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 Formulary Chapter 20: Unlicensed Medicines / Significant off-label use - Full Chapter
20  Expand sub section  Unlicensed Medicines / Significant off-label use
Rituximab
(Other indications)
View adult BNF View SPC online View childrens BNF
Restricted Drug Restricted
GP - Red
High Cost Medicine
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NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Truxima brand is first choice (JFC March 2017).

Approved for:

  • Granulomatous–lymphocytic interstitial lung disease (GLILD); RFL ONLY (September 2016)
  • Ocular mucous membrane pemphigoid; approved for use in patients refractory to standard treatment; MEH ONLY (January 2015)
  • Neuromyelitisoptica (NMO); pending satisfactory clarification of funding/ shared care pathyway (October 2013)
  • Myasthenia Gravis; pending approval of treatment protocol and funding pathway; UCLH ONLY (October 2014)
  • Stiff person syndrome; pending approval of treatment protocol and funding pathway; UCLH ONLY (October 2014)
  • Interstitial lung disease; for 2 patient ONLY pending funding; RFH ONLY (April 2015)
  • Orbital inflammatory disease; RFH ONLY (January 2015)
  • IgG4-related disease; in line with NHS England Commissioning Policy; for RFL ONLY (March 2017)
  • Second line treatment for anti-NMDAR autoimmune encephalitis (all ages) in line with NHSE Commissioning Policy (JFC May 2018)
  • Pemphigus in line with NHSE commissioning policy (RFL only)
  • Refractory MADSAM neuropathy (RFL - Prof Ginsbery only)
  • Refractory Vasculitic neuropathy (RFL - Dr Kidd only)
  • Neurosarcoid (RFL - Dr Kidd only)

Provider notes

  • NMUH:
    • Non-formulary
  • RFL:
    • See above
  • RNOH:
    • Non-formulary
  • UCLH:
  • WH:
    • Non-formulary
 
Link  NHSE 16057/P: Rituximab for immunoglobulin G4- related disease (IgG4-RD)
Link  NHSE 170039P: Rituximab for second line treatment for anti-NMDAR autoimmune encephalitis (all ages)
TROMETAMOL (THAM) Injection
View childrens BNF
Unlicensed Drug Unlicensed
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Provider notes

  • NMUH:
    • TROMETAMOL (Tris (hydroxymethyl) aminomethane, THAM) For treatment of severe metabolic acidosis in paediatric patients. See the BNF for Children for further information. Trometamol 7.2% Injection, available from ‘special-order’ manufacturers or specialist importing companies
  • RFL:
    • Non-formulary
  • RNOH:
    • Non-formulary
  • UCLH:
  • WH:
    • Non-formulary
 
 ....
 Non Formulary Items
Papaverine
(Intraoperative vasospasm)

View adult BNF View SPC online View childrens BNF
Unlicensed Drug Unlicensed
GP - Red

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Approved as topical application intraoperatively for vasospasm during microvascular anastomosis in patients who may be undergoing free flap surgery including mandibulectomy, major glossectomy or laryngectomy (JFC March 2018)

Provider notes

  • NMUH:
    • Non-formulary
  • RFL:
    • Non-formulary
  • RNOH:
    • Non-formulary
  • UCLH:
  • WH:
    • Non-formulary
Rituximab
(Hyperhaemolysis)

View adult BNF View SPC online View childrens BNF
Non Formulary
Black

NOTE: There is more than one monograph for this medicine, click here to search for formulary status and its use for other indications. 

Not approved for treatment and prophylaxis of hyperhaemolysis (JFC July 2019).

  
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
Homecare
Homecare

Traffic Light Status Information

Status Description

GP - 1st

Medicines suitable for first-line use within primary care.

Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing. 

  

GP - 2nd

Medicines suitable for second-line use within primary care.

Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing. 

  

GP - Amber

Medicines that should be initiated by a specialist. Prescribing can be transferred to primary care once the patient has been stabilised.  

Shared care: For drugs with regular, ongoing need for monitoring and/or assessment of efficacy or toxicity. Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the North Central London JFC.

Fact sheet: For drugs with some concerns surrounding safety or efficacy but do not require regular monitoring and/or monitoring of effectiveness/toxicity.

  

GP - Red

Medicines which should normally be prescribed by specialists only (hospital only).

For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.

See link for the complete NCL Red List https://www.ncl-mon.nhs.uk/wp-content/uploads/2017/08/ncl_red_list.pdf

  

GP - Grey

Medicines on hospital formularies which have not been reviewed for suitability in primary care.  

Black

Medicines not recommended for routine use in primary or secondary care.

Medicines, which the North Central London JFC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.

  

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