disodium clodronate: clinical use

Prescribing considerations

• Confirm that the indication is represented by the selected product licence.
• Assess renal function, hydration and gastrointestinal history.
• Consider dental assessment and preventive dentistry when jaw-osteonecrosis risk is increased.
• Advise good oral hygiene, routine dental care and reporting of oral symptoms.
• Safety and efficacy have not been established in children.

Contraindications and cautions

• Hypersensitivity to clodronate or an excipient.
• Acute, severe inflammatory gastrointestinal disease.
• Pregnancy or breastfeeding.
• Creatinine clearance below 10 mL/min, subject to the limited SmPC exception.
• Concurrent treatment with another bisphosphonate.

Monitoring

• Renal function, including serum creatinine, before and during treatment.
• Serum calcium and phosphate.
• Liver transaminases.
• Hydration, gastrointestinal intolerance, oral or jaw symptoms, persistent ear symptoms, and new thigh, hip or groin pain.

Clinical pharmacology

Oral bioavailability is approximately 2%. Clodronate is not metabolised; the absorbed fraction is incorporated into bone or eliminated unchanged, mainly in urine. Its skeletal fraction suppresses osteoclast-mediated bone resorption without adversely affecting mineralisation.

Formulation and product differences

• The selected product is a divisible film-coated oral tablet containing lactose and a clinically relevant amount of sodium.
• Oral formulations can differ appreciably in bioavailability. Review treatment when changing formulation rather than assuming direct interchangeability.

Tablet

Route: Oral

Strengths: 520 mg