Refer to the following NICE guidelines: 

• NICE NG73: Endometriosis: diagnosis and management (September 2017)
• NICE CG164: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer (June 2013, updated November 2023)
• NICE NG101: Early and locally advanced breast cancer: diagnosis and management (July 2018, updated January 2024)
• NICE NG131: Prostate cancer: diagnosis and management (May 2019, updated December 2021)

Drugs used for breast cancer, listed elsewhere in the formulary:

• Raloxifene, see section 6.4.1 Female sex hormones and their modulators

Aromatase inhibitors

NICE NG101: Early and locally advanced breast cancer: diagnosis and management (July 2018, updated January 2024)

• Offer an aromatase inhibitor as the initial adjuvant endocrine therapy for postmenopausal women with ER‑positive invasive breast cancer who are at medium or high risk of disease recurrence

NICE CG164: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer (June 2013, updated November 2023)

• Offer anastrozole for 5 years to postmenopausal women at high risk of breast cancer unless they have severe osteoporosis 
• Consider anastrozole for 5 years for postmenopausal women at moderate risk of breast cancer unless they have severe osteoporosis 

Anastrozole

• Tablets 1mg (£1.19 = 1mg once daily)

Indications and dose

• Adjuvant treatment of oestrogen-receptor-positive early invasive breast cancer in postmenopausal women
  • 1mg daily
• Adjuvant treatment of oestrogen-receptor-positive early breast cancer in postmenopausal women following 2–3 years of tamoxifen therapy
  • 1mg daily
• Advanced breast cancer in postmenopausal women which is oestrogen-receptor-positive or responsive to tamoxifen
  • 1mg daily
• Chemoprevention of breast cancer in postmenopausal women at moderate to high risk (refer to NICE CG164)
  • 1mg daily for 5 years

Exemestane

• Tablets 25mg (£4.87 = 25mg once daily)

Indications and dose

• Adjuvant treatment of oestrogen-receptor-positive early breast cancer in postmenopausal women following 2–3 years of tamoxifen therapy
  • 25mg daily
• Advanced breast cancer in postmenopausal women in whom anti-oestrogen therapy has failed
  • 25mg daily

Letrozole

• Tablets 2.5mg (£1.76 = 2.5mg once daily)

Indications

• First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer
• Adjuvant treatment of oestrogen-receptor-positive invasive early breast cancer in postmenopausal women
• Advanced breast cancer in postmenopausal women (naturally or artificially induced menopause) in whom other anti-oestrogen therapy has failed
• Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received standard adjuvant tamoxifen therapy for 5 years
• Neo-adjuvant treatment in postmenopausal women with localised hormone-receptor-positive, human epidermal growth factor-2 negative breast cancer where chemotherapy is not suitable, and surgery not yet indicated

Dose

• Adult: 2.5mg daily

Notes

1. Manufacturer advises effective contraception required until postmenopausal status fully established (return of ovarian function reported in postmenopausal women).

Anti-oestrogens

NICE NG101: Early and locally advanced breast cancer: diagnosis and management (July 2018, updated January 2024)

• Offer tamoxifen as the initial adjuvant endocrine therapy for men and premenopausal women with ER‑positive invasive breast cancer
• Offer tamoxifen to postmenopausal women with ER-positive invasive breast cancer who are at low risk of disease recurrence, or if aromatase inhibitors are not tolerated or are contraindicated

NICE CG164: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer (June 2013, updated November 2023)

• Unless the patient has a past history or may be at increased risk of thromboembolic disease or endometrial cancer:
  • Offer tamoxifen for 5 years to premenopausal women at high risk of breast cancer
  • Offer tamoxifen for 5 years to postmenopausal women at high risk of breast cancer who have severe osteoporosis or do not wish to take anastrozole
  • Consider tamoxifen for 5 years for premenopausal women at moderate risk of breast cancer
  • Consider tamoxifen for 5 years for postmenopausal women at moderate risk of breast cancer who have severe osteoporosis or do not wish to take anastrozole
• If they have no history or increased risk of thromboembolic disease, consider raloxifene for 5 years for postmenopausal women with a uterus at moderate or high risk of breast cancer who have severe osteoporosis or do not wish to take anastrozole or tamoxifen (see section 6.4.1 Female sex hormones and their modulators)

