l NATIONAL FUNDING/ACCESS DECISIONS
▶ Bisphosphonates for treating osteoporosis (updated February
This technology appraisal guidance should be applied
clinically in conjunction with:
. NICE guideline on assessing the risk of fragility fractures
(CG146), which defines who is eligible for osteoporotic
. NICE quality standard on osteoporosis (QS149), which
defines the clinical intervention thresholds for the
10-year fracture probability of a major osteoporotic
fracture, in those patients who have undergone fracture
Alendronic acid is recommended as an option for treating
osteoporosis in patients, only if:
. the person is eligible for risk assessment as defined in
the full NICE guideline on osteoporosis, and
. the 10-year probability of osteoporotic fragility fracture
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
www.nice.org.uk/guidance/ta464
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2016)
that alendronic acid (Binosto ®) is accepted for restricted
use within NHS Scotland for the treatment of
postmenopausal osteoporosis where alendronic acid is the
appropriate treatment choice, but the patient is unable to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral solution
▶ Alendronic acid (Non-proprietary)
Alendronic acid 700 microgram per 1 ml Alendronic acid
70mg/100ml oral solution unit dose sugar free sugar-free | 4 unit
▶ Binosto (Internis Pharmaceuticals Ltd)
Alendronic acid (as Alendronate sodium) 70 mg Binosto 70mg
effervescent tablets sugar-free | 4 tablet P £22.80 DT = £22.80
▶ Alendronic acid (Non-proprietary)
Alendronic acid (as Alendronate sodium) 10 mg Alendronic acid
10mg tablets | 28 tablet P £3.25 DT = £1.46
Alendronic acid (as Alendronate sodium) 70 mg Alendronic acid
70mg tablets | 4 tablet P £22.80 DT = £0.86
▶ Fosamax Once Weekly (Merck Sharp & Dohme Ltd)
Alendronic acid (as Alendronate sodium) 70 mg Fosamax Once
Weekly 70mg tablets | 4 tablet P £22.80 DT = £0.86
Alendronic acid with colecalciferol
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, alendronic acid p. 727, colecalciferol
Treatment of postmenopausal osteoporosis in women at
▶ Adult (female): 1 tablet once weekly.
l INTERACTIONS → Appendix 1: bisphosphonates . vitamin D
l DIRECTIONS FOR ADMINISTRATION Tablets should be
swallowed whole with plenty of water while sitting or
standing; to be taken on an empty stomach at least
30 minutes before breakfast (or another oral medicine);
patient should stand or sit upright for at least 30 minutes
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer alendronic acid with
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Alendronic acid with colecalciferol (Non-proprietary)
Colecalciferol 70 microgram, Alendronic acid (as Alendronate
sodium) 70 mg Alendronic acid 70mg / Colecalciferol 70microgram
tablets | 4 tablet P £22.80–£24.94 DT = £24.94
▶ Bentexo (Consilient Health Ltd)
Colecalciferol 140 microgram, Alendronic acid (as Alendronate
sodium) 70 mg Bentexo 70mg/5,600unit tablets | 4 tablet P £4.25
▶ Fosavance (Merck Sharp & Dohme Ltd)
Colecalciferol 70 microgram, Alendronic acid (as Alendronate
sodium) 70 mg Fosavance tablets | 4 tablet P £22.80 DT =
Reduction of bone damage in bone metastases in breast
▶ Adult: 50 mg daily, alternatively (by intravenous
infusion) 6 mg every 3–4 weeks
▶ Adult: 2–4 mg as a single infusion, dose to be adjusted
according to serum calcium concentration
Treatment of postmenopausal osteoporosis
▶ Adult (female): 150 mg once a month, alternatively (by
intravenous injection) 3 mg every 3 months, to be
administered over 15–30 seconds.
