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Implant containing 3.6 mg goserelin.

Drugs List

  • goserelin 3.6mg implant
  • ZOLADEX 3.6mg implant
  • Therapeutic Indications


    Alternative to chemotherapy for women with ER positive early breast cancer
    Breast cancer - advanced
    Carcinoma - prostate (if suitable for hormonal manipulation)
    Pituitary downregulation prior to superovulation in assisted reproduction
    Thinning of uterine endometrium before or instead of surgery
    Treatment of endometriosis
    Treatment of uterine fibroids prior to surgery

    Treatment of prostate cancer where hormonal therapy suitable in the following settings:

    Treatment of metastatic prostate cancer.
    Treatment of locally advanced prostate cancer instead of surgical castration.
    Adjuvant to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
    Neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
    Adjuvant to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.

    Treatment of advanced breast cancer in pre- and peri-menopausal women where hormonal therapy is suitable.

    Treatment of oestrogen receptor (ER) positive early breast cancer as an alternative to chemotherapy in pre- and peri-menopausal women.

    In the management of endometriosis to reduce the size and number of endometrial lesions and alleviate pain.

    Endometrial thinning prior to endometrial ablation or resection.

    In uterine fibroids with iron to raise the blood count of patients with concomitant anaemia prior to surgery.

    To induce pituitary downregulation in assisted reproduction in preparation for superovulation.

    Unlicensed Uses

    Gonadotrophin-dependent precocious puberty



    Inject one 3.6 mg implant every 28 days.

    Inject one implant a month for up to 6 months. A second course of 6 months should not be given due to concern about loss of bone mineral density.

    Endometrial thinning
    Inject one implant, repeat in 4 weeks for women with a large uterus or to enable flexible surgical timing.

    Uterine fibroids with anaemia
    Inject one implant each month and give supplemental iron for up to 3 months before surgery.

    Assisted reproduction
    Inject one implant to downregulate the pituitary gland, as defined by serum estradiol levels similar to those observed in the early follicular phase (approximately 150 pmol/l). This will usually take between 7 and 21 days.


    Gonadotrophin-dependent precocious puberty (unlicensed)
    Inject one 3.6 mg implant every 28 days.


    The implant is injected subcutaneously into the anterior abdominal wall.

    Prior to administration the instruction card must be read.

    Rotate the injection site to prevent atrophy and nodule formation.


    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Children under 18 years
    Chronic use of drugs that cause osteoporosis
    Family history of long QT syndrome
    Females of childbearing potential
    Strong family history of osteoporosis
    Tobacco smoking
    Underweight patients
    Chronic alcoholism
    Diabetes mellitus
    History of torsade de pointes
    Long QT syndrome
    Metabolic bone disease
    Polycystic ovarian syndrome

    Concurrent HRT may reduce bone mineral loss
    Prostate cancer: Prophylaxis of flare with anti-androgen is recommended
    Treatment to be initiated and supervised by a specialist
    If spinal cord compression present/develops,use specific standard treatment
    Monitor closely men at risk of tumour flare for first month of treatment
    Monitor closely patient with depression
    Monitor ECG in patients at risk of QT prolongation
    Monitor for signs and symptoms of glucose intolerance
    Monitor patients at risk of spinal cord compression or urinary obstruction
    Monitor patients with pre-existing hypertension
    Advise patients to report signs of hypercalcaemia
    Disease flare may occur at beginning of treatment
    If ureteric obstruction present/develops,use specific standard treatment
    May cause loss of bone mineral density
    May increase follicle recruitment in polycystic ovarian syndrome
    Ovarian hyperstimulation syndrome can occur
    Not licensed for use in children under 18 years
    Endometriosis: Maximum treatment duration 6 months
    Female: Barrier or non-hormonal contraception advised during treatment
    Advise patient hyperhidrosis/hot flushes may continue after treatment stops

    The use of LHRH agonists may cause a reduction in bone mineral density. Therefore, goserelin should be used with caution when treating patients with metabolic bone disease. Bone mineral density should be monitored.