Tamoxifen

• Tablets 10mg, 20mg, 40mg (£2.49 = 20mg once daily)
• Oral solution sugar free 10mg/5ml (£217.32 = 20mg once daily)

Indications and dose

• Pre- and perimenopausal women with oestrogen-receptor-positive breast cancer not previously treated with tamoxifen
  • Adult: 20mg daily
• Chemoprevention of moderate-to-high risk breast cancer in women
  • Adult: 20 mg daily for 5 years

Notes

1. Effective contraception must be used during treatment and for 2 months after stopping.
2. Inform women that they should stop tamoxifen at least:
   1. 2 months before trying to conceive
   2. 6 weeks before elective surgery.
3. Tamoxifen is used for the prevention of gynaecomastia in men, but it is not licensed for this indication.
4. MHRA Drug Safety Update (November 2010): Tamoxifen for breast cancer: Drug interactions involving CYP2D6, genetic variants, and variability in clinical response. Advice for healthcare professionals:
   1. Concomitant use of drugs that are potent inhibitors of the CYP2D6 enzyme should be avoided whenever possible in patients treated with tamoxifen for breast cancer.
   2. Current data for the effect of genetic polymorphisms are insufficient to support recommending genotyping of patients.

Elacestrant

• Tablets 86mg, 345mg

Notes

1. NICE TA1036 (February 2025): Elacestrant (Korserdu) is recommended as an option for treating oestrogen receptor (ER)-positive HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation that has progressed after at least 1 line of endocrine treatment plus a cyclin-dependant kinase (CDK) 4 and 6 inhibitor in: women, trans men and non-binary people who have been through the menopause, and trans women and men. It is only recommended if the cancer has progressed after at least 12 months of endocrine treatment plus a CDK 4 and 6 inhibitor, and the company provides it according to the commercial arrangement.

Fulvestrant

• NICE TA239 (December 2011): Fulvestrant (Faslodex) is not recommended, within its marketing authorisation, as an alternative to aromatase inhibitor drugs for the treatment of oestrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women whose cancer has relapsed on or after adjuvant anti-oestrogen therapy, or who have disease progression on anti-oestrogen therapy.
• NICE TA503 (January 2018): Fulvestrant (Faslodex) is not recommended, within its marketing authorisation, for treating locally advanced or metastatic oestrogen-receptor positive breast cancer in postmenopausal women who have not had endocrine therapy before.

Gonadotrophin-releasing hormones (GnRH) analogues

Gonadorelin analogues are contraindicated where there is undiagnosed vaginal bleeding, in pregnancy and in breast-feeding.

Triptorelin is the preferred first choice GnRH analogue where appropriate for newly diagnosed patients.

Efficacy is the same for all GnRH analogues. Patients can be switched from one GnRH analogue to another with no loss of efficacy. There is no trial data to demonstrate that switching between agents is unsafe and the likelihood of patients experiencing problems is very low.

Triptorelin

• Powder and solvent for prolonged-release suspension for injection vials 3mg (I/M injection every 4 weeks) (£69.00 = 4 weeks)
• Powder and solvent for prolonged-release suspension for injection vials 11.25mg (I/M injection every 3 months) (£207.00 = 3 months)
• Powder and solvent for prolonged-release suspension for injection vials 22.5mg (I/M injection every 6 months) (£414.00 = 6 months)

Indications

• Endometriosis (maximum duration of treatment 6 months; do not repeat)
• Uterine fibroids (maximum duration of treatment 6 months; do not repeat)
• Prostate cancer

Notes

1. West Devon: refer to individual shared care guidelines.
2. Triptorelin is available as a 1-month, 3-month or a 6-month injection. Not all injections are licensed for all indications, prescribers should check the individual product SPCs.
3. Dosing intervals and regimes vary depending on individual patient clinical history. Often secondary care initiate therapy with a 1-month injection; it is advised that GPs consider treatment tolerability before extending dosing interval to 3 or 6 months. Specialist advice should be sought for guidance where the individual patient management plan is unclear.
4. The injection should be given intramuscularly, ideally in the gluteal muscle. Inject the contents of the syringe immediately to avoid precipitation.

