OXALIPLATIN AQVIDA 5 mg/ml Concentrate for solution for infusion

What is OXALIPLATIN AQVIDA 5 mg/ml

OXALIPLATIN AQVIDA 5 mg/ml is a prescription chemotherapy medication containing the active substance Oxaliplatin, a platinum-based cytotoxic agent. It is supplied as a clear concentrate that must be diluted prior to intravenous infusion. Each 10 ml glass vial contains 50 mg of oxaliplatin.

• Generic Name: Oxaliplatin
• Brand Name: OXALIPLATIN AQVIDA
• Concentration: 5 mg/ml
• Form: Concentrate for solution for infusion
• Container: 10 ml glass vial (contains 50 mg Oxaliplatin)
• Therapeutic Use: Primarily used for:
  • Stage III colon cancer (adjuvant treatment post-surgery)
  • Metastatic colorectal cancer (in combination with 5-fluorouracil and leucovorin)

OXALIPLATIN AQVIDA is designed for hospital use under the supervision of oncology professionals. It is not intended for self-administration or use outside a medical facility.

How to use OXALIPLATIN AQVIDA 5 mg/ml

This medicine must be handled and administered by qualified medical personnel in a controlled clinical setting. It requires dilution and cannot be used undiluted or in direct IV push form.

• Preparation:
  • Withdraw the prescribed amount of concentrate using aseptic technique.
  • Further dilute in 250–500 ml of 5% glucose (dextrose) solution.
  • Do not use sodium chloride (saline) solutions for dilution or flushing due to the risk of precipitation.
• Administration:
  • Administer via intravenous infusion over 2 to 6 hours.
  • Administer oxaliplatin before 5-fluorouracil when used in combination regimens such as FOLFOX.
• Safety Precautions:
  • Use gloves, masks, and protective clothing when handling cytotoxic agents.
  • Ensure infusion is conducted in an area with immediate access to resuscitation equipment.

Patients should be closely monitored for signs of hypersensitivity, neuropathy, and blood cell count abnormalities during and after administration.

Mode of Action OXALIPLATIN AQVIDA 5 mg/ml

Oxaliplatin exerts its antineoplastic effect by disrupting the DNA structure and function of cancer cells, ultimately leading to cell death.

• DNA Cross-linking: Forms platinum-DNA adducts by covalently binding to nucleic acids, especially guanine and adenine bases.
• Prevention of DNA Replication: The cross-links inhibit DNA strand separation, an essential step in transcription and replication.
• Cellular Apoptosis: The DNA damage activates cell-cycle checkpoints and apoptotic pathways, resulting in cancer cell death.
• DACH Ligand Advantage: Oxaliplatin contains a diaminocyclohexane (DACH) ligand, which improves antitumor activity and reduces cross-resistance with other platinum agents like cisplatin and carboplatin.

Due to its unique mechanism and improved pharmacokinetics, oxaliplatin is a cornerstone in the management of colorectal cancer, especially when combined with other chemotherapeutic agents.

OXALIPLATIN AQVIDA 5 mg/ml Interactions OXALIPLATIN AQVIDA 5 mg/ml

Oxaliplatin has several significant interactions that must be considered before initiating therapy. It can potentiate or be affected by other medications, increasing the risk of side effects or altering efficacy.

• Fluoropyrimidines (e.g., 5-FU): Enhances anticancer efficacy but increases risk of gastrointestinal and hematologic toxicity.
• Nephrotoxic Drugs: Use caution with aminoglycosides, NSAIDs, or contrast agents due to cumulative renal toxicity.
• Live Vaccines: Should be avoided due to immunosuppressive effects of chemotherapy.
• Anticoagulants (e.g., warfarin): Close INR monitoring is required to prevent bleeding risks.
• Other Cytotoxic Drugs: Combination therapy may exacerbate neuropathy, neutropenia, or mucositis. Regular monitoring is essential.

Patients must inform healthcare providers about all medications and supplements they are taking, including herbal remedies and over-the-counter products.

Dosage of OXALIPLATIN AQVIDA 5 mg/ml

Dosage depends on factors such as body surface area (BSA), renal function, treatment intent, and tolerability. It is generally calculated and adjusted by the prescribing oncologist.

• Standard Dose: 85 mg/m² IV every 2 weeks when used in combination with 5-FU/leucovorin (FOLFOX).
• Adjuvant Therapy: The same dosing schedule is followed post-surgery for colon cancer for 6 months (12 cycles).
• Renal Impairment: Use with caution. In moderate renal dysfunction, consider dose reduction and monitor closely. Severe renal impairment is a contraindication.
• Antiemetic Support: Pre-treatment with anti-nausea medication is strongly recommended to manage gastrointestinal side effects.
• Monitoring: Dose adjustments may be required based on toxicity, especially neurotoxicity, blood counts, and liver/kidney function.

Dose delays or discontinuation may be necessary in cases of unresolved adverse effects, cumulative neuropathy, or hypersensitivity reactions.

Possible side effects of OXALIPLATIN AQVIDA 5 mg/ml

Side effects are common with oxaliplatin and vary from mild to life-threatening. Most are dose-dependent and may require supportive care or treatment interruption.

• Very Common:
  • Peripheral sensory neuropathy (cold-induced or chronic)
  • Nausea, vomiting, diarrhea
  • Fatigue and asthenia
  • Myelosuppression (neutropenia, thrombocytopenia, anemia)
• Common:
  • Stomatitis and mucositis
  • Increased liver enzymes
  • Hypersensitivity reactions (rash, bronchospasm, hypotension)
• Rare but Serious:
  • Anaphylaxis
  • Interstitial lung disease
  • Prolonged and irreversible neuropathy
  • Severe gastrointestinal toxicity leading to dehydration

Patients are advised to report any unusual symptoms promptly. Long-term monitoring may be required, particularly for neurological or hematological adverse effects.

OXALIPLATIN AQVIDA 5 mg/ml Contraindications OXALIPLATIN AQVIDA 5 mg/ml

Use of oxaliplatin is contraindicated in specific conditions due to the risk of serious or life-threatening complications.

• Hypersensitivity: To oxaliplatin or any platinum-containing compound (e.g., cisplatin, carboplatin).
• Severe Renal Impairment: Patients with creatinine clearance < 30 ml/min should not receive oxaliplatin.
• Pregnancy: Contraindicated due to teratogenicity; use only when clearly necessary under oncologic supervision.
• Breastfeeding: Breastfeeding must be discontinued during therapy.
• Severe Sensory Neuropathy: Existing neuropathies may be exacerbated, increasing the risk of permanent nerve damage.

A detailed assessment of the patient’s health status and comorbidities is essential before initiating therapy with oxaliplatin.

Storage of OXALIPLATIN AQVIDA 5 mg/ml

Proper storage is vital to maintain the stability and potency of this cytotoxic medication.

• Before Dilution:
  • Store below 25°C in the original packaging to protect from light.
  • Do not freeze the concentrate.
• After Dilution:
  • If not used immediately, store at 2–8°C (refrigerator).
  • Stability is maintained for up to 24 hours if diluted in 5% glucose under sterile conditions.
• Disposal:
  • Unused medication and waste must be disposed of following cytotoxic handling protocols.
  • Avoid environmental exposure. Follow local hospital or national guidelines for hazardous waste disposal.

Always inspect the solution before use. Do not use if discolored or if particulate matter is observed.