Chapter 6 page number 1 Produced: February 2014 Last Amended: Chapter 6 Endocrine. Primary & Secondary Care Notes Secondary Care

Transcription

1 Chapter 6 page number 1 Chapter 6 Endocrine First line drugs Drugs recommended in both primary and secondary care. Second line drugs Alternatives (often in specific conditions) in both primary and secondary care. Specialist initiated drugs Secondary care, authorised independent prescribers or GPs with special interest initiation. Suitable for continuation by primary care. Shared care agreements may be applicable. Secondary care only drugs Drugs only suitable for secondary care use and initiated by appropriate team or specialist. Primary care prescribers should not be asked to prescribe. Primary & Secondary Care Notes Secondary Care 6.1 Drugs used in diabetes Insulins Hypurin animal based insulins are only used for existing patients. Insulin therapy The following recommendations on insulin treatment are for new patients or patients with clinical need to change; stabilised patients should continue on their existing insulin regimens. Any practitioner involved in the prescribing or administration of insulin is advised to complete the safe use of insulin e-learning package Initiation of insulin in patients requiring ongoing therapy should only be undertaken by a practitioner with specialist training in insulin initiation and in most cases only following discussion with a diabetes specialist. Insulins colour coded green or blue can be initiated without referral to hospital specialist/diabetic nurse specialist. Cartridges with reusable pens should be considered first line as they are cost effective and more ecologically sound. Where patients have difficulty using standard devices (for example due to manual dexterity problems or poor sight), refer to a Diabetes Nurse Specialist for further assessment. For Hyperosmololar Non-ketotic Diabetic Coma (HONK), see Trust treatment guidelines for Adults. For CCU Intravenous Insulin Glucose Regimen post MI, see Trust treatment guidelines. For Perioperative IV Insulin and Dextrose Regime (IVID), see Trust treatment guidelines in Adults and Children. For use of insulin pump therapy see NICE guidance TA151. Please see also NPSA alert regarding the use of Insulin Passports. Type 1 diabetes mellitus Please refer to NICE CG15 Type 1 Diabetes - Diagnosis and management of type 1 diabetes in children, young people and adults. Type 2 diabetes mellitus see also 3Ts Analogue Insulins in Type 2 Diabetes In Type 2 diabetes, NICE CG87 recommends that human insulin is used first-line, with insulin analogues only to be considered in certain circumstances, namely: Where the patient is reliant on a professional to inject insulin, and use of a long-acting insulin analogue (insulin detemir, insulin glargine) would reduce the frequency of injections from twice to once daily, OR Where the person s lifestyle is severely restricted by recurrent symptomatic hypoglycaemic episodes, OR In those patients who can only use a device which delivers an insulin analogue Short-acting insulins Please note insulins should ALWAYS be prescribed by brand. Human Soluble insulin Insuman Rapid Analogue Insulin aspart NovoRapid Soluble insulin Human Actrapid Soluble insulin Humulin S (existing patients only). Insulin lispro Humalog 100units/ml Insulin glulisine Apidra

2 Chapter 6 page number Intermediate and long-acting insulins Intermediate- acting insulins Please note insulins should ALWAYS be prescribed by brand. Please note Insuman basal is the first line isophane insulin, and other isophane insulins should be used second line as they are considerably more expensive. Human Analogue Isophane insulin Insuman Basal Isophane insulin Humulin I Isophane insulin Human Insulatard Biphasic isophane insulin Insuman Comb 25 (1 st choice in Type 2)and Insuman Comb 50 Biphasic isophane insulin Humulin M3 Biphasic insulin aspart NovoMix 30 1 st choice in Type 1 Biphasic insulin lispro Humalog Mix25 or Humalog Mix50 See 3T's Guidance on Withdrawal of Human Mixtard 30. Long acting insulin Please note insulins should ALWAYS be prescribed by brand. Human Analogue Insulin detemir Levemir Hypodermic equipment consult diabetic team if in doubt Refer needle phobic patients to the diabetes specialist nurse GlucoRx Finepoint To be used /considered for use first-line pen needles 8mm, 4mm & 5mm Insulin glargine Abasaglar For all new patients suitable for Insulin glargine and for consideration as an alternative for Type 2 Diabetics poorly controlled on Lantus. Insulin glargine Lantus 100units/ml For existing patients only. Insulin Degludec Tresiba 100unit/ml and Insulin degludec Tresiba 200unit/ml ONLY for initiation by a Consultant Diabetologist in patients who require a high volume of 100unit/ml insulin or in patients who would otherwise require an insulin pump. Use for any other patient group must be approved via the respective CCG s Individual Funding Request process before prescription. BD-Microfine pen needles To be used second-line if GlucoRx Finepoint pen needles are not available / inappropriate for use. 8mm, 4mm & 5mm B-D Safe-Clip Needle clipping device Disposable Insulin Syringes (0.5ml/1.0ml) Sharps Bin 1Litre