Goserelin

• Implant pre-filled syringes 3.6mg (every 4 weeks) (£70.00 = 4 weeks)
• Implant pre-filled syringes 10.8mg (every 12 weeks) (£235.00 = 12 weeks)

Indications

• Endometriosis (maximum duration of treatment 6 months; do not repeat)
• Uterine fibroids (for up to 3 months before surgery)
• Prostate cancer
• Breast cancer
• Endometrial thinning before intra-uterine surgery (4 to 8 weeks' treatment)
• IVF (hospital only)

Notes

1. West Devon: refer to individual shared care guidelines.
2. Not all injections are licensed for all indications, prescribers should check the individual product SPCs.

Relugolix

• Tablets 120mg (£81.62 = 120mg once daily)
  

Indication and dose

• Prostate cancer in line with NICE TA995 (see note 8)
  • 360mg (three tablets) on the first day, followed by a 120mg once daily
  • Hepatic impairment: no dose adjustment for mild or moderate impairment. No pharmacokinetic data in severe impairment.
  • Renal impairment: no dose adjustment for mild or moderate impairment. Refer to SmPC for severe impairment.
    

Notes

1. Refer to the entry for Ryeqo below for the combination product (relugolix / estradiol / norethisterone) for the treatment of uterine fibroids.
2. Treatment initiation:
   1. Specialist to provide first prescription for relugolix. Primary care may be asked to continue prescribing.
3. Because relugolix does not induce an increase in testosterone concentrations, it is not necessary to add an anti-androgen as surge protection at initiation of therapy.
4. If treatment with relugolix is interrupted for greater than 7 days, it must be restarted with a loading dose of 360mg on the first day, followed by 120mg once daily.
5. Drug interactions: refer to the BNF or SmPC for advice if concurrent use of a p-glycoprotein inhibitor or combined p-glycoprotein / strong CYP3A inducer is required. An increase in the daily dose of relugolix is required if co-administered with a combined p-glycoprotein / strong CYP3A inducer.
6. Monitor liver function in patients with known or suspected hepatic disorder during treatment (refer to SmPC). Specialist to advise on monitoring.
7. Contraception: if a patient engages in sexual intercourse with a woman of childbearing potential, effective contraception must be used, during treatment and for up to 2 weeks after the last dose of this medicine (SmPC).
8. NICE TA995 (August 2024): Relugolix is recommended, within its marketing authorisation, as an option for treating prostate cancer in adults:
   1. with advanced hormone-sensitive prostate cancer
   2. alongside radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer
   3. as neoadjuvant treatment before radiotherapy for high-risk localised or locally advanced hormone-sensitive prostate cancer.

Anti-gonadotrophin-releasing hormones

Degarelix

• Powder and solvent for solution for injection vials 80mg, 120mg

Notes

1. NICE TA404: Degarelix (Firmagon) is recommended as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the NHS in June 2016 (August 2016).
2. The routine commissioning of degarelix is not accepted in Devon for the management of advanced hormone-dependent prostate cancer in patients without spinal metastases (see Commissioning Policy for more details).

Linzagolix

• Tablets 100mg, 200mg

Indication

• Moderate to severe symptoms of uterine fibroids in adults of reproductive age only if it is intended to be used for longer-term treatment (normally for more than 6 months) in line with NICE TA996 (see note 4)

Dose

• With hormonal add-back therapy: linzagolix 200mg once daily plus Kliovance 1mg/0.5mg once daily
• Without hormonal add-back therapy: linzagolix 200mg once daily for 6 months, then 100mg once daily
• Preferably start treatment with linzagolix in the first week of the menstrual cycle
• Hepatic impairment: no dose adjustment in mild or moderate impairment. Patients with liver disease: see SmPC.
• Renal impairment: Monitor for adverse effects in mild impairment (eGFR 60-89 mL/min/1.73m²), no dose adjustment required. Avoid if eGFR <60 mL/min/1.73m²

Notes

1. Pregnancy must be ruled out prior to initiating treatment or re-initiating treatment. See note 2 below on contraception.
2. Contraception
   1. Any hormonal contraception needs to be stopped prior to initiation of treatment.
   2. Linzagolix with or without concomitant hormonal add-back therapy has not been demonstrated to provide contraception.
   3. Women of childbearing potential at risk of pregnancy must use effective non-hormonal contraception while on treatment with linzagolix.
3. If concomitant hormonal add-back therapy is prescribed, refer to the add-back therapy SmPC for information on contraindications, precautions and warnings, and drug interactions.
4. NICE TA996 (August 2024): Linzagolix is recommended as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age only if:
   1. it is intended to be used for longer-term treatment (normally for more than 6 months and not for people who need short-term treatment, for example, before planned surgery)
   2. the following dosage is used:
      1. with hormonal add-back therapy (ABT): 200mg once daily
      2. without hormonal ABT: 200mg once daily for 6 months, then 100mg once daily.

