Formulary Chapter 6: Endocrine system - Full Chapter
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Chapter Links... |
NTAG Endocrine System Recommendations |
Details... |
06.01 |
Drugs used in diabetes |
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06.01.01.01 |
Short-acting insulins |
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Note: preloaded pens and Innolet® devices should only be used where cartridges are not suitable. |
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Insulin (Actrapid® ) (Rapidly acting)
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Formulary
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- Human Actrapid® 10ml vial approved.
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Insulin (Humulin® S) (Rapidly acting)
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Formulary
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- Approved formulations of Humulin® S include:
- 10ml vials;
- 5x3ml cartridges.
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Insulin Aspart (Fiasp®) (Ultra-fast, short acting)
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Formulary
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- Approved formulations for Fiasp® include:
- 10ml vial;
- 5x3ml cartridge;
- 5x3ml FlexpTouch pen®.
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Insulin Aspart (NovoRapid® Trurapi®) (Very rapidly acting )
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Formulary
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- Approved formulations for Novorapid® include:
- 10ml vial;
- 5x3ml cartridge (for use with Novopen and Novopenmate devices);
- 5x3ml Flexpen®.
- Approved formulations for Trurapi® include:
- 100 units/ml 10ml vial
- 100 units/ml cartridge
- 100 units/ml pre-filled pen
Trurapi = BLACK TRIANGLE
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Insulin Lispro 100 units/ml (Humalog®) (Very rapidly acting)
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Formulary
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- Approved formulations for Humalog 100 ® include:
- 10ml vial;
- 5x3ml cartridge;
- 5x3ml Kwiikpen®.
- Prescriptions need to be written as Insulin Lispro Sanofi® or Humalog® to avoid prescribing/dispensing errors.
- Note that there are two strengths of Humalog® (insulin lispro). Caution should be exercised when prescribing and dispensing
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Insulin Lispro 200 units/ml (Humalog®) (Very rapidly acting)
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Formulary
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- 200 units per ml
- Approved formulations for Humalog 200® include the 5x3ml Kwikpen®.
- Note that there are two strengths of Humalog® (insulin lispro). Caution should be exercised when prescribing and dispensing
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Insulin Lispro Sanofi (Very rapidly acting)
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Formulary
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- 100units /ml
- 10ml vial 3ml cartridges (for AllStar Pro and JuniorSTAR pen), 3ml SoloStar prefilled pen
- Prescriptions need to be written as Insulin Lispro Sanofi® or Humalog® to avoid prescribing/dispensing errors. Insulin lispro biosimilar
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Insulin Glulisine (Apidra®) (Very rapidly acting)
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Formulary
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- Approved Apidra® formulations include:
- 10ml vials;
- 5x3ml cartridges
- 5x3ml Solostar® pens.
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Insulin Human 500 units in 1mL (Humulin R®) (Rapidly acting)
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Unlicensed
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- Humulin R 500units in 1ml (10ml vial) approved for a very small number of insulin resistant patients that require very high doses of insulin.
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06.01.01.01 |
Short-acting human insulin analogues |
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06.01.01.02 |
Intermediate- and long-acting insulins |
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Note: preloaded pens and Innolet® devices should only be used where cartridges are not suitable. |
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Isophane Insulin (Insulatard®)
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Formulary
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- Approved Insulatard® formulations include:
- 10ml vial;
- 5x3ml cartridges (for use with Novopen® and Novopenmate® devices);
- 5x3ml Innolet® pens.
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Isophane Insulin (Humulin® I)
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Formulary
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- Approved Humulin® I formulations include:
- 10ml vials;
- 5x3ml cartridges;
- 5x3ml pens.
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Insulin Glargine biosimilar Abasaglar® (Long acting)
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Formulary
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- First choice long acting basal insulin in patients eligible for treatment in line with NICE and NTAG
- Approved Abasaglar® formulations include:
- 5x3ml cartridge
- 5x3ml Kwikpen®.
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NG17: Type 1 diabetes in adults: diagnosis and management
NTAG: Abasaglar® Insulin Glargine Biosimilar 100 units/ml for the treatment of type 1 or type 2 diabetes mellitus.
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Insulin degludec (Tresiba®) (Long acting)
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Formulary
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- 100 units/mL only
- Pre-filled pen and cartridges
- Approved for use in patients with Type 1 diabetes with
- Nocturnal/Severe Hypogycaemia (with or without hypoglycaemic unawareness) in patients who would otherwsie progress to insuling pump treatment as per NICE TA151); or
- Recurrent DKA episodes despite good compliance and who would otherwise progress to insulin pump therapy
- Paediatric patients who cannot tolerate glargine sting
- Paediatric patients with poor control on the high HbA1c pathway
- Patients or Parents/Carers with unpredictable lifestyles such as students or shift workers.
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Insulin Detemir (Levemir®) (Long acting)
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Formulary
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- Alternative choice long acting basal insulin.
- Approved Levemir® formualtions include:
- 5x3ml cartridges;
- 5x3ml pens.
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Insulin Glargine (Lantus®) (Long acting)
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Formulary
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- Alternative choice long acting basal insulin.
- Approved Lantus® formulations include:
- 10ml vials;
- 5x3ml cartridges;
- 5x3ml pens (Solostar® - in line with NICE).
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Insulin Glargine (Toujeo®) (Long acting)
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Formulary
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- Alternative choice long acting basal insulin.
- Approved Toujeo® formulations include:
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06.01.01.02 |
Biphasic insulins |
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Biphasic Isophane Insulin (Humulin® M3) (Conventional )
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Formulary
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- Approved Humulin®M3 formulations include:
- 10ml vials;
- 5x3ml cartridges;
- 5x3ml pens.