    Patients with injection site injury should be monitored for signs and symptoms of abdominal haemorrhage. Caution should be used when administering to patients with a low BMI and/or patients receiving anticoagulants.


    Consideration should be given to the initial use of an anti-androgen (e.g. cyproterone acetate 300 mg daily for three days before and three weeks after commencement of goserelin) at the start of LHRH analogue therapy since this has been reported to prevent the possible sequelae of the initial rise in serum testosterone, which may be associated with the progression of prostate cancer.

    Concurrent use of a bisphosphonate may reduce bone mineral loss.


    During early treatment vaginal bleeding may occur, usually within the first month. Such bleeding should stop spontaneously, however if this is not the case, the reason should be investigated.

    In patients receiving treatment for endometriosis, the addition of hormone replacement therapy, a daily oestrogenic and progestogenic agent, has been shown to reduce bone mineral density loss and vasomotor symptoms.

    Goserelin may cause an increase in uterine cervical resistance, dilating the cervix may become more difficult.

    Some women may enter the menopause during treatment and not resume menses after completion of therapy.

    As with other LHRH agonists, there have been reports of ovarian hyperstimulation syndrome (OHSS), associated with the use of goserelin combination with gonadotrophin. The stimulation cycle should be monitored carefully to identify patients at risk of developing OHSS because its severity and incidence may be dependent on the dose regimen of gonadotrophin. Human chorionic gonadotrophin (hCG) should be withheld, if possible.

    Pregnancy and Lactation


    Goserelin is contraindicated in pregnancy.

    Studies on the effects of goserelin during human pregnancy are very limited however, and there are concerns about the potential effects of goserelin on the foetus, along with a theoretical risk of spontaneous abortion or foetal abnormality. Most of the clinical data from the use of goserelin in this area do not indicate an association between goserelin and serious adverse effects such as increased miscarriage, birth defects or foetal growth restriction. Concern about its potential effects on the CNS exist however, and there are reports of neurological development disorders in children who were antenatally exposed to goserelin.

    Schaefer advises that inadvertent exposure is not grounds for termination or invasive diagnostic procedures.

    Animal studies regarding goserelin have shown no evidence of teratogenic potential.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Goserelin is contraindicated in breastfeeding.

    There is insufficient data concerning the use of goserelin during breastfeeding and it is unknown whether goserelin is excreted in breast milk. Due to its structure and high molecular weight however, it is considered unlikely. Caution is recommended regarding potential loss of milk supply as the effect of goserelin on milk production is unknown.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal discomfort
    Breast swelling
    Breast tenderness
    Bruising at injection site
    Cardiac failure
    Changes in breast size
    Changes in scalp or body hair
    Decrease in bone mineral density
    Decreased glucose tolerance
    Degeneration of fibroids
    Dry skin
    Erectile dysfunction
    Exacerbation of symptoms
    Gastro-intestinal disturbances
    Hepatic disorders
    Hot flushes
    Hypersensitivity reactions
    Increase in serum cholesterol (transient)
    Increased bone pain (temporary)
    Increased sweating
    Injection site reactions
    Interstitial pneumonia
    Leg cramps
    Mood changes
    Myocardial infarction
    Ovarian cysts
    Ovarian hyperstimulation
    Peripheral oedema
    Pituitary adenomas
    Pituitary apoplexy
    Premature menopause
    Prolongation of QT interval
    Psychotic disorder
    Pulmonary embolism
    Reduced libido
    Sleep disturbances
    Spinal cord compression
    Testicular atrophy
    Tumour flare
    Tumour pain
    Ureteric obstruction
    Vaginal bleeding
    Vaginal discharge
    Vaginal dryness
    Visual disturbances
    Voice changes
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2014

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Zoladex Implant 3.6mg, AstraZeneca UK Ltd. June 2015.

    NICE Evidence Services Available at: Last accessed: 07 September 2017

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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