• Second line treatment for eosinophilic esophagitis in adults and paediatric patients unable to manage administration of fluticasone.


• A slurry can be made by mixing the contents of budesonide nebules with a sugar solution- a patient instruction leaflet exists with directions on how to do this, see below. 

• Unlicensed medicine, still in phase 3 trials

• JDTC May 2018:- Approved for use to treat resistance to thyroid Hormone due to defective MCT8 thyroid hormone transporter (Allan Herndon Dudley Syndrome) continuation of therapy post trial, on a compassionate access basis

• Used in the treatment of pulmonary fibrosis at a dose of 600mg THREE times daily.


• Off-label for meconium ileus in neonates (often these neonates go on to be diagnoses with CF) and Distal Intestinal Obstructive syndrome in CF

Available as (all unlicensed):

L-arginine 5g/10ml injection (emergency treatment)

L-arginine oral solution 100mg/ml (on drug tariff specials list)

 L-arginine tablets 1g Urea cycle disorders, MELAS, Mitochondrial disorders (neuro)

• Adult and Paediatric - Metabolic Disorders.


• Powder is licensed for urea cycle disorders.
  For paediatric use must be specialist prescribed


• Powder is non formulary

• CUHFT and NWAFT: Severe malaria falciparum.


• ID/Micro recommended only.

• For consideration when powder unavailable or patient intolerant to.


• 500mg

• Unlicensed


• Approved for use in paeds patients with chronic constipation and ACE formation

CUHFT:

• Approved clinically  for symptomatic Adenovirus infection in immunosuppressed patients including transplant recipients with specified criteria including toxicity experienced by cidofovir subject to agreed supply from manufacturer


• Please contact ChimerixNPP@ubc.com to apply for use if patient likley to be eligible


• 100mg oral tablets and 10mg/ml oral solution (both unlicensed) only available through expanded access/compassionate use programme.Phase III trial product in the US only


• Hospital only via inpatient pharmacy  


• Standard dose for >or = to 50kg is 100mg twice weekly and for < 50kg is 2mg/kg twice weekly (max. 100mg twice weekly).


• If a patient is taking ciclosporin then dose of 1.4mg/kg (up to max. of 70mg) twice weekly is recommended for 5 weeks or until Adenovirus cleared.

Injection 5mg/ml BASE (10mg/ml caffeine citrate)- licensed
Oral Solution 5mg/ml BASE (10mg/ml caffeine citrate)- unlicensed for use in NICU/paeds

CUHFT only:

• Clinically approved by CUHFT for up to seven children aged 2-8 years with at least one life threatening episodes per month (requiring urgent medical assessment or rescue therapy), with either Dravets or Lennox-Gastaut syndromes causing epilepsy, on the basis of recommendation of RCP and ABPN interim guidance (see document below).


• Current best evidence for the use of cannabis based medicinal products suggests efficacy and short-term safety of Epidiolex® (cannabidiol) in two epileptic encephalopathies (Dravet and Lennox-Gastaut syndromes)


• There is no licensed cannabis based medicinal product available in the UK; Epidiolex® is licensed in the US (but not in the UK or Europe) for Dravet and Lennox-Gastaut syndromes only.


• Access to Epidiolex is limited to a compassionate use programme (max 5 patients allocated to CUHFT)


• Epidiolex® is not currently commissioned; NICE is due to review clinical and cost effectiveness and is expected to publish guidance by the end of 2019.


• Patients will need to be consented in line with current policies on the use of unlicensed medicines and compassionate use.


• Epidiolex® is available in 100mg/ml. The starting dose is 2.5mg/kg twice daily, after a week this can be increased to a maintenance dose of 5mg/kg twice daily and this can be increased further to a max. of 10mg/kg twice daily as tolerated.

Medical device
Contains:-
Dibasic Sodium Phosphate 0.052, Monobasic Sodium Phosphate 0.009, Calcium Chloride 0.052, Sodium Chloride 0.569, Purified water qs (%w/w).
To treat and prevent oral mucositis caused by radiation or high dose chemotherapy
Hospital only

• JDTC May 2019: clinically approved to trat acquired thrombotic thrombocytopenic purpura (aTTP) via compassionate access scheme only


• Drug is licensed but not yet launched in the UK


• Can be obtained out of hours in emergency from company (they operate 24hrs)


• 10mg powder adn solvent for injection. Normally given as 10mg i/v given with plasma exchange followed by 10mg s/c daily for 30 days

