Oral sodium Clodronate - ICID - Salisbury NHS Foundation Trust

Salisbury NHS Foundation Trust Drugs and Therapeutics Committee
SUPPORTING INFORMATION
Summary of condition and licensed indications.
The indication covered by this shared care guideline is, the prevention of hypercalcaemia, bone pain and
fractures in patients with multiple myeloma
Treatment Aims (Therapeutic plan)
Current UK guidelines recommend that all patients with symptomatic multiple myeloma receive
bisphosphonate therapy, whether bone lesions are evident or not, as randomised studies have shwon
significant reductions in bony complications (pain, pathological fracture, radiotherapy) when these drugs are
administered. Three bisphosphonates, pamidronate, zoledronate (Zometa ® ) and clodronate (Bonefos ® ) are
licensed for this indication, and there are currently no data to indicate superiority of any of these three
agents. Sodium clodronate has the advantage of oral administration, and is therefore the preferred first line
treatment for most patients. Treatment should be continued for at least 2 years, although it is current practice
to continue these drugs indefinitely while the patient is still undergoing active treatment and follow-up. It is
therefore desirable that this drug be subject of a shared care agreement.
Treatment Schedule (including dosage and administration)
The patient will be initiated and stabilised on the drug by the Consultant Haematologist responsible for their
care. The licensed dose for sodium clodronate (Bonefos ® ) is 1.6g in single or two divided doses. The drug is
available as capsules of 400mg and tablets of 800mg. Patients should avoid food, particularly calciumcontaining
products such as milk, for 1 hour before and after each dose. Iron and mineral supplements, and
antacids, should also be avoided, and an adequate fluid intake maintained. Treatment should be continued
for at least 2 years, although current practice is to continue treatment indefinitely whilst the patient remains
under active haematological follow-up. Most patients will remain under active haematological follow-up, with
the consultant deciding when treatment may be discontinued, but patients should be referred back if
symptoms of drug intolerance (nausea, diarrhoea, skin reactions, bronchospasm, hypocalcaemia, renal
impairment, osteonecrosis) develop.
Contra-indications and precautions for use
Contraindications: acute gastrointestinal inflammatory conditions, pregnancy, breastfeeding.
Cautions: monitor renal and hepatic function during use, also monitor calcium and phosphate periodically.
Renal dysfunction reported in patients receiving concomitant NSAIDs. Maintain adequate fluid intake during
treatment. Consider preventive dental treatment before initiating clodronate because of risk of osteonecrosis
of the jaw. Adequate oral hygiene should be maintained during and after treatment.
Side-effects
The commonest side effects are: nausea, diarrhoea, skin reactions, bronchospasm
Monitoring
Parameter Frequency of monitoring Action (adjustment of dose by specialist
and referral back to hospital by GP if
acute renal of hepatic dysfunction )
Renal function
Hepatic function
Calcium/phosphate
At least every 3 months (responsibility of
Consultant Haematologist)
Drug Interactions
Absorption reduced by antacids, calcium salts and oral iron
Increased risk of hypocalcaemia when given with aminoglycosides
Cost
At current prices, one year's treatment with medicine at the dose is £2039.04
References
50% dose if CrCl 10-30ml/min
Stop if CrCl