▶ With oral use Abnormalities of the oesophagus . other
factors which delay emptying (e.g. stricture or achalasia)
l CAUTIONS Atypical femoral fractures . cardiac disease
l INTERACTIONS → Appendix 1: bisphosphonates
▶ Common or very common Face oedema
▶ With oral use Acute phase reaction . gastrointestinal
disorders . muscle cramps . musculoskeletal stiffness
increased . myocardial ischaemia . palpitations . pelvic pain
728 Disorders of bone metabolism BNF 78
. pulmonary oedema .radiculopathy .renal cyst. sleep
disorder. stridor. urinary retention . weight decreased
▶ With intravenous use Hypersensitivity
▶ With oral use Oesophagitis erosive (discontinue)
l BREAST FEEDING Avoid—present in milk in animal studies.
l RENAL IMPAIRMENT When used for postmenopausal
osteoporosis, avoid if eGFR less than
Dose adjustments ▶ With intravenous use When used for
bone metastases, if eGFR 30–50 mL/minute/1.73 m2
reduce dose to 4 mg and infuse over 1 hour; if eGFR less
than 30 mL/minute/1.73 m2 reduce dose to 2 mg and infuse
▶ With oral use When used for bone metastases, if eGFR
30–50 mL/minute/1.73 m2 reduce dose to 50 mg on
alternative days; if eGFR less than 30 mL/minute/1.73 m2
reduce dose to 50 mg once weekly.
l MONITORING REQUIREMENTS Monitor renal function and
serum calcium, phosphate and magnesium.
l DIRECTIONS FOR ADMINISTRATION Tablets should be
swallowed whole with plenty of water while sitting or
standing; to be taken on an empty stomach at least
30 minutes (for most ibandronic acid tablets, 50 mg) or
1 hour (for Bonviva ® tablets, 150 mg) before first food or
drink (other than water) of the day, or another oral
medicine; patient should stand or sit upright for at least
For intravenous infusion (Bondronat ®), give
intermittently in Glucose 5% or Sodium chloride 0.9%;
dilute requisite dose in 500 mL infusion fluid and give over
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer ibandronic acid tablets.
Oesophageal reactions Patients and carers should be advised
to stop tablets and seek medical attention for symptoms of
oesophageal irritation such as dysphagia, pain on
swallowing, retrosternal pain, or heartburn.
Patient reminder card A patient reminder card should be
provided to patients receiving intravenous ibandronic acid
(risk of osteonecrosis of the jaw).
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Bisphosphonates for treating osteoporosis (updated February
This technology appraisal guidance should be applied
clinically in conjunction with:
. NICE guideline on assessing the risk of fragility fractures
(CG146), which defines who is eligible for osteoporotic
. NICE quality standard on osteoporosis (QS149), which
defines the clinical intervention thresholds for the
10-year fracture probability of a major osteoporotic
fracture, in those patients who have undergone fracture
With oral use ibandronic acid is recommended as an option
for treating osteoporosis in patients, only if:
. the person is eligible for risk assessment as defined in
the full NICE guideline on osteoporosis, and
. the 10-year probability of osteoporotic fragility fracture
With intravenous use ibandronic acid is recommended as an
option for treating osteoporosis in patients, only if:
. the person is eligible for risk assessment as defined in
the full NICE guideline on osteoporosis, and
. the 10-year probability of osteoporotic fragility fracture
. the 10-year probability of osteoporotic fragility fracture
is at least 1% and the person has difficulty taking oral
bisphosphonates (alendronic acid, ibandronic acid or
risedronate sodium) or these drugs are contra-indicated
