ZolaCos CP

What it is

ZolaCos CP is a composite pack containing bicalutamide and leuprorelin acetate. Bicalutamide is a non-steroidal anti-androgen that binds to androgen receptors without activating gene expression, thus inhibiting the androgen stimulus, which impairs the growth and encourages apoptosis in androgen-dependent tumour cells and regression of prostatic tumours. Leuprorelin ELIGARD is a sterile polymeric matrix formulation of leuprorelin acetate for subcutaneous injection designed to deliver leuprorelin acetate at a controlled rate over a therapeutic period.

Approved indications

— Treatment of advanced prostate cancer in combination with LHRH agonist therapy (bicalutamide component). — Palliative treatment of advanced prostate cancer (leuprorelin component).

Dosing overview

Bicalutamide: one tablet (50 mg) once a day in adult males including the elderly. Treatment with bicalutamide 50 mg should be started at the same time as treatment with a LHRH agonist. Leuprorelin: the recommended dose of ELIGARD 1 month is one injection every month, and the recommended dose of ELIGARD 3 month is one injection every three months.

Key safety warnings

In patients with metastatic prostate cancer, treatment with bicalutamide monotherapy has been associated with reduced survival compared with castration; bicalutamide should therefore not be used without concomitant LHRH agonist therapy in these patients. Rare cases of death or hospitalisation due to severe liver injury have been observed with bicalutamide; therapy should be discontinued if at any time a patient develops jaundice or if serum ALT rises above two times the upper limit of normal. A reduction in glucose tolerance has been observed in males receiving LHRH agonists, which may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes; consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists. Potentiation of coumarin anticoagulant effects have been reported in patients receiving concomitant bicalutamide therapy, which may result in increased Prothrombin Time (PT) and International Normalised Ratio (INR), with some cases associated with risk of bleeding; close monitoring of PT/INR is advised and anticoagulant dose adjustment should be considered. Androgen deprivation therapy may prolong QT/QTc interval; prescribers should consider whether the benefits outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. ELIGARD, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment; patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, haematuria, or bladder outlet obstruction. Isolated cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using LH-RH agonists. 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, and blood glucose and/or glycosylated hemoglobin (HbA1c) should be monitored periodically. 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.

Contraindications

Bicalutamide is contraindicated in females and children, and in patients with known hypersensitivity to bicalutamide or any other constituents of the formulation. Co-administration of terfenadine, astemizole or cisapride with bicalutamide is contraindicated. ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogues or any of the components of ELIGARD. ELIGARD is contraindicated in women who are breastfeeding, pregnant or intending to become pregnant and in paediatric patients. ELIGARD is contraindicated in patients who previously underwent orchiectomy. ELIGARD is contraindicated as a sole treatment in prostate cancer patients with spinal cord compression or evidence of spinal metastases.

Regulatory history

ZolaCos CP was first listed on the ARTG on 1 December 2006.