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6.0 Endocrine

6.0 Endocrine

6.2.1 Thyroid hormones

GREEN       Levothyroxine tablets 25, 50, 100 microgram 
BLACK       Levothyroxine liquid (all strengths)
RED            Liothyronine injection 20 microgram  (hospital use only in thyroid emergencies) 
BLACK       Armour Thyroid  
BLACK       Liothyronine tablets/capsules 
                   link to UKMi Clinical evidence  
                   link to RCP - Diagnosis and management of primary hypothyroidism
                   link to New Medicines Assessment January 2020

        

6.2.2 Antithyroid drugs

Carbimazole is the drug of choice, with propylthiouracil used for patients with sensitivity to carbimazole or in pregnancy. Warn patients that if a sore throat develops in the first 6 - 8 weeks of therapy they should stop treatment and seek medical advice.

GREEN      Carbimazole tablets 5mg, 20mg
GREEN      Propylthiouracil tablets 50mg
 
Partial thyroidectomy
Iodine may be given for 10 - 14 days before surgery.
 

RED           Aqueous iodine oral solution 100mL (Lugol’s solution)

Equivalent anti-inflammatory doses of corticosteroids:

Prednisolone 5mg
Betamethasone 750 microgram
Cortisone Acetate 25mg
Deflazacort 6mg
Dexamethasone 750 microgram
Hydrocortisone 20mg
Methylprednisolone 4mg
Triamcinolone 4mg

6.3.1 Replacement therapy

A combination of hydrocortisone and the mineralocorticoid fludrocortisone are needed in primary adrenal deficiency states.
GREEN        Fludrocortisone tablets 100 microgram
 

6.3.2 Glucocorticoid therapy

The proportions of glucocorticoid to mineralocorticoid activity determine the uses of these corticosteroids:
 
Glucocorticoid and mineralocorticoid activity 
These are suitable for adrenal replacement therapy and as injection for emergency management of some conditions.
 
GREEN       Hydrocortisone   tablets 10mg, 20mg
AMBER      Hydrocortisone sodium succinate injection 100mg
RED            Hydrocortisone Emergency  Injection Kit
 
Glucocorticoid activity mainly 
Most common corticosteroid for long term disease suppression.
GREEN      Prednisolone     
                   tablets 1mg, 5mg, 25mg
                   (N.B- the 5mg tablets will disperse in water.)
                   tablets e/c 2.5mg     
 
High glucocorticoid activity with insignificant mineralocorticoid activity 
Suitable for high dose therapy when water retention would be a disadvantage.
GREEN      Betamethasone tablets 500 microgram 
RED           Betamethasone injection 4mg/mL 
GREEN      Dexamethasone 
                   tablets 500 microgram, 2mg
                   oral solution 2mg/5mL
RED           Dexamethasone injection 8mg/2mL
 
Other corticosteroid preparations 
RED           Methylprednisolone injection 500mg, 1g (Solu-Medrone®) 
GREEN      Methylprednisolone acetate injection 40mg/mL (Depo-Medrone®) 
GREEN       Triamcinolone injection 40mg/mL [NOT receommended for use in hayfever] 
 
Deflazacort 
Deflazacort may only be initiated by a paediatrician for the management of Duchenne Muscular Dystrophy.  Deflazacort 
should only be used for patients in whom oral prednisolone is not tolerated due to cushingoid side effects.   Treatment
is likely to be long term and prescribers should continue to monitor patients for side effects routinely (especially
asymptomatic cataracts and weight gain).  Therapy may be transferred to the primary care prescriber (following prior 
agreement) once therapy has been initiated by the specialist.  Duration of treatment and dose adjustments should be

clearly communicated at regular intervals.

AMBER     Deflazacort tablets 1mg, 6mg, 30mg

6.3.3 Dexamethasone and Covid-19


Offer dexamethasone  or hydrocortisone to people with severe or critical Covid-19 (in line with updated WHO guidance): that is, people with any of the following:
       > acute respiratory distress syndrome (ARDS)
       > sepsis or septic shock
       > other conditions that would normally need life-sustain therapies such as ventilation or vasopressor therapy
       > signs of severe respiratory distress
       > oxygen saturation <90% (or deteriorating) on room air
       > increased respiratory rate (>30 breaths per minute in adults and children over 5 years).

