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Optruma is a brand name for Raloxifene. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Optruma is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman,…
Verbatim from this product's EMA label. Tap a section to expand.
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, Optruma 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, Optruma should be used with caution. 4).
Paediatric population:
Optruma should not be used in children of any age. There is no relevant use of Optruma in the paediatric population. 3
a. 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 postmarketing 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. The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 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).
Blood and lymphatic system disorders Uncommon:
Thrombocytopenia a Nervous system disorders Common: Headache, including migraine a Uncommon: Fatal strokes 6 Vascular disorders Very common: Vasodilation (hot flushes) Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a Gastrointestinal disorders Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia Skin and subcutaneous tissue disorders Common: Rash a Musculoskeletal and connective tissue disorders Common: Leg cramps Reproductive system and breast disorders Common: Mild breast symptoms a such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome Common: Peripheral oedema Investigations Very common: Increased blood pressure a a Term(s) included based on postmarketing experience.
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.
Optruma 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, hospitalized 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 ischemic attack or atrial fibrillation.
There is no evidence of endometrial proliferation. Any uterine bleeding during Optruma 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 Optruma 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.
Optruma should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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c. 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 Optruma 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.
Rare cases of moderate increases in AST and/or ALT have been reported where a […]
Patients with this medical history should have serum triglycerides monitored when taking raloxifene. 4 The safety of Optruma in patients with breast cancer has not been adequately studied. No data are available on the concomitant use of Optruma and agents used in the treatment of early or advanced breast cancer.
Therefore, Optruma should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed. As safety information regarding co-administration of raloxifene with systemic oestrogens is limited, such use is not recommended.
Optruma is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency. Optruma contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.