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

What is OXALIPLATIN "EBEWE" 50mg/10ml

OXALIPLATIN "EBEWE" 50mg/10ml is an injectable chemotherapy medication that contains the active substance Oxaliplatin, a third-generation platinum compound. It is used to treat advanced colorectal cancer and is typically part of combination chemotherapy protocols like FOLFOX (5-Fluorouracil, Leucovorin, and Oxaliplatin).

• Form: Powder for solution for infusion (to be reconstituted and diluted before IV administration)
• Strength: 50 mg Oxaliplatin per 10 ml vial
• Class: Platinum-based cytotoxic antineoplastic agent
• Indications:
  • Adjuvant treatment of stage III colon cancer
  • First-line treatment of advanced metastatic colorectal cancer

OXALIPLATIN works by interfering with DNA synthesis and repair, thus inhibiting cancer cell replication and inducing apoptosis.

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

OXALIPLATIN must only be administered by trained medical professionals in a hospital or cancer treatment center.

• Reconstitution:
  • Dissolve the powder in sterile water or 5% glucose solution (as per the manufacturer's instruction).
  • Further dilute in 250–500 ml of 5% glucose solution before administration.
• Administration:
  • Via intravenous infusion over 2–6 hours, depending on the treatment protocol.
  • Do not administer via bolus injection or undiluted.
• Important Notes:
  • Do not mix with or dilute using saline or other chloride-containing solutions due to risk of precipitation.
  • Handle using cytotoxic safety precautions, including gloves and proper disposal containers.

Always confirm the reconstitution procedure and compatibility information before administration. Monitor for allergic reactions during the infusion.

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

Oxaliplatin works primarily by forming platinum-DNA adducts, which inhibit DNA replication and transcription, leading to apoptosis of cancer cells.

• DNA Binding: Binds to DNA bases (mostly guanine) and causes intrastrand and interstrand crosslinks.
• Cell Cycle Arrest: Prevents DNA synthesis, primarily affecting rapidly dividing cancer cells during the S and G2 phases.
• Induction of Apoptosis: DNA damage activates programmed cell death pathways in tumor cells.
• DACH Carrier Advantage: The 1,2-diaminocyclohexane (DACH) carrier group increases efficacy and reduces cross-resistance with other platinum drugs like cisplatin.

This mechanism makes oxaliplatin particularly effective in combination therapies aimed at reducing tumor load and improving survival in colorectal cancer patients.

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

Drug interactions with Oxaliplatin can alter its efficacy or increase toxicity. Physicians should review the patient’s full medication list prior to starting treatment.

• With Nephrotoxic Agents: Caution with aminoglycosides or NSAIDs due to increased risk of renal damage.
• With Anticoagulants: Increased bleeding risk, especially with mucosal toxicity.
• With Vaccines: Avoid live vaccines due to immunosuppression risk.
• With 5-FU/Leucovorin: Synergistic anticancer activity when used in combination, but may increase toxicity.
• With Calcium/Magnesium: Previously thought to reduce neuropathy, though evidence is mixed.

Regular monitoring for adverse reactions and therapeutic response is essential during combined chemotherapeutic regimens.

Dosage of OXALIPLATIN "EBEWE" 50mg/10ml

The dosage of OXALIPLATIN is calculated based on the patient’s body surface area (BSA) and clinical condition. It is not administered daily but given in cycles.

• Standard Dose: 85 mg/m² every 2 weeks when used in the FOLFOX regimen.
• Dosage Adjustments:
  • Required in patients with renal impairment or severe hematologic toxicity.
  • May be reduced or paused in the presence of severe peripheral neuropathy.
• Infusion Duration: Typically over 2–6 hours depending on the combination protocol.
• Premedication: Antiemetics (e.g., ondansetron) are often given to prevent nausea and vomiting.

The specific protocol and dose schedule must be defined by the oncology team based on individual patient factors and clinical guidelines.

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

OXALIPLATIN has a range of side effects, from mild to serious. Some effects are dose-dependent and may worsen with cumulative exposure.

• Very Common Side Effects:
  • Peripheral neuropathy (often cold-induced)
  • Nausea, vomiting, diarrhea
  • Fatigue, loss of appetite
• Hematologic Toxicities:
  • Neutropenia, anemia, thrombocytopenia
• Severe Adverse Reactions:
  • Hypersensitivity reactions (rash, bronchospasm, rarely anaphylaxis)
  • Respiratory distress or interstitial lung disease (rare)
  • Persistent paresthesia or functional impairment from chronic neuropathy

Patients should be monitored throughout treatment cycles to identify and manage side effects early.

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

OXALIPLATIN is contraindicated in certain medical scenarios where risks outweigh benefits.

• Known hypersensitivity: To Oxaliplatin or other platinum-containing compounds
• Severe renal impairment: Contraindicated due to accumulation and toxicity
• Pregnancy: Should not be used unless life-saving for the mother; teratogenic potential exists
• Breastfeeding: Discontinue breastfeeding during treatment
• Existing severe peripheral neuropathy: Use may worsen neurological symptoms

Patients should be thoroughly evaluated before treatment begins, and contraindications should be ruled out through history, lab testing, and clinical judgment.

Storage of OXALIPLATIN "EBEWE" 50mg/10ml

Proper storage ensures the stability and safety of the drug prior to reconstitution and use.

• Before Reconstitution:
  • Store below 25°C (room temperature), away from direct light.
  • Keep vial in the outer packaging until ready for use.
• After Reconstitution:
  • Use immediately or store at 2–8°C for up to 24 hours if aseptic technique was followed.
  • Discard any unused solution beyond this period.
• Handling Precautions:
  • Use protective gear during handling and administration.
  • Dispose of in accordance with hospital cytotoxic waste protocols.

Never freeze the reconstituted solution. Always inspect for particulates or discoloration prior to administration.