Goserelin

Registered South African indications:

• Prostate cancer
• Breast cancer
• Endometriosis
• Uterine fibroids
• Endometrial thinning
• Assisted reproduction

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients listed
• Pregnancy
• Breastfeeding  
• Porphyria

Cautions

• Depression
• QT interval prolongation and risk factors thereof
• Ureteric obstruction (male)
• Spinal cord compression (male)
• Risk factors for decreased bone density
• Hypertension  
• Diabetes mellitus (male)
• Cardiovascular disease
• Vaginal bleeding

Forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

3.6mg injection

Males

Prostate cancer
- Management of prostate cancer suitable for hormonal manipulation

Females

Breast cancer
- Advanced or metastatic breast cancer suitable for hormonal manipulation, in pre- and perimenopausal women
- Early breast cancer, as adjuvant therapy to surgery and/or radiotherapy in pre-menopausal women with oestrogen receptor positive early breast cancer suitable for hormonal manipulation, as an alternative to chemotherapy
Endometriosis
- Relief of clinical symptoms associated with endometriosis
Uterine fibroids
- Reduction of uterine fibroid size before surgery

• SC: 3.6mg, into the anterior abdominal wall, every 28 days

Endometrial thinning
- For the pre-thinning of the uterine endometrium prior to endometrial ablation for severe dysfunctional uterine bleeding, which cannot be managed by non-surgical intervention and if unsuitable for immediate surgical intervention

• SC: One or two 3.6mg doses admin. 4 weeks apart; When 1 depot is admin., surgery should be performed at 4 weeks; Second depot may be required for the patient with a large uterus or to allow flexible timing of surgery; When 2 depots are admin., surgery should be performed within 2 weeks after the administration of the second depot

Assisted reproduction: Once pituitary down regulation has been achieved with goserelin 3.6mg, superovulation and oocyte retrieval should be carried out in accordance with normal practice

10.8mg injection

Males

Prostate cancer
- Management of prostate cancer suitable for hormonal manipulation

• SC: 10.8mg, into the anterior abdominal wall, every 3 months

Females

Endometriosis
- Relief of clinical symptoms associated with endometriosis
Uterine fibroids
- Reduction of uterine fibroid size before surgery
Breast cancer
- Management of oestrogen-receptor-positive breast cancer in premenopausal women

• SC: 10.8mg, into the anterior abdominal wall, every 12 weeks

All strengths: Goserelin should not be used for more than 6 months for gynaecological indications in women due to its effects on bone metabolism

Not indicated for use in children

Pregnancy

• Contraindicated
• Goserelin should not be used during pregnancy since concurrent use of LHRH agonists is associated with a theoretical risk of abortion or foetal abnormality. Prior to treatment, potentially fertile women should be examined carefully to exclude pregnancy. Non-hormonal methods of contraception should be employed during therapy until menses resume
• Pregnancy should be excluded before goserelin is used for fertilisation treatment. When goserelin is used in this setting, there is no clinical evidence to suggest a causal connection between goserelin and any subsequent abnormalities of oocyte development or pregnancy or outcome

Breastfeeding

• Contraindicated
• The use of goserelin during breastfeeding is not recommended

Renal Impairment

• No dose adjustment recommended 

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Porphyrinogenic (P)

Drugs in Sport

• Prohibited - In male athletes

Central Nervous System Disorders

• Decreased libido 
• Mood changes
• Depression
• Psychotic disorder
• Paraesthesia
• Spinal cord compression
• Headache

Cardiovascular Disorders

• Cardiac failure
• Myocardial infarction
• QT prolongation 
• Hot flush
• Abnormal blood pressure 

Genitourinary Disorders

• Ureteric obstruction
• Erectile dysfunction
• Vulvovaginal dryness
• Breast enlargement
• Gynaecomastia
• Breast tenderness
• Ovarian cyst
• Ovarian hyperstimulation syndrome
• Withdrawal bleeding 
• Degeneration of uterine fibroid

Endocrine and Metabolic Disorders

• Pituitary haemorrhage
• Glucose tolerance impaired
• Hypercalcaemia
• Pituitary tumour

Immune, Blood and Lymphatic System Disorders

• Drug hypersensitivity
• Anaphylactic reaction

Musculoskeletal Disorders

• Bone pain
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis
• Acne
• Rash
• Alopecia

Others

• Injection site reaction
• Tumour flare
• Tumour pain

• QT prolonging agents
• Agents which are able to induce Torsade de points
• Class IA or class III antiarrhythmics
• Methadone
• Moxifloxacin
• Antipsychotics

• Bone mineral density
• Blood glucose
• Urinary tract obstruction
• Spinal cord compression  
• Mental status
• Blood pressure

Drug-Laboratory Test Interactions

• Treatment with goserelin acetate may lead to positive reactions in anti-doping tests

Goserelin is a synthetic decapeptide analogue of luteinizing hormone-releasing hormone. It acts as a potent inhibitor of pituitary gonadotropin secretion, leading to a fall in serum testosterone concentrations in males and serum estradiol concentrations in females.

Injection 3.6mg

• Zoladex-Depot (AstraZeneca) originator

Injection 10.8mg

• Zoladex-Depot (AstraZeneca) originator