6.6.2 Bisphosphonates and other drugs affecting bone metabolism

NICE TA279 Vertebral fractures - vertebroplasty and kyphoplasty (April 2013)

Please refer to formulary guidance: Management of osteoporosis

Bisphosphonates

Alendronic acid
  • Tablets 10mg (£1.83)
  • Weekly tablets 70mg (£0.74 = 4 tablets)

Dose

  • 70mg once weekly or 10mg daily

Notes

  1. Alendronate is not recommended for patients with renal impairment - eGFR less than 35mL/minute/1.73m2
  2. NICE TA464: Bisphosphonates for treating osteoporosis. Alendronic acid is recommended as an option for treating osteoporosis in adults (August 2017)
Risedronate sodium
  • Tablets 5mg, 30mg (£18.85 = 5mg)
  • Weekly tablets 35mg (£0.85 = 4 tablets)

Dose

  • 35mg once weekly or 5mg daily

Notes

  1. The use of risedronate sodium is contraindicated in patients with severe renal impairment - avoid if eGFR less than 30 mL/minute/1.73 m2
  2. NICE TA464: Bisphosphonates for treating osteoporosis. Risedronate sodium is recommended as an option for treating osteoporosis in adults (August 2017)
Sodium clodronate
  • Capsules 400mg (£139.83 = 120)
  • Tablets 800mg (£146.43 = 60)
  • Tablets 520mg (£152.59 = 60)

Indications

  • Osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with breast cancer or multiple myeloma

Notes

  1. Sodium clodronate is eliminated mainly via the kidneys. Please refer to the manufacturer's information for guidance regarding dose alterations.
Denosumab
  • Prolia® Injection 60mg/ml (£183.00 = 1ml syringe)
  • Xgeva® Injection 70mg/ml (hospital only)

Indications

  • Prevention of postmenopausal osteoporotic fractures (60mg/ml)
  • Prevention of skeletal-related events in adults with bone metastases from solid tumours (70mg/ml)

Notes

  1. To avoid unnecessary out of pocket expenses, practices or pharmacies should order Prolia® direct from Movianto: www.prolia.co.uk/HCP/how_to_order_prolia.html
  2. See here for the NEW Devon CCG Specialised Medicines Service Guideline for Denosumab (Prolia®) for osteoporosis
  3. NICE TA204 - Osteoporotic fractures – denosumab (October 2010)
  4. NICE TA265 - Bone metastases from solid tumours - denosumab (October 2012)
  5. MHRA Drug Safety Update July 2015 and MHRA Drug Safety Update June 2017:
    • Before prescribing denosumab or intravenous bisphosphonates:
      1. give patients the patient reminder card for their medicine
      2. explain the risk of osteonecrosis of the jaw, and osteonecrosis of the external auditory canal, and advise patients on precautions to take
      3. do not prescribe denosumab 120mg (cancer indication) to patients with unhealed lesions from dental or oral surgery
      4. advise patients to report any problems with their mouth or teeth, any ear pain, discharge from the ear, or an ear infection during denosumab treatment
      5. please continue to report suspected side effects to denosumab, bisphosphonates or any other medicines on a Yellow Card.
Ibandronic acid
  • Tablets 150mg
  • Solution for injection 1mg/ml

Notes

  1. NICE TA464: Bisphosphonates for treating osteoporosis. Ibandronic acid is recommended as an option for treating osteoporosis in adults (August 2017)
Zoledronic acid
  • IV infusion 50 micrograms/ml
  • Concentrate for IV infusion 800 micrograms/ml
  • Solution for IV infusion 40 micrograms/ml

Indications

  • Multiple myeloma (see below)
  • Osteoporosis
  • Adjuvant therapy in post-menopausal women with breast cancer (unlicensed use)

Notes

  1. Bisphosphonate therapy is commissioned as part of routine care of patients with symptomatic multiple myeloma. Zoledronic acid may be used as the bisphosphonate at least until disease progression if it can be provided at a negotiated contract price consistent with the financial modelling used for this decision (see Commissioning Policy for more information).
  2. NICE TA464: Bisphosphonates for treating osteoporosis. Zoledronic acid is recommended as an option for treating osteoporosis in adults (August 2017)
Pamidronate disodium
  • Concentrate for intravenous infusion

Indications

  • Hypercalcaemia of malignancy
  • Osteolytic lesions and bone pain in bone metastases associated with breast cancer or multiple myeloma
  • Paget's disease

 

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