Zoladex/Zoladex LA Special Precautions

The use of ZOLADEX/ZOLADEX LA 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.
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.
Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men.
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 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/ZOLADEX LA.
Injection site injury has been reported with ZOLADEX/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/ZOLADEX LA to patients with a low BMI and/or receiving full anticoagulation medications [see Dosage & Administration].
Effect on ability to drive or operate machinery: There is no evidence that ZOLADEX/ZOLADEX LA results in impairment of ability to drive or operate machinery.
Use in Children: ZOLADEX/ZOLADEX LA is not indicated for use in children, as safety and efficacy have not been established in this group of patients.
Zoladex: 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 an LHRH agonist may reduce bone mineral loss.
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.
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: ZOLADEX LA 10.8 mg is not indicated for use in females, since there is insufficient evidence of reliable suppression of serum oestradiol. For female patients requiring treatment with goserelin, refer to the prescribing information for ZOLADEX 3.6mg.