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Presentation

Implants of leuprorelin.

Drugs List

  • leuprorelin 10.72mg implant
  • STALADEX 10.72mg implant
  • Therapeutic Indications

    Uses

    Carcinoma - prostate

    Treatment of hormone-dependent, advanced prostate cancer.
    Treatment of high risk, localised and locally advanced, hormone-dependent prostate cancer in combination with radiotherapy.

    Dosage

    Adults

    1 implant once every 3 months.

    Administration

    For abdominal subcutaneous injection.

    Contraindications

    Children under 18 years
    Females
    Long QT syndrome
    Orchiectomy
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Obesity
    Predisposition to diabetes mellitus
    Predisposition to seizures
    Tobacco smoking
    Cerebral metastases
    Chronic alcoholism
    Diabetes mellitus
    Electrolyte imbalance
    Epileptic disorder
    History of depression
    History of seizures
    History of torsade de pointes
    Spinal cord compression
    Spinal metastasis
    Urinary obstruction
    Vertebral metastases

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Consider anti-androgen treatment to prevent initial testosterone increase
    Prostate cancer: Prophylaxis of flare with anti-androgen is recommended
    Monitor testosterone levels at baseline and periodically during treatment
    Perform digital rectal examination & PSA prior to and following treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    If spinal cord compression present/develops,use specific standard treatment
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor hepatic function
    Monitor patient for signs and symptoms of depression
    Monitor patients with brain metastases for the first few weeks of therapy
    Monitor patients with metabolic disorders
    Monitor patients with pre-existing hypertension
    Monitor patients with urinary obstruction for the first weeks of therapy
    Monitor serum electrolytes
    Monitor testosterone level in event of injection site abscess
    Advise patient to report any new or worsening depression/suicidal ideation
    Advise patient to report sudden headache, vomiting or visual disturbances

    Pregnancy and Lactation

    Pregnancy

    Not indicated for use in women.

    Lactation

    Not indicated for use in women.

    Side Effects

    Alopecia
    Anaemia
    Anaphylactic reaction
    Back pain
    Blood glucose disturbances
    Blood lipid changes
    Blood pressure changes
    Bone pain
    Decrease in bone mineral density
    Decreased appetite
    Depression
    Diarrhoea
    Dizziness
    Dry mucous membranes
    Dry skin
    Dysgeusia
    Dysuria
    Eosinophilia
    Erectile dysfunction
    Erythema at injection site
    Fatigue
    Fever
    Gynaecomastia
    Headache
    Hot flushes
    Increased appetite
    Increased sweating
    Increases in hepatic enzymes
    Injection site reactions
    Interstitial lung disease
    Jaundice
    Joint pain
    Leukopenia
    Local pain (injection site)
    Mood changes
    Muscle weakness
    Nausea
    Night sweats
    Nocturia
    Oedema (injection site)
    Palpitations
    Paraesthesia
    Peripheral oedema
    Pituitary apoplexy
    Pollakiuria
    Prolongation of QT interval
    Pruritus
    Pulmonary embolism
    Rash
    Reduced libido
    Seizures
    Sleep disorders
    Testicular atrophy
    Testicular pain
    Thrombocytopenia
    Urinary obstruction
    Visual disturbances
    Vomiting
    Weight changes

    Overdosage

    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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: January 2020

    Reference Sources

    Summary of Product Characteristics: Staladex 10.72mg Implant. Typharm Limited. Revised October 2019.

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

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.