 Corticosteroids should not normally be used in people with COVID-19 that is not severe or critical, because there is
 a possibility of harm to such people.  See NICE Guidance - Covid-19 prescribing briefing: corticosteroids
 
RED        Dexamethasone [in Covid-19]
                tablets 500 microgram, 2mg
                injection 8mg/2mL

RED        Hydrocortisone sodium succinate injection 100mg  [in Covid-19]

 


 
 

 All material in this section is aimed at health care professionals, but is information currently held in the public domain,

 members of the public seeking advice on medicine-related matters are advised to speak with their GP, 

 pharmacist, nurse or contact NHS111 Service 

 Email: info.elmmb@nhs.net

 Copyright© 2016 - 2020  East Lancashire Medicines Management Board 

 All rights reserved.  Disclaimer/Terms and conditions

 
 



 6.4.1 Female sex hormones

 6.4.1.1 Oestrogens and HRT

Guidance is given below on the type of product required in different situations.  The choice of actual
preparation (tablet, patch, gel) to remain with the prescriber bearing in mind patient preference and the
cost differences between the preparations.
 
Note: HRT should only be used for osteoporosis prevention in patients where other therapies are 
contra-indicated, not tolerated, or there is a lack of response.  This should ideally be under the direction 
of a specialist.   
 
Women with uterus      
Sequential preparations for patients with an  intact uterus &   perimenopausal i.e.  have not yet had 1 year amenorrhoea.
GREEN       1st line Elleste Duet 1mg, 2mg      
                   (Estradiol / norethisterone combination)      
GREEN       2nd line Femoston 1/10, 2/10         
                    (Estradiol / dydrogesterone  combination)             
 
Continuous combined preparations for period free HRT, should only to be used in patients who are 
amenorrhoeic for 1 year or over 54 years if currently on sequential preparation.

GREEN      1st line Elleste-Duet Conti     
                   (Estradiol/ norethisterone continuous 'no bleed' combination)                                 
GREEN      2nd line Femoston-Conti        
                   (Estradiol/dydrogesterone  continuous 'no bleed' combination)                                  
GREEN      3rd line Premique  
                   (Conj. oestrogens/ medroxyprogesterone continuous 'no bleed' combination)      
BLACK       0.45mg conjugated oestrogens & Bazedoxifene (Duavive®)
                   (click here for New Medicines Recommendation)

HRT should be trialled for 4 months and reviewed. If progesterone side effects are reported consider
switching to Femoston products. If oestrogen side effects are reported switch to Prempak-C/ Premique. 
If side effects of both are severe, consider transdermal patches (Evorel Sequi or Evorel Conti) 
 
HRT patches should be reserved for use in patients with diabetes, liver disease or severe side effects.
 
GREEN      Evorel Sequi 50,and 50/170 micrograms  in 24 hours     
                  (Estradiol/ norethisterone sequential combination) 
GREEN      Evorel Conti 50/170 micrograms in 24 hours

                     (Estradiol/ norethisterone continuous 'no bleed' combination)                                                                          

Women without uterus                                                                                                                                               Unopposed oestrogen is used for patients with hysterectomy, however in endometriosis, endometrial foci may remain and the use of combination preparations should be considered. 

GREEN      1st line Elleste Solo 1mg, 2mg     
                   (Estradiol)        
GREEN      2nd line Premarin 0.625, 1.25      
                   (Conjugated oestrogens)
 
HRT patches should be reserved for use in patients with diabetes, liver disease or severe side effects. 

GREEN      Evorel 25, 50, 75, 100 (micrograms in 24 hours)    

                      (Estradiol)          

Where patches are not tolerated but symptoms of menopause require treatment, estradiol gel is an option.   
GREEN     Estradiol gel (Sandrena), 500mcg/sachet & 1mg/sachet


Tibolone

Tibolone increases the risk of breast cancer recurrence in women with a history of breast cancer. Tibolone should not be used in women with known or suspected breast cancer, or in those with a history of breast cancer. It should be used for loss of libido only.

