Presentation and Status in Health Basket
1 X 10.8 mg/vial
Adult males (including the elderly): one depot injected subcutaneously into the anterior abdominal wall every 12 weeks.
Children: This product is not indicated for use in children.
Renal Impairment: no dosage adjustment is necessary for patients with renal impairment.
Hepatic Impairment: no dosage adjustment for patients with hepatic impairment.
This product is indicated for prostate cancer suitable for hormonal manipulation.
This product should not be given to patients with a known hypersensitivity to the active substance, or to other LHRH analogues, or to any of the excipients of this product.
This product 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. 3.6 mg. This product is not indicated for use in children, as safety and efficacy have not been established in this group of patients. 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. Page 2 of 7 2 Initially, this product, like other GnRH agonists, causes transient increases in serum levels of testosterone. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostatic cancer, may occasionally develop during the first few weeks of treatment. A small number of patients may experience a temporary increase in bone pain, which can be managed symptomatically. The use 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. Consideration should be given to the initial use of an antiandrogen (eg. cyproterone acetate 300mg daily for three days before and three weeks after commencement of this product) at the start of LHRH analogue therapy since this has been reported to prevent the possible sequelae of the initial rise in serum testosterone. 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 in men may cause a reduction in bone mineral density. In men, preliminary data suggest the use of a bisphosphonate in combination with a LHRH agonist may reduce 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. 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 Treatment may lead to positive reactions in anti-doping tests. Hyperglycemia and Diabetes Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes Cardiovascular Diseases Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.
The most commonly observed adverse reactions include hot flushes, sweating and injection site reactions.
For full details see prescribing information.
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Zoladex LA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated
Pregnancy and Lactation
This product is not indicated for use in females.
There is limited experience of overdose in humans. In cases where this product has unintentionally been readministered early or given at a higher dose, no clinically relevant adverse effects have been seen. Animal tests suggest that no effect other than the intended therapeutic effects on sex hormone concentrations and on the reproductive tract will be evident with higher doses. If overdose occurs, this should be managed symptomatically.