Due to be licensed as Labtayo® in near future

• JDTC/OSTS April 2019. Clinically approved as per compassionate access scheme for cutaneous squamous cell cancer  ie.e. free of charge scheme only


• 350mg/7ml solution infusion

Unlicensed medicine.
Available as 2,000IU and 5,000IU
Imported from Italy.
JDTC Jan ’18:-
o Clinically and financially approved
o Formulary status: Hospital only via clinic
To be used by Cambridge IVF for hypogonadoptrophanism to aid spermatogenesis and

the HCG stimulation test, to determine the Leydig cell responsiveness of the testes.

this replaces Pregnyl which has now been discontinued. Gonasi and Pregnyl are conisdered to be therapeutically equivalent. There is no UK licensed product available in strength required.

250mg/5ml

 For chronic hypoglycaemia

* For use when supply issues with tablets

Standard dose is 5mg/kg/day

• 4mg adnd 12mg kit for implant
  
  


• JDTC Sept 2018: Approved as per NHSE CCP

JDTC July 2014: Agreed for migraine prophylaxis (incl. in paeds population)

To be  prescribed as a 3^rd or 4^th line for patients with difficult to manage migraine, where other conventional agents and botulinum toxin have not been. Flunarizine is  an earlier option for patients with prominent aura or hemiplegic migraine.

JDTC Dec 2017:
Stat dose of 100mg as challenge (indotest) for responsive headaches; hemichrania continua and paroxysmal hemichrania to be given on R3 day unit
If test positive then treatment with po thereafter should continue (unless contra-indicated) as specialist advice except in circumstances where above licensed dose is recommended and GPs may be unhappy to prescribe in which case hospital should conitnue

• CUHFT: Restricted to use in Pre-operative patch testing and ENT


• NWAFT: Restricted to use in ENT


• Non-formulary at all other Trusts and in Primary Care

For paediatric ENT and anaethestitst use only for topicalisation of the airway

CUHFT only

• Unlicensed import


• Approved for hot flushes caused by hormonal treatment of breast cancer


• Dose is 20mg once or twice daily for a maximum of 6 months


• Full course dispensed in one episode from Lloyds OP

CUHFT

• Oct 2018,licensed product supersedes leptin that was the previous product available as free of charge and is no longer available


• For use by endocrinologists for lipodystrophy, partial lipodystrophy and congential leptin deficiency


• A compassionate supply of licensed product has been offered for existing pateints who were already receiving leptin until NICE considers this product.


• Applications to use for any patient would need to be via a chairs action

JDTC March 2018: Approved for the 1st line treatment for fungal keratitis

Natamycin 5% eye drops are a licensed drug in the U.S

Standard dose: 1 drop every 2 hours during the day between 6 am and 10 pm for 3 days and reduced to 6 times a day for 2 weeks and then 4 times a day for 4-6 weeks

Normal treatment course is 4-6 weeks (1-2 bottles), patient will be regularly reviewed within that time. Hospital only via LLoydsds outpatients

For paediatrics only

• CUH: Neonates and paediatrics.

• CUH: Paediatric neurologists for epilepsy in children with suspected pyridoxal phosphate sensitive seizures or folinic acid responsive seizures.

Remdesivir in the treatment of COVID-19 is being made available on EAMS (updated 12.06.20)

Indicated for:

The treatment of adults and adolescent patients aged ≥ 12 years and weighing at least 40 kg hospitalised with suspected or laboratory confirmed SARS-CoV-2 infection and severe disease. 

Patients with severe disease are those with an SpO2 ≤ 94% on room air or requiring supplemental oxygen, or requiring non-invasive or invasive ventilation or extracorporeal membrane oxygenation (ECMO).

Prescribing clinicians will need to follow the MHRA Treatment Protocol when initiating therapy (https://www.gov.uk/government/publications/early-access-to-medicines-scheme-eams-scientific-opinion-remdesivir-in-the-treatment-of-patients-hospitalised-with-suspected-or-laboratory-confirme)  

Children aged 12 and under and pregnant mothers are able to access remdesivir through a separate compassionate use scheme.

The supply allocation to individual NHS hospitals will be determined each week.

New registrations to the EAMS in England have now closed. Trusts must retrospectively complete a remdesivir Blueteq form in order to register patients who have received remdesivir and in order to receive further allocated stock.