Ryeqo

(Relugolix with estradiol hemihydrate and norethisterone acetate)

• Tablets (relugolix 40mg, estradiol 1mg, norethisterone 0.5mg)

Indication

• Moderate to severe symptoms of uterine fibroids in adults of reproductive age in line with NICE TA832

Dose

• One tablet once daily
  • First tablet must be taken within 5 days of onset of menstrual bleeding
• Hepatic impairment: no dose adjustment in mild or moderate hepatic impairment. Patients with liver disease: see SmPC
• Renal impairment: no dose adjustment required

Notes

1. Prescribe by brand (to aid identification where products contain multiple ingredients).
2. Pregnancy must be ruled out prior to initiating treatment or re-initiating treatment. See note 4 on contraception.
3. Ryeqo contains estradiol and a progestin. See the SmPC for information on contraindications, precautions and warnings, and drug interactions.
4. Contraception:
   1. Any hormonal contraception needs to be stopped prior to initiation of treatment. Concomitant use with Ryeqo is contraindicated.
   2. Non-hormonal methods of contraception must be used for at least 1 month after initiation of Ryeqo. Ryeqo provides adequate contraception after at least one month of use.
   3. Women of childbearing potential must be advised that ovulation will return rapidly after discontinuing treatment. See SmPC for further information.
   4. If doses are missed for 2 or more consecutive days, a nonhormonal method of contraception is to be used for the next 7 days of treatment.
5. NICE TA832: Relugolix–estradiol–norethisterone acetate (Ryeqo) is recommended as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age (October 2022).

Anti-androgens

Cyproterone acetate

• See section 6.4.2 Male sex hormones and antagonists

Bicalutamide

• Tablets 50mg, 150mg (£1.66 = 50mg x 28 tablets; £3.06 = 150mg x 28 tablets)

Indication

• Prostate cancer

Notes

1. Bicalutamide does not suppress testosterone and can therefore avoid the distressing effects of testosterone suppression, particularly in asymptomatic men. Bicalutamide is not licensed for metastatic disease.
2. Bicalutamide is the only anti-androgen licensed as a single agent for monotherapy in a patient with locally advanced disease. The dosage of bicalutamide is 150mg daily as a single agent, or 50mg daily when given in conjunction with gonadorelin analogue injection therapy. Care should be taken to ensure correct choice of dose.

Flutamide

• Tablets 250mg (£167.88 = 250mg x 84 tablets)

Indication

• Prostate cancer

Notes

1. Prevention of tumour flare in patients starting treatment with gonadorelin analogues should be achieved by the use of flutamide 250mg three times daily starting at least 3 days before the gonadorelin analogue and continuing for 3 weeks.
2. Flutamide does not suppress testosterone and can therefore avoid the distressing effects of testosterone suppression, particularly in asymptomatic men.

Abiraterone

• Tablets 250mg, 500mg

Notes

1. NICE TA259: Abiraterone (Zytiga) in combination with prednisone or prednisolone is recommended as an option of castration-resistant metastatic prostate cancer in adults, only when the criteria of the NICE TA are met (July 2016).
2. NICE TA387: Abiraterone (Zytiga) in combination with prednisone or prednisolone is recommended as an option for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated (July 2016).
3. NICE TA721: Abiraterone (Zytiga) with prednisone or prednisolone plus androgen deprivation therapy (ADT) is not recommended, within its marketing authorisation, for treating newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer in adults (August 2021).

