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Pan Mersey
Area Prescribing Committee
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 Formulary Chapter 6: Endocrine system - Full Chapter
Notes:

Review date: Sept 2019 (Currently under review).

Non-formulary drugs: Any drug or formulation not listed in the formulary is deemed to be non-formulary.

Off-label use: Drugs are included in the formulary for their licensed indications – where inclusion of off-label use is considered to be included in the formulary this is specifically stated in the formulary entry for the drug N.B. also see Paediatrics note below.

Paediatrics: Drugs are included in the formulary for paediatric use for their BNF for Children recommended indications (indicated by symbol View childrens BNF) which may be off-label, unless otherwise stated. All drugs are deemed to have the same RAG status as they have for adults unless stated otherwise.

NHS England Specialised Commissioning
Drugs carrying the NHS England logo are commissioned by them. Links to key documents, national programmes of care, and clinical reference groups are found below.

NHSE NHS England Specialised Commissioning: Key documents

NHSE NHS England Specialised Commissioning: National programmes of care and clinical reference groups

Medications which are indicated for medically assisted reproduction, including ovulation induction (e.g. clomifene, letrozole and tamoxifen) and assisted reproduction, such as In Vitro Fertilisation or Ex Vitro Fertilisation (e.g. gonadotrophins) are restricted to use by specialist secondary care physicians, and are categorised as RED drugs for these purposes.

 Details...
06.01.02.03  Expand sub section  Other antidiabetic drugs
 note 

Please see NICE NG28 Type 2 diabetes in adults: management.

Repaglinide, although rarely used, is a treatment option in the current NICE guidance.

Thiazolidinediones

Thiazolidinediones reduce peripheral insulin resistance.
Pioglitazone is the only available option and is recommended in accordance with NICE. Treatment should be reviewed at 3-6 months and should only be continued if the person is deriving benefit.
See pioglitazone entry for links to MHRA warnings re increased risk of heart failure, bladder cancer and bone fracture.

Dipeptidylpeptidase-4 [DPP-4] Inhibitors (Gliptins)

DPP-4 inhibitors act by increasing insulin secretion and lowering glucagon secretion.
They are recommended in accordance with NICE and their licensed indications.
For further details see Pan Mersey Gliptins statement.
The MHRA has issued advice on the risk of acute pancreatitis with DPP-4 Inhibitors. See Drug Safety Update

Sodium-glucose co-transporter 2 [SGLT-2] Inhibitors (‘Flozins’)

SGLT-2 inhibitors lower blood glucose by blocking the reabsorption of glucose in the kidneys and promoting excretion of excess glucose in the urine.
They are recommended in accordance with NICE.
For further details see Pan Mersey monotherapy and combination therapy statements.
The MHRA has issued updated advice on the risks with SGLT-2 inhibitors:
Diabetic ketoacidosis
Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)

Glucagon-Like Peptide-1 Receptor  (GLP-1) Agonists

GLP-1 agonists activate the GLP-1 receptor to increase insulin secretion, suppress glucagon secretion and slow gastric emptying. They are available as injectable preparations. Care should be taken that the correct administration schedule is prescribed and administered.
The MHRA has issued updated advice on the risks with SGLT-2 inhibitors:
Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. See MHRA Drug Safety Update: Exenatide (Byetta ▼): risk of severe pancreatitis and renal failure Drug Safety Update - GOV.UK
Further advice is also available on the risk of ketoacidosis when reducing or stopping concomitant insulin. See the Drug Safety Update GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued

 

Canagliflozin tablets
View adult BNF View SPC online
Formulary
Green

100mg, 300mg

Sodium-glucose co-transporter 2 (SGLT2) inhibitor

Third-line option when used as monotherapy

Paediatrics: No BNFc entry, seek specialist advice 

 
Link  CANAGLIFLOZIN, DAPAGLIFLOZIN and EMPAGLIFLOZIN as COMBINATION THERAPIES: Pan Mersey Area Prescribing Committee Multiple Policy Statement
Link  CANAGLIFLOZIN, DAPAGLIFLOZIN and EMPAGLIFLOZIN as MONOTHERAPIES: Pan Mersey Area Prescribing Committee Multiple Policy Statement
Link  NICE TA 390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
Link  NICE TA315: Canagliflozin in combination therapy for treating type 2 diabetes
   
Canagliflozin with metformin (Vokanamet®)
View adult BNF View SPC online
Formulary
Black
50mg/850mg; 50mg/1g

Sodium-glucose co-transporter 2 (SGLT2)(combination therapy)

 
Link  CANAGLIFLOZIN with METFORMIN tablets (Vokanamet®▼) Pan Mersey Area Prescribing Committee Policy Statement
   
Dapagliflozin tablets
View adult BNF View SPC online
Formulary
Green

5mg, 10mg

Sodium-glucose co-transporter 2 (SGLT2) inhibitorThird-line option when used as monotherapyPaediatrics: No BNFc entry, seek specialist advice.