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Biphasic Insulin Aspart (NovoMix® 30) (Analogue)
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Formulary
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- Approved NovoMix® 30 formulations include:
- 5x3ml cartridges (for use with Novopen® and Novopen® Penmate injection devices)
- 5x3ml Flexpen® pens.
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Biphasic Insulin Lispro (Humalog® Mix 25 amd Mix 50) (Analogue)
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Formulary
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- Approved formulations of Humalog® Mix 25 and Mix 50 include:
- 5x3ml cartridges
- 5x3ml Kwikpen®
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06.01.01.03 |
Hypodermic equipment |
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06.01.02 |
Antidiabetic drugs |
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06.01.02.01 |
Sulphonyureas |
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Gliclazide
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First Choice
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- 40mg & 80mg tablets
- 30mg MR tablets
- *Not to be prescribed for new patients*
- Exisiting patients can continue until clinically appropriate to change in line with switch policy
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Glimepiride
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Formulary
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Glipizide
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Formulary
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Tolbutamide
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Formulary
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Metformin
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Formulary
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- Metformin 500mg tablets
- Metformin 500mg oral powder sachets
- Metformin MR (once daily - Glucophage® SR) are only approved for use in patients who have failed to tolerate the conventional tablets despite careful dose titration.
- Note: metformin is also approved for use in Polycystic Ovary Syndrome.
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MHRA Drug Safety Update (June 2022): Metformin and reduced vitamin B12 levels: new advice for monitoring patients at risk
MHRA Drug Safety Update (Mar 2022): Metformin in pregnancy: study shows no safety concerns
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06.01.02.03 |
Other antidiabetic drugs |
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Repaglinide
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Formulary
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06.01.02.03 |
Alpha glucosidase inhibitors |
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Acarbose
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Formulary
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06.01.02.03 |
DPP4 inhibitors (gliptins) |
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Alogliptin (DPP4 inhibitor)
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Formulary
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Linagliptin (DPP4 inhibitor)
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Formulary
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Saxagliptin (Onglyza®) (DPP4 inhibitor)
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Formulary
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Sitagliptin (DPP4 inhibitor)
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Formulary
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06.01.02.03 |
GLP1 agonists |
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Dulaglutide (Trulicity®)
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Formulary
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- 0.75mg, 1.5mg, 3mg and 4.5mg prefilled syringes
- Approved for use in patients who require once-weekly GLP-1 receptor agonist therapy.
- This has replaced once-weekly exenatide. Existing patients can continue to receive exenatide until reviewed by a specialist
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National Patient Safety Alert - Shortage of GLP-1 receptor agonists (GLP-1 RA) update
NICE NG18: Diabetes (type 1 and type 2) in children and young people: diagnosis and management
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Exenatide
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Formulary
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- 5 microgram and 10 microgram per dose are prefilled injection pens containing a 250microgram/ml solution for subcutaneous injection.
- Only approved for use in accordance with NICE guidance Treatment must be initiated by a consultant diabetologist and use is limited to overweight patients with type 2 diabetes in line with NICE guidelines.
- 2.5mg/0.85ml prolonged-release suspension for injection
- temporarily approved due to supply issues with semaglutide and dulaglutide (please refer to linked advice below)
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National Patient Safety Alert - Shortage of GLP-1 receptor agonists (GLP-1 RA) update
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Lixisenatide
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Formulary
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National Patient Safety Alert - Shortage of GLP-1 receptor agonists (GLP-1 RA) update
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Semaglutide
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Formulary
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- 0.25mg/0.19mL, 0.5mg/0.37mL and 1mg/0.7mL solution for injection pre-filled pen (Ozempic®)
- Approved for the treatment of type 2 diabetes in patients who require an intensification in treatment
- 3mg, 7mg & 14mg tablets (Rybelsus®) - BLACK TRIANGLE
- Approved as an option for patients with type 2 diabetes mellitus who require intensification of treatment, if use of a glucagon-like peptide 1 receptor agonist (GLP1RA) is clinically appropriate, in line with licensing and relevant guidance, and if an oral option is preferred.
- 0.25mg/0.37ml, 0.5mg/0.37ml, 1mg/0.75ml, 1.7mg/0.75ml & 2.4mg/0.75ml solution for injection pre-filled pens (Wegovy®)
- Approved for managing overweight and obesity in line with NICE guidance within a specialist weight management service (including but not limited to tiers 3 and 4)
- Also available via NHSE pilot sites involving primary care
- Note: As of 29th April 2024 there is an ICB weight management strategy in development which is seeking to review the arrangements and capacity of current service provision across the ICS
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National Patient Safety Alert - Shortage of GLP-1 receptor agonists (GLP-1 RA) update
NICE TA875: Semaglutide for managing overweight and obesity
NTAG Treatment Appraisal: Oral semaglutide for the treatment of type 2 diabetes mellitus.
