Bisphosphonate

Hypercalcaemia, Paget’s Disease

Pamidronate Disodium Injection 15mg and 30mg Injection 

*Hospital Use Only*

Adjuvant bisphosphonate therapy in breast cancer

Rationale 1,2

*Hospital Use Only*

Bone malignancies and Pagets disease

Rationale 1,2

*Hospital Use Only*

NICE TA464 Bisphosphonates for treating osteoporosis

NICE NG35 Myeloma: diagnosis and management

Drug Safety Update
Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Full details can be found at: https://www.gov.uk/drug-safety-update/bisphosphonates-very-rare-reports-of-osteonecrosis-of-the-external-auditory-canal
Dec 2015

The following precautions should be taken into account to minimise the risk of renal adverse reactions with zoledronic acid

For all patients receiving zoledronic acid:
* Renal function should be measured before each infusion of zoledronic acid
* Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated before administration of zoledronic acid
* The duration of infusion of zoledronic acid should be at least 15 minutes
* Monitoring of renal function after zoledronic acid infusion should be considered, particularly in at-risk patients such as: those with pre-existing renal dysfunction; those of advanced age; those using concomitant nephrotoxic drugs or diuretic therapy; or those who are dehydrated
* Zoledronic acid should be used with caution when used concomitantly with medicines that could affect renal function

For patients receiving Zometa
* The recommended dose for Zometa in patients with normal renal function is 4 mg, which should be reduced in patients with mild-to-moderate renal impairment
* Zometa for cancer treatment is not recommended for use in patients with creatinine clearance <30 mL/min, and should only be considered for the treatment of hypercalcaemia in cancer patients with severe renal impairment after evaluating the risk and benefits of treatment
* In patients who show evidence of renal deterioration during the treatment period, Zometa should be with-held and only resumed when serum creatinine returns to within 10% of baseline

MHRA Drug Safety Update Volume 3 Issue 9 April 2010

Bone malignancies and Pagets disease, Treat osteoporosis in men and reduce risk of new fractures following hip fracture

Rationale 1,2

*Hospital Use Only*

NICE TA464 recommends as treatment for osteoporosis

NICE NG35 Myeloma: diagnosis and management

Drug Safety Update
Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Full details can be found at: https://www.gov.uk/drug-safety-update/bisphosphonates-very-rare-reports-of-osteonecrosis-of-the-external-auditory-canal
Dec 2015

The following precautions should be taken into account to minimise the risk of
renal adverse reactions with zoledronic acid

For all patients receiving zoledronic acid:
* Renal function should be measured before each infusion of zoledronic acid
* Patients, especially elderly patients and those receiving diuretic therapy,
should be appropriately hydrated before administration of zoledronic acid
* The duration of infusion of zoledronic acid should be at least 15 minutes
* Monitoring of renal function after zoledronic acid infusion should be
considered, particularly in at-risk patients such as: those with pre-existing
renal dysfunction; those of advanced age; those using concomitant
nephrotoxic drugs or diuretic therapy; or those who are dehydrated
* Zoledronic acid should be used with caution when used concomitantly with
medicines that could affect renal function

For patients receiving Aclasta
* A single dose of Aclasta for the treatment of osteoporosis and Paget's
disease of the bone should not exceed 5 mg
* Aclasta should not be used in patients with creatinine clearance
<35 mL/min

MHRA Drug Safety Update Volume 3 Issue 9 April 2010