Larfen Special Precautions

Cardiovascular Disease: Raloxifene should not be used for the primary or secondary prevention of cardiovascular disease. In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene for 5 years.
Venous Thromboembolism: In clinical trials, Raloxifene-treated women had an increased risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism.) Other venous thromboembolic events also could occur. A less serious event, superficial thrombophlebitis, also has been reported more frequently with Raloxifene. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, and the independent of therapy, raloxifene should be discontinued at least 72 hours prior to and magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy. Because immobilization increases the risk of venous thromboembolic events independent of therapy. Raloxifene should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and Raloxifene therapy should be resumed only after the patient is fully ambulatory. In addition, women taking Raloxifene should be advised to move about periodically during prolonged travel. The risk-benefit balance should be considered in women at risk of thromboembolic disease for other reasons, such as congestive heart failure, superficial thrombophlebitis, and active malignancy.
Death Due to Stroke: In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an increased risk of death due to stroke was observed after treatment with Raloxifene. During an average follow-up of 5.6 years, 59 (1.2%) Raloxifene-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women (22 versus 15 per 10,000 women-years; hazard ratio 1.49; 95% confidence interval, 1.00-2.24; p=0.0499). There was no statistically significant difference between treatment groups in the incidence of stroke (249 in Raloxifene [4.9%] versus 224 placebo [4.4%]). Raloxifene had no significant effect on all-cause mortality. The risk-benefit balance should be considered in women at risk for stroke, such as prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking.
Premenopausal Use: There is no indication for premenopausal use of Raloxifene. Safety of Raloxifene in premenopausal women has not been established and its use is not recommended.
History of Breast Cancer: Raloxifene has not been adequately studied in women with a prior history of breast cancer.
Use in Men: There is no indication for the use of Raloxifene in men. Raloxifene has not been adequately studied in men and its use is not recommended.
Unexplained Uterine Bleeding: Any unexplained uterine bleeding should be investigated as clinically indicated. Raloxifene-treated and placebo-treated groups had similar incidences of endometrial proliferation.
Breast Abnormalities: Any unexplained breast abnormality occurring during Raloxifene therapy should be investigated. Raloxifene does not eliminate the risk of breast cancer.
History of Hypertrigtyceridemia when Treated with Estrogens: Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridaemia (>5.6 mmol/l), raloxifene may be associated with a marked increase in serum triglycerides. Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
Hepatic Dysfunction: Raloxifene is metabolised primarily in the liver. Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5-times the controls. The increase correlated with total bilirubin concentrations. Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of Raloxifene is not recommended in this patient population. Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Effects on ability to drive and use machines: Raloxifene has no known effect on driving or the ability to use machinery.
Renal Impairment: Raloxifene should not be used in patients with severe renal impairment. In patients with moderate and mild renal impairment, Raloxifene should be used with caution.
Hepatic Impairment: Raloxifene should not be used in patients with hepatic impairment.
Use in children: Safety and effectiveness in pediatric patients have not been established.
Use in elderly: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Based on clinical trials, there is no need for dose adjustment for geriatric patients.