GREEN      Tibolone tablets 2.5mg   

6.4.1.2 Progestogens and progesterone receptor modulators

GREEN      Medroxyprogesterone tablets 5mg,10mg
GREEN      Norethisterone tablets 5mg
GREEN      Progesterone pessaries 200mg, 400mg
BLACK      *Ulipristal tablets 5mg (Esmya®) 
 
Clonidine 25mcg tablets - for vasomotor symptoms associated with menopause
Where HRT is contraindicated or declined, a trial of clonidine 25mcg tablets may be considered for menopausal VMS.
Patients should be reviewed after 4 weeks and if no improvement in symptoms is observed or the 
patient is experiencing significant adverse events, treatment should be discontinued.
GREEN [restricted use]  Clonidine 25mcg tablets
 
*MHRA - Esmya - February 2018 - temporary safety measures have been introduced whilst EMA conducts
review following reports of serious liver injury, No new treatment courses to be prescribed until further notice
Click here to access further information 


  
 

6.4.2 Male sex hormones and antagonists

Used for replacement therapy in pituitary or testicular disease.                                                     NOT licensed or indicated for use in increasing libido   

AMBER     Testosterone  Link to Shared Care Guideline   
SHARED          esters injection (Sustanon 100®, Sustanon 250®)
CARE                depot injection 250mg/mL (Nebido®)
                         transdermal gel 50mg/5gram sachet (Testogel®)*
                         (*One pump actuation delivers 1.25g of gel containing 20.25mg of testosterone)
                         transdermal gel 20mg/1gram pump dispenser (Tostran®)**      
                          (**One press of the canister piston delivers 0.5 g of gel  containing 10 mg testosterone). 
                         transdermal gel 20mg/1gram pump dispenser (Testavan®)
                         The dose should be applied either to  the abdomen, or spread over both inner thighs.



Anti-androgens
Finasteride is used for benign prostatic hyperplasia, cyproterone is used for severe hypersexuality and 
sexual deviation in males, and to treat hyperandrogenism in women with polycystic ovary syndrome 
(unlicensed).
 
GREEN      Cyproterone tablets 50mg (Androcur®)

GREEN      Finasteride tablets 5mg  

Dutasteride

Consultant Urologist initiation only then primary care prescribing. Only to be used for 1 years treatment, when patients should be reviewed by the consultant urologist to either stop dutasteride, switch to finasteride, or progress to other management strategies and this communicated to the GP. Dutasteride is restricted for a high risk patient group, used in combination with tamsulosin in patients with moderate to severe symptoms (IPSS>12) with larger prostates (>30cc) and elevated PSA (>1.5ng/mL). 

)AMBER     Dutasteride capsules 500mcg  (Avodart®)

6.5.1 Hypothalamic and anterior pituitary hormones and anti-oestrogens

 Clomifene is used in the treatment of female infertility. The gonadatrophins found in this section (but not listed) are only used by
 specialist centres  who should retain all the prescribing – GPs should not be asked to prescribe.
 
RED           Clomifene tablets 50mg
RED           All gonadatrophins listed in section 6.5.1 of the BNF
RED           Human Chorionic Gonadotropin (Gonasi®) [unlicensed medicine  for use by endocrinolgoy only] 
 
Corticotrophins
RED           Tetracosactide 250microgram injection  (Synacthen®)
RED           Tetracosactide 1mg depot injection (Synacthen depot®)
 
Growth hormone 
In line with NICE guidelines for adults and children. 
AMBER     Somatropin injection 
 (all brands included within section 6.5.1 of the BNF - Omnitrope is the least costly brand)
 
Growth hormone receptor antagonists
Only to be initiated and prescribed by tertiary referral centres
RED           Pegvisomant (Somavert®)


6.5.2 Posterior pituitary hormones and antagonists

Desmopressin

Desmopressin is a synthetic analogue of vasopressin, and is indicated for treatment of primary nocturnal enuresis (PNE); nocturia associated with multiple sclerosis when other treatments have failed; and diagnosis and treatment of vasopressin-sensitive cranial diabetes insipidus; it is also indicated for establishment of renal concentration capacity.

At the request of the MHRA, the indication for the treatment of primary nocturnal enuresis (PNE) has been removed from all desmopressin nasal spray products. Desmopressin nasal sprays remain available for the treatment of patients with cranial diabetes insipidus or nocturia associated with multiple sclerosis. In comparison with oral formulations of desmopressin, nasal forms were associated with the majority of serious adverse drug reactions (ADRs) reported in patients with PNE.

Rare, serious ADRs included hyponatraemia, water intoxication and convulsions. As the risk benefit profile of the oral formulations is more favourable than the nasal spray, the nasal form should no longer be used for the treatment of PNE in adults and children.