3 Chapter 6 page number Oral hypoglycaemic drugs See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. Metformin is generally used 1 st line (Metformin SR may be used if dose limiting side effects are problematic), and gliclazide, DPP4 inhibitors, SGLT2 and pioglitazone are 2 nd line, with choice dependent on patient specific factors. Women planning pregnancy should not take a sulphonylurea, (eg gliclazide), GLP1 (eg lixisenatide) or a glitazone. Women treated with oral hypoglycaemic agents may require a switch to insulin by the hospital team pre-conceptually. Refer to the Hospital Trust IVID policy and discuss with the diabetic team if further advice needed Sulphonylureas and glinides See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. Can cause hypoglycaemia. Therapy should be initiated with gliclazide. In rare instances when patients are non-specifically intolerant of gliclazide, an alternative sulphonylurea may be used. Generic gliclazide is the most cost effective treatment option. Only consider gliclazide MR in exceptional circumstances if there are major compliance issues. Gliclazide Take before breakfast/evening meal. Repaglinide Reserved for use in selected patients only Useful especially for patients for whom gliclazide is not appropriate or in patients with renal failure. Repaglinide should only be initated on the advice of a diabetes specialist Biguanides See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. Metformin First line especially if over weight. Should ALWAYS be taken with food. Start low dose with food and titrate up slowly against side-effects to maximum tolerated dose. Usually continue Metformin when insulin started. Review the dose of metformin if the serum creatinine exceeds 130 micromol/litre or the estimated glomerular filtration rate (egfr) is below 45 ml/minute/1.73-m 2. Stop the metformin if the serum creatinine exceeds 150 micromol/litre or the egfr is below 30 ml/minute/1.73-m 2. Prescribe metformin with caution for those at risk of a sudden deterioration in kidney function and those at risk of egfr falling below 45 ml/minute/1.73-m 2. The risk and benefits of metformin therapy should be discussed with a person with mild to moderate liver dysfunction or cardiac impairment. Temporarily withold prior to use of x-ray contrast media due to increased risk of renal impairment. It is important to consider re-starting metformin once renal function has improved. Metformin MR For use in patients who experience dose-limiting side effects on plain metformin. In primary care, please prescribe as Sukkarto SR, as this is significantly more cost-effective on FP10.

4 Chapter 6 page number Other oral hypoglycaemic drugs Glitazones See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. Pioglitazone Assess risk of fluid retention and congestive heart failure prior to starting a glitazone. After initiation or dose change, observe patients for signs and/or symptoms of heart failure and discontinue if cardiac status deteriorates. Contra-indicated in patients with heart failure, history of heart failure, significantly deranged baseline LFTs, active bladder cancer, history of bladder cancer, uninvestigated haematuria and in pregnancy. See SPC and MHRA alert for further details.