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Tirzepatide (Mounjaro®)
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Formulary
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- 2.5mg/0.6ml, 5mg/0.6ml, 7.5mg/0.6ml, 10mg/0.6ml, 12.5mg/0.6ml & 15mg/0.6ml solution for injection (pre-filled pens)
- Approved for treating type 2 diabetes in line with NICE
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NICE TA924: Tirzepatide for treating type 2 diabetes
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Liraglutide
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Formulary
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- Victoza®
- Approved for the treatment of type 2 diabetes mellitus in accordance with NICE guidance
- Saxenda®
- Approved as an option for managing overweight and obesity alongside a reduced-calorie diet and increased physical activity in adults in line with NICE and providing:
- it is prescribed in secondary care by a specialist multidisciplinary tier 3 weight management service; and
- the company provides it according to the commercial arrangement
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National Patient Safety Alert - Shortage of GLP-1 receptor agonists (GLP-1 RA) update
NICE NG18: Diabetes (type 1 and type 2) in children and young people: diagnosis and management
NICE NG28: Type 2 diabetes in adults: management
NICE TA664: Liraglutide for managing overweight and obesity
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06.01.02.03 |
SGL2 inhibitors |
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Canagliflozin
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA315: Canagliflozin for type 2 diabetes
NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
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Dapagliflozin (Forxiga®)
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Formulary
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- 5mg and 10mg tablets
- Approved for treating type 2 diabetes in adults
- Approved for the treatment of chronic kidney disease in adults in line with NICE and NTAG
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NICE TA288: Dapagliflozin in combination therapy for treating type 2 diabetes
NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
NICE TA418: Dapagliflozin in triple therapy for treating type 2 diabetes
NICE TA775: Dapagliflozin for treating chronic kidney disease
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Empagliflozin
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Formulary
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- Approved in combination therapy for treating type 2 diabetes in line with NICE
- Approved for the treatment of type 2 diabetes in line with NICE
- Approved for treating chronic kidney disease in line with NICE
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NICE NG18: Diabetes (type 1 and type 2) in children and young people: diagnosis and management
NICE TA336: Empagliflozin for type 2 diabetes
NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
NICE TA942: Empagliflozin for treating chronic kidney disease
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Ertugliflozin
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Formulary
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- Approved as monotherapy or with metformin for the treatment of type 2 diabetes in line with NICE
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NICE TA572: Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes
NICE TA583: Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes
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Sotagliflozin
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Formulary
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- 200mg tablet
- Approved with insulin for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy in line with NICE
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NICE TA622: Sotagliflozin with insulin for treating type 1 diabetes
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06.01.02.03 |
Thiazolidinediones |
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Pioglitazone (Thiazolidinedione)
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Formulary
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06.01.03 |
Diabetic ketoacidosis |
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06.01.04 |
Treatment of hypoglycaemia |
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Diazoxide
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Formulary
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- Diazoxide suspensions can be obtained/prepared if needed. unlicensed
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Glucagon
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Formulary
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- GlucaGen® Hypokit - 1mg powder and solvent for solution for injection
- Ogluo® - 500mcg/0.1ml & 1mg/0.2ml solution for injection (pre-filled pens)
- To be used in accordance with Medicine Supply Notification (MSN/2023/051U) due to supply issues with GlucaGen® Hypokit
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Glucose 5%, 10%, 25% & 50% (Injection)
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Formulary
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LIFT Juice Shot
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Formulary
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- Carbohydrate drink
- Approved for the treatment of mild to moderate hypoglycaemia in children and young people
- First choice ahead of Glucogel®
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Glucose 40% Oral Gel (GlucoGel®)
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Formulary
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06.01.04 |
Chronic hypoglycaemia |
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06.01.05 |
Treatment of diabetic nephropathy and neuropathy |
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06.01.05 |
Diabetic nephropathy |
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06.01.05 |
Diabetic neuropathy |
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Duloxetine 30mg and 60mg capsules
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First Choice
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Amitriptyline
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Second Choice
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Gabapentin
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Third Choice
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- Also approved for hospital use as an adjunct to other treatment in
the management of peri/post-operative pain.
- GPs should not be asked to prescribe gabapentin for this unlicensed indication.
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MHRA Drug Safety Alert (Oct 2017): Gabapentin (Neurontin): risk of severe respiratory depression
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Pregabalin
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Alternatives
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MHRA Drug Safety Update (Apr 2022): Pregabalin (Lyrica): findings of safety study on risks during pregnancy
MHRA Drug Safety Update (Feb 2021): Pregabalin (Lyrica): reports of severe respiratory depression
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Tramadol
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Alternatives
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- 50mg capsules, 50mg dispersible tablets & 100mg/2ml injection
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06.01.06 |
Diagnostic and monitoring agents for diabetes mellitus |
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06.01.06 |
Blood glucose monitoring |
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Dexcom One®
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Formulary
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- Recommended for use only as per NTAG advice and NHS England Guidance.
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NTAG Continuous Glucose Monitoring (CGM) System Position Statement (May 2024)
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Dexcom ONE+®
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Formulary
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- Recommended for use only as per NTAG advice and NHS England Guidance.
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NTAG Continuous Glucose Monitoring (CGM) System Position Statement (May 2024)
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Freestyle Libre 2®
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Formulary
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- Flash Blood Glucose Monitoring System
- Recommended for use only as per NTAG advice and NHS England Guidance.
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NTAG Continuous Glucose Monitoring (CGM) System Position Statement (May 2024)
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Freestyle Libre 2 Plus®
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Formulary
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- Flash Blood Glucose Monitoring System
- Recommended for use only as per NTAG advice and NHS England Guidance.
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NTAG Continuous Glucose Monitoring (CGM) System Position Statement (May 2024)
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i-Port Advance®
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Formulary
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- Recommended for use only as per NTAG advice and NHS England Guidance.
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NTAG i-Port Advance® Position Statement
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Freestyle Libre 3®
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Restricted
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- Flash Blood Glucose Monitoring System
- Freestyle Libre 3 is not to be prescribed by primary care. Use is limited to type 1 diabetes patients only with a compatible insulin pump. It is to be prescribed/supplied by secondary care diabetes teams only.
