8.3. Sex hormones and hormone antagonists in malignant disease
Restrictions: The treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases is restricted to specialist use in accordance with regional protocol (in development) when the service infrastructure is in place to support the safe delivery of this treatment.
Use of Lubion® injection is restricted to women who are unable to use or tolerate vaginal preparations.
Use for luteal support as part of an assisted reproductive technology (ART) treatment program for infertile women is restricted to specialist use only in line with national guidance.
8.3.4. Hormone antagonists
220.127.116.11. Breast cancer
Use in combination with tamoxifen or an aromatase inhibitor, for adjuvant treatment of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy is restricted to specialist initiation in accordance with regional protocol (in development).
For other indications for triptorelin, see sections 6.7.2 and 18.104.22.168
Restricted to specialist use in accordance with regional protocol for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.
The following indication is not recommended by SMC and remains non-Formulary:
- Treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy
Restrictions: Restricted to specialist initiation.
Excludes tamoxifen liquid.
For the management of advanced breast cancer (in pre- and peri- menopausal women), goserelin (but not Zoladex LA®) is approved where other treatments have failed.
For other indications, see sections 6.7.2 and 22.214.171.124
126.96.36.199. Gonadorelin analogues and gonadotrophin-releasing hormone antagonists
Restricted to specialist initiation in accordance to regional protocols for the following indications:
- Prostate cancer
- Breast cancer:
- Treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation
- Use as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence
- Prostap® is the first line LHRH agonist for new patients with prostate cancer based on regional recommendations following the development of a national consensus statement.
- Prostap® is available in two different presentations; Prostap® 3 DCS and Prostap® SR DCS, which have different frequencies of administration and as such, should be prescribed by brand name clearly specifying the preparation to avoid confusion.
- Please note, although other brands of leuprorelin are available, the regional recommendation relates to Prostap® only.
Restricted to use in accordance with regional protocol for metastatic castration resistant prostate cancer (mCRPC).
The Regional Protocol for metastatic castration resistant prostate cancer (mCRPC) can be accessed here (NHS network access required).
Non- formulary indication:
- Treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) is not recommended by SMC
Restricted to specialist use in accordance with regional protocol for the indications as outlined below.
Metastatic castration resistant prostate cancer (mCRPC):
- Use in adult men in whom chemotherapy is not yet clinically indicated after failure of androgen deprivation therapy according to regional protocol
- Use in adult men who have received only one prior chemotherapy regimen (The Regional Protocol can be accessed here - NHS network access required)
- With prednisone or prednisolone for the treatment of newly diagnosed high-risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy. Click here for regional protocol (NHS network access required)
Restrictions: Restricted to specialist initiation. Owing to the risk of hepatotoxicity, cyproterone should be used for long-term treatment only where other treatments are not tolerated.
- Decapeptyl SR 11.25mg is restricted for treatment of advanced prostate cancer in patients for whom the use of triptorelin is appropriate and would benefit from reduced frequency of administration compared with Decapeptyl SR 3mg.
- Triptorelin 22.5mg injection (Decapeptyl SR) for the treatment of locally advanced, non-metastatic or metastatic prostate cancer should be in accordance with Regional Protocol.
For other indications for triptorelin, see section 6.7.2 and 188.8.131.52
- Gonapeptyl Depot has not been recommended by SMC for the treatment of advanced prostate cancer
Note: This Formulary entry relates to triptorelin acetate and triptorelin pamoate. Triptorelin embonate is not indicated for prostate cancer and is not included in the GGC Formulary. Care should be taken to ensure the correct triptorelin preparation is prescribed and dispensed.
184.108.40.206. Somatostatin analogues
Restricted to specialist use for the treatment of adults with acromegaly for whom surgery is not an option is has been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Pasireotide is non-Formulary for the treatment of Cushing's disease in adults for whom surgery is not an option or where surgery has failed (not recommended for use in NHSScotland).
Restrictions: Restricted to specialist initiation. The use in the treatment of thyrotrophic adenomas is non-Formulary.