OXALIPLATIN BENDALIS 5mg/ml Concentrate for Solution for Injection

What is OXALIPLATIN BENDALIS 5mg/ml

OXALIPLATIN BENDALIS is a chemotherapy medication containing the active ingredient Oxaliplatin. It is presented as a concentrate for solution for injection, supplied in a 20 ml glass vial with a concentration of 5 mg/ml. Oxaliplatin belongs to the class of drugs known as platinum-based antineoplastic agents.

• Therapeutic use: It is primarily used in the treatment of various cancers, especially colorectal cancer, often in combination with other chemotherapy agents like fluorouracil and leucovorin.
• Cancer target: It works against solid tumors by interfering with DNA replication and transcription processes in cancer cells, ultimately inhibiting their growth and inducing cell death.
• Administration: The drug is administered intravenously by healthcare professionals in a clinical setting due to the requirement of precise dosing and monitoring of side effects.
• Importance: Oxaliplatin has become an essential part of modern chemotherapy regimens, improving survival rates and outcomes in patients with advanced cancers.
• Formulation: As a concentrate for solution, it must be diluted before administration and handled with care to avoid exposure and ensure accurate dosing.

How to use OXALIPLATIN BENDALIS 5mg/ml

Using OXALIPLATIN BENDALIS correctly is crucial for maximizing therapeutic efficacy while minimizing potential risks. It must be administered under strict medical supervision, typically by an oncology specialist or trained healthcare professional.

• Preparation: The concentrate must be diluted with an appropriate intravenous fluid, usually 5% dextrose solution, as oxaliplatin is incompatible with chloride-containing fluids like saline.
• Administration route: Given intravenously, usually as a slow infusion over 2 to 6 hours, depending on the treatment protocol.
• Treatment cycles: The drug is often administered in repeated cycles, with rest periods in between to allow the patient's body to recover.
• Combination therapy: Frequently combined with other chemotherapy drugs (e.g., 5-fluorouracil and leucovorin) for synergistic effects.
• Monitoring: Close monitoring of blood counts, kidney and liver function, and neurological status is mandatory before, during, and after administration to detect and manage adverse effects promptly.
• Precautions: Extravasation (leakage of the drug outside the vein) must be avoided as it can cause severe tissue damage. The infusion site should be observed carefully.

Mode of Action OXALIPLATIN BENDALIS 5mg/ml

OXALIPLATIN BENDALIS works by disrupting the replication machinery of cancer cells, leading to cell death and tumor regression. Its mode of action involves multiple biochemical interactions:

• DNA binding: Oxaliplatin forms reactive platinum complexes that covalently bind to DNA, creating intra- and inter-strand crosslinks.
• DNA crosslinks: These crosslinks distort the DNA double helix structure, impairing the ability of the DNA to unwind and replicate effectively.
• Inhibition of replication and transcription: By blocking DNA replication and RNA transcription, oxaliplatin prevents cancer cells from dividing and producing essential proteins.
• Induction of apoptosis: The DNA damage triggers cellular pathways leading to programmed cell death (apoptosis), selectively targeting rapidly dividing cancer cells.
• Resistance mechanism: Some cancer cells may develop resistance through enhanced DNA repair or detoxification processes, which can influence treatment outcomes.
• Distinctive features: Oxaliplatin’s chemical structure confers different activity and toxicity profiles compared to other platinum agents like cisplatin, often with a better safety profile in some patients.

OXALIPLATIN BENDALIS 5mg/ml Interactions OXALIPLATIN BENDALIS 5mg/ml

Oxaliplatin may interact with various drugs and substances, potentially altering its efficacy or increasing the risk of adverse effects. Key interactions to consider include:

• Other chemotherapy agents: Combination with drugs like 5-fluorouracil or leucovorin is common and generally synergistic, but requires careful monitoring for enhanced toxicity.
• Nephrotoxic drugs: Concurrent use with drugs that impair kidney function (e.g., aminoglycosides, NSAIDs) may increase the risk of nephrotoxicity.
• Neurotoxic agents: Co-administration with neurotoxic drugs (e.g., vincristine, paclitaxel) can exacerbate peripheral neuropathy, a known side effect of oxaliplatin.
• Live vaccines: Should be avoided during treatment due to immunosuppression caused by chemotherapy.
• Anticoagulants: Oxaliplatin can affect platelet counts and coagulation; thus, use with blood thinners requires caution and monitoring.
• Alcohol and herbal supplements: These may affect liver metabolism and overall patient tolerance; it is advisable to avoid or discuss with the healthcare provider.

