Drug reference

Leuprorelin acetate

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 802, 803

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Drug Action

Administration of gonadorelin analogues produces an initial phase of stimulation; continued administration is followed by down-regulation of gonadotrophin-releasing hormone receptors, thereby reducing the release of gonadotrophins (follicle stimulating hormone and luteinising hormone) which in turn leads to inhibition of androgen and oestrogen production.

PDF page 802

Indications And Dose

PROSTAP 3 DCS ® Prostate cancer (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 11.25 mg every 3 months Endometriosis (specialist use only) ▶BY INTRAMUSCULAR INJECTION ▶Adult: 11.25 mg every 3 months for maximum duration of 6 months (not to be repeated), to be started during ﬁrst 5 days of menstrual cycle Pre- and perimenopausal breast cancer (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 11.25 mg every 3 months, for further information on use with adjuvant treatments, consult product literature PROSTAP SR DCS ® Prostate cancer (specialist use only) ▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR INJECTION ▶Adult: 3.75 mg every month Endometriosis (specialist use only) ▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR INJECTION ▶Adult: 3.75 mg every month for maximum duration of 6 months (not to be repeated), to be started during ﬁrst 5 days of menstrual cycle Endometrial thinning before intra-uterine surgery (specialist use only) ▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR INJECTION ▶Adult: 3.75 mg for 1 dose, dose to be given as a single dose between day 3 and 5 of menstrual cycle, 5–6 weeks before surgery Reduction of size of uterine fibroids and of associated bleeding before surgery (specialist use only) ▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR INJECTION ▶Adult: 3.75 mg every month usually for 3–4 months (maximum 6 months) Preservation of ovarian function (specialist use only) ▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR INJECTION ▶Adult: Initially 3.75 mg as a single dose 2 weeks before starting chemotherapy, followed by 3.75 mg every month for the duration of chemotherapy treatment Pre- and perimenopausal breast cancer (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 3.75 mg every month, for further information on use with adjuvant treatments, consult product literature STALADEX ® 10.72MG Prostate cancer (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 10.72 mg every 3 months, to be administered under the skin of the abdomen

PDF page 802

Contra Indications

GENERAL CONTRA-INDICATIONS Undiagnosed vaginal bleeding SPECIFIC CONTRA-INDICATIONS ▶When used for endometriosis Use longer than 6 months (do not repeat)

PDF page 802

Cautions

Diabetes. family history of osteoporosis. patients with metabolic bone disease (decrease in bone mineral density can occur). risk of spinal cord compression in men with prostate cancer. risk of ureteric obstruction in men with prostate cancer

PDF page 802

Safety

Side Effects

▶Common or very common Appetite decreased. arthralgia. bone pain. breast abnormalities. depression. dizziness. fatigue. gynaecomastia. headache. hepatic disorders. hot ﬂush. hyperhidrosis. injection site necrosis. insomnia. mood altered. muscle weakness. nausea. paraesthesia. peripheral oedema. sexual dysfunction. testicular atrophy . vulvovaginal dryness. weight change ▶Uncommon Alopecia. diarrhoea. fever. myalgia. palpitations. visual impairment. vomiting ▶Rare or very rare Haemorrhage ▶Frequency not known Anaemia. glucose tolerance impaired . hypertension. hypotension. interstitial lung disease. leucopenia. paralysis. pulmonary embolism. QT interval prolongation. seizure. spinal fracture. thrombocytopenia . urinary tract obstruction SIDE-EFFECTS, FURTHER INFORMATION In prostate cancer, during the initial stage (1–2 weeks) increased production of testosterone may be associated with progression of prostate cancer. In susceptible patients this tumour ‘ﬂare’ may cause spinal cord compression, ureteric obstruction or increased bone pain.

PDF pages 802, 803

Conception And Contraception

Non-hormonal, barrier methods of contraception should be used during entire treatment period. Pregnancy should be excluded before treatment, the ﬁrst injection should be given during menstruation or shortly afterwards or use barrier contraception for 1 month beforehand.

PDF page 803

Pregnancy

Avoid—teratogenic in animal studies.

PDF page 803

Breast Feeding

Avoid.

PDF page 803

Monitoring Requirements

▶Monitor liver function. ▶Men at risk of tumour ‘ﬂare’ should be monitored closely during the ﬁrst month of therapy.

PDF page 803

Dose and formulations

Directions For Administration

Rotate injection site to prevent atrophy and nodule formation.

PDF page 803

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Implant ▶Staladex (Typharm Ltd) Leuprorelin (as Leuprorelin acetate) 10.72 mg Staladex 10.72mg implant pre-filled syringes | 1 pre-filled disposable injection P £208.79 (Hospital only) Powder and solvent for suspension for injection ▶Prostap 3 DCS (Takeda UK Ltd) Leuprorelin acetate 11.25 mg Prostap 3 DCS 11.25mg powder and solvent for suspension for injection pre-filled syringes | 1 pre-filled disposable injection P £225.72 DT = £225.72 ▶Prostap SR DCS (Takeda UK Ltd) Leuprorelin acetate 3.75 mg Prostap SR DCS 3.75mg powder and solvent for suspension for injection pre-filled syringes | 1 pre-filled disposable injection P £75.24 DT = £75.24

PDF page 803

Dose text by age group

Adult

11.25 mg every 3 months

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

11.25 mg every 3 months for maximum duration

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

11.25 mg every 3 months, for further

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month for maximum duration of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg for 1 dose, dose to be given as a single

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month usually for 3–4 months

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

Initially 3.75 mg as a single dose 2 weeks before

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month, for further information on

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

10.72 mg every 3 months, to be administered

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Leuprorelin acetate

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 802, 803

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Drug Action

PDF page 802

Indications And Dose

PDF page 802

Contra Indications

GENERAL CONTRA-INDICATIONS Undiagnosed vaginal bleeding SPECIFIC CONTRA-INDICATIONS ▶When used for endometriosis Use longer than 6 months (do not repeat)

PDF page 802

Cautions

PDF page 802

Safety

Side Effects

PDF pages 802, 803

Conception And Contraception

PDF page 803

Pregnancy

Avoid—teratogenic in animal studies.

PDF page 803

Breast Feeding

Avoid.

PDF page 803

Monitoring Requirements

▶Monitor liver function. ▶Men at risk of tumour ‘ﬂare’ should be monitored closely during the ﬁrst month of therapy.

PDF page 803

Dose and formulations

Directions For Administration

Rotate injection site to prevent atrophy and nodule formation.

PDF page 803

Medicinal Forms

PDF page 803

Dose text by age group

Adult

11.25 mg every 3 months

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

11.25 mg every 3 months for maximum duration

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

11.25 mg every 3 months, for further

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month for maximum duration of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg for 1 dose, dose to be given as a single

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month usually for 3–4 months

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

Initially 3.75 mg as a single dose 2 weeks before

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

3.75 mg every month, for further information on

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Adult

10.72 mg every 3 months, to be administered

First-line fragment. Read the complete Indications and Dose section above.

PDF page 802

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.