• Human Actrapid® 10ml vial approved. 

• Approved formulations of Humulin® S include:
  
  • 10ml vials;
  • 5x3ml cartridges.
  
  

• Approved formulations for Fiasp® include:
  
  
  
  
  • 10ml vial;
  
  
  • 5x3ml cartridge;
  
  
  • 5x3ml FlexpTouch pen®.
  
  
  
  

• 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

• 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

• 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

• 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

• Approved Apidra® formulations include:
  
  • 10ml vials;
  • 5x3ml cartridges
  • 5x3ml Solostar® pens.
  
  

• Humulin R 500units in 1ml (10ml vial) approved for a very small number of insulin resistant patients that require very high doses of insulin. 

• Approved Insulatard® formulations include:
  
  • 10ml vial;
  • 5x3ml cartridges (for use with Novopen® and Novopenmate® devices);
  • 5x3ml Innolet® pens. 
  
  

• Approved Humulin® I formulations include:
  
  • 10ml vials;
  • 5x3ml cartridges;
  • 5x3ml pens. 
  
  

• 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®.
  
  

• 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.

• Alternative choice long acting basal insulin.
• Approved Levemir® formualtions include:
  
  • 5x3ml cartridges;
  • 5x3ml pens. 
  
  

• Alternative choice long acting basal insulin. 
• Approved Lantus® formulations include:
  
  • 10ml vials;
  • 5x3ml cartridges;
  • 5x3ml pens (Solostar® - in line with NICE). 

• Alternative choice long acting basal insulin.
• Approved Toujeo® formulations include:
  
  • 3x1.5ml pen (Solostar®).
  
  

• Approved Humulin®M3 formulations include:
  
  • 10ml vials;
  • 5x3ml cartridges;
  • 5x3ml pens. 
  
  

• Approved NovoMix® 30 formulations include:
  
  • 5x3ml cartridges (for use with Novopen® and Novopen® Penmate injection devices)
  • 5x3ml Flexpen® pens. 
  
  

• Approved formulations of Humalog® Mix 25 and Mix 50 include:
  • 5x3ml cartridges
  • 5x3ml Kwikpen®

• 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.

• 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

• 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)

• 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 29^th 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

• 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

• 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 
  
  
  

• Only approved for use in accordance with NICE guidance. 

• 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 

• 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

• Approved as monotherapy or with metformin for the treatment of type 2 diabetes in line with NICE

• 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

• Diazoxide suspensions can be obtained/prepared if needed. unlicensed

• 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

• Carbohydrate drink
• Approved for the treatment of mild to moderate hypoglycaemia in children and young people 
  • First choice ahead of Glucogel® 

• 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.

• See 04.07.03 Neuropathic Pain

• 50mg capsules, 50mg dispersible tablets & 100mg/2ml injection

• Recommended for use only as per NTAG advice and NHS England Guidance.

• Recommended for use only as per NTAG advice and NHS England Guidance.

• Flash Blood Glucose Monitoring System 
• Recommended for use only as per NTAG advice and NHS England Guidance.

• Flash Blood Glucose Monitoring System 
• Recommended for use only as per NTAG advice and NHS England Guidance.

• Recommended for use only as per NTAG advice and NHS England Guidance.

• 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.

• 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. 

20mcg injection

• Oral solution containing 130mg total iodine/ml (5% iodine & 10% potassium iodide).

• Propranolol 80mg MR capsules is the preferred formulation for relief of thyrotoxic symptoms.

• Approved for use in rapid blockade of thyrotoxicosis in otherwise medically resistant patients prior to surgery/thyroidectomy.

• Mainly used by medical physics.

• Hydrocortisone 10mg in 5ml suspension is also approved for use.  unlicensed

• 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.

• 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

• 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).