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NTAG Continuous Glucose Monitoring (CGM) System Position Statement (May 2024)
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06.01.06 |
Oral glucose tolerance test |
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06.01.06 |
Blood glucose meters for adults with type 2 diabetes |
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06.01.06 |
Blood glucose meters for children and adults with type 1 diabetes |
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06.01.06 |
Blood glucose meters for patients on continuous insulin infusion pump |
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06.01.06 |
Blood glucose meters for patients with dexterity problems |
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06.01.06 |
Talking blood glucose meters |
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06.02 |
Thyroid and Antithyroid drugs |
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06.02.01 |
Thyroid hormones |
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Levothyroxine (Thyroxine)
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First Choice
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- 25microgram, 50microgram, 75microgram & 100 microgram tablets
- 25microgram in 5ml, 50microgram in 5ml & 100microgram in 5ml sugar-free oral solution
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MHRA Drug Safety Update (May 2021): Levothyroxine: new prescribing advice for patients who experience symptoms on switching between different levothyroxine products
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Liothyronine
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Formulary
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- The most cost effective strength/formulation should be used
- Note: Liothyronine tablets should only be prescribed as per the following guidance:
- In line with British Thyroid Association (BTA) guidance, where levothyoroxine has failed, liothyronine may be recommended for individual patients after a carefully audited trial of at least 3 months duration of liothyronine.
- Existing patients should be reveiwed, as appropriate, by an endocrinologist to ensure the continuing need for liothyronine. Patients shouldn't have treatment stopped without review by an endocrinologist.
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NHSE Liothyronine – advice for prescribers
Items which should not routinely be prescribed in primary care
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Liothyronine Injection (Triiodothyronine)
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Formulary
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20mcg injection
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Items which should not routinely be prescribed in primary care
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06.02.02 |
Antithyroid drugs |
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Carbimazole
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First Choice
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MHRA Drug Safety Update (Feb 2019): Carbimazole: increased risk of congenital malformations; strengthened advice on contraception
MHRA Drug Safety Update (Feb 2019): Carbimazole: risk of acute pancreatitis
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Propylthiouracil
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Alternatives
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Iodine (Lugol's® Iodine) (Aqueous iodine oral solution)
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Alternatives
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- Oral solution containing 130mg total iodine/ml (5% iodine & 10% potassium iodide).
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Propranolol 80mg MR capsules
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Alternatives
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- Propranolol 80mg MR capsules is the preferred formulation for relief of thyrotoxic symptoms.
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Iopanoic acid
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Unlicensed
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- Approved for use in rapid blockade of thyrotoxicosis in otherwise medically resistant patients prior to surgery/thyroidectomy.
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Potassium Iodate 85mg tablets
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Unlicensed
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- Mainly used by medical physics.
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06.03.01 |
Replacement therapy |
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Hydrocortisone 10 mg, and 20mg tablets
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Formulary
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- Hydrocortisone 10mg in 5ml suspension is also approved for use. unlicensed
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Hydrocortisone sodium succinate (Injection)
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Formulary
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Fludrocortisone
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Formulary
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06.03.02 |
Glucocorticoid therapy |
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Prednisolone
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First Choice
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- The lowest cost formulation should be used when clinically appropriate. Formulations approved include:
- 1mg in 1ml oral solution (Prednisolone Dompé®);
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Hydrocortisone sodium phosphate (Efcortesol®)
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Formulary
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- 100mg/ml solution for injection
- As an additional option to hydrocortisone sodium succinate for patients who are steroid dependent (pituitary or adrenal cause and occasionally non-endocrine reasons for long term steroid use) to manage sick day rules to avoid an Addisonian crisis.
- Paraesthesia and pain may follow intravenous injection.
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Dexamethasone
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Alternatives
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- 500microgram & 2mg tablets
- 500microgram soluble tablets
- 2mg in 5ml oral solution and 5mg in 5ml oral solution is also approved. unlicensed
- 20mg/5ml oral solution
- Approved for use in patients requiring high dose to reduce pill burden
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MHRA Alert (Oct 2014): Dexamethasone 4 mg/ml injection (Organon Laboratories Limited): reformulation with changes in name, concentration, storage conditions, and presentation
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Methylprednisolone sodium succinate 2mg, 4mg, and 16mg (tablets)
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Alternatives
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Dexamethasone 3.3mg in 1ml and 6.6mg in 2ml (injection )
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Alternatives
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- Note: there are two different strength preparations of dexamethasone injection available in the UK (3.8mg/ml and 3.3mg/ml) where traditionaly a 4mg/ml preparation was available and prescribed as such. To avoid confusion the 3.3mg/ml strength is the preparation of choice in the acute Trusts. Where previously a 4mg dose would have prescribed it is appropriate to prescribe a 3.3mg dose (or multiples thereof). This is because the range of doses given in clinical practice varies widely and subsequent doses tend to be adjusted to reflect clinical response. If 4mg is required please ensure that the appropriate volume of 3.3mg/ml is (e.g. 1.2ml) prescribed (or mulitples thereof).