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
www.nice.org.uk/guidance/ta464
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Ibandronic acid (Non-proprietary)
Ibandronic acid (as Ibandronic sodium monohydrate) 1 mg per
1 ml Ibandronic acid 3mg/3ml solution for injection pre-filled syringes
| 1 pre-filled disposable injection P £65.20–£66.00 DT = £65.40
▶ Bonviva (Atnahs Pharma UK Ltd)
Ibandronic acid (as Ibandronic sodium monohydrate) 1 mg per
1 ml Bonviva 3mg/3ml solution for injection pre-filled syringes |
1 pre-filled disposable injection P £68.64 DT = £65.40
▶ Ibandronic acid (Non-proprietary)
Ibandronic acid (as Ibandronic sodium monohydrate) 1 mg per
1 ml Ibandronic acid 6mg/6ml concentrate for solution for infusion
vials | 1 vial P £130.42 (Hospital only)
▶ Bondronat (Atnahs Pharma UK Ltd)
Ibandronic acid (as Ibandronic sodium monohydrate) 1 mg per
1 ml Bondronat 2mg/2ml concentrate for solution for infusion vials | 1 vial P £89.36 (Hospital only)
Bondronat 6mg/6ml concentrate for solution for infusion vials |
▶ Ibandronic acid (Non-proprietary)
Ibandronic acid (as Ibandronic sodium monohydrate)
50 mg Ibandronic acid 50mg tablets | 28 tablet P £186.69 DT =
Ibandronic acid (as Ibandronic sodium monohydrate)
150 mg Ibandronic acid 150mg tablets | 1 tablet P £19.95 DT =
£1.10 | 3 tablet P £2.94–£55.21
▶ Bondronat (Atnahs Pharma UK Ltd)
Ibandronic acid (as Ibandronic sodium monohydrate)
50 mg Bondronat 50mg tablets | 28 tablet P £183.69 DT =
▶ Bonviva (Atnahs Pharma UK Ltd)
Ibandronic acid (as Ibandronic sodium monohydrate)
150 mg Bonviva 150mg tablets | 1 tablet P £18.40 DT = £1.10
Ibandronic acid (as Ibandronic sodium monohydrate)
50 mg Iasibon 50mg tablets | 28 tablet P £174.50 DT = £26.30
▶ Quodixor (Aspire Pharma Ltd)
Ibandronic acid (as Ibandronic sodium monohydrate)
150 mg Quodixor 150mg tablets | 1 tablet P £18.40 DT = £1.10
aminohydroxypropylidenediphosphonate
▶ Adult: 15–60 mg, to be given (via cannula in a
relatively large vein) as a single infusion or in divided
doses over 2–4 days, dose adjusted according to serum
calcium concentration; maximum 90 mg per course
Osteolytic lesions and bone pain in bone metastases
associated with breast cancer or multiple myeloma
▶ Adult: 90 mg every 4 weeks, to be administered via
cannula in a relatively large vein, dose may continued→
BNF 78 Disorders of bone metabolism 729
alternatively be administered every 3 weeks, to
coincide with chemotherapy in breast cancer
▶ Adult: 30 mg every week for a 6 week course (total dose
180 mg), alternatively initially 30 mg once weekly for
1 week, then increased to 60 mg every 2 weeks (max.
per dose 60 mg) for a 6 week course (total dose 210 mg),
to be administered via cannula in a relatively large
vein, course may be repeated every 6 months;
l CAUTIONS Atypical femoral fractures . cardiac disease
l INTERACTIONS → Appendix 1: bisphosphonates
▶ Uncommon Agitation . dyspnoea . hypotension . muscle
▶ Frequency not known Atrial fibrillation
SIDE-EFFECTS, FURTHER INFORMATION Oral supplements
are advised to minimise potential risk of hypocalcaemia for
those with mainly lytic bone metastases or multiple
myeloma at risk of calcium or vitamin D deficiency (e.g.
through malabsorption or lack of exposure to sunlight)
and in those with Paget’s disease.
l PREGNANCY Avoid—toxicity in animal studies.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe hepatic impairment (no information available).
Dose adjustments Max. infusion rate 20 mg/hour. Avoid if
eGFR less than 30 mL/minute/1.73 m2
, except in lifethreatening hypercalcaemia if benefit outweighs risk.
