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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
1. Please refer to Appendix 11 of the BHT Medicines Policy for full details of policies and procedures for the prescribing, preparation and administration of chemotherapy (including intrathecal chemotherapy)

2. Use chemotherapy in accordance with NHSE National dose banding tables. For latest version see here.
 Details...
08.03.04.02  Expand sub section  Cancer: gonadorelin analogues and gonadotrophin-releasing hormone antagonists
08.03.04.02  Expand sub section  Gonadorelin analogues
08.03.04.02  Expand sub section  Anti-androgens
Abiraterone Actetate 500mg
(tablet)
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Restricted Drug Restricted
Red
High Cost Medicine
Restricted - prescribing by Consultant Oncologists (prostate) only

1. For patients with castration resistant metastatic prostate cancer in accordance with NICE TA259. NICE compliance form required - see link from Formulary homepage

2. For the treatment of metastatic hormone-relapsed prostate cancer before chemotherapy is indicated in accordance with NICE TA387 and NHSE SSC 1637. A completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required. 
Link  NICE TA 259: Abiraterone for castration resistant prostate cancer
Link  NICE TA387: Abiraterone for treating metasatic hormone-relapsed prostate cancer before chemotherapy is indicated
   
Bicalutamide 50mg, 150mg
(tablet)
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Formulary
Amber Recommended

Prescribing on the recommendation of a specialist, continuation by GPs.


For treatment of  tumour flare in prostate cancer.  Use in accordance with guideline BHTCG 789FM Gonadorelin analogues for use in prostate cancer.  

 
Link  Gonadorelin analogues for use in prostate cancer - Amber Recommendation guideline (BHTCG 789FM)
   
Cyproterone Acetate 50mg, 100mg
(tablet)
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Formulary
Green
 
Link  MHRA Drug Safety Update:- Cyproterone acetate: new advice to minimise risk of meningioma (June 2020)
   
Enzalutamide 40mg
(capsule)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.
Restricted - prescribing by Consultant Oncologists (Prostate) for:
1. Treatment of metastatic hormone-relapsed prostate cancer in adults whose disease has progressed during, or after, docetaxel-containing chemotherapy, in accordance with NICE TA316
2. Treatment of metastatic castration-resistant hormone relapsed prostate cancer before chemotherapy is indicated in accordance with NICE TA 377 
Link  NICE TA 316: Enzalutamide for metastatic hormone‑relapsed prostate cancer previously treated with a docetaxel‑containing regimen
Link  NICE TA 377: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
   
Flutamide 250mg
(tablet)
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Formulary
Amber Recommended

Prescribing on the recommendation of a specialist, continuation by GPs.


For treatment of  tumour flaire in prostate cancer. 

 
   
Goserelin 3.6mg, 10.8mg (Zoladex®)
(implant)
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Restricted Drug Restricted
Amber Recommended

Sub-cutaneous injection every 28 days.

For treatment of prostate cancer.  Use in accordance with guideline BHTCG 789FM Gonadorelin analogues for use in prostate cancer.


Non-formulary for endocrine uses  (section 06.07.02)


 

 
Link  Gonadorelin analogues for use in prostate cancer - Amber Recommendation guideline (BHTCG 789FM)
   
Triptorelin 11.25mg (Decapeptyl® SR)
(injection)
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Restricted Drug Restricted
Amber Recommended

Intra-muscular injection every 3 months.


For treatment of prostate cancer. Use in accordance with guideline BHTCG 789FM Gonadorelin analogues for use in prostate cancer.


Triptorelin  22.5mg SR injecton is first choice gonadorelin analogue for metastatuc prostate cancer.


See Section 06.07.02 (Endocrine uses) for treatment of endometriosis and uterine fibroids.

 
Link  Gonadorelin analogues for use in prostate cancer - Amber Recommendation guideline (BHTCG 789FM)
   
Triptorelin 22.5mg (Decapeptyl® SR)
(injection)
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Restricted Drug Restricted
Amber Recommended

Intra-muscular injection, every 6 months.


First choice Gonadorelin analogue for treatment of metastatic prostate cancer. Use in accordance with guideline BHTCG 789FM Gonadorelin analogues for use in prostate cancer.


 

 
Link  Gonadorelin analogues for use in prostate cancer - Amber Recommendation guideline (BHTCG 789FM)
   
Triptorelin 3mg (Decapeptyl® SR)
(injection)
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Restricted Drug Restricted
Amber Recommended

Intra-muscular injection every 4 weeks.


For treatment of prostate cancer. Use in accordance with guideline BHTCG 789FM Gonadorelin analogues for use in prostate cancer.


Triptorelin 22.5mg SR injecton is first choice gonadorelin analogue for metastatuc prostate cancer.


See Section 06.07.02 (Endocrine uses) for treatment of endometriosis or uterine fibroids. 

 
Link  Gonadorelin analogues for use in prostate cancer - Amber Recommendation guideline (BHTCG 789FM)
   
08.03.04.02  Expand sub section  Gonadotrophin-releasing hormone antagonists
 ....
 Non Formulary Items
Buserelin  (Suprefact®)
(Prostate)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
 
Leuprorelin Acetate  (Prostap® 3, Prostap® SR)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
 
  
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

Black

Not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.
Drugs which have been evaluated and rejected by the Medicines Value Group (MVG)
Drugs defined as ‘Low Priority’ by the South Central Priorities Committee
New drugs which have not as yet been evaluated by the MVG
Any drug not listed in the Buckinghamshire Formulary  

Red

Drugs which should only be prescribed in secondary care by a specialist.
Require specialist knowledge and/or equipment for patient selection and initiation
Require long term on-going monitoring and dose adjustment to ensure efficacy and minimise toxicity by a specialist
Designated as “hospital only“ by product licence, NICE, DoH or BNF
May need further evaluation by a specialist
Are hospital initiated clinical trial materials  

Red Specialist Centre

As for ‘red’ (above) with the addition of the following:
Designated by NHS England to require initiation by or in prior agreement with a Specialist Centre. Continuation where appropriate by BHT (or other secondary care provider)
Detailed requirements for Specialist Centre initiation to be described in the wording of the formulary restriction  

Amber Protocol

Drugs which should be initiated in secondary care by the specialist with follow-on prescription and monitoring according to a drug specific Shared Care Protocol(SCP). Prescribing may be continued in primary care following the SCP
Require specialist knowledge and/or equipment for patient selection and initiation
Require short or medium term (eg. 3 to 6 months) specialist monitoring of efficacy or toxicity. The need for stabilisation will vary with different drugs and patients, but is usually a minimum of 2 months (see principles for shared care)
Require significant long term monitoring
Require ongoing communication between the GP and the specialist
Have clearly defined consultant, GP and patient responsibilities documented in a shared care protocol (see responsibilities for amber protocol drugs)  

Amber Initiation

Drugs suitable for primary care prescribing following specialist initiation
Require specialist knowledge and/or equipment for patient selection
Monitoring does not require specialist knowledge or equipment
If the drug is one with which the primary care prescriber is unfamiliar the specialist is expected to provide sufficient information on the drug indication, dose, duration , monitoring and any further necessary dose adjustments
Require the first prescription to be written by the specialist  

Amber Recommended

Drugs suitable for primary care prescribing following specialist recommendation
As for amber initiation except that:- The first prescription may be written by the GP after specialist recommendation.  

Green

Drugs for which primary care prescribers would normally take full responsibility for prescribing and monitoring
Drugs not included in the Traffic Light list but included on joint formulary.
New drugs classified as red or amber but as greater experience regarding their safety and efficacy is established may move to Green after re-consideration by the MVG and APC.  

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