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 Formulary Chapter 6: Endocrine system - Full Chapter
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06.07.02  Expand sub section  Drugs affecting gonadotrophins
 note 

GnRH analogues (including goserelin) for the treatment of patients with gender dysphoria are classified as Amber 2 (specialist recommendation) in line with NHS England guidance (pg 30-31) Dosing and monitoring information is contained in the Royal College of Psychiatrists guidelines (see page 39 onwards).

Cetrorelix (Cetrotide)
View adult BNF View SPC online View childrens BNF
Restricted Drug Restricted
Red
Injection
Restricted for use by Nurture clinic
Red - Treatment of infertility
 
   
Danazol
View adult BNF View SPC online View childrens BNF
Restricted Drug Restricted
Red

Capsule

  • Discontinued Decmber 2019. No new patients to be started. Unlicensed supplies may be available for patients taking for unlicensed indications and unable to be switched to alternatives. See CAS alert for more info.
 
   
06.07.02  Expand sub section  Gonadorelin analogues
Buserelin
(Infertility/ endometriosis)
View adult BNF View SPC online View childrens BNF
Restricted Drug Restricted
Red
Nasal spray - for endometriosis restricted to NUH only
Injection - Restricted to Nurture clinic only as per approved guidelines
  • For malignant disease indications See section 8.3.4.2 
  •    
    Nafarelin
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    Nasal spray
  • Restricted for use by Nurture clinic
  • Red - Treatment of infertility, restricted to Nuture clinic 
  •    
    Triptorelin
    (Non- malignant indications)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red

    Decapeptyl® SR:
    Injection MR 3mg - 1 monthly
    Injection MR 11.25mg - 3 monthly
    Injection MR 22.5mg - 6 monthly - only approved for use in precocious puberty
    (The slightly different doses are due to whether or not it includes the overage and is caused by European labelling rules)

    • Traffic light classifications:
      Red - Gynae indications
      Red - Chronic pain of unknown origin
      Red - Precocious puberty
    • For malignant disease indications see section 8.3.4.2
     
    Link  Click here for independent reviews
       
    06.07.02  Expand sub section  Breast pain (mastalgia)
     ....
     Non Formulary Items
    Ganorelix  (Orgalutran®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
     
    Gestrinone  (Dimetriose)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
     
    Goserelin
    (Non- malignant indications)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Red
  • Triptorelin preferred for all indications except breast cancer
  • For malignant disease indications See section 8.3.4.2
  • Classified Red for the treatment of infertility and Gynaecological conditions
  • See notes above for the treatment of patients with gender dysphoria
  •  
    Leuprorelin
    (Non- malignant indications)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Red
  • Triptorelin preferred
  • For malignant disease indications see section 8.3.4.2
  • Classified red for the treatment of infertility and Gynaecological conditions
  •  
    Triptorelin  (Gonapeptyl Depot)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    See above for Decapeptyl SR
     
    Triptorelin  (Salvacyl®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
     
    Ulipristal  (Esmya)
    (fibroids)

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

    Tablets.

    • Ulipristal 5mg tablets have been discontinued and must not be started for new patients and should be stopped for existing patients as soon as possible due to risk of liver injury - see MHRA Advice
    • Note that the recall does not affect the 30mg single dose emergency contraceptive product.
    Link  MHRA Recall: All Esmya 5mg recalled due to risk of liver failure (Mar2020)
    Link  MHRA safety alert - Esmya: Aug 2018
    Link  NICE guidelines on heavy menstrual bleeding
    Link  Link to reviews
     
      
    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

    Grey

    Grey / Non-Formulary: Medicines, which the Nottinghamshire APC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.
    Grey / Non-Formulary (undergoing assessment): Work is ongoing and will be reviewed at a future APC meeting.
    Grey / Non-Formulary (no formal assessment): APC has not formally reviewed this medicine or indication because it had never been requested for formulary inclusion. Often used for drugs new to market.
      

    Red

    Medicines which should normally be prescribed by specialists only. eg hospital only.
    For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.
      

    Amber 1

    Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised.
    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 Nottinghamshire APC.
      

    Amber 2

    Medicines suitable to be prescribed in primary care / general practice after specialist* recommendation or initiation.
    A supporting prescribing guideline may be requested which must have been agreed by the relevant secondary care trust DTCs and approved by the Nottinghamshire APC.
    *Specialist is defined by the APC as a clinician who has undertaken an appropriate formal qualification or recognised training programme within the described area of practice
      

    Amber 3

    Primary care/ non specialist may initiate as per APC guideline.
    The supporting prescribing guideline must have been agreed by the relevant secondary care trust D&TC(s) and approved by the Nottinghamshire APC.
      

    Green

    Medicines suitable for routine 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.   

    OTC

      

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