Treatment of primary nocturnal enuresis (PNE)
GREEN      Desmopressin tablets 100, 200 microgram
                   oral lyphilisate 120microgram (Desmomelt®)        
                   NB- 120microgram melt is equivalent to 200 microgram oral tablet)
 
BLACK      Nasal spray 10microgram/metered spray (see notes above)  

Used for diagnosis and treatment of pituitary diabetes insipidus 
GREEN      Desmopressin tablets 100, 200 microgram 
                   oral lyphilisate 120microgram (Desmomelt®)      
                   (NB- 120microgram melt is equivalent to 200 microgram oral tablet) 
                   nasal spray 10microgram/metered spray (see notes above)    
 
RED           Desmopressin injection 4 microgram/mL   
 
Used for bleeding oesophageal varices
RED           Terlipressin injection 1mg
 
Used for treatment of hyponatraemia associated with inappropriate secretion of anti-diuretic hormone
RED         Demeclocycline 150mg capsules
Existing patients to be referred back to secondary care. 
 
Autosomal dominant polycystic kidney disease 
Tolvaptan for treating autosomal dominant polycystic kidney disease is recommended as an option in NICE TA358 
RED           Tolvaptan (Jinarc®)  
                   tablets 15mg, 30mg,45mg, 60mg, 90mg   
 
Tolvaptan for treating SIADH in patients requiring cancer chemotherapy
Consultant prescribing only.
RED           Tolvaptan (Samsca®)                                                                                            (NHS England Commissioned)  
 
 

 

 



Management of Patients Receiving Treatment with Bisphosphonates 

Treatment of Osteonecrosis of the Jaw 
RED    Pentoxyfylline tablets (off licence use, consultant use only) 
RED    Vitamin E tablets (off licence use, consultant use only) 

Osteoporosis
occurs most commonly in postmenopausal women and in those taking long-term oral corticosteroids (glucocorticosteroids). Other risk factors for osteoporosis include low body weight, cigarette smoking, excess alcohol intake, lack of physical activity, family history of osteoporosis, and early menopause.
 


Those at risk of osteoporosis should maintain an adequate intake of calcium and vitamin D and any deficiency should be corrected by increasing dietary intake or taking supplements  
 

See section 9.5.1.1 for calcium and 9.6.4 for vitamin D replacement.

NICE TA265 -  Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours.

Denosumab is recommended as an option for preventing skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from breast cancer and from solid tumours other than prostate if:

  • bisphosphonates would otherwise be prescribed and  
  • the manufacturer provides denosumab with the discount agreed in the patient access scheme.

RED                 Denosumab injectionpre-filled syringe 120mg (XGEVA®)

The treatment of corticosteroid-induced osteoporosis

To reduce the risk of osteoporosis, doses of oral corticosteroids should be as low as possible and courses of treatment as short as possible. The risk of osteoporosis may be related to cumulative dose of corticosteroids; even intermittent courses can therefore increase the risk. The greatest rate of bone loss occurs during the first 6-12 months of corticosteroid use and so early steps to prevent the development of osteoporosis are important. Long-term use of high-dose inhaled corticosteroids may also contribute to corticosteroid-induced osteoporosis. 

Patients taking (or who are likely to take) a corticosteroid for 3 months or longer should be assessed and where necessary given prophylactic treatment; those aged 65 years are at a greater risk. Patients taking oral corticosteroids who have sustained a low-trauma fracture should receive treatment for osteoporosis. The therapeutic options for prophylaxis and treatment of corticosteroid-induced osteoporosis are the same.

First Line Bisphosphonate

GREEN      Alendronate tablets 70mg once weekly + prescribe Adcal D3 1 tab twice daily

An effervescent formulation of alendronic acid , for specific patients with swallowing difficulties, is available as an alternative to improve compliance. Consultant initiation only.   