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Methylprednisolone Acetate 40mgin 1ml and 120mg in 3ml (depot) (injection)
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Alternatives
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Methylprednisolone sodium succinate 40mg, 125mg, 500mg & 1000mg (injection)
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Alternatives
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MHRA Drug Safety Alert (Oct 2017): Methylprednisolone injectable medicine containing lactose (Solu-Medrone 40 mg): do not use in patients with cows’ milk allergy
NICE NG220: Multiple sclerosis in adults: management
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Triamcinolone acetonide 40 mg in 1ml (Intramuscular/intra-articular injection)
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Alternatives
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Betamethasone 4mg in 1ml (injection)
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Alternatives
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06.03.02 |
Disadvantages of corticosteroids |
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06.03.02 |
Use of corticosteroids |
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06.03.02 |
Pregnancy and breastfeeding |
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06.03.02 |
Withdrawal of corticosteroids |
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06.04.01 |
Female sex hormones and their modulators |
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06.04.01.01 |
Oestrogens and Hormone Replacement Therapy HRT |
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Oestrogen conjugated tablets 625microgram and 1.2mg (Premarin®)
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Formulary
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Estradiol patches/gel/spray (Oestrogen only patches/gel)
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Formulary
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- Twice weekly matrix patches releasing approximately 25, 37.5 (Estradot® only), 50, 75 & 100 microgram/24 hours (Estradot®,Evorel®, Estraderm® MX);
- Weekly matrix patches releasing approximately 25, 50, 75 & 100 microgram/24 hours (Femseven®);
- Once weekly matrix patches releasing approx. 50 & 100 microgram estradiol/24 hours (Progynova TS®)
- Estradiol 0.1% gel (Sandrena®)
- Estradiol 0.06% gel (Oestrogel®)
- Approved for use in gender dysphoria therapy
- Approved for use as hormone replacement therapy
- Estradiol 1.53mg/spray transdermal spray (Lenzetto®)
- Approved as an alternative to patches and gels for patients who have issues with absorption, find patch adhesive irritating or the gel messy
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Estradiol tablets (Oestrogen only tablets)
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Formulary
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Ethinylestradiol (Oestrogen only tablets)
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Formulary
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- Note: ethinylestradiol 2microgram tablets are unlicensed.
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Continuous combined HRT patch (Evorel® Conti)
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Formulary
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Combined cyclical HRT tablet (Elleste Duet®)
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Formulary
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- Pack of 16 x 1mg estradiol tablets + 12 x 1mg estradiol and 1mg norethisterone tablets
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Combined cyclical HRT tablet (Femoston®)
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Formulary
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- Femoston® 1/10 Tablets:
- Pack of 14 x 1mg estradiol tablets + 14 tablets containing estradiol 1mg and dydrogesterone 10mg
- Femoston® 2/10 Tablets:
- Pack of 14 x 2mg estradiol tablets + 14 tablets containing estradiol 2mg and dydrogesterone 10mg
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Continuous combined HRT tablets (Elleste-duet Conti, Kliofem, Kliovance, Femosten Conti, Premique-low dose)
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Formulary
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Estradiol vaginal tablet
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Formulary
|
- 10mg vaginal tablet
- Vagifem® 10mg vaginal tablets
- Vagirux® 10mg vaginal tablets (alternative)
|
|
Sequential combined cyclical HRT patch (Evorel® Sequi)
|
Formulary
|
|
|
Tibolone
|
Formulary
|
|
|
|
|
|
06.04.01.01 |
Hormone replacement therapy |
|
|
06.04.01.01 |
Ethinylestradiol |
|
|
|
Raloxifene Hydrochloride
|
Formulary
|
- For use on the advice of specialists in the prevention and treatment of osteoporosis where alternative treatments are inappropriate.
|
NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women (Not Approved)
NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
|
06.04.01.01 |
Oestrogen only tablets |
|
|
06.04.01.01 |
Oestrogens and progestogen sequential combined therapy |
|
|
06.04.01.01 |
Continuous combined therapy |
|
|
06.04.01.01 |
Gonadomimetic |
|
|
06.04.01.01 |
Selective oestrogen modulator |
|
|
|
Norethisterone 5mg tablets
|
First Choice
|
|
|
Levonorgestrel (Mirena®)
|
Formulary
|
- Levonorgestrel 52mg in a T-shaped intra-uterine system.
- For idiopathic menorrhagia. Especially in women requiring (reversible) contraception. Also used for protection with endometrial hyperplasia during oestrogen replacement therapy. Lasts for up to 5 years - for use in accordance with agreed guidelines.
|
|
Medroxyprogesterone Acetate
|
Formulary
|
Approved Medroxyprogesterone formulations include:
- 2.5mg, 5mg, and 10mg tablets (sometimes used as a progestogen component of HRT).
- 100mg & 200mg tablets (for use in malignant disease see section 8.3.2).
- 50mg in ml injection - see sections 7.3.2.2 for use of medroxyprogesterone acetate injection in contraception.
|
|
Micronised progesterone (Utrogestan®)
|
Formulary
|
- 100mg oral capsules
- Approved for:
- adjunctive use with estrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT)
- Perimenopause (off-label)
- Premature ovarian insufficiency (off-label)
- Adolescents undergoing pubertal induction following chemotherapy (off-label)
|
|
Ulipristal (Esmya®)
|
Restricted
|
- 5mg tablets
- Approved for the pre-operative treatment of uterine fibroids for one 3 month course, as per its product licence.
- Approved for the medical treatment of uterine fibroids in women unsuitable for surgery, up to a maximum of four 3 month intermittent courses, as per its product licence and reviewed regularly.
- Contraindicated in women with underlying liver disorders.
- Requirements for liver function monitoring before, during, and after treatment
|
MHRA Drug Safety Update (Feb 2021): Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury
|
|
|
|
06.04.02 |
Male sex hormones and antagonists |
|
|
Testosterone undecanoate oily injection (Nebido®)
|
First Choice
|
- 1g in 4 mL injection (250 mg/mlL oily injection)
|
|
Testosterone Enantate
|
Alternatives
|
- 250mg/ml solution for injection ampoules
|
|
Testosterone Gel
|
Alternatives
|
Testogel®
- Gel pump dispenser 16.2mg/g (60 x 1.25g metered doses)
- Approved for hypogonadism on the advice of an endocrinologist
- 2.5g sachets (40.5mg/2.5g)
- Approved for hypogonadism on the advice of an endocrinologist
- Management of low libido in menopausal (both natural and surgical) and post-menopausal women (unlicensed indication) in accordance with attached guidance
Tostran®
- 10mg in 0.5ml (2%)/metered dose
- Approved for hypogonadism on the advice of an endocrinologist
- Management of low libido in menopausal (both natural and surgical) and post-menopausal women (unlicensed indication) in accordance with attached guidance
Testavan®
- 20mg/g transdermal gel
- Approved for hypogonadism on the advice of an endocrinologist
|
NENC ICB - Management of the Menopause
NICE NG23: Menopause: diagnosis and management
|
Testosterone 1ml injection (Sustanon 250®)
|
Alternatives
|
- Sustanon® 250 1ml injection contains testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg and testosterone decanoate 100mg.
