There is no data on removal or dissolution of the implant.
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as Goserelin. Patients should be informed accordingly and treated as appropriate if symptoms occur.
Androgen deprivation therapy may prolong the QT interval.
In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see Interactions) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Zoladex LA.
Injection site injury has been reported with Zoladex LA, including events of pain, haematoma, haemorrhage and vascular injury. Monitor affected patients for signs or symptoms of abdominal haemorrhage. In very rare cases, administration error resulted in vascular injury and haemorrhagic shock requiring blood transfusions and surgical intervention. Extra care should be taken when administering Zoladex LA to patients with a low BMI and/or receiving full anticoagulation medications (see Dosage & Administration).
Males: The use of Zoladex LA in patients at particular risk of developing ureteric obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. If spinal cord compression or renal impairment due to ureteric obstruction are present or developed, specific standard treatment of these complications should be instituted.
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 Zoladex) at the start of LHRH analogue therapy since this has been reported to prevent the possible sequelae of the initial rise in serum testosterone.
The use of LHRH agonists may cause reduction in bone mineral density. In men, preliminary data suggest that the use of a bisphosphonate in combination with an LHRH agonist may reduce bone mineral loss. Particular caution is necessary in patients with additional risk factors for osteoporosis (e.g. chronic alcohol abusers, smokers, long-term therapy with anticonvulsants or corticosteroids, family history of osteoporosis).
Patients with known depression and patients with hypertension should be monitored carefully.
Myocardial infarction and cardiac failure were observed in a pharmacoepidemiology study of LHRH agonists used in the treatment of prostate cancer. The risk appears to be increased when used in combination with anti-androgens.
Reduction in glucose tolerance has been observed in men receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in patients with pre-existing diabetes mellitus. Thus, monitoring blood glucose levels should be considered.
Treatment with Zoladex may lead to positive reactions in anti-doping tests.
Females: In women, Zoladex LA 10.8mg is only indicated for use in breast cancer in premenopausal women. For female patients requiring treatment with goserelin for other conditions, refer to the prescribing information for Zoladex 3.6mg.
In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority. In patients receiving Zoladex 3.6mg for the treatment of endometriosis, the addition of hormone replacement therapy (a daily oestrogenic agent and a progestogenic agent) has been shown to reduce bone mineral loss and vasomotor symptoms. There is no experience of the use of hormone replacement therapy in women receiving Zoladex LA 10.8mg.
Time to return of menses after cessation of therapy with Zoladex 10.8 mg may be prolonged in some patients.
Effects on ability to drive or operate machinery: Zoladex LA has no or negligible influence on the ability to drive and use machinery.
Use in Children: Zoladex LA is not indicated for use in children, as safety and efficacy have not been established in this patient group.