BMD should be measured at baseline, and then a year later as a minimum. These complications may be potentiated when patients are already osteoporotic due to their advanced age at diagnosis of prostate cancer.īone mineral density (BMD) should be measured regularly to identify patients at higher risk for fractures.
The risk of bone fractures increases with the duration of combined androgen blockade.
WHAT IS A PROSCAN TABLET PLUS
In recent studies this has been seen in patients treated with LHRH analogues plus Proscan. Monitoring of the blood glucose and/or glycosylated haemoglobin (HbA1c) levels must be considered in patients who are in treatment with Proscan in combination with LHRH agonists.Īndrogen depletion therapy is known to reduce bone mineral density and increase the risk of osteoporotic fractures. This may manifest as diabetes or a loss of glycaemic control in patients with pre-existing diabetes. 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 physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Proscan.Ī decreased tolerance to glucose has been observed in males in treatment with combined androgen blockade. Androgen deprivation therapy may prolong the QT interval. The potential QT/QTc prolongation with Proscan has not been studied. Patients treated whose signs or symptoms suggest the development of a cardiovascular disease must be monitored. It must be evaluated whether the benefits of the combined androgen blockade compensate the potential cardiovascular risk in patients with risk factors. It has been reported in the literature that increased cardiovascular risk (myocardial infarction, cardiac insufficiency, sudden cardiac death) and the adverse effects on independent cardiovascular risk factors (serum lipoproteins, insulin sensitivity and obesity) may be linked to androgen deprivation with LHRH analogues in patients with prostate cancer. It can exacerbate oedema or ankle swelling in patients prone to these conditions.Īn increase in oestradiol levels may predispose to thromboembolic events. Therefore caution should be exercised in the use of Proscan if cardiac disease is present.
In severe cases this can lead to an increased risk of angina and heart failure. Proscan administration may lead to elevated plasma testosterone and oestradiol levels in such patients, resulting in fluid retention. Periodic sperm counts should be considered in patients receiving chronic treatment with Proscan who have not received medical or surgical castration. Proscan should be administered with caution in patients with impaired renal function. If the patient presents liver function test results indicative of liver damage, clinical jaundice in the absence of hepatic metastasis confirmed by biopsy, or serum transaminase levels of 2 to 3 times above the normal limits in patients that do not present pathological signs, treatment with Proscan must be suspended. Patients should be advised to discontinue Proscan therapy and seek medical advice immediately if any symptoms or signs suggestive of hepatotoxicity occur. pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained “flu-like†symptoms). Appropriate laboratory liver function tests should also be performed for every patient once a month for the first 4 months and then periodically or when the first sign or symptom of hepatic dysfunction occur ( e.g. Periodic liver function tests must be performed before initiation and during treatment, especially in patients receiving long term treatment with Proscan. Treatment with Proscan should not be initiated in patients with serum transaminase levels exceeding 2-3 times the upper limit of normal. Hepatic function should be monitored regularly before, during and after initiation of Proscan therapy. Hepatotoxicity, which may be fatal, may occur after several weeks or months of therapy. The hepatic effects were usually reversible following discontinuation of Proscan, although cases have been reported of death after severe liver damage linked to the use of Proscan. There have been reports of elevated serum transaminase levels, cholestatic jaundice, hepatic necrosis and hepatic encephalopathy associated with Proscan treatment. Proscan may be hepatotoxic and should be used with caution in patients with pre-existing hepatic dysfunction only after considering the benefits and potential risks.