBEWE" 100mg/20ml

Proper storage ensures the stability, potency, and safety of OXALIPLATIN "EBEWE". Follow strict guidelines for hospital pharmacy handling and patient administration.

• Storage Temperature: Store below 25°C (77°F). Do not freeze.
• Protection: Protect from light by keeping in the original packaging until use.
• Shelf Life: Check expiration date on vial; typically stable for 2-3 years if unopened and stored properly.
• After Dilution: Infusion solution should be used immediately, or stored for no more than 24 hours at 2–8°C.
• Handling Precautions: Cytotoxic drug – must be handled using appropriate personal protective equipment (PPE) and disposed of in accordance with hospital protocol for hazardous substances.