Oxaliplatin Hikma Farmacêutica (Portugal) (Oxaliplatin)

Oxaliplatin is a platinum‑based chemotherapeutic that interferes with DNA synthesis in gastrointestinal malignancies.

• Colorectal cancer: used in combination with fluoropyrimidines and leucovorin to improve response rates and survival.
• Gastric cancer: part of combination regimens for advanced disease.
• Pancreatic cancer: incorporated into multi‑drug protocols for metastatic cases.
• Ovarian cancer: employed in selected regimens for recurrent disease.
• Small‑cell lung cancer: used off‑label in specific clinical trials for refractory disease.

• Oxaliplatin forms reactive platinum‑DNA adducts that cause intra‑strand cross‑links, disrupting DNA replication and transcription. The resulting DNA damage triggers cell‑cycle arrest and apoptosis, particularly in rapidly dividing tumor cells. Its activity is enhanced when combined with fluoropyrimidines, which inhibit thymidylate synthase and further impair DNA synthesis.

Oxaliplatin may cause a range of adverse reactions, from mild to severe, requiring monitoring during therapy.

Common Side Effects

• Nausea and vomiting: mild to moderate gastrointestinal upset.
• Peripheral neuropathy: tingling or numbness, often dose‑related.
• Diarrhoea: loose stools that may require supportive care.
• Fatigue: generalised tiredness affecting daily activities.
• Myelosuppression: reduced blood cell counts, increasing infection risk.
• Elevated liver enzymes: transient rise in hepatic function tests.

Serious or Rare Side Effects

• Severe hypersensitivity reactions: anaphylaxis or bronchospasm.
• Acute neurotoxicity: sudden onset of muscle cramps or jaw pain.
• Hemolytic‑uremic syndrome: rare renal impairment with haemolysis.
• Cardiotoxicity: arrhythmias or myocardial injury in susceptible patients.
• Severe neutropenia: profound drop in neutrophils leading to febrile infection.

Oxaliplatin requires careful monitoring and specific handling precautions to minimise toxicity and maintain product integrity.

• Renal function: assess baseline creatinine and adjust if impaired.
• Hepatic function: monitor liver enzymes before each cycle.
• Neuropathy risk: evaluate pre‑existing peripheral neuropathy before dosing.
• Pregnancy and lactation: avoid use unless benefits outweigh risks.
• Concomitant ototoxic drugs: limit use with other agents that affect hearing.
• Store at ambient temperature: keep vials in original packaging, protect from light and moisture.

Oxaliplatin may interact with several medicines, altering efficacy or safety. Clinicians should review patient medication lists before initiating therapy.

Major Interactions (Avoid)

• Aminoglycoside antibiotics: increased risk of nephrotoxicity.
• High‑dose vitamin C: may reduce platinum‑DNA adduct formation.
• Live vaccines: immunosuppression can lead to severe infection.

Moderate Interactions (Monitor Closely)

• Anticoagulants: heightened bleeding risk due to thrombocytopenia.\n- CYP450 inducers: potential reduction in drug exposure.
• NSAIDs: may exacerbate myelosuppression.
• Proton pump inhibitors: possible impact on gastrointestinal tolerance.