RALOXIFENE

Posology The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. Due to the nature of this disease process, Raloxifene is intended for long-term use. Generally, calcium and vitamin D supplements are advised in women with a low dietary intake.

Elderly No dose adjustment is necessary for the elderly. 3). In patients with moderate and mild renal impairment, Raloxifene should be used with caution. 4). Paediatric population Raloxifene should not be used in children of any age. There is no relevant use of Raloxifene in the paediatric population.

4), which occurred in less than 1% of treated patients. b) Tabulated summary of adverse reactions The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from post-marketing reports.

The duration of treatment in these studies ranged from 6 to 60 months. The majority of adverse reactions have not usually required cessation of therapy. 633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.

1% of 584 placebo-treated patients. 1% of 2,576 placebo-treated patients. The following convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

1% placebo). This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time. 7% in the placebo-treated patients. 22 cases per 1,000 patient years. 71) was observed in raloxifene -treated patients compared to placebo.

The risk of a thromboembolic event was greatest in the first four months of therapy. Superficial vein thrombophlebitis occurred in a frequency of less than 1%. 70 cases per 1,000 patient-years in the placebo group. 95). 6% in the placebo group.

In the RUTH study, raloxifene did not affect the incidence of stroke, compared to placebo. However, there was an increase in death due to stroke in women assigned to raloxifene. 4). 8%) placebo- treated women. 0% for placebo in the treatment population).

3% of placebo-treated patients. 0% of placebo-treated patients. 05), but which did show a significant dose trend. 1% for placebo. 7% of the placebo-treated patients, which was statistically significant. Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo-controlled clinical trials of raloxifene in osteoporosis.

Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy. The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.

Raloxifene should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation. Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.

Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile. In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalised acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.

However, there was an increase in death due to stroke in women assigned to raloxifene. 8). This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischaemic attack or atrial fibrillation.

There is no evidence of endometrial proliferation. Any uterine bleeding during Raloxifene therapy is unexpected and should be fully investigated by a specialist. The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.

3% in women who received placebo treatment. Raloxifene is metabolised primarily in the liver. 5- times the controls. The increase correlated with total bilirubin concentrations. Therefore, Raloxifene is not recommended to be used in patients with hepatic insufficiency.

Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed. 6 mmol/l), raloxifene may be associated with a marked increase in serum triglycerides.

1. 6). • Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. • Hepatic impairment, including cholestasis. • Severe renal impairment. • Unexplained uterine bleeding.

Raloxifene should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.