Red for the treatment of Type 1 Diabetes (in combination with insulin) - Temporary RAG rating, awaiting development of pathway and additional prescribing support information.

 
Link  Pan Mersey APC (2019): Dapagliflozin tablets (Forxiga®) in combination with insulin for the treatment of Type 1 Diabetes Mellitus
Link  CANAGLIFLOZIN, DAPAGLIFLOZIN and EMPAGLIFLOZIN as COMBINATION THERAPIES: Pan Mersey Area Prescribing Committee Multiple Policy Statement
Link  CANAGLIFLOZIN, DAPAGLIFLOZIN and EMPAGLIFLOZIN as MONOTHERAPIES: Pan Mersey Area Prescribing Committee Multiple Policy Statement
Link  NICE TA288: Dapagliflozin in combination therapy for treating type 2 diabetes
Link  NICE TA 390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
Link  NICE TA418: Dapagliflozin in triple therapy for treating type 2 diabetes
Link  NICE TA597 (2019): Dapagliflozin with insulin for treating type 1 diabetes
   
Dapagliflozin with metformin (Xigduo®)
View adult BNF View SPC online
Formulary
Black
5mg/850mg; 5mg/1g

Sodium-glucose co-transporter 2 (SGLT2)(combination therapy)

 
Link  DAPAGLIFLOZIN with METFORMIN tablets (Xigduo®▼) Pan Mersey Area Prescribing Committee Policy Statement
   
Empagliflozin tablets
View adult BNF View SPC online
Formulary
Green

10mg, 25mg

Sodium-glucose co-transporter 2 (SGLT2) inhibitor

Third-line option when used as monotherapy

Paediatrics: No BNFc entry, seek specialist advice 

 

 
Link  CANAGLIFLOZIN, DAPAGLIFLOZIN and EMPAGLIFLOZIN as COMBINATION THERAPIES: Pan Mersey Area Prescribing Committee Multiple Policy Statement
Link  CANAGLIFLOZIN, DAPAGLIFLOZIN and EMPAGLIFLOZIN as MONOTHERAPIES: Pan Mersey Area Prescribing Committee Multiple Policy Statement
Link  NICE TA390: Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes
Link  NICE TA336: Empagliflozin in combination therapy for treating type 2 diabetes
   
Empagliflozin with metformin tablets (Synjardy®)
View adult BNF View SPC online
Formulary
Black
5mg/850mg, 5mg/1000mg, 12.5mg/850mg, 12.5mg/1000mg

Sodium-glucose co-transporter 2 (SGLT2)(combination therapy)
 
Link  EMPAGLIFLOZIN with METFORMIN tablets (Synjardy®▼) Pan Mersey Area Prescribing Committee Policy Statement
   
Ertugliflozin tabletsBlack Triangle
View adult BNF View SPC online
Formulary
Green

5mg, 15mg. For use as monotherapy and in combination with metformin.

Sodium-glucose co-transporter 2 (SGLT2) inhibitor

Third-line option when used as monotherapy. 

Use only with metformin and DPP4 inhibitor for triple therapy,

Paediatrics: No BNFc entry, seek specialist advice 

 
Link  NICE TA572 (2019): Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes
Link  NICE TA583 (2019): Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes
Link  Pan Mersey APC (2019). ERTUGLIFLOZIN film-coated tablets (Steglatro®▼) in a triple therapy regimen for treating type 2 diabetes
Link  Pan Mersey APC (2019): ERTUGLIFLOZIN film-coated tablets (Steglatro®▼) as monotherapy or with metformin for treating type 2 diabetes
   
Liraglutide injection (Saxenda®)
View adult BNF View SPC online View childrens BNF
Formulary
Black

6mg/mL, 3mL prefilled pen

Max dose 3.0mg

Saxenda® is not licensed for the treatment of type 2 diabetes and is not interchangeable with Victoza® brand, which is licensed for type 2 diabetes and used at a lower dose.