Apalutamide

• Tablets 60mg

Notes

1. NICE TA740: Apalutamide (Erleada) plus androgen deprivation therapy (ADT) is recommended, within its marketing authorisation, as an option for treating hormone‑relapsed non‑metastatic prostate cancer that is at high risk of metastasising in adults. High risk is defined as a blood prostate-specific antigen (PSA) level that has doubled in 10 months or less on continuous ADT, only if the company provides it according to the commercial arrangement (October 2021).
2. NICE TA741: Apalutamide (Erleada) plus androgen deprivation therapy (ADT) is recommended as an option for treating hormone-sensitive metastatic prostate cancer in adults (October 2021), only if:
   1. docetaxel is not suitable
   2. the company provides apalutamide according to the commercial arrangement.

Darolutamide

• Tablets 300mg

Notes

1. NICE TA660: Darolutamide (Nubeqa) with androgen deprivation therapy (ADT) is recommended, within its marketing authorisation, as an option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease (November 2020).
2. NICE TA903: Darolutamide (Nubeqa) with docetaxel is recommended, within its marketing authorisation, as an option for treating hormone-sensitive metastatic prostate cancer in adults, only if the company provides it according to the commercial arrangement (June 2023).

Enzalutamide

• Tablets 40mg

Notes

1. NICE TA316: Enzalutamide (Xtandi) is recommended as an option for treating metastatic hormone-relapsed prostate cancer in adults whose disease has progressed during or after docetaxel-containing chemotherapy (July 2014).
2. NICE TA377: Enzalutamide (Xtandi) is recommended as an option for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated (January 2016).
3. NICE TA580: Enzalutamide (Xtandi) is not recommended for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults (May 2019).
4. NICE TA712: Enzalutamide (Xtandi) plus androgen deprivation therapy (ADT) is recommended, within its marketing authorisation, as an option for treating hormone-sensitive metastatic prostate cancer in adults,  only if the company provides it according to the agreed commercial arrangement (July 2021).

Radiotherapy

Radium [RA-223] dichloride

• Xofigo [RA-223] solution for injection vials 6.6MBq/6ml

Notes

1. NICE TA412 Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (NHS England commissioned) (September 2016).

Lutetium [177Lu] oxodotreotide

• Solution for infusion vials 7,400MBq/20.5-25ml

Notes

1. NICE TA539: Lutetium (177Lu) oxodotreotide (Lutathera) is recommended as an option for treating unresectable or metastatic, progressive, well-differentiated (grade 1 or grade 2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs) in adults (August 2018).

Lutetium [LU-177] vipivotide tetraxetan

• NICE TA930: Lutetium-177 vipivotide tetraxetan (Pluvicto) is not recommended, within its marketing authorisation, for treating prostate-specific membrane antigen (PSMA)-positive hormone-relapsed metastatic prostate cancer in adults (November 2023):
  • after taxane-based chemotherapy and an anti-androgen or
  • when taxanes are 'medically unsuitable'.

Intrabeam radiotherapy system

• NICE TA501: Intrabeam radiotherapy system for adjuvant treatment of early breast cancer (January 2018):
  • The Intrabeam radiotherapy system is not recommended for routine commissioning for adjuvant treatment of early invasive breast cancer during breast-conserving surgical removal of the tumour.
  • Use of the Intrabeam radiotherapy system is recommended only using machines that are already available and in conjunction with NHS England specified clinical governance, data collection and submission arrangements.

Somatostatin analogues

Lanreotide

• Powder and solvent for suspension for injection vials 30mg
• Solution for injection pre-filled syringes 60mg/0.5ml, 90mg/0.5ml, 120mg/0.5ml

Indications

• Acromegaly (NHS England Commissioned)
• Gastropancreatic tumours (NHS England Commissioned)

Octreotide

• Solution for injection ampoules 50micrograms/1ml, 100micrograms/1ml, 500micrograms/1ml, 1mg/5ml
• Powder and solvent for suspension for injection vials 10mg, 20mg, 30mg

Indications

• Acromegaly (NHS England Commissioned)
• Gastropancreatic tumours (NHS England Commissioned)

Pasireotide

• Solution for injection ampoules 300micrograms/1ml, 600micrograms/1ml, 900micrograms/1ml

Indications

• Cushing's disease

Notes

1. For the treatment of Cushing's disease in line with the NHS England Commissioning Policy.

Miscellaneous

Padeliporfin

• NICE TA546: Padeliporfin (Tookad) is not recommended, within its marketing authorisation, for untreated, unilateral, low-risk prostate cancer in adults (November 2018).