Data extracted : 24/11/2017
 Formulary Section 20: Unlicensed Medicines / Significant off-label use
Includes unlicensed medicines and off-label use
20 Unlicensed Medicines
Restricted Drug  Acetylcysteine  
Supported by TAS May 2005 To avoid renal impairment following the use of contrast media
Restricted Drug  Adalimumab (Immunology) 
Behcet’s Disease restricted to specialist immunology use only.
Off label use

Restricted Drug  Ajmaline  
For provocation testing in Brugada syndrome

Specialist cardiology use only in adult and paediatric patients
Restricted Drug  Alemtuzumab  
For Graft versus Host Disease

Restricted Drug  Duloxetine  
For Fibromyalgia
For use by pain clinic only
Restricted Drug  Fumaderm  
Restricted Drug  Gabapentin 
Congenital nystagmus
For use by Professor Gottlob only. First line choice except for patients with multiple sclerosis where memantine is first line choice
Restricted Drug  GHRH and L Arginine  
Specialist endocrinology use only
Diagnostic test for growth hormone reserve
Restricted Drug  Hydroxycobalamin   (Cyanokit ®)
Cyanide poisoning for use in A&E only
Short shelf life and difficulty in predicting no of vials required.
Restricted Drug  Infliximab (Immunology) 
Behcet’s Disease restricted to specialist immunology use only. Off-label use. Currently using Remicade brand in existing patients and Inflectra to be used in new patients
Restricted Drug  Levosimendan  
Specialist paediatric cardiology use only for patients with low output cardiac syndrome unresponsive to other therapies
Restricted Drug  Lidocaine, Adrenaline and Tetracaine Gel (LAT)  
For use in A&E only
Restricted Drug  Memantine  
For use by Professor Gottlob only
Supported for use for acquired nystagmus in 2002. Also supported for use in congenital nystagmus. This would be first line for those with multiple sclerosis and second line after gabapentin for remaining patients.
Restricted Drug  Bosentan (Rheumatology) 
For severe digital ulceration in scleroderma /
Raynaulds restricted to initiation by consultant Rheumatologists.
Restricted Drug  Mycophenolate  
Interstitial lung diseases (Connective tissue disease related ILD) unresponsive to other immunosuppressives

Starting criteria: A patient with Interstitial lung disease of the ‘non-specific interstitial pneumonitis’ or connective tissue disease related variety, or severe refractory cryptogenic organising pneumonia - Response to other immunosuppressives such as prednisolone, cyclophosphamide or azathiaprine -Inability to continue with other immunosuppressives due to cumulative toxicities - Recommendation from Interstitial lung disease MDT - No contraindications

Stopping criteria: - Intolerance of medication - Deterioration in symptoms, pulmonary function testing and radiographically
Restricted Drug  Mycophenolate mofetil 
Specialist Rheumatology prescribing for severe lupus, severe polymyositis, systemic vasculitis.

For use in patients who have not responded to other treatment options. Recommendation that protocol is developed and that use is subject to agreement by 2 consultants from differing specialities where possible
Restricted Drug  Mycophenolate mofetil  
Specialist haematology use in graft versus host disease in bone marrow transplant
Restricted Drug  Naltrexone 
Pruritis in chronic liver disease if other therapies have not been effective
Restricted Drug  Sildenafil (PAH) 
For Pulmonary Arterial Hypertension in adults restricted to initiation by consultants at Adult Congenital Heart Disease Centre in line with NHSE policy and shared care agreement with Sheffield. Continuation of supply should be undertaken by Sheffield through homecare

NB use of generic preparation 25mg, 50mg, 100mg tablets is significantly lower than the branded Revatio.
Restricted Drug  Sildenafil (Rheumatology) 
For severe digital ulceration in scleroderma /
Raynaulds restricted to initiation by consultant Rheumatologists.
NB use 25mg, 50mg, 100mg tablets only
Restricted Drug  Sodium Butyrate enema  
Distal ulcerative colitis
Restricted Drug  Stanozolol  
Prophylaxis of acute attacks in hereditary angioedema
Second line after danazol.
Supported by TAS Feb 15 for prescribing by Dr Duddridge via FP10
Restricted Drug  Oxandrolone 
Prophylaxis of acute attacks in hereditary angioedema

Third line after danazol and stanozolol when stanozolol is unavailable.
Restricted Drug  Timolol gel 0.5%  (Timoptol LA®)
Small infantile haemangiomas. Specialist initiation as per GOSH guidelines.
Restricted Drug  Tissue Plasminogen Activator (tPa) - Alteplase 
Massive submacular haemorrhage. Restricted to use by consultant retinal ophthalmologists only.
Restricted Drug  Fomepizole  
For treatment of ethylene glycol and methanol poisoning
Restricted Drug  Magnesium Sulphate IV  
Consultant use only for life threatening asthma in line with BTS guidelines