risedronate sodium hemipentahydrate: clinical use

Prescribing considerations

• Correct hypocalcaemia and address vitamin D deficiency or other mineral-metabolism disorders before treatment
• Confirm that the patient can follow fasting, swallowing and upright-position instructions
• Review active or recent upper gastrointestinal disease, oesophageal transit disorders and Barrett’s oesophagus
• Assess dental health and osteonecrosis risk factors; ensure the dentist knows about bisphosphonate exposure
• Reassess ongoing benefit and risk periodically

Contraindications and cautions

• Hypersensitivity to risedronate or an excipient
• Hypocalcaemia
• Severe renal impairment with creatinine clearance below 30 mL/min
• Pregnancy
• Breastfeeding

Monitoring

• Renal function before prescribing and when clinically indicated
• Calcium and vitamin D status
• Adherence to administration technique and new oesophageal symptoms
• Jaw or dental symptoms, particularly around invasive dental treatment
• Persistent thigh, hip or groin pain suggesting an incomplete atypical femoral fracture
• Treatment benefit and continuing fracture risk at periodic review

Clinical pharmacology

A pyridinyl bisphosphonate with very low oral bioavailability. It binds bone hydroxyapatite, inhibits osteoclast-mediated resorption, is not systemically metabolised and is eliminated through the kidneys or retained on bone surfaces.

Formulation and product differences

• The selected product is a lactose-containing film-coated tablet that must be swallowed whole
• The tablet is described as light orange, round and marked F27
• The selected eMC product record is marked discontinued