5 Chapter 6 page number 5 Gliptins See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. Gliptins must be stopped if a patient is moving onto a GLP-1. Alogliptin First line DPP-4 inhibitor for all new patients who fulfil criteria set out in NICE Guidance NG28. Linagliptin Second line DPP-4 inhibitor for use in patients with unstable renal function, who fulfil criteria set out in NICE Guidance NG28. No dose reduction is required in renal impairment. Sitagliptin Second line DPP-4 inhibitor for use in patients with concomitant heart failure, who fulfil criteria set out in NICE Guidance NG28. In mild renal impairment (CrCl 50ml/min), no dose adjustment is required. In moderate renal impairment (CrCl 30 to <50ml/min), dose is 50mg once daily. In severe renal impairment (CrCl <30ml/min) or with end-stage renal disease requiring haemodialysis or peritoneal dialysis, dose is 25mg once daily. Please note saxagliptin has now been removed from formulary (January 2018). SGLT2 inhibitors See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. Empagliflozin, Canagliflozin and Dapagliflozin may be used in patients with mild renal impairment with no dose adjustment necessary. Dapagliflozin is not recommended for use in patients with moderate to severe renal impairment (i.e. creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [egfr] < 60 ml/min/1.73 m 2 ). Canagliflozin should not be initiated in patients with an egfr < 60 ml/min/1.73 m 2 or CrCl < 60 ml/min. In patients tolerating canagliflozin whose egfr falls persistently below 60 ml/min/1.73 m 2 or CrCl 60 ml/min, the dose of canagliflozin should be adjusted to or maintained at 100 mg once daily. Canagliflozin should be discontinued when egfr is persistently below 45 ml/min/1.73 m 2 or CrCl persistently below 45 ml/min Empagliflozin should not be initiated in patients with an egfr below 60 ml/min/1.73 m 2 or CrCl <60 ml/min. In patients tolerating empagliflozin whose egfr is persistently below 60 ml/min/1.73 m 2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. Empagliflozin should be discontinued when egfr is persistently below 45 ml/min/1.73 m 2 or CrCl persistently below 45 ml/min. Empagliflozin should not be used in patients with ESRD or in patients on dialysis as it is not expected to be effective in these patients. Dapagliflozin is not recommended for use in patients on pioglitazone. Dapagliflozin and Canagliflozin are not recommended for use in patients on loop diuretics. Use with caution in patients with recurrent Urinary Tract Infections or recurrent thrush. See MHRA Drug Safety Update June 2015 for further information and advice on risk of diabetic ketoacidosis. See MHRA Drug Safety Update April 2016 for further information on, and advice of ways to minimise the risk of, serious adverse effects. See MHRA Drug Safety Update Mar 17 for updates advice on increased risk of lower limb amputation.

6 Chapter 6 page number 6 Empagliflozin Empagliflozin Dapagliflozin Dapagliflozin Canagliflozin First line SGLT2 inhibitor. For use in combination therapy for treating type 2 diabetes, ONLY in accordance with NICE TA336. For use as monotherapy for treating type 2 diabetes, ONLY in accordance with NICE TA390. For use in combination with insulin ONLY in accordance with NICE TA336 and on the advice of a diabetes specialist. Second line SGLT2 inhibitor. For use in combination therapy for treating type 2 diabetes, ONLY in accordance with NICE TA288 & NICE TA418 For use as monotherapy for treating type 2 diabetes, ONLY in accordance with NICE TA390. For use in combination with insulin ONLY in accordance with NICE TA288 and on the advice of a diabetes specialist. Second line SGLT2 inhibitor. For use in combination therapy for treating type 2 diabetes, ONLY in accordance with NICE TA315. For use as monotherapy for treating type 2 diabetes, ONLY in accordance with NICE TA390. See MHRA Drug Safety Update June 2016 for further information and advice on the increased risk of lower limb amputation identified in canagliflozin patients in the CANVAS trial. Canagliflozin For use in combination with insulin ONLY in accordance with NICE TA315 and on the advice of a diabetes specialist. See MHRA Drug Safety Update June 2016 for further information and advice on the increased risk of lower limb amputation identified in canagliflozin patients in the CANVAS trial.

7 Chapter 6 page number 7 GLP1 mimetics See 3Ts Guidance- Management of Hyperglycaemia in Type 2 Diabetes Mellitus. GLP1 mimetics should only be commenced in patients who have taken part in a DESMOND, or other equivalent, expert patient training programme. GLP1 mimetics should ONLY be initiated by prescribers with additional training in the management of Diabetes, and ONLY a Consultant Endocrinologist may initiate a GLP1 mimetic, or advise that a GLP1 mimetic should be initiated, in combination with insulin.

