Oxiplat 100 Infusion 20ml

✔️ Uses of Oxiplat 100 Infusion

• Colon cancer (stage III)
• Metastatic colorectal cancer

✔️ How does Oxiplat 100 Infusion work?

Oxiplat 100 works by damaging the genetic material (DNA and RNA) of the cancer cells which stops their growth and multiplication.

✔️ Side Effects of Oxiplat 100 Infusion

• Common (≥40%):
  • Peripheral sensory neuropathy.
  • Neutropenia, thrombocytopenia, anemia.
  • Nausea, diarrhea, vomiting, fatigue.
  • Increased liver enzymes (transaminases, alkaline phosphatase).
• Other: Stomatitis, allergic reactions, and cardiovascular events.

✔️ Quick Suggestions:

• Oxaliplatin is administered in a proper healthcare setting by specialized healthcare professionals.
• It is given in multiple cycles and it is important to receive every scheduled dose. Hence, make a note of the next scheduled dose.
• It may take a few months to show its complete effect, hence do not discontinue therapy without consulting your doctor.
• Anti-cancer medicines are usually very strong and can have many side effects. Discuss with your doctor to understand all the benefits and risks before starting the treatment.
• Consult your doctor if any side effects appear or if they become severe. Oxaliplatin may affect blood cell count and liver enzyme levels, therefore close monitoring is required.
• Oxaliplatin 100mg Infusion is given as an injection into veins under the supervision of a doctor.

✔️ Pharmacology

• Oxaliplatin undergoes nonenzymatic conversion in the body to active compounds via displacement of the oxalate ligand.
• Forms DNA crosslinks (inter- and intrastrand) that inhibit replication and transcription, ultimately leading to cytotoxicity.
• Cytotoxic effects are cell-cycle nonspecific.
• Combination with 5-fluorouracil: Enhances antiproliferative activity, as shown in tumor models (e.g., colon carcinoma, mammary tumor, leukemia).

✔️ Oxiplat: Detailed Administration Guidelines

IV Preparation Instructions

1. Reconstitution:
   • For a 50 mg vial, add 10 mL of Sterile Water for Injection (SWI) or 5% Dextrose (D5W).
   • For a 100 mg vial, add 20 mL of SWI or D5W.
2. Dilution:
   • Dilute the required amount of the reconstituted solution into 250–500 mL of D5W.
   • Do NOT use normal saline (NS) or any chloride-containing solutions, as they can cause degradation of the drug.
3. Precautions:
   • Avoid using aluminum-containing needles or IV sets, as aluminum reacts with oxaliplatin, leading to precipitate formation and reduced potency.

IV Administration

• Flush the infusion line with D5W before administering oxaliplatin or any concomitant drugs.
• Use separate infusion bags for oxaliplatin and leucovorin when administered together (through a Y-site).
• Infuse oxaliplatin over the recommended time using appropriate infusion sets to avoid compatibility issues.

✔️ Dosage Recommendations: Oxiplat 100

Adult Dose

Advanced Colorectal Cancer:

• Day 1:
  • Oxaliplatin: 85 mg/m² IV infusion over 2 hours.
  • Leucovorin: 200 mg/m² IV infusion over 2 hours (administered simultaneously with oxaliplatin via Y-site).
  • 5-FU Bolus: 400 mg/m² IV over 2–4 minutes.
  • 5-FU Infusion: 600 mg/m² IV in 500 mL D5W over 22 hours.
• Day 2:
  • Repeat Leucovorin and 5-FU (bolus + infusion) WITHOUT oxaliplatin.
• Repeat the cycle every 2 weeks.

Adjuvant Therapy for Stage III Colon Cancer:

• Same regimen as above.
• Total duration: 12 cycles (6 months).

Dose Modifications

• Neuropathy:
  • Persistent Grade 2 neuropathy: Reduce oxaliplatin to 75 mg/m².
  • Persistent Grade 3 neuropathy: Consider discontinuing oxaliplatin.
• Hematological or GI Toxicity:
  • After recovery from Grade 3/4 toxicity, reduce:
    • Oxaliplatin to 75 mg/m².
    • 5-FU bolus to 300 mg/m² and infusion to 500 mg/m².

✔️ Renal Dose Adjustments

• Mild Impairment (CrCl 50–80 mL/min): No dose adjustment is needed.
• Moderate Impairment (CrCl 30–49 mL/min): No dose adjustment required.
• Severe Impairment (CrCl <30 mL/min): Reduce the starting dose of oxaliplatin.

✔️ Pediatric Use

• Safety and efficacy in children have not been established.

✔️ Monitoring Recommendations

• Neurological Toxicity: Regular neurological exams before and during treatment.
• Hematological Profile: Monitor for neutropenia, anemia, and thrombocytopenia.
• Renal Function: Especially in patients with pre-existing renal impairment.
• Electrolytes: Check for potassium and magnesium levels to prevent QT prolongation.

✔️ Special Considerations

• Do not mix oxaliplatin with saline or chloride-containing solutions.
• Avoid cold drinks, foods, or exposure to cold for 48 hours after infusion to minimize laryngopharyngeal dysesthesia.
• Administer under the supervision of an experienced oncologist.

✔️ Overdose Effects

• No known antidote.
• Symptoms: Thrombocytopenia, myelosuppression, severe nausea/vomiting, neurotoxicity, and hypersensitivity.
• Management: Supportive treatment and monitoring.

✔️ Interaction

• No significant interactions between Oxiplat and 5-fluorouracil/folinic acid have been observed.
• Co-administration with nephrotoxic drugs may reduce oxaliplatin clearance (not specifically studied).
• Increased 5-fluorouracil plasma concentration (up to 20%) was noted with higher Oxiplat doses.

✔️ Contraindications:

Allergy to oxaliplatin or other platinum compounds.

✔️ Pregnancy & Lactation

• Pregnancy Category D: May harm the fetus; avoid use during pregnancy.
• Women of childbearing potential should use effective contraception.
• Not known if excreted in breast milk; discontinue nursing or the drug, based on the mother's need for treatment.

✔️ Precautions & Warnings

1. Allergic Reactions:
   • Grade 3/4 hypersensitivity reactions (2-3%) may occur, including fatal anaphylaxis.
   • Discontinue therapy and manage reactions with epinephrine, corticosteroids, and antihistamines.
2. Neurological Toxicity:
   • Monitor for peripheral neuropathy and other nerve damage symptoms.
   • To prevent laryngopharyngeal dysesthesia, avoid cold exposure and cold foods for 48 hours post-infusion.
3. Pulmonary Toxicity:
   • Rare but serious risk of pulmonary fibrosis. Discontinue Oxiplat if unexplained respiratory symptoms occur.
4. Hepatotoxicity:
   • Monitor for liver sinusoidal obstruction syndrome or unexplained portal hypertension.
5. Cardiovascular Toxicity:
   • QT prolongation and ventricular arrhythmias (e.g., Torsade de Pointes). Monitor ECG, electrolytes, and cardiac function.

✔️ Storage:

• Store in a cool, dry place, away from light and moisture.
• Keep out of reach of children.