 
Link  LIRAGLUTIDE 6 mg/mL solution for injection (Saxenda®▼) for weight management Pan Mersey Area Prescribing Committee Policy Statement
   
Liraglutide injection (Victoza®)
View adult BNF View SPC online
Formulary
Green

6mg/mL, 3mL prefilled pen

 Amber Patient Retained  when used in combination with insulin.

 

GREY when used as monotherapy

 

 Black  Liraglutide with insulin degludec (Xultophy®▼)

 

Paediatrics: No BNFc entry, seek specialist advice 

 

Victoza® is not licensed for obesity/weight management and is not interchangeable with Saxenda® brand, which is licensed for weight management and used at a higher dose. It is recommended liraglutide is prescribed by brand name to avoid confusion.

 
   
Insulin degludec and liraglutide (Xultophy®)
View adult BNF View SPC online
Formulary
Black

Insulin Degludec 100units/ml + Liraglutide 3.6mg/ml solution for injection

Where the combination of a GLP-1 analogue with insulin is clinically indicated, clinicians should continue to prescribe a separate GLP-1 analogue and insulin in line with current Pan Mersey recommendations.

 
   
Insulin glargine and lixisenatideBlack Triangle (Suliqua®)
View adult BNF View SPC online
Formulary
Grey

Insulin Glargine 100 units/ml + Lixisenatide 50 micrograms/ml solution for injection; 3ml pre-filled pen

Insulin Glargine 100 units/ml + Lixisenatide 33 micrograms/ml solution for injection; 3ml pre-filled pen

Where the combination of a GLP-1 analogue with insulin is clinically indicated, clinicians should continue to prescribe a separate GLP-1 analogue and insulin in line with current Pan Mersey recommendations.

 
   
Alogliptin
View adult BNF View SPC online
Formulary
Green

Tablets 6.25mg, 12.5mg, 25mg

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Dulaglutide injection
View adult BNF View SPC online
Formulary
Green

Pre-filled pen 0.75mg, 1.5mg Pre-filled syringe 0.75mg, 1.5mg

Amber Patient Retained when used in combination with insulin.

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Exenatide prolonged release injection
View adult BNF View SPC online
Formulary
Green

m/r, powder and solvent, 2 mg pre-filled pen

Use in accordance with recommendations in NICE NG28.

Amber Patient Retained  when used in combination with insulin - off label indication with insulin.

Paediatrics: No BNFc entry, seek specialist advice 

 
Link  NICE NG28: Type 2 diabetes in adults: management
   
Exenatide standard release injection
View adult BNF View SPC online
Formulary
Green

250 micrograms/mL, 5 microgram/dose prefilled pen (60 doses), 10 microgram/dose prefilled pen (60 doses)

Amber Patient Retained  when used in combination with insulin.

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Pioglitazone tablets
View adult BNF View SPC online
Formulary
Green

15mg, 30mg, 45mg

Glitazone.

Pioglitazone is GREEN. However, please see: - MHRA safety advice Pioglitazone: risk of bladder cancer - MHRA and MHRA/CHM advice: incidence of heart failure increased when pioglitazone is combined with insulin.

No BNFc entry, seek specialist advice 

 
Link  Insulin combined with pioglitazone: risk of cardiac failure MHRA Drug Safety Update January 2011
Link  Pioglitazone: risk of bladder cancer MHRA Drug Safety Update August 2011
   
Saxagliptin tablets
View adult BNF View SPC online
Formulary
Green

2.5mg, 5mg

Dipeptidylpeptidase-4 (DPP-4) Inhibitors

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Saxagliptin with dapagliflozin (Qtern®)
View adult BNF View SPC online
Formulary
Black

5mg/10mg film-coated tablets

 
Link  Oral Combination Products: Pan Mersey Area Prescribing Committee Policy Statement
   
SemaglutideBlack Triangle
View adult BNF View SPC online View childrens BNF
Formulary
Green

0.25mg, 0.5mg, 1mg pre-filled pen

Amber Patient Retained  when used in combination with insulin

 Paediatrics: No BNFc entry, seek specialist advice 

 
   
Sitagliptin tablets
View adult BNF View SPC online
Formulary
Green

25mg, 50mg, 100mg

Dipeptidylpeptidase-4 (DPP-4) Inhibitor

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Linagliptin tablets
View adult BNF View SPC online
Formulary
Green