AMBER     Alendronic acid effervescent tablets 70mg (Binosto®)

Second Line Bisphosphonate

GREEN      Risedronate                                                                                                                                                                        tablets 35mg once weekly + prescribe Adcal D3 1 tab twice daily                                                                   tablets 5mg daily + prescribe Adcal D3 1 tab twice daily        

Third Line Bisphosphonate

GREEN      Disodium Etidronate 400mg + Calcium Carbonate eff 1.25g  (Didronel PMO®)   

Denosumab 
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture
Patients with any of the following clinical features may be considered for treatment with denosumab:
       >     Upper gastrointestinal abnormalities, including oesophageal stricture, achalasia, abnormalities 
              which delay oesophageal emptying, dysphagia, oesophageal disease (oesophagitis, ulcers, 
              erosions), gastritis, duodenitis, gastric ulcers, previous upper GI surgery.
       >     Inability to sit or stand upright for at least 30 minutes.
       >     Renal impairment (eGFR <35ml/min). (Denosumab’s SPC states there is no data for patients 
              with eGFR < 30ml/min. Many clinicians are happy to use if eGFR > 20ml/min, provided serum 
              calcium is closely monitored after each injection).
       >     Concerns about compliance with treatment – may include patients with cognitive impairment.
 
 
AMBER                        Denosumab (Prolia®)
SHARED CARE            access the shared care agreement here


6.6.1 Calcitonin and teriparatide

Calcitonin    

Calcitonin is sometimes used in patients with hypercalcaemia of malignancy. 

RED           Calcitonin (Salmon)/Salcatonin injection 50 units/ml

Teriparatide (NICE TA161) 

Teriparatide is recommended as an alternative treatment, after Alendronate, Risedronateand Raloxifene have been considered, for the secondary prevention of osteoporotic fragility fractures in postmenopausal women: 

  • who are unable to take alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined in section 2),  or who have an insatisfactory response (as defined in section 3) to treatment with alendronate, risedronate or etidronate  and
  • who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than two fractures, or who are aged 55 - 64 years and have a T-score of -4 SD or below plus more than 2 fractures.

1. For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

2. For the purposes of this guidance, intolerance of alendronate, risedronate or etidronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly.

3. For the purposes of this guidance, an unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline.

NB. Teriparatide for the treatment of osteoporosis in men at increased risk of fragility fractures has a BLACK traffic light. 

RED           Teriparatide pre-filled pen 750microgram/3mL

6.6.2 Bisphosphonates and other drugs affecting bone metabolism

Raloxifene for the PRIMARY prevention of osteoporotic fragility fractures in postmenopausal women (NICE TA160) - updated February 2018.
 (The title and guidance of TA160 have been updated to reflect the current recommendations.) 

Nice has issued up-to-date guidance  on bisphosphonates for treating osteoporosis. 
 
NICE  withdrew its guidance on the issue of etidronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures ipostmenopausal women because etidronate and strontium ranelate
are no longer marketed in the UK. 
 
For an overview of the Management of osteoporosis <click here> 
 
Alendronate 
Alendronate is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in post menopausal women.
When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.

Alendronate - First Line Bisphosphonate 
GREEN      Alendronate tablets 70mg once weekly + prescribe Adcal D3 1 tab twice daily 
 
Apart from alendronate, no other bisphosphonate (or any other treatment) should be initiated first line for primary or secondary prevention of osteoporosis. 

 
An effervescent formulation of alendronic acid , for specific patients with swallowing difficulties is available as an alternative to improve compliance. Consultant initiation only.    

AMBER     Alendronic acid effervescent tablets 70mg (Binosto®) 
 
Risedronate - Second Line Bisphosphonate    
Risedronate is recommended as alternative treatment option for the PRIMARY prevention of osteoporotic fragility fractures in postmenopausal women:
                >   who are unable to comply with the special instructions for the administration of                                              alendronate, or have a   contraindication to or are intolerant of alendronate, and
                >   who also have a combination  of T-score, age and number of independent clinical risk                                    factors for fracture as in the  attached  table.
                      
GREEN      Risedronate    
                   tablets 35mg once weekly + prescibe Adcal D3 1 tab twice daily 
                   tablets 5mg daily + prescribe Adcal D3 1 tab twice daily 
 
Denosumab  
Position Statement  - Denosumab as a second line treatment option for the prevention of osteoporotic                                           fragility fractures in men and women from  the age of 50 years.
                                      
Denosumab is recommended as a second line treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women and men from the age of 50 years at 
increased risk of fracture  who are unable to comply with the special instructions for administering 
alendronate and risedronate, or have an intolerance of, or a contraindication to those treatments and
the patient has a combination of T-score, age and number of independent clinical risk factors for fracture as indicated in NICE TA204 

AMBER SHARED CARE    Denosumab injection, pre-filled syringe 60mg (Prolia®) 
                                            click here for Shared Care Agreement 
 
Denosumab for the prevention of skeletal-related events in adults with bone metastases from solid tumours NICE TA265 

Treatment of Osteonecrosis of the Jaw  - click here 

6.6.2 Bisphosphonates and other drugs affecting bone metabolism

Raloxifene and triparatide for the SECONDARY prevention of osteoporotic fragility fractures in postmenopausal women who have osteoporosis (NICE TA161)- updated February 2018. 

