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Injection site injury has been reported with ZOLADEX, 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 results in vascular injury and haemorrhagic shock requiring blood transfusions and surgical intervention. Extra care should be taken when administering ZOLADEX 3.6 mg/ZOLADEX LA 10.8 mg to patients with a low body mass index and/or receiving full anticoagulation medications.
The use of ZOLADEX 3.6 mg/ZOLADEX LA 10.8 mg in men 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 develop, specific standard treatment of these complications should be instituted.
The use of LHRH agonists may cause a reduction in bone mineral density. Currently available ZOLADEX 3.6 mg data indicate a mean loss of 4.6% in vertebral bone mineral density following a six month course of treatment with progressive recovery to a mean loss compared to baseline of 2.6% six months after cessation of treatment. In patients receiving ZOLADEX 3.6 mg 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 density loss and vasomotor symptoms. In men, preliminary data suggest the use of a bisphosphonate in combination with a LHRH agonist may reduce mineral loss.
A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes mellitus. Consideration should therefore be given to monitoring blood glucose.
Androgen deprivation therapy may prolong the QT interval, although a causal association has not been established with ZOLADEX. In patients with a history of or who have risk factors for QT prolongation and in patients receiving concomitant medicinal products that may prolong the QT interval (see Interactions) physicians should assess the benefit risk ratio including the potential for Torsade de Pointes prior to initiating ZOLADEX.
Cardiovascular Diseases: Increased risk of myocardial infarction and sudden cardiac death has been reported in association with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice.
Zoladex: ZOLADEX 3.6 mg should be used with caution in women with known metabolic bone disease.
ZOLADEX 3.6 mg may cause an increase in uterine cervical resistance, which may result in difficulty in dilating the cervix.
Currently, there are no clinical data on the effects of treating benign gynaecological conditions with ZOLADEX 3.6 mg for periods in excess of six months.
Androgen deprivation therapy may prolong the QT interval. In patients with a history of or who have risk factors for QT prolongation and in patients receiving concomitant medicinal products that may prolong the QT interval, physicians should assess the benefit risk ration including the potential for Torsade de Pointes prior to initiating ZOLADEX.
Assisted Reproduction: ZOLADEX 3.6 mg should only be administered as part of a regimen for assisted reproduction under the supervision of a specialist experienced in the area.
As with other LHRH agonists, there have been reports of ovarian hyperstimulation syndrome (OHSS) associated with the use of ZOLADEX 3.6 mg, in combination with gonadotrophin. It has been suggested that the downregulation achieved with a depot agonist may lead, in some cases, to an increased requirement for gonadotrophin. The stimulation cycle should be monitored carefully to identify patients at risk of developing OHSS because its severity and incidence may be dependent on the dose regimen of gonadotrophin. Human chorionic gonadotrophin (hCG) should be withheld, if appropriate.
It is recommended that ZOLADEX 3.6 mg be used with caution in assisted reproduction regimens in patients with polycystic ovarian syndrome as follicle recruitment may be increased.
Zoladex LA: In women, ZOLADEX LA 10.8 mg is only indicated for use in endometriosis, fibroids and breast cancer in premenopausal women. For female patients requiring treatment with goserelin for other conditions, refer to the prescribing information for ZOLADEX 3.6 mg. There is no experience of the use of hormone replacement therapy in women receiving ZOLADEX LA 10.8 mg.
Time to return of menses after cessation of therapy with ZOLADEX LA 10.8mg may be prolonged in some patients.
The use of ZOLADEX may cause an increase in cervical resistance and care should be taken when dilating the cervix.
There are no clinical data on the effects of treating benign gynaecological conditions with ZOLADEX for periods in excess of six months.
In the case of disease progression without anti-tumour effect of ZOLADEX, multiple treatments may be considered.
Effects on ability to drive and use machines: There is no evidence that ZOLADEX 3.6 mg/ZOLADEX LA 10.8 mg results in impairment of ability to drive or operate machinery.
Use in children: ZOLADEX 3.6 mg/ZOLADEX LA 10.8 mg is not indicated for use in children as safety and efficacy have not been established in this group of patients.