• 10mg and 20mg tablets
• 5mg, 10mg and 20mg dispersible tablets   
• 2.5mg buccal tablets 
• 5mg/5ml and 10mg/5ml oral solution (Colonis®)
• In patients who are unable to swallow or have swallowing difficulties the most cost effective product should be used     
• 0.5mg, 1mg, 2mg & 5mg granules (in capsules for opening) 
  • Approved for treatment of adrenal insufficiency in infants, children and adolescents
  • Patients should be transitioned onto tablets once they are able to take them

• 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

• 1mg and 2mg tablets

• Note: ethinylestradiol 2microgram tablets are unlicensed.

• Pack of 16 x 1mg estradiol tablets + 12 x 1mg estradiol and 1mg norethisterone tablets

• 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

• 10mg vaginal tablet
  
  • Vagifem® 10mg vaginal tablets
  • Vagirux® 10mg vaginal tablets (alternative)
  
  
  

• For use on the advice of specialists in the prevention and treatment of osteoporosis where alternative treatments are inappropriate.

• 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.

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.

• 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)
  
  
  

• Approved formulations include:
  
  • 200mg & 400mg pessaries (Cyclogest®) 
    • To support the pregnancies of women who have a history of miscarriage or premature labour as per NICE NG25: Preterm labour and birth AND NICE NG126: Ectopic pregnancy and miscarriage: diagnosis and initial management.
  • 200mg vaginal capsules (Utrogestran®) 
    • To support the pregnancies of women who have a history of miscarriage or premature labour as per NICE NG25: Preterm labour and birth AND NICE NG126: Ectopic pregnancy and miscarriage: diagnosis and initial management.
  • 25mg SC/IM injection (Lubion®) 
    
    • Approved for luteal support in patients who have had a previous failed biochemical pregnancy in a froxen embryo transfer (FET) cycle

• CD&TV  for Luteal Phase support following IVF.
  • Full course to be supplied by hospital

• 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

• 250mg/ml solution for injection ampoules

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  

• Sustanon® 250 1ml injection contains testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg and testosterone decanoate 100mg.

• 500mcg capsules

• Approved for use on the advice of a urologist.

• 150 micrograms per spray; 268 dose spray

• Tablets: 50mg & 100mg

• Tablets: 25 mg & 100 mg

• Sustanon® 250 1ml injection contains testosterone propionate 30mg, testosterone phenylpropionate 60mg, testosterone isocaproate 60mg and testosterone decanoate 100mg.

• 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^®)

1g in 4 mL (250 mg/ml oily injection)

3 mg, 3.75 mg, 11.25 mg and 22.5 mg

• Approved for patients at risk of ovarian hyper stimulation syndrome (OHSS).

• Approved formulations include:
  
  • 250microgram in 1ml injection;
  • 1mg in 1ml depot injection. 
  
  

•   Fertility treatment 


•   Hypogonadism 

24mg and 60mg solution for injection in pre-filled pen

• 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.

• 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.

• 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.

• 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

• 150mg capsules
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
    Treatment to be intitated by specialist.

• 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

• 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

• 10mg, 20mg & 30mg solution for injection


• Approved for treating X-linked hypophosphataemia in children and young people in accordance with NICE

• 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) 

• 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

• 520mg and 800mg tablets

• 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®

• Prescribe by brand name
• Approved for the treatment of osteoporosis in line with NICE

• 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  

• 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. 

• 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.
  
  
  
  

• Approved for severe osteoporosis in people after menopause who are at high risk of fracture in line with NICE.

Tablets: 200mg

Indication: Cushing's Syndrome 

• 10mg/1ml vial for injection
  • Approved for treating obesity caused by LEPR or POMC deficiency in people 6 years and over in line with NICE and any associated NHSE Commissioning Guidance
  • Approved for treating obesity and hyperphagia in Bardet-Biedl syndrome in people 6 years and over, only if they are between 6 and 17 years when treatment starts in line with NICE and any associated NHSE Commissioning Guidance

• Approved as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age - in line with NICE TA832.

• 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

• 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:
  
  • 3mg, 11.25mg and 22.5mg

• 250mg capsules

• 3mg, 5.5mg and 11.3mg powder for solution for injection

• Approved for treating lipodystrophy in children and adults in line with NICE