Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Bonefos tablets are indicated in the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma.
Bonefos tablets are also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous bisphosphonate.
A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended below.
Bonefos has not been evaluated in children.
There are no special dosage recommendations in the elderly. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.
Clodronate is eliminated mainly via the kidneys. Therefore, it should be used with caution in patients with renal failure; daily doses exceeding 1600mg should not be used continuously.
It is recommended that the clodronate dosage be reduced as follows:
| Degree of renal failure | Creatinine Clearance, ml/min | Dose |
|---|---|---|
| Mild | 50-80 ml/min | 1600 mg daily (no dose reduction recommended) |
| Moderate | 30- <50 ml/min | 1200 mg/daily |
| Severe | 10 - <30 ml/min | 800 mg/daily |
Adequate fluid intake should be maintained during treatment. A Bonefos 800mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time of administration. Bonefos tablets should not be crushed or dissolved before intake.
The single daily dose and the first dose of two should preferably be taken in the morning on an empty stomach together with a glass of water. The patient should then refrain from eating, drinking (other than plain water), and taking any other oral drugs for one hour.
When twice daily dosing is used, the first dose should be taken as recommended above. The second dose should be taken between meals, more than two hours after and one hour before eating, drinking (other than plain water), or taking any other oral drugs.
Clodronate should in no case be taken with milk, food or drugs containing calcium or other divalent cations because they impair the absorption of clodronate.
The oral bioavailability of bisphosphonates is poor. Bioequivalence studies have shown appreciable differences in bioavailability between different oral formulations of sodium clodronate, as well as marked inter- and intra-patient variability. Dose adjustment may be required if the formulation is changed.
Dose adjustment is not recommended when switching between Bonefos capsule and tablet formulations (please refer to section 5.2 below for additional information).
Increases in serum creatinine and renal dysfunction have been reported with high intravenous doses of clodronate. One case of acute renal failure and liver injury has been reported after accidental ingestion of 20,000 mg (50x400 mg) clodronate. It is theoretically possible that hypocalcaemia may develop up to 2 or 3 days following the overdose.
Management of overdose should be symptomatic. Adequate hydration should be ensured, and renal, hepatic function and serum calcium should be monitored. Serum calcium should be monitored and oral or parenteral calcium supplementation may be needed.
3 years.
Do not store above 25°C.
Bonefos tablets are supplied in clear, colourless PVC/aluminium blister packs of 10 and 60 tablets.
Not all pack sizes may be marketed.
None stated.
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