(The title and guidance of TA161 have been updated to reflect the current recommendations.) Guidance on strontium ranelate and etidronate have been removed because these drugs are no longer marketed 
in the UK.
 
Nice has issued up-to-date guidance  on bisphosphonates for treating osteoporosis.  
 
For an overview of the Management of osteoporosis <click here> 
 
Alendronate   
Alendronate is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis
(that is, a T-score of - 2.5 SD or below). In women aged 75 years or older, a DXA scan may not be 
required if the responsible clinician considers it to be inappropriate or unfeasible.

When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.

Alendronate - First Line Bisphosphonate 
GREEN      Alendronate tablets 70mg once weekly + prescribe Adcal D3 1 tab twice daily 
 
Apart from alendronate, no other bisphosphonate (or any other treatment) should be initiated first line for primary or secondary prevention of osteoporosis. 

An effervescent formulation of alendronic acid , for specific patients with swallowing difficulties, is available as an alternative to improve  compliance. Consultant initiation only.  
 
AMBER     Alendronic acid effervescent tablets 70mg (Binosto®) 
 
Risedronate - Second Line Bisphosphonate 
Risedronate is recommended as 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, or 
           have a contraindication to or are intolerant of alendronate, and
      >   who also have a combination  of T-score, age and number of independent clinical risk factors for 
           fracture as in theattached table
GREEN      Risedronate  
                   tablets 35mg once weekly + prescribe Adcal D3 1 tab twice daily
                   tablets 5mg daily + prescribe Adcal D3 1 tab twice daily
 
Raloxifene and Teriparatide  - alternative SECONDARY prevention treatments for post menopausal women. 
The guidance does not cover the following: 
 
       >    The use of raloxifene or teriparatide for the secondary prevention of osteoporotic fragility
             fractures in women with normal BMD or osteopenia (that is, women with T-score between
              –1 and –2.5 SD below peak BMD).
 
       >    The use of these drugs for the secondary prevention of osteoporotic fragility fractures in women
             who are on long-term systemic corticosteroid treatment.
 
Teriparatide  
Teriparatide is recommended as an alternative, after Alendronate, risedronate and raloxifene have been considered, for the secondary prevention of osteoporotic fragility fractures in postmenopausal women 
see guidance 
 
RED           Teriparatide pre-filled pen 750microgram/3mL 
 
NB. Teriparatide for the treatment of osteoporosis in men at increased risk of fragility fractures has a BLACK traffic light.    
       
Raloxifene      
Raloxifene is recommended as an alternative treatment option for the secondary secondary prevention of osteoporotic fragility fractures in women: see guidance
 
GREEN        Raloxifene 60mg fc tablets (Evista®)

Chronic Kidney Disease NICE CG73

Bone Conditions
Bisphosphonates appear to have benefits in people with CKD without an increased risk of adverse
effects:
        >     use when needed for the prevention and treatment of osteoporosis in people with stage 1, 2,
               3A or 3B Chronic Kidney Disease
        >     check the Summary of Product Characteristics for any recommendations on dose adjustment
               according to GFR
 
When needed, give vitamin D supplementation as follows:
        >     stage 1, 2, 3A or 3B CKD - cholecalciferol or ergocalciferol,
        >     stage 4 or 5 CKD - alfacalcidol or calcitriol.  
 
 Capture.PNG


Oral Ibandronic acid

Ibandronic acid is recommended for the treatment of post menopausal osteoporosis to prevent vertebral fractures when a weekly bisphosphonate is not tolerated or where there is poor adherence.  Only to be initiated on the recommendation of a specialist. Recommendation may involve discussion with a GP over the telephone or by letter.  Efficacy on femoral neck (hip) fractures has not been established.  See full review online  - click here to access it.

