pamidronate disodium: clinical use

Prescribing considerations

• Assess hydration and fluid status; avoid overhydration, particularly in older people and those with cardiac disease.
• Review renal impairment, nephrotoxic co-medication and previous renal deterioration.
• Assess jaw-risk factors and arrange preventive dentistry when indicated; delay non-emergency initiation if oral soft-tissue lesions remain unhealed.
• Use caution following thyroid surgery because relative hypoparathyroidism may increase hypocalcaemia risk.
• The selected product is recommended only for adults because paediatric clinical experience is lacking.
• Severe hepatic impairment has not been adequately studied.

Contraindications and cautions

• Hypersensitivity to pamidronate, another bisphosphonate or any formulation excipient.

Monitoring

• Renal function before each administration and during treatment if clinically indicated.
• Calcium, phosphate and other relevant electrolytes.
• Hydration, urine output and fluid balance in at-risk patients.
• Oral symptoms and dental health; investigate suspected osteonecrosis of the jaw.
• New thigh, hip or groin pain for possible atypical femoral fracture.

Clinical pharmacology

Pamidronate is a nitrogen-containing bisphosphonate with high affinity for hydroxyapatite. Its predominant action is local inhibition of osteoclast-mediated bone resorption. It is not appreciably metabolised; a proportion is excreted unchanged by the kidneys and the remainder is retained in calcified tissue.

Formulation and product differences

• The selected product is a sterile concentrate for solution for intravenous infusion and requires dilution before administration.
• It must not be administered as a bolus or mixed with calcium-containing infusion solutions such as Ringer’s solution.
• The SmPC supports dilution with sodium chloride or glucose infusion solution under appropriate aseptic conditions.
• Inspect before use and do not administer a solution containing visible particles; vial contents are for single use.