Dosage of OXALIPLATIN BENDALIS 5mg/ml

The dosage of OXALIPLATIN BENDALIS is carefully calculated based on the patient’s body surface area (BSA), cancer type, treatment regimen, and overall health status. Common dosing guidelines include:

• Typical dose: Usually 85 mg/m² administered intravenously every two weeks in combination chemotherapy protocols.
• Adjustment factors: Dosage may be adjusted according to renal function, hepatic status, and hematologic parameters to reduce toxicity risks.
• Special populations: Elderly patients or those with significant organ impairment may require dose reductions or increased monitoring.
• Cycle frequency: Administered in cycles, typically every 14 or 21 days, allowing recovery periods between treatments.
• Maximum dose: Limited by cumulative toxicity, especially peripheral neuropathy; ongoing assessment helps determine safe continuation.
• Administration guidelines: Must be diluted in suitable fluids and infused slowly; abrupt or rapid administration can increase adverse effects.

Possible side effects of OXALIPLATIN BENDALIS 5mg/ml

Oxaliplatin treatment can cause a range of side effects, some of which may be severe. It is important to recognize these early and manage symptoms appropriately:

• Neurological: Peripheral neuropathy is common, manifesting as numbness, tingling, or pain in hands and feet. It can be acute (triggered by cold) or chronic.
• Gastrointestinal: Nausea, vomiting, diarrhea, and mucositis may occur, often managed with supportive care and antiemetics.
• Hematological: Bone marrow suppression leading to anemia, leukopenia, and thrombocytopenia, increasing infection and bleeding risks.
• Allergic reactions: Rare but serious hypersensitivity reactions can occur, including rash, fever, or anaphylaxis.
• Fatigue: Generalized weakness and tiredness are common during chemotherapy.
• Other: Elevated liver enzymes, renal impairment, and changes in blood electrolytes may also be observed.
• Monitoring: Frequent clinical and laboratory evaluations are essential to detect and mitigate adverse effects promptly.

OXALIPLATIN BENDALIS 5mg/ml Contraindications OXALIPLATIN BENDALIS 5mg/ml

OXALIPLATIN BENDALIS is contraindicated in certain clinical scenarios where its use could cause harm or worsen patient outcomes:

• Hypersensitivity: Patients with known allergy to oxaliplatin, other platinum compounds, or formulation excipients should not receive this drug.
• Severe renal impairment: Patients with significantly reduced kidney function may be at increased risk of toxicity and should avoid or adjust dosage carefully.
• Pregnancy and breastfeeding: Oxaliplatin can cause fetal harm and should not be used during pregnancy or lactation unless absolutely necessary and under strict medical supervision.
• Severe bone marrow suppression: Patients with pre-existing severe hematologic abnormalities should not receive oxaliplatin due to risk of exacerbation.
• Uncontrolled infections: Immunosuppressive effects increase vulnerability; treatment should be postponed until infection is controlled.

Storage of OXALIPLATIN BENDALIS 5mg/ml

Proper storage of OXALIPLATIN BENDALIS is vital to maintain its stability and efficacy. Recommendations include:

• Temperature: Store the vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Light protection: Keep the vial in its original packaging to protect from light exposure.
• Handling: Use aseptic techniques during preparation. Once diluted, the solution should be used promptly according to stability guidelines.
• Disposal: Any unused or expired medication should be disposed of following local regulations for cytotoxic drugs.
• Shelf life: Check the expiration date on the vial and do not use beyond this date to ensure safety and effectiveness.