• Revatio 10mg/12.5ml solution for injection vials                      


• JDTC April 2019 -Clinically approved as a 2^nd line additional agent for pulmonary hypertension in neonates especially in cases with congenital diaphragmatic hernia (CDH),when nitrous oxide alone ineffective, and patient is NBM so cannot have oral sildenafil


• Suggested dosing 25 mcg/kg/hour (note per HOUR, not per minute) increasing every 6-12 hours by 25 mcg/kg/hour to a maximum of 100 mcg/kg.hour i.e (0.6mg/kg/day- 2.4mg/kg/day), normally fro a max. of 7 days

• 2g/10ml injection, 500mg/5ml oral solution, 125mg/5ml oral solution (paeds only), 500mg tablets 


• For urea cycle disorders, for paediatric use must be specialist advice only

• Urea cycle disorders


• Tablets and granules also allowed and these are licensed


• For paeds metabolic disorders on specilaist advice only

• CUHFT only - these will be dispensed from clinical trials dispensary for named patients only (FOC) for prevention of cisplatin-induced hearing loss. 

• 
  

  JDTC Dec 2015

  
  
  
  
  • Tacrolimus suppositories (Licensed drug, unlicensed formulation and indication) clinically and financially approved for use in refractory proctitis unresponsive to first-line agents have been approved for use in up to 20 patients per annum by the gastroenterologists, subject to an audit being completed assessing safety and efficacy at year 1.
  
  
  • Hospital only.
  
  
  • Dose 2mg twice daily for weeks (treatment should be discontinued after 4 weeks or one week after a patient enters clinical remission). The anticipation is that a patient may require up to 3 courses per annum
  
  
  
  Batch has expiry date of 30 days

October 2013 JDTC

• FOC supply only.


• Rheumatoid arthritis treatment licensed in the US.Patients to be cesased if compassionate access programme ceased.
  JDTC Jan '18
  Approved as per NICE TA
  Bluteq required

Oct 2018 JDTC:-

• Approved for use in ulcerative colitis via free of charge scheme from manufacturer. Full NICE TA is due imminently

• Injection given orally.


• Limited evidence.


• Dr Fitzgerald for gastroendoscopy. The use of acetylcysteine provided better visual examination of the GI tract, stomach and oesophagus, therefore enhancing early diagnosis.


• Off-label for meconium ileus in neonates (often these neonates go on to be diagnoses with CF) and Distal Intestinal Obstructive syndrome in CF

• CUHFT: Approved for use as a stat dose (rarely repeated once) for severe cases of acute retinal necrosis. Hospital only via inpatient pharmacy.

• 
  

  *Inflectra® as brand of choice.  If you require any support with prescribing please contact biologics pharmacy team  on distribution list ‘pharmacy biologics’.*

  
  1.All new Infliximab patients to be prescribed Inflectra.
  

  2.All infliximab prescriptions to be prescribed using a therapy plan in EPIC. 

  
  


• Ipilimumab associated Immune-related diarrhoea.

See section 15.02

JDTC July 2018: Moviprep, neomycin and metronidazole combination ( mechanical bowel preparation and antibiotics)  for elective bowel cancer resections in adults approved for use on day prior to surgery as follows;

Macrogol (2 x sachet and 2 sachet B- given as A +B)   twice daily

Neomycin 1g three times daily                 

Metronidazole 400mg three times daily    

To be prescribed by surgeon in clinic, dispensed from Lloyds

• CUH: Paediatric neurologists for epilepsy in children with suspected pyridoxal phosphate sensitive seizures or folinic acid responsive seizures.

• JDTC April 2015 approved for thromboembolism prophylaxis in lower limb injury requiring immobilisation started in ED only in 16 years and over (off label use).


• JDTC May 2016 Clinically approved for VTE prophylaxis in acetabular and pelvic fracture for 3 months by Orthopaedic team. Funding/tariff now agreed.Full 12 weeks to be supplied from Lloyds (off label use).


• JDTC February 2019 approved for superficial thrombophlebitis - 10mg daily for 6 - 12 weeks. Hospital only via Lloyds OP (off label use). 

• As per NHSE Commissioning policy for Takayasu arteritis.


• JDTC July 2018: Approved for use as per NICE TA 518 criteria

• CUHFT: Hospital only via Lloyds for acute retinal necrosis. Usual dosage 2g three times daily for 3 weeks followed by 1g three times daily for 3 months.

June 2020 - Supply issues with valaciclovir 500mg tablets

• Ranbaxy and Aurobindo the generic suppliers are both out of stock with resupply dates to be confirmed.
• GSK, the supplier of the brand Valtrex, has confirmed sufficient supplies are available to meet normal UK demand.

• 40% diluted to 4% soak.


• For soaking warts.