8 Chapter 6 page number 8 Lixisenatide To be used / considered for use first-line. Prescribe in accordance with the criteria set out in NICE Guidance NG28. No dose adjustment is required for patients with mild or moderate renal impairment. There is no therapeutic experience in patients with severe renal impairment (CrCl< 30 ml/min) or endstage renal disease and so lixisenatide is not recommended in these populations. Dulaglutide To be used / considered for use second-line. Prescribe in accordance with the criteria set out in NICE Guidance NG28. No dosage adjustment is required in patients with mild or moderate renal impairment. Clinical experience of dulaglutide in patients with severe renal impairment (egfr < 30 ml/min/1.73 m 2 ) or end stage renal disease is very limited, and so dulaglutide is not recommended in this patient population. Liraglutide To be used / considered for use second-line. Prescribe in accordance with the criteria set out in NICE Guidance NG28. No dose adjustment is required for patients with mild, moderate or severe renal impairment. There is no therapeutic experience in patients with end-stage renal disease, and so Liragluitde is not recommended for use in these patients. Once- weekly Exenatide To be used / considered for use second-line. Initiate ONLY if there are compliance issues OR if district nurse administration is necessary OR if the patient experiences excessive nausea on shorteracting lixisenatide and liraglutide. Prescribe in accordance with NICE TA 248. Not recommended for use in patients with end-stage renal disease or severe renal impairment (CrCl <30ml/min or egfr<30ml/min/1.73m2). Clinical experience of Exenatide in patients with moderate renal impairment (CrCl 30-50ml/min or egfr 30-59ml/min/1.73m2) is very limited and so it should be used in such patients with extreme caution.

9 Chapter 6 page number 9 Exenatide For use in existing patients only No dosage adjustment is necessary in patients with mild renal impairment (CrCl ml/min). In patients with moderate renal impairment (CrCl ml/min), dose escalation from 5 mcg to 10 mcg should proceed conservatively. Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (CrCl <30 ml/min) Diabetic ketoacidosis Please see The Management of Diabetic Ketoacidosis in Adults (NHS Diabetes) and the acute trust Integrated Care Pathway for children and young people with Diabetic Ketoacidosis Treatment of hypoglycaemia Initially for the conscious patient give 10g 20g of glucose as a liquid or 2 teaspoonfuls or lumps of granulated sugar. In the unconscious patent give 1mg glucagon sc/im. If no response in 10min give IV glucose 50%. Glucagon is of no value in hypoglycaemia induced by alcohol. Please see Hospital Management of Hypoglycaemia in Adults with Diabetes Mellitus (acute trust) or Recognition, treatment and prevention of hypoglycaemia in the community (primary care) Glucose gel Glucagon injection 1mg (GlucaGen HypoKit) 3g tubes. Glucose injection (50%) Diazoxide - rare use in insulinomas Treatment of diabetic neuropathy Simple analgesics initially, then duloxetine, amitriptyline, gabapentin or pregabalin. see CNS chapter 4. Please see acute trust Diabetic Foot Care Pathway and NICE CG10 Please see chapter 13 for Flexitol Heel Balm Diagnostic and monitoring agents for diabetes mellitus Frequency of blood glucose monitoring Please see Swindon CCG Blood Glucose Monitoring Guidance and Wiltshire CCG Blood Glucose Monitoring Guidance for more in-depth information. Frequency of blood glucose monitoring should be agreed between the patient and their diabetes team Patients should test more frequently if: - troubled by hypoglycaemia - pregnancy, pre-pregnancy - work, exercise times and meals vary a lot In stable situations less frequent monitoring may be appropriate. Blood glucose monitoring strips and meters Please note the type of blood glucose test strips prescribed will depend on the blood glucose meter chosen. Choice of blood glucose meter for patients in primary care will depend on the local agreement in place. Patients requiring specific monitoring in line with DVLA guidance may require different meters. Diabetic specialist nurses may recommend use of different meters in complex patients with specific monitoring needs.

10 Chapter 6 page number 10 Urinalysis Ketostix Ascensia Lancets Type C (Roche) Type A + B 6.2 Thyroid and antithyroid drugs Thyroid hormones Levothyroxine (Thyroxine) Liothyronine (Tri-iodothyronine) Not for routine long-term treatment. Orally - initiate using 2.5mcg (made up by Pharmacy manufacturing but require at least 24 hours notice.)

