• FCMS
  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • Rotherham Doncaster and South Humber NHS Foundation Trust
  • Nottingham and Nottinghamshire
  • South Yorkshire ICB

For information and guidance relating to Denosumab 60mg/mL injection including Shared Care Protocol on the SY MO website  Click here

For information and guidance relating to Ibandronic Acid 50mg tablets as adjuvant therapy in early breast cancer on the SY MO website click here 

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Alendronic Acid Tablets

Adrenocortical Function Testing and Antidiuretic Hormone Disorders

(and Other Hormone-Relate Disorders)

Pack Price
4 tablet £1.35

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

 

Bisphosphonate

Only prescribe effervescent tablets where patient has swallowing difficulties

Osteoporosis

Ibandronic Acid 150mg Tablets

Brand: Bonviva

NICE TA464 Bisphosphonates for treating osteoporosis Aug 2017

THE SHEFFIELD AREA PRESCRIBING GROUP Prescribing Guidance For Ibandronic Acid 50mg tablets in post-menopausal women with breast cancer can be found on page 6.6.2

Drug Safety update  Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal Dec 2015

Drug Safety update Bisphosphonates: osteonecrosis of the jaw November 2009

Information and advice for healthcare professionals and patients to minimise risk of oesophageal adverse reactions with oral bisphosphonates:

* Alendronate and oral ibandronate should not be given to patients with abnormalities of the oesophagus and/or other factors which delay oesophageal emptying such as stricture or achalasia. Risedronate should be used with caution in such patients
* Alendronate, oral ibandronate, and risedronate should be used with caution in patinets with active or recent upper gastrointestinal problems
*In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate and oral ibandronate on an individual basis.

Advice for patients:

* Patients should be advised about the importance of adhering to dose instructions. Tablets should be swallowed whole with at least 200 mL water on an empty stomach immediately after getting up in the morning. Patients should stay fully upright for at least 30 minutes or 1 hour after taking the tablet and before taking any food, drink, or other medicine as outlined in the product information

MHRA Drug Safety Update Volume 4, Issue 4 November 2010

Ibandronate may be an alternative in patients who find the current weekly or daily regimens inconvenient. It offers no advantage over once weekly alendronate.

Pack Price
1 tablet £1.51

Secondary prevention of osteoporotic fractures in postmenopausal women

NICE CG164 Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer

Raloxifene is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
* who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate
and
* who also have a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in the table within the guidance

NICE TA161 Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (amended January 2010)
October 2008

Pack Price
28 tablet £5.73

Osteoporosis (prevention) in postmenopausal women at increased risk of fractures

Men with increase risk of fracture

Brand: Prolia

Rationale: 1,2,3,8

Refer to the Clinical Guideline For Denosumab 60mg/ml Injection (Prolia ®)

MHRA - Drug Safety Update & NHS England Patient Safety alerts May 2022 ‘Denosumab should not be prescribed to anyone under the age of 18 years’

Drug Safety Update
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab
June 2017

Pack Price
1 pre-filled disposable injection £183.00

Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

Ibandronic Acid Tablets 50mg 

Brand: Avansor

NICE TA464 Bisphosphonates for treating osteoporosis 

Drug Safety Update: Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal Dec 2015

Cancer - Breast (Post-menopausal women)

NICE NG101

Off Label Use. Initiated by hospital specialist. Drug Safety Update : Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal Dec 2015

Pack Price
28 tablet £18.95

Adjuvant bisphosphonate therapy in breast cancer

Brand : Clasteon, Bonefos, Lorons

Pack Price
120 capsule £139.83
Pack Price
60 tablet £114.44
Pack Price
60 tablet £146.43

Treating osteoporosis after menopause

Rationale 1,6

NICE Guidance

NICE Guidance

Rationale: 1

Denosumab is Amber for the following indications; see guidance for details

Denosumab (60mg subcutaneous injection every 6 months) is licensed for the treatment of:
(a) osteoporosis in postmenopausal women and in men at increased risk of fractures due to
osteoporosis
(b) bone loss associated with hormone ablation in men with prostate cancer at increased risk of
fractures
(c) bone loss associated with long term systemic glucocorticoid therapy in patients at increased
risk of fractures

 

Hyperparathyroidism, secondary (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy

Rationale: 1

NICE Guidance 

Osteoporosis in post menopausal women to reduce risk of vertebral fracture

Rationale: 1,2

Drug Safety Update
Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal
Dec 2015

For the secondary prevention of osteoporotic fragility fractures in postmenopausal women

NICE TA161

Rationale 1

 

 

Osteoporosis

Rationale 1

NICE TA791

Primary prevention of osteoporotic fractures in postmenopausal women

Rationale: 1

Raloxifene is not recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women.

NICE TA160
Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women (amended January 2010) October 2008