AMBER     Ibandronic acid tablets 150mg once monthly (Bonviva®) + prescribe Adcal D3 1 tab twice daily

Intravenous Zoledronic  acid

Intravenous zoledronate should only be initiated and prescribed by a specialist in the management of osteoporosis.  It should be used in preference to pamidronate for the treatment of osteoporosis in postmenopausal women in all new patients. It is also indicated for treating osteoporosis in men. It should be reserved for patients who are intolerant, unresponsive or unsuitable for oral treatment with bisphosphonates and other oral treatments such as strontium ranelate.  Patients must still receive supplemental calcium and vitamin D. 

RED           Zoledronic acid injection 5mg annually (Aclasta®)

                           + prescribe Adcal D3 1 tab twice daily

For the treatment of bone pain in cancer

AMBER     Sodium clodronate capsules 400mg (Bonefos®)

For the treatment of bone metastases in breast cancer

SHARED CARE    Ibandronic acid tablets 50mg daily (Bondronat®)

Zoledronic Acid

For the treatment of hypercalcaemia of malignancy and bone damage in advanced malignancies

RED           Zoledronic acid injection 4mg (Zometa®)

Caution - There are two different strengths of IV zoledronic acid, please ensure you have selected the right strength.

For the treatment of Paget’s disease of the bone

Zoledronic acid should be prescribed only by physicians with experience in treatment of Paget's disease of the bone in line with its licensed indication.  It may be used first line, or as subsequent therapy in patients for whom other treatments are not tolerated, ineffective or inappropriate. Patients must be appropriately hydrated prior to administration of zoledronic acid and this is especially important for patients receiving diuretic therapy. In addition, it is advised that supplemental calcium corresponding to at least 500 mg elemental calcium twice daily (with vitamin D) is prescribed for patients with Paget's disease for at least 10 days following administration of zoledronic acid.  For further recommendations on the use of zoledronic acid 5mg for Paget's disease, refer to the new drug review which can be accessed online at www.elmmb.nhs.uk.

RED           Zoledronic acid injection 5mg (Aclasta®)

Caution - There are two different strengths of IV zoledronic acid, please ensure you have selected the right strength.


6.7.1 Bromocriptine and other dopaminergic drugs

First line

AMBER     Cabergoline tablets 500 microgram

Second line

AMBER     Bromocriptine tablets 2.5mg

6.7.2 Drugs affecting gonadotrophins

Danazol has been discontinued - available as an unlicensed special
Danazol combines androgenic, antioestrogenic and antiprogestogenic activity
RED         Danazol capsules 100mg, 200mg [unlicensed special] 


Gonadorelin analogues:-

Goserelin and leuprorelin are recommended for use within their licensed indications, with goserelin recommended as the first line product. Any unlicensed uses (e.g. precocious puberty) should not be transferred to primary care prescribers –prescribing should be retained by secondary care.  There are two shared care protocols in place for the use of goserelin (the preferred LHRH analogue).  One covers the use in gynaecology, the other covers the use in oncology settings (breast & prostate cancer), and they can be accessed online at www.elmmb.nhs.uk/shared-care .

First Line 

AMBER with SHARED CARE     Goserelin injection 3.6mg, 10.8mg      

Second Line                                                

AMBER with SHARED CARE     Leuprorelin injection 3.75mg, 11.25mg

(currently no shared care protocols exist for the use of leuprorelin locally as it is a second line agent)

RED          Triptorelin SR 3mg  (currently no shared care guideline available for triptorelin) 

Specialist initiation only. For use in patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration.

AMBER   Decapeptyl 22.5mg SR powder for suspension for injection [Triptorelin®] 
                For use in the treatment of high-risk localised or locally advanced prostate cancer, as an adjuvant to radical 
                 treatments for localised or locally advanced prostate cancer, and for metastatic prostate cancer. To be given 
           


6.7.3 Other Endocrine Drugs 

Management of Cushing's Syndrome (specialist supervision in hospital) 
RED                 Metyrapone capsules 250mg
 
Management of foot ulcers in the diabetic population
RED                 VACOcast Diabetic Boot
To be initiated by specialist and prescribing retained within secondary care.
All patients should be under the care of a diabetic foot team. The appropriate point of supply for the VACOcast
Diabetic Boot is this specialist service. The VACOcast Diabetic Boot is recommended for the management of
foot ulcers in the diabetic population where a total contact cast is contra-indicated (presence of infection/ ischaemia / 
daily inspection required),not tolerated or until casting can be provided (NICE NG19).