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Parenteral formulations of buserelin.

Drugs List

  • buserelin 5.5mg/5.5ml injection
  • SUPRECUR 5.5mg/5.5ml injection
  • SUPREFACT 5.5mg/5.5ml injection
  • Therapeutic Indications


    Advanced prostate cancer
    Pituitary desensitisation in preparation for ovulation induction regimes



    Advanced prostate cancer
    Initial treatment: 500 micrograms every 8 hours for 7 days.

    For maintenance treatment, on the 8th day change to intranasal buserelin.

    Pituitary desensitisation before induction of ovulation by gonadotrophins
    200 to 500 micrograms once a day as a single injection.

    Treatment should start in the early follicular phase (day 1) or, if pregnancy has been excluded, in the mid-luteal phase (day 21), until down-regulation has been achieved (serum estradiol less than 180picomol / l and serum progesterone less than 3nanomol / l). Usually between 1 and 3 weeks.

    Dosage may need to be increased up to 500 micrograms twice daily to achieve these levels or adjusted according to individual response.

    Once down-regulation has been achieved, stimulation with gonadotrophin is started whilst the dose of buserelin is maintained. When the appropriate stage of follicular development is reached, the gonadotrophin and buserelin are both stopped, and human chorionic gonadotrophin (hCG) is then given to induce ovulation.

    Treatment monitoring, fertilisation techniques and oocyte transfer should be carried out according to the normal practices of the individual clinic.

    Luteal support with hCG or progesterone should be given as appropriate.


    For subcutaneous injection only.


    Hormone dependent neoplasm
    Hormone-refractory prostatic cancer
    Undiagnosed gynaecological haemorrhage

    Precautions and Warnings

    Family history of long QT syndrome
    Predisposition to long QT syndrome
    Predisposition to prolongation of QT interval
    Diabetes mellitus
    History of long QT syndrome
    History of torsade de pointes
    Long QT syndrome
    Metabolic bone disease
    Polycystic ovarian syndrome

    Not effective following surgical removal of testes
    Advise patient dizziness may affect ability to drive or operate machinery
    Evaluate patients for cardiovascular disease prior to treatment
    Not all available brands are licensed for all indications
    Prostate cancer: Prophylaxis of flare with anti-androgen is recommended
    Treatment to be initiated and supervised by a specialist
    Contains benzyl alcohol
    Exclude pregnancy prior to initiation of treatment
    Monitor plasma testosterone levels before and 3 monthly during treatment
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor blood pressure in hypertensive patients
    Monitor closely patient with depression
    Monitor estradiol and progesterone levels closely during treatment
    Monitor for occurrence of anaemia
    Monitor patients with cardiovascular conditions
    Monitor stimulation cycle
    Review treatment if deterioration of cardiovascular disease
    Disease flare may occur at beginning of treatment
    May increase follicle recruitment in polycystic ovarian syndrome
    May precipitate depression
    Ovarian cysts can develop in the initial treatment phase
    Ovarian hyperstimulation syndrome can occur
    Discontinue if no improvement in spite of adequate testosterone suppression
    Discontinue if testosterone levels do not reach therapeutic range in 4-6wks
    Advise patient to seek medical advice if reaction occurs on self-injection

    Caution is required in patients with metabolic bone disease because reduced bone mineral density can occur. Periodically monitor bone mineral density and use preventative measures during therapy to prevent osteopenia/osteoporosis in patients with additional risk factors for osteoporosis, including chronic alcohol abuse, smoking, long term treatment with anticonvulsants or corticosteroids or a family history of osteoporosis.

    Pituitary desensitisation prior ovulation induction regimes
    The combined use of buserelin and gonadotrophins may constitute a higher risk of ovarian hyperstimulation syndrome (OHSS) than with gonadotrophins alone. Monitor the stimulation cycle carefully to identify patients at risk of developing OHSS, the addition of hCG should be withheld if necessary.

