4.4. Special Warnings and Precautions for Use
Addition of following:
Patients known to suffer from depression should be carefully monitored and treated if necessary during treatment with Suprefact.
In patients with hypertension, blood pressure must be monitored regularly.
In diabetic patients blood glucose levels must be checked regularly.
Disease flare is prevented by the prophylactic use of an anti-androgen so it is strongly recommended that administration of an anti-androgen be started as adjunctive therapy (e.g. cyproterone acetate, 300 mg daily) about 5 days before starting treatment. This adjunctive therapy must be continued in parallel with buserelin therapy for 3 to 4 weeks.
Neurological sequelae have been reported where secondary deposits impinge upon the spinal cord or CNS. In patients with known metastases, e.g. of the spinal column, this adjunctive therapy with an anti-androgen is indispensable to prevent initial complications up to and including , for example, spinal compression and paralysis, arising from a transient activation of the tumour and metastases.
4.6 Pregnancy and lactation
Addition of following:
Buserelin passed into breast milk in small amounts. Although negative effects on the infant have not been observed, it is recommended that breast-feeding be avoided during treatment with Suprefact in order to prevent the infant from ingesting small quantities of buserelin with breast milk.
4.8 Undesirable effects
Addition of the following:
Psychiatric disorders – Frequent nervousness, emotional instability. Occasional anxiety, depression or worsening of existing depression.
Nervous system disorders – Dizziness, headache, sleep disturbances, tiredness, drowsiness. Occasional paraesthesia (especially in the arms or legs), disturbances of memory and concentration.
Musculoskeletal and bone disorders – Frequent musculoskeletal discomfort and pain (including shoulder pain/stiffness). The use of LHRH-agonists may be associated with decreased bone density and may lead to osteoporosis and an increased risk of bone fracture. The risk of skeletal fracture increases with the duration of therapy.
Reproductive system and breast disorders – Occasional gynaecomastia (increase in breast size) which is usually painless, decrease in libido and potency.
Most of the effects listed above are directly or indirectly related to the suppression of testosterone by buserelin (symptoms of androgen deficiency).
4.9. Overdose
Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedemas of the lower extremities, and mastodynia as well as to local reactions at the injection site such as pain, haemorrhage and induration (see section 4.8). Treatment should be symptomatic.