11 Chapter 6 page number Antithyroid drugs Carbimazole Propylthiouracil Initiate following discussion with/at the point of referral to a specialist. Can suppress bone marrow, monitor for signs of infection and warn patients to report sore throat or other signs of infection, counsel patient of possible risk of skin rash or agranulocytosis. (1) Discuss any course of treatment over 3 years with a specialist. 5mg carbimazole is equivalent to 50mg propylthiouracil Stop medications if reduced WBC, severe sore throat or other signs of infection. Not required routinely. Use for rapid relief of thyrotoxic symtoms, may be used in conjunction with antithyroid drugs or as an adjunct to radioactive iodine (1) Use: Pre-conception. In pregnancy. During breast feeding. If intolerant of carbimazole. Give BD or more often. Aqueous Iodine Iopanoic Acid 500mg Useful in thyroid storm. Stored in emergency cupboard. Propranolol Consider if severe palpitations, tremor and/ +or anxiety. Use SR preparation 80mg-160mg once daily. Stop once euthyroid. 6.3 Corticosteroids Use in Rheumatology, GI or Respiratory Medicine see separate chapters 10, 1 or 3. E.C prednisolone has no advantage over plain prednisolone and may result in erratic absorption Give a steroid card with all except Fludrocortisone. Advise patient to carry medi-alert bracelet. Monitor for osteoporosis. See Joint Trusts guideline Chapter 10. Temporary dose increase required for intercurrent illness or surgery Replacement therapy Please see MHRA Drug Safety Update Aug 2017 for information and advice on the rare risk of central serous chorioretinopathy with local and systemic administration of corticosteroids. Fludrocortisone Hydrocortisone tablets Glucocorticoid therapy Local treatment is preferred to systemic See BNF for guidance on use of steroid cards and guidance on reducing doses See also Chapter 1 Gastro-intestinal system and Chapter 10 Musculoskeletal and joint diseases. Please see MHRA Drug Safety Update Aug 2017 for information and advice on the rare risk of central serous chorioretinopathy with local and systemic administration of corticosteroids.

12 Chapter 6 page number 12 Prednisolone tablets 1mg, 5mg & 25mg Prednisolone oral solution 1mg/ml Prednisolone soluble tablets 5mg Dexamethasone Hydrocortisone Injection Methylprednisolone (Depo-Medrone intramuscular injection) Methylprednisolone tablets 100mg Non EC tablets should be prescribed. Please note plain prednisolone tablets 5mg may be crushed and dispersed in water and administered orally or via NG/PEG tube (off-label). For chronic use, prescribe minimum effective dose. Monitor for osteoporosis. ONLY for use in patients unable to tolerate plain prednisolone tablets 5mg. Please note oral solution 1mg/ml is more expensive than plain tablets 5mg. ONLY for use in patients unable to tolerate prednisolone oral solution 1mg/ml. Please note soluble tablets 5mg are considerably more expensive than both plain tablets 5mg and oral solution 1mg/ml. Hydrocortisone oromucosal tablets Injectable steroids see Respiratory section and Musculoskeletal section. Methylprednisolone (Solu- Medrone intravenous injection) See MHRA Drug Safety Update Oct 17 for background information on the warning not to use Solu-Medrone 40mg Injection in patients with cows' milk allergy. 6.4 Sex hormones Female sex hormones - also see Malignant Disease & Immunosuppression section Oestrogens and HRT Please see Wiltshire HRT Guidance and Treatment Pathway, as well as prescribing notes below. See BNF for information regarding risks of HRT HRT should not be used first line for prevention of osteoporosis. For Raloxifene use see Chapter 10. CSM has estimated that using ANY type of HRT increases the risk of breast cancer within 5 years of initiating therapy. The increased risk is related to the duration of use but not to the starting age and disappears within about 5 years of stopping. (1) Please refer to BNF for more information on risk and choice. The following 1 st line choices are recommended. 2 nd line and further alternatives are not considered as the reasons for requiring these are many, with much inter-patient variation. These 1 st line products have been chosen using the following criteria: - Oestrogen dose this should be the lowest which controls symptoms (1, 2), in line with MHRA advice. (3) - Cost. Progestogen use (where applicable) medroxyprogesterone may be better tolerated than norethisterone or levonorgestrel (1). However, patches are only available containing the latter two. Note: Prescribe by brand name where applicable. When changing the HRT product for a patient, always consider the comparative costs of possible alternative products. See MIMS table. See also Osteoporosis guidelines and MHRA HRT statement. Conjugated oestrogens with progestogen Prempak C Prempak C 1.25 Estradiol with progestogen