    Symptoms of OHSS include:
    abdominal pain
    abdominal tension
    weight gain
    ovarian cysts
    ovarian enlargement

    An acute abdomen may occur as a result of pedicle tension or rupture of the ovary. Severe OHSS may result in thromboembolic events, with the possibility of fatal outcomes.

    Treatment of prostate cancer
    Clinical improvement should become apparent once testosterone levels have begun to fall below their baseline concentration. If testosterone levels do not reach the therapeutic range within 4 to 6 weeks the dosage schedule should be checked to ensure it is being followed exactly. In the unlikely event that a patient receiving the full dose does not show a suppression of testosterone to the therapeutic range, an alternative therapy should be considered.

    Following the initial determination of testosterone levels, monitoring should be carried out at 3 monthly intervals. Absence of clinical improvement despite adequate testosterone suppression may be indicative of a tumour that is unresponsive to hormone manipulation. In these circumstances continuing therapy will not yield further benefit and treatment should be discontinued.

    Pregnancy and Lactation


    Buserelin is contraindicated in pregnancy.

    At the time of writing there is little published information regarding the use of buserelin during pregnancy.

    Much of the data concerning the safety of GnRH analogues have not demonstrated serious side effects such as miscarriage, birth defects or foetal growth restriction. However it is suggested GnRH analogues can cross the placenta due to their relatively low molecular weight therefore there is still concern about the effects on the CNS (Schaefer et al, 2015). In several studies the children of pregnant women exposed to GnRH antagonists during pregnancy have shown subsequent neurological development disorders, however Schaefer states although it is not recommended to use GnRH analogues during pregnancy, they are also not contraindicated.

    The manufacturer states the use of buserelin is contraindicated during pregnancy and suggests pregnancy must be excluded before starting treatment.

    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 ( ).


    Buserelin is contraindicated in breastfeeding.

    Buserelin is excreted in breast milk in small quantities. At the time of writing there is limited published information regarding the use of buserelin during breastfeeding. Studies have not shown buserelin to cause harm to breastfed infants, however the manufacturer suggest to avoid the use of buserelin during breastfeeding.

    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

    Allergic asthma with dyspnoea
    Anaphylactic shock
    Blood lipid changes
    Blurred vision
    Bone pain (transient)
    Breast tenderness
    Changes in breast size
    Changes in libido
    Changes in scalp or body hair
    Concentration disturbances
    Contact lenses may irritate
    Decrease in bone mineral density
    Decreased glucose tolerance
    Decreased glycaemic control in diabetes
    Deterioration in blood pressure in hypertensive patients
    Deterioration in general well-being
    Difficulty in micturition
    Disturbances of appetite
    Dry skin
    Dryness of eyes
    Elevation of liver enzymes
    Emotional lability
    Facial oedema
    Feeling of pressure behind the eyes
    Hearing disturbances
    Hot flushes
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increased risk of fractures
    Increased sweating
    Increased thirst
    Local pain (injection site)
    Lower abdominal pain
    Memory disturbances
    Menopausal-like symptoms
    Migraine-like headache
    Mood changes
    Musculoskeletal pain
    Oedema of the extremities (arms and legs)
    Ovarian cysts
    Ovarian hyperstimulation syndrome (OHSS)
    Pituitary adenomas
    Prolongation of QT interval
    Pulmonary embolism
    Rise in the serum testosterone level (transient)
    Serum bilirubin increased
    Shoulder pain
    Skin reddening
    Sleep disturbances
    Splitting nails
    Stomach pain
    Testicular atrophy
    Tumour flare
    Tumour pain
    Vaginal bleeding on withdrawal
    Vaginal discharge
    Vaginal dryness
    Weakness of legs
    Weight changes
    Worsening depression


    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: August 2017

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Suprefact Injection. Aventis Pharma Limited. Revised February 2015.

    Summary of Product Characteristics: Suprecur Injection. Aventis Pharma Limited. Revised February 2015.

    NICE Evidence Services Available at: Last accessed: 03 August 2017

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