5mg

Dipeptidylpeptidase-4 (DPP-4) Inhibitors

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Linagliptin with metformin tablets
View adult BNF View SPC online
Formulary
Black

2.5mg/850mg, 2.5mg/1g Dipeptidylpeptidase-4 (DPP-4) Inhibitors

 
   
Alogliptin with metformin tablets
View adult BNF View SPC online
Formulary
Black
12.5mg/1g

Dipeptidylpeptidase-4 (DPP-4) Inhibitors

 
   
Repaglinide tablets
View adult BNF View SPC online
Formulary
Green

500micrograms, 1mg, 2mg

Although rarely used, is a treatment option in the current NICE guidance.

Paediatrics: No BNFc entry, seek specialist advice 

 
   
Lixisenatide injection
View adult BNF View SPC online
Formulary
Green

50 micrograms/mL, 10 micrograms/dose prefilled pen (14 doses) 100 micrograms/mL, 20 micrograms/dose prefilled pen (14 doses) Treatment initiation pack, 10 micrograms/dose prefilled pen and 20 micrograms/dose prefilled pen Incretin mimetic Second line - use only when both exenatide and liraglutide are unsuitable or not tolerated.

Amber Patient Retained  when used in combination with insulin

Paediatrics: No BNFc entry, seek specialist advice 

 
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Green

Medicines considered suitable for non-specialist prescribing in primary or secondary care.  

Amber Recommended

Requires specialist assessment to enable patient selection.  Amber Recommended medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Following specialist assessment, the medicine is suitable for prescribing in Primary Care.  

Amber Initiated

Amber Initiated. Requires specialist initiation of prescribing. Prescribing to be continued by the specialist until stabilisation of the dose is achieved and the patient has been reviewed. Amber Initiated medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable   

Amber Retained

Amber Patient Retained. Requires specialist initiation of prescribing. Prescribing to be continued by specialist until stabilisation of the dose is achieved and the patient had been reviewed. Patient remains under the care of specialist (ie not discharged) as occasional specialist input may be required. Amber Patient Retained medicines must meet criteria: (1)Requires specialist assessment to enable patient selection (2)Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable (4) May require occasional specialist input indefinitely and therefore the patient should not be discharged from specialist care   

Amber

Medicines recommended or initiated by specialists in primary or secondary care. Non-specialist prescribing in primary care may follow according the RAG criteria. In process of being superceded by Amber Recommended, Amber Initiated and Amber Patient Retained.  

Purple

Shared Care. Medicines are considered suitable for Primary Care prescribing and/or management, following specialist initiation of therapy, with on-going communication between the Primary Care prescriber and specialist, within the framework of a Shared Care Agreement. Medicines designated as requiring Shared Care require on-going input from both Specialist and Primary Care clinicians and patients should not be discharged from Specialist care. Where prescribing and monitoring are required under shared care, it is implicit that the responsibility for both of these tasks rests with the prescriber. A Shared Care Agreement will always be available for Shared Care medicines and this document will include a Shared Care Agreement pro-forma which will be completed by all involved clinicians. This pro-forma will record agreement to take on defined aspects of care e.g. monitoring and/or on-going prescribing for the individual patients. A policy detailing clinician responsibilities in Shared Care Agreements must be referred to in all cases of Shared Care. All drugs to be included in this category must meet Shared Care criteria 1 to 3: SC1 Requires specialist assessment to enable patient selection and also initiation, stabilisation and review of treatment and the patient`s condition. SC2 Prescribing and/or management of the drug in Primary Care with specialist support and input, within the framework of the Shared Care Agreement is safe and convenient and that there is an appropriate mechanism for individual patient access in Primary Care. SC3 Requires specific long-term monitoring (blood test or other measurement) for adverse effects and / or efficacy of the drug to be completed in Primary Care, and requires on-going specialist support for the dose changes or management of adverse effects. Monitoring is required on a regular basis (typically four times a year). Implicit in any shared care agreement is the understanding that participation is at the discretion of the Primary Care prescriber subject to their clinical confidence.   

Red

Primary care prescribing of these medicines is NOT recommended. These treatments should be initiated by specialists only; ongoing prescribing is retained within secondary care.   

Black

Not recommended for use. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist.   

Grey

Not recommended for use at this time. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist. Further guidance will be issued when more information or evidence is made available.  

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