13 Chapter 6 page number 13 Oral: Elleste-Duet tablets Femoston 1/10 tablets Femoston -conti tablets Kliovance tablets Kliofem Period free HRT for women with intact uterus and at least 1year amenorrhoea or >54years age on sequential therapy. Start/ Switch: Persistent breast tenderness or headaches on tablets. Transdermal: Evorel Sequi patches Evorel Period free HRT for women with intact uterus and at Conti patches least 1year amenorrhoea or >54years age on sequential therapy. Start/ Switch: Persistent breast tenderness or headaches on tablets. Unopposed Estrogens (Estradiol only) - no uterus Start/ Switch: Transdermal for unstable diabetic, liver and gallbladder disease, headaches and migraine or persistent side effects on tablets. Oral: Elleste-Solo tablets Transdermal: Elleste solo Patches Evorel patches See BNF for starting dose. Topical Sandrena 1mg Sandrena is more expensive than other preparations however some patients may prefer a topical preparation Sandrena 500 microgram Adjunct Progestogens - for use with continuous oestrogen. See also chapter 7 Intrauterine System: Mirena (levonorgestrel 20mcg/24hrs initial release rate) Estradiol, estriol, estrone Tibolone Also provides contraception. For HRT use maximum 4 years between changes. Has been associated with an increased risk of stroke. (4) Ethinylestradiol Progestogens Norethisterone Can be used for hot flushes at a dose range of 5 10mg daily continuous (unlicensed use). Progesterone (Cyclogest) Pessaries For recurrent miscarriage for up to 14 weeks (unlicensed). Not for use in post-natal depression or fertility treatment Male sex hormones and antagonists also see Malignant Disease & Immunosuppression section.

14 Chapter 6 page number 14 Finasteride See genito-urinary disorders Flutamide Cyproterone acetate Testosterone gel Male hypersexuality. Also can be used to treat acne & hirsutism see skin section Topical application has less effect on biochemical monitoring. Please specify brand on prescription. Testosterone buccal tablets (Striant SR ) Testosterone intramuscular injection (Nebido ) Testosterone implant See below for statement on off-label use in women with discontinuation of licensed testosterone implant. Sustanon 100/250 - existing adult patients and paediatrics only ONLY currently available as a high cost, imported preparation (unlicensed). In view of this, it is recognised that there may be a need to prescribe testosterone gel off-label for use in women, in line with British Menopause Society Guidance and Wiltshire HRT Guidance Somatostatin analogues Octreotide (incl. longacting preparation). Also used in palliative care For relief of symptoms associated with acromegaly. (unlicensed). Octreotide (incl. longacting preparation). Lanreotide (Somatuline Autogel ) For relief of symptoms associated with neuroendocrine (particularly carcinoid) tumours. For relief of symptoms associated with acromegaly. Lanreotide For relief of symptoms associated with neuroendocrine (Somatuline Autogel ) (particularly carcinoid) tumours. 6.5 Hypothalamic and pituitary hormones and anti-oestrogens Hypothalamic and anterior pituitary hormones and anti-oestrogens Anti-oestrogens Clomifene See NICE guidance No.11. Tamoxifen For use in malignant disease. Anterior pituitary hormones Gonadotrophins Funding lies with secondary care Tetracosactrin injection (Synacthen ) for diagnostic use. Chorionic Gonadotrophin trigger ovulation. Follitropin Alfa (Gonal-F ) Growth hormone prescribe in accordance with NICE guidance No 64 (adults) and No 188 (children) Somatropin For use in children (see SCA). Somatropin For use in adults. Hypothalamic hormones Gonadorelin injection Posterior pituitary hormones and antagonists

15 Chapter 6 page number 15 Desmopressin tablets Desmopressin Nasal Spray For nocturnal enuresis/diabetes insipidus. Excessive dose or fluid intake can cause severe hyponatreamia. Please note, where clinically appropriate, 200mcg tablets are more cost-effective than 100mcg tablets. For diabetes insipidus. NOT for use in nocturnal enuresis. Desmopressin injection Desmopressin drops paediatric use. Terlipressin injection - see GI section. Demeclocycline Antidiuretic Hormone Antagonist for the treatment of SiADH. 6.6 Drugs affecting bone metabolism Calcitonin and parathyroid hormone Calcitonin For the short-term treatment of: Paget's disease - now restricted to patients who do not respond to, or cannot tolerate, alternative treatments (i.e. patients with renal impairment). Duration of calcitonin should be limited to up to 3 months, but may be extended to 6 months under exceptional circumstances (e.g. patients with impending pathologic fractures) Acute bone loss due to sudden immobilisation, for up to 4 weeks only Hypercalcaemia of malignancy At minimum effective dose See MHRA Drug Safety Update for further information on associated cancer risk. Teriparatide For use in the secondary prevention of osteoporosis, in line with NICE TA161. Appropriate for initiation by Consultant Orthogeriatricians (DOME) otherwise Consultant Rheumatologist approval required Bisphosphonates Please refer to 3T s Guidance on Primary & Secondary Prevention of Osteoporotic Fragility Fractures. For use in treatment of osteoporosis, see also NICE TA 160, NICE TA161 & NICE TA464. For use in malignancy, see also Malignant Disease and Immunosuppression Chapter 8. For advice following reports of osteonecrosis of the external auditory canal, see MHRA Drug Safety Update Dec 15. Osteoporosis treatment

