Ácido zoledrónico

Regulatory sources consulted

• ema-epar-EMEA/H/C/002439
• aemps-cima-76294
• RxNorm rxcui 77655 ↗

Approved indications

• Prevention of skeletal-related events (pathological fractures, spinal cord compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
• Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Contraindications

Clinical warnings

• Major warning · Renal function deterioration: Monitor serum creatinine before each dose. Consider withholding treatment if renal function deteriorates. Ensure adequate hydration prior to administration. — EMA
• Major warning · Osteonecrosis of the jaw (ONJ): ONJ has been reported in cancer patients treated with bisphosphonates. A dental examination with preventive dentistry is recommended before starting treatment. Avoid invasive dental procedures during treatment. — EMA
• Hypocalcaemia: Severe hypocalcaemia can occur. Pre-existing hypocalcaemia must be treated before starting therapy. Adequate supplementation with calcium and vitamin D is essential. — EMA

Drug interactions

• ModerateAminoglycosidesJ01G

  Mechanism: Additive hypocalcaemic effect, resulting in lower serum calcium levels for longer periods.

  Recommendation: Caution is advised. Monitor serum calcium levels closely.

  EMA SPC

• ModerateNephrotoxic drugs

  Mechanism: Increased risk of renal dysfunction.

  Recommendation: Caution is indicated when used with other potentially nephrotoxic medicinal products. Ensure adequate hydration and monitor renal function.

  EMA SPC

Adverse events

Pregnancy and lactation

FDA category: D

Should not be used during pregnancy due to potential risks to the foetus (skeletal toxicity). Contraindicated during breast-feeding.