If renal function deteriorates in patients with bone
metastases, withhold dose until serum creatinine returns
to within 10% of baseline value.
▶ Monitor serum electrolytes, calcium and phosphate—
possibility of convulsions due to electrolyte changes.
▶ Assess renal function before each dose.
l DIRECTIONS FOR ADMINISTRATION For slow intravenous
infusion (Pamidronate disodium, Hospira, Medac,
Wockhardt), give intermittently in Glucose 5% or Sodium
chloride 0.9%; give at a rate not exceeding 1 mg/minute;
not to be given with infusion fluids containing calcium.
For Pamidronate disodium (Medac, Hospira, Wockhardt)
dilute with infusion fluid to a concentration of not more
l PATIENT AND CARER ADVICE A patient reminder card
should be provided (risk of osteonecrosis of the jaw).
Driving and skilled tasks Patients should be warned against
performing skilled tasks (e.g. cycling, driving or operating
machinery) immediately after treatment (somnolence or
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Pamidronate disodium (Non-proprietary)
Pamidronate disodium 3 mg per 1 ml Pamidronate disodium
15mg/5ml solution for infusion vials | 1 vial P £27.50 (Hospital
only) | 5 vial P £149.15 (Hospital only)
Pamidronate disodium 30mg/10ml solution for infusion vials | 1 vial P £55.00–£59.66 (Hospital only)
Pamidronate disodium 60mg/20ml solution for infusion vials |
1 vial P £110.00 (Hospital only)
Pamidronate disodium 90mg/30ml solution for infusion vials | 1 vial P £165.00 (Hospital only)
Pamidronate disodium 9 mg per 1 ml Pamidronate disodium
90mg/10ml solution for infusion vials | 1 vial P £170.45 (Hospital
Pamidronate disodium 15 mg per 1 ml Pamidronate disodium
60mg/4ml solution for infusion ampoules | 1 ampoule P £119.32
Pamidronate disodium 15mg/1ml solution for infusion ampoules | 4 ampoule P £119.32
Pamidronate disodium 90mg/6ml solution for infusion ampoules |
Pamidronate disodium 30mg/2ml solution for infusion ampoules | 2 ampoule P £119.32
Risedronate sodium 28-Mar-2019
▶ Adult: 30 mg daily for 2 months, course may be
repeated if necessary after at least 2 months
Treatment of postmenopausal osteoporosis to reduce risk
▶ Adult (female): 5 mg daily, alternatively 35 mg once
Prevention of osteoporosis (including corticosteroidinduced osteoporosis) in postmenopausal women
Treatment of osteoporosis in men at high risk of fractures
▶ Adult (male): 35 mg once weekly.
l CONTRA-INDICATIONS Hypocalcaemia
l CAUTIONS Atypical femoral fractures . oesophageal
abnormalities . other factors which delay transit or
emptying (e.g. stricture or achalasia)
l INTERACTIONS → Appendix 1: bisphosphonates
▶ Uncommon Gastrointestinal disorders
vasculitis . increased risk of infection . leg cramps . liver
l RENAL IMPAIRMENT Avoid if eGFR less than
▶ Correct hypocalcaemia before starting.
▶ Correct other disturbances of bone and mineral
metabolism (e.g. vitamin-D deficiency) at onset of
l DIRECTIONS FOR ADMINISTRATION Swallow tablets whole
with full glass of water; on rising, take on an empty
stomach at least 30 minutes before first food or drink of
the day or, if taking at any other time of the day, avoid
food and drink for at least 2 hours before or after
730 Disorders of bone metabolism BNF 78
risedronate (particularly avoid calcium-containing
products e.g. milk; also avoid iron and mineral
supplements and antacids); stand or sit upright for at least
30 minutes; do not take tablets at bedtime or before rising.
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer risedronate sodium
Oesophageal reactions Patients should be advised to stop
taking the tablets and seek medical attention if they
develop symptoms of oesophageal irritation such as
dysphagia, pain on swallowing, retrosternal pain, or
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Bisphosphonates for treating osteoporosis (updated February
This technology appraisal guidance should be applied
clinically in conjunction with:
. NICE guideline on assessing the risk of fragility fractures
(CG146), which defines who is eligible for osteoporotic
. NICE quality standard on osteoporosis (QS149), which
defines the clinical intervention thresholds for the
10-year fracture probability of a major osteoporotic
fracture, in those patients who have undergone fracture
Risedronate sodium is recommended as an option for
treating osteoporosis in patients, only if:
. the person is eligible for risk assessment as defined in
the full NICE guideline on osteoporosis, and
. the 10-year probability of osteoporotic fragility fracture
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
www.nice.org.uk/guidance/ta464
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
▶ Risedronate sodium (Non-proprietary)
Risedronate sodium 5 mg Risedronate sodium 5mg tablets | 28 tablet P £24.78 DT = £18.85
Risedronate sodium 30 mg Risedronate sodium 30mg tablets | 28 tablet P £155.26 DT = £155.25
Risedronate sodium 35 mg Risedronate sodium 35mg tablets | 4 tablet P £19.12 DT = £0.77
▶ Actonel (Warner Chilcott UK Ltd, Teva UK Ltd)
Risedronate sodium 5 mg Actonel 5mg tablets | 28 tablet P £17.99 DT = £18.85
Risedronate sodium 30 mg Actonel 30mg tablets | 28 tablet P £143.95 DT = £155.25
Risedronate sodium 35 mg Actonel Once a Week 35mg tablets | 4 tablet P £19.12 DT = £0.77
Actonel 35mg tablets | 4 tablet P s DT = £0.77
Risedronate with calcium carbonate
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, risedronate sodium p. 730, calcium
carbonate p. 1045, colecalciferol p. 1084.
Treatment of postmenopausal osteoporosis to reduce risk
▶ Adult: 1 tablet once weekly on day 1 of the weekly
cycle, followed by 1 sachet daily on days 2–6 of the
l INTERACTIONS → Appendix 1: bisphosphonates . calcium
l DIRECTIONS FOR ADMINISTRATION Tablets should be
swallowed whole with plenty of water while sitting or
standing; to be taken on an empty stomach at least
30 minutes before breakfast (or another oral medicine);
patient should stand or sit upright for at least 30 minutes
after taking tablet. Granules should be stirred into a glass
of water and after dissolution complete taken
l PRESCRIBING AND DISPENSING INFORMATION Actonel
Combi ® effervescent granules contain calcium carbonate
2.5 g (calcium 1 g or Ca2+ 25 mmol) and colecalciferol
22 micrograms (880 units)/sachet.
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer risedronate with
calcium carbonate and colecalciferol tablets and granules.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Actonel Combi (Theramex HQ UK Ltd)
Actonel Combi 35mg tablets and 1000mg/880unit effervescent
granules sachets | 4 week supply P £19.12
Osteolytic lesions, hypercalcaemia and bone pain
associated with skeletal metastases in patients with
breast cancer or multiple myeloma
▶ Adult: 1.6 g daily in 1–2 divided doses, then increased
if necessary up to 3.2 g daily in 2 divided doses
Osteolytic lesions, hypercalcaemia and bone pain
associated with skeletal metastases in patients with
breast cancer or multiple myeloma
▶ Adult: Initially 2 tablets daily in 1–2 divided doses,
increased if necessary up to 4 tablets daily
l CONTRA-INDICATIONS Acute gastro-intestinal
l CAUTIONS Atypical femoral fractures . maintain adequate
l INTERACTIONS → Appendix 1: bisphosphonates
l SIDE-EFFECTS Proteinuria .respiratory disorder
l BREAST FEEDING Manufacturer advises avoid—no
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