16 Chapter 6 page number 16 Alendronic acid Risedronate Ibandronic acid 150mg tablets Raloxifene Denosumab 60mg injection First-line bisphosphonate Osteoporosis - 70mg once weekly. Please note licensed soluble tablets or a licensed liquid are available for patients with swallowing difficulties. Second-line bisphosphonate Osteoporosis - 35mg once weekly. Paget s disease - 30mg daily for 8 weeks then stop. Third-line bisphosphonate Osteoporosis- 150mg pnce a month. For use as an alternative treatment option in osteoporosis in line with NICE TA161. For the treatment of postmenopausal osteoporosis, see NICE TA204, Guidance on Hypocalcaemia with Denosumab, Shared Care Agreement and Treatment Pathway. See MHRA Safety Update (February 2013) for information on risk of atypical femoral fracture. See MHRA Drug Safety Update (Sept 2015) for advice on minimising the risk of osteonecrosis of the jaw and monitoring for hypocalcaemia. Zoledronic acid 5mg IV infusion ONLY for initiation and ongoing prescribing by Rheumatologist. Ibandronic acid 3mg IV injection ONLY for initiation and ongoing prescribing by Rheumatologist. See MHRA Drug Safety Update June 17 for information on the risk of osteonecrosis of external auditory canal. Treatment of bone pain & hypercalcaemia Sodium Clodronate Tablets 800mg, capsules 400mg & tablets 520mg Hypercalcaemia and bone pain associated with bone metastases in patients with breast cancer or multiple myeloma. ONLY for initiation by Consultant Oncologist or Consultant Haematologist. Disodium Pamidronate injection Ibandronic Acid tablets 50mg For use as an oral alternative to disodium pamidronate in patients with metastatic breast cancer. For use by Oncology only. Zoledronic acid 4mg IV infusion For the prevention of skeletal related events in patients with myeloma & treatment of hypercalcaemia. Denosumab 70mg injection For the prevention of skeletalrelated events in adults with bone metastases from solid tumours, refer to NICE TA265. See MHRA Drug Safety Update (Jul 2015) for advice on minimising the risk of osteonecrosis of the jaw and monitoring for hypocalcaemia. 6.7 Other endocrine drugs Bromocriptine and other dopaminergic drugs See MHRA Drug Safety Update (June 17) for information on the risk of osteonecrosis of the external auditory canal.

17 Chapter 6 page number 17 Cabergoline Quinagolide Second line for consultant initiation only Drugs affecting gonadotrophins Danazol For cyclical mastalgia at a dose of 100mg tds. Goserelin (Zoladex ) Leuprorelin acetate (ProStap ) For endometriosis ONLY. For endometriosis ONLY. Ulipristal (Esmya ) ONLY for use in women completing a course of Esmya for treatment for uterine fibroids. NOT to be initiated in new patients or re-started in patients who have previously completed one or more treatment courses of Esmya - see MHRA letter (Feb 2018). Please note the requirement to monitor liver function tests at least monthly in all patients who are taking, or have recently taken, Esmya - see MHRA letter (Feb 2018). For use by Gynaecology consultants only. Nafarelin (Synarel ) /Buserelin(Suprefact ) Swindon CCG, Wiltshire CCG and Great Western Hospitals NHS Foundation Trust in collaboration with Avon & Wiltshire Mental Health Partnership NHS Trust. References: 1. BNF No. 66 September 2013 March PRODIGY guidance: Menopause accessed 08/05/ Hormone replacement therapy (HRT) latest data from the Million Women Study and Women s Health Initiative trial: MHRA statement 19 April accessed 08/05/ The Effects of Tibolone in Older Postmenopausal Women. Cummings SR et al. NEJM.. 359;7: