Buserelin

Registered South African indications:

• Advanced prostatic cancer

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Tumour insensitive to hormone manipulation 
• After surgical removal of the testes
• Newborns or premature neonates

Cautions

• Renal impairment
• Hepatic impairment
• History of depression
• Hypertension
• History or risk factors for QT prolongation
• Risk factors for osteoporosis
• Diabetes mellitus
• Patients with known metastases

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

Used for the treatment of

Advanced prostatic cancer
- In which suppression of testosterone production is indicated

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Consult specialist for dosages and regimens

No information available

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Nervousness
• Emotional instability
• Anxiety
• Depression 
• Mood changes
• Dizziness
• Headache
• Sleep disturbances
• Tiredness
• Drowsiness
• Occasional paraesthesia 
• Disturbances of memory and concentration
• Neurological deficit 

Cardiovascular Disorders

• Palpitations
• QT prolongation
• Occasional oedema 
• Hot flushes
• Hypertension

Gastrointestinal Disorders

• Lower abdominal pain
• Stomach ache
• Nausea and vomiting
• Diarrhoea
• Constipation

Hepatobiliary Disorders

• Increase in serum hepatic enzyme levels 
• Increase in serum bilirubin

Genitourinary Disorders

• Gynaecomastia 
• Atrophy of the testes
• Decrease in libido and potency
• Increased serum testosterone 
• Impaired micturition
• Hydronephrosis

Endocrine and Metabolic Disorders

• Change in weight 
• Changes in appetite 
• Increased thirst
• Change in blood lipid levels
• Reduced glucose tolerance 

Musculoskeletal Disorders

• Musculoskeletal discomfort and pain 
• Decreased bone density 
• Osteoporosis 
• Increased risk of bone fracture
• Bone pain
• Muscle weakness 

Skin and Subcutaneous Tissue Disorders

• Dry skin
• Acne
• Alopecia
• Hirsutism
• Change in body hair
• Splitting nails
• Reddening of the skin
• Itching
• Skin rashes 

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia 
• Leucopenia
• Hypersensitivity reactions 
• Shock 
• Allergic asthma with dyspnoea 
• Anapylactic shock
• Local reaction at the injection site
• Lymphostasis
• Thrombosis with pulmonary embolism
• Tumour pain 
• Pituitary adenomas 

Sensory Disorders

• Dry eyes 
• Impaired vision 
• Pressure behind the eyes
• Tinnitus
• Hearing disorders

Others

• Deterioration in general well 

• Antidiabetic agents 
• QT prolonging agents
• Medicinal products able to induce Torsade de pointes

• Serum testosterone levels
• Prostate specific antigen
• Prostatic acid phosphatase 
• Bone scan

Specific cases may require

• Blood glucose
• Blood pressure
• Computerized tomography scan/ IV pyelogram/ Ultrasound
• Digital rectal examination
• ECG 
• Serum oestradiol levels
• Electrolytes

Buserelin is a synthetic peptide. It is a superactive analogue of natural gonadotrophin releasing hormone (gonadorelin, LHRH or GNRH). After an initial stimulation of gonadotrophin release, it down-regulates the hypothalanic-pituitary-gonadal axis.

Implant 9.9mg

• Suprefact (Sanofi Aventis) originator