|
|
|
|
|
Dutasteride
|
Formulary
|
|
|
Finasteride 5mg tablets
|
Formulary
|
|
NICE CG97 Lower urinary tract symptoms: quick reference guide
|
Cyproterone Acetate 50mg and 100mg tablets
|
Alternatives
|
- Approved for use on the advice of a urologist.
|
MHRA Drug Safety Update (June 2020): Cyproterone acetate: new advice to minimise risk of meningioma
|
06.04.03 |
Anabolic steroids |
|
|
06.04.04 |
Gender dysphoria |
|
|
Buserelin 150microgram Nasal Spray (Suprecur®)
|
Unlicensed
|
- 150 micrograms per spray; 268 dose spray
|
|
Cyproterone Acetate
|
Unlicensed
|
|
MHRA Drug Safety Update (June 2020): Cyproterone acetate: new advice to minimise risk of meningioma
|
Estradiol 1mg and 2mg tablets
|
Unlicensed
|
|
|
Finasteride 5mg tablets
|
Unlicensed
|
|
|
Goserelin 3.6mg injection
|
Unlicensed
|
|
|
Leuprorelin 11.25mg injection
|
Unlicensed
|
|
|
Spironolactone
|
Unlicensed
|
|
|
Testosterone 1ml injection (Sustanon® 250)
|
Unlicensed
|
- Sustanon® 250 1ml injection contains testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg and testosterone decanoate 100mg.
|
|
Testosterone Gel
|
Unlicensed
|
- 23 mg/1.15 g (23 mg per actuation); 85.5 g (Testavan®)
- 50 mg/5 g (50 mg per tube); 30 tubes (Testim®)
- 16.2 mg/g (20.25 mg per actuation); 88 g (Testogel®)
- 50 mg/5 g sachet; 30 sachets (Testogel®)
- 20 mg/g (10 mg per actuation); 60 g (Tostran®)
|
|
Testosterone undecanoate 1gram in 4ml oily injection (Nebido®)
|
Unlicensed
|
1g in 4 mL (250 mg/ml oily injection)
|
|
Triptorelin Injection
|
Unlicensed
|
3 mg, 3.75 mg, 11.25 mg and 22.5 mg
|
|
|
06.05 |
Hypothalamic and pituitary hormones and anti-oestrogens |
|
|
06.05.01 |
Hypothalamic and anterior pituitary hormones and anti-oestrogens |
|
|
Follitropin delta (Rekovelle®)
|
Formulary
|
- Approved for patients at risk of ovarian hyper stimulation syndrome (OHSS).
|
|
|
Clomifene Citrate
|
Formulary
|
|
|
06.05.01 |
Anterior pituitary hormones |
|
|
Tetracosactide (Synacthen®) (Corticotrophin)
|
Formulary
|
- Approved formulations include:
- 250microgram in 1ml injection;
- 1mg in 1ml depot injection.
|
|
Choriogonadotropin Alfa (Ovitrelle®) (Gonadotrophin)
|
Formulary
|
- Fertility treatment
- Hypogonadism
|
|
Lutropin Alfa
|
Formulary
|
|
|
Menotrophin (75 units FSH & 75 units LH activity) injection (Gonadotrophin)
|
Formulary
|
|
|
Pegvisomant (Somavert®)
|
Formulary
|
|
|
Somatrogon (Ngenla®)
|
Formulary
|
24mg and 60mg solution for injection in pre-filled pen
|
NICE TA863: Somatrogon for treating growth disturbance in children and young people aged 3 years and over
|
Somatropin (children) (Growth hormone - children)
|
Formulary
|
- First line
- Omnitrope® 5-mg (15-unit) vial (powder with diluent) for use with Omnitrope Pen L® device, 3.3 mg (10 units)/ml, 1.5 ml (5-mg, 15-unit) cartridge & 6.7 mg (20 units)/ml, 1.5 ml (10-mg, 30-unit) cartridge - for use with Omnitrope Pen 5® & Omnitrope Pen 10® devices respectively.
- Note: Omnitrope is the least expensive formulation of somatropin and should be used in all de novo paediatric patients where possible.
- Second line
- Norditropin SimpleXx® 1.5ml cartridges for use in Nordipen® devices - 5mg (15 units), 10mg (30 units) and 15mg (45 units). Note: norditropin is the second least expensive alternative formulation for patients who cannot tolerate omnitrope.
- Saizen® 8mg vials (powder with diluent), Saizen® 5.83 mg/ml solution for injection (6mg cartridges), 8 mg/ml solution for injection (12mg and 20mg cartridges) - for use in EasyPod® device (to be used in patients with compliance issues).
- Third line
- Genotropin Miniquick® syringes - 0.2mg (0.6 units) 0.8mg (2.4 units) 1.4mg (4.2 units), 0.4mg (1.2 units) 1mg (3 units) 1.6mg (4.8 units) 0.6mg (1.8 units), 1.2mg (3.6 units) 2mg (6 units). To be used for patients when travelling.
- Zomacton® (needle free presentation) 12 unit (4mg) injection; 1st line: 75% to 85% of total mg usage; 2nd line: 15% to 25% of total mg usage; 3rd line: up to 5% of total mg usage.
|
NICE TA188: Human growth hormone (somatropin) for the treatment of growth failure in children
|
Somatropin - adults (Growth hormone - adults)
|
Formulary
|
- Genotropin® cartridges for use in Genotropin pens - 16 unit (5.3mg) & 36 unit (12mg) in 1ml.
- Genotropin Miniquick® syringes - 0.2mg (0.6 units), 0.8mg (2.4 units), 1.4mg (4.2 units) 0.4mg (1.2 units) 1mg (3 units) 1.6mg (4.8 units) 0.6mg (1.8 units) 1.2mg (3.6 units) 2mg (6 units) - to be used for patients when travelling.
|
NICE TA64: Human growth hormone (somatropin) in adults with growth hormone deficiency
|
Follitropin Alfa (Recombinant human follicle stimulating hormone)
|
Formulary
|
|
|
06.05.01 |
Hypothalmic hormones |
|
|
Gonadorelin 100microgram in 1ml
|
Formulary
|
|
|
Protirelin (TRH)
|
Unlicensed
|
|
|
06.05.02 |
Posterior pituitary hormones and antagonists |
|
|
Tolvaptan (vasopressin V2-receptor antagonist)
|
Formulary
|
- 15mg, 30mg, 45mg, 60mg and 90mg tablets (Jinarc®) - approved for the treatment of autosomal dominant polycystic kidney disease in line with NICE.
- 15mg and 30mg tablets (Samsca®) - approved for the treatment of hyponatraemia secondary to the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) in patients requiring cancer chemotherapy in accordance with NHS England Policy.
|
NICE TA358: Autosomal dominant polycystic kidney disease - tolvaptan
|
06.05.02 |
Posterior pituitary hormones |
|
|
Argipressin 20units in 1ml injection (Synthetic vasopressin)
|
Formulary
|
|
|
Desmopressin
|
Formulary
|
- The following desmopressin formualtions are approved for use:
- 10 microgram/dose nasal spray.
- 2.5 & 150 microgram/dose nasal sprays (unlicensed).
- 100 microgram & 200 microgram tablets.
- 120 microgram sublingual tablets.
- 4 microgram in 1ml injection and 15 microgram in 1ml injection
|
|
Terlipressin 1mg injection
|
Formulary
|
|
MHRA Drug Safety Update (March 2023): Terlipressin: new recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome
|
06.05.02 |
Antidiuretic hormone antagonists |
|
|
Demeclocycline
|
Formulary
|
- 150mg capsules
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Treatment to be intitated by specialist.
|
|
06.06 |
Drugs affecting bone metabolism |
|
|
|
|
06.06.01 |
Calcitonin and parathyroid hormone |
|
|
Calcitonin 400units in 2ml (Salcatonin Injection)
|
Formulary
|
|
|
Teriparatide 250microgram in 1ml prefilled pen (Biosimilar brands - Movymia®,Terrosa® & Teva)
|
Formulary
|
- Approved for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis primary in line with NICE.**All new patients**
- Approved for the treatment of osteoporosis in males and juveniles in line with NHSE Commissioning Policy
|
Biosimilar teriparatide for the treatment of osteoporosis in postmenopausal women as per NICE TA161.
NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women
NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
|
Teriparatide 250microgram in 1ml prefilled pen (Forsteo®)
|
Formulary
|
- Approved for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis primary in line with NICE. **Exisiting patients only**
- Approved for the treatment of osteoporosis in males and juveniles in line with NHSE Commissioning Policy
|
NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women
NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
|
06.06.02 |
Bisphosphonates and other drugs affecting bone metabolism |
|
|
Burosumab (Crysvita®)
|
Formulary
|
- 10mg, 20mg & 30mg solution for injection
- Approved for treating X-linked hypophosphataemia in children and young people in accordance with NICE
|
NICE HST 8: Burosumab for treating X-linked hypophosphataemia in children and young people
|
|
|
|
|
|
|
|
|
Alendronic Acid (osteoporosis)
|
First Choice
|
- Approved alendronic acid formulations include:
- 10mg tablets (taken daily)
- 70mg tablets (taken once weekly) – preferred
- 70mg effervescent tablets (Binosto®) - for use only in patients with documented swallowing difficulties
- Alendronic acid is approved for the primary prevention of osteoporosis in postmenopausal women in line with NICE
- Approved for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis primary in line with NICE.
- Approved for the treatment of osteoporosis in line with NICE
|
NICE TA464 Bisphosphonates for treating osteoporosis
|
Disodium Pamidronate 30mg injection (hypercalcaemia)
|
Formulary
|
|
|
Ibandronic Acid (osteoporosis)
|
Alternatives
|
- Ibandronic acid 50mg tablets are approved for use in the reduction of bone damage in patients with metastatic breast cancer. Not approved for use in the treatment of patients with other forms of cancer (e.g. prostate).
- Ibandronic acid 150mg tablets are approved for the treatment of osteoporosis in line with NICE
- Ibandronic acid 3mg in 3ml injection is approved for use where oral bisphosphonates are not appropriate (not tolerated, contra-indicated because of upper gastro-intestinal problems or insufficiently effective)
|
NICE TA464 Bisphosphonates for treating osteoporosis
|
Risedronate (Osteoporosis/Paget's)
|
Alternatives
|
- Approved risedronate formulations include:
- 5mg tablets (taken daily);
- 35mg tablets (taken once weekly for osteoporosis) -preferred.
- Risedronate is approved for the primary prevention of osteoporosis in line with NICE, and for for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis in line with NICE.
- Risedronate 30mg tablets are also approved for Paget’s disease.
- Approved for the treatment of osteoporosis in line with NICE
|
NICE TA464 Bisphosphonates for treating osteoporosis
|
Sodium Clodronate (Hypercalcaemia)
|
Alternatives
|
|
|
Zoledronic Acid 4mg injection (Hypercalcaemia/breast cancer)
|
Alternatives
|
- Approved for use in treating hypercalcaemia of malignancy and the prevention of skeletal events in patients with metastatic breast cancer.
- Approved for the adjuvant treatment of post-menopausal women with early breast cancer (subject to agreement with the CCGs and provider trusts regarding the extra activity).
- Not approved for preventing skeletal events in patients with prostate cancer.
- To avoid confusion it is recommended that this product is prescribed by brand name i.e. Zometa®
|
|
Zoledronic Acid 5mg injection (Osteoporosis/Paget's)
|
Alternatives
|
- Prescribe by brand name
- Approved for the treatment of osteoporosis in line with NICE
|
NICE TA464 Bisphosphonates for treating osteoporosis
|
06.06.02 |
Denosumab |
|
|
Denosumab (Xgeva®) (Metastases)
|
Formulary
|
- Denosumab 70mg in 1ml (120mg) vial is approved for the prevention of skeletal-related events in adults with bone metastases from solid tumours in line with NICE
- Note: denosumab is not approved for therapy induced bone loss in non- metastatic prostate cancer (NICE).
- North Cumbria only
- New patients
- Exisiting patients
|
MHRA Drug Safety Updates: Denosumab
NICE TA265: Bone metastases from solid tumours - denosumab: guidance
|
Denosumab (Prolia®) (Osteoporosis)
|
Alternatives
|
- Denosumab 60mg in 1ml solution in prefilled syringe is approved for use in the treatment of postmenopausal osteoporosis in line with NICE. Also approved for male patients who dont tolerate bisphosphonates or strontium ranelate.
- NOTE: Denosumab will remain as in most localities until a shared care guideline has been produced.
|
NICE TA204: Osteoporotic fractures - denosumab
MHRA Drug Safety Updates: Denosumab
North of Tyne, Gateshead and North Cumbria: DENOSUMAB (Prolia®) 60mg sc twice yearly for osteoporosis Information for Treatment of Adults in Primary Care
CD&TV APC Information sheet to support prescribing and monitoring of Denosumab (Prolia®
|
06.06.02 |
Strontium renelate |
|
|
Strontium Ranelate (Sachets)
|
Formulary
|
- Treatment of severe osteoporosis
- in post menopausal women and adult men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
|
|
|
Romosozumab (Evenity ®)
|
Formulary
|
- Approved for severe osteoporosis in people after menopause who are at high risk of fracture in line with NICE.
|
NICE TA791: Romosozumab for treating severe osteoporosis
|
06.07 |
Other endocrine drugs |
|
|
Ketoconazole (Ketoconazole HRA)
|
Formulary
|
Tablets: 200mg
Indication: Cushing's Syndrome
|
|
06.07.01 |
Bromocriptine and other dopaminergic drugs |
|
|
Bromocriptine 2.5mg tablets
|
Formulary
|
|
|
Cabergoline 500microgram and 1mg tablets
|
Formulary
|
|
|
Quinagolide
|
Formulary
|
|
|
06.07.02 |
Drugs affecting gonadotrophins |
|
|
|
Leuprorelin
|
First Choice
|
- Approved formualtions include 3.75mg and 11.25mg pre filled syringes (also see section 8.3.4.2).
|
|
Relugolix–estradiol–norethisterone acetate (Ryeqo®)
|
Formulary
|
- Approved as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age - in line with NICE TA832.
|
NICE TA832: Relugolix–estradiol–norethisterone acetate for treating moderate to severe symptoms of uterine fibroids
|
Buserelin 150microgram nasal spray
|
Alternatives
|
|
|
Cetrorelix
|
Alternatives
|
|
|
Danazol 100mg and 200mg capsules
|
Alternatives
|
|
|
Goserelin
|
Alternatives
|
- The following goserelin formulations are approved for use 3.6mg & 10.8mg injections (also see section 8.3.4.2).
- Note: leuprorelin is now substantially less expensive than goserelin
|
|
Nafarelin
|
Alternatives
|
|
|
Triptorelin
|
Alternatives
|
- The following formulations are approved for use in treating precocious puberty:
- Gonapeptyl Depot® 3.75mg injection;
- Decapeptyl SR®11.25mg injection.
- Refer to Chapter 8 - Gonadorelin analogues for the treatment of prostate cancer. The following strengths are approved:
|
|
|
06.07.02 |
Gonadorelin analogues |
|
|
06.07.02 |
Breast pain (mastalgia) |
|
|
|
Metyrapone (Metopirone®)
|
Formulary
|
|
|
|
Mecasermin (Increlex®)
|
Formulary
|
|
MHRA Drug Safety Update (Jan 2020): Mecasermin (Increlex▼): risk of benign and malignant neoplasia
|
06.08 |
Metreleptin |
|
|
Metreleptin
|
Formulary
|
- 3mg, 5.5mg and 11.3mg powder for solution for injection
- Approved for treating lipodystrophy in children and adults in line with NICE
|
NICE HST14: Metreleptin for treating lipodystrophy
|
.... |
Key |
|
|
Cytotoxic Drug
|
|
Controlled Drug
|
|
High Cost Medicine
|
|
NHS England |
|
Homecare |
|
CCG |
|
Traffic Light Status Information
Status |
Description |
|
Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
|
Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
|
Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
|
Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
|
NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
|
UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
|
NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
|
|
|