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Dosage Forms And Strengths. They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink. EVISTA 60 mg tablets are white, elliptical, and film coated. They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink. They are available as follows: Bottles of 30 (unit of use) NDC 0002-4165-30 Bottles of 100 (unit of use) NDC 0002-4165-02 Bottles of 2000 NDC 0002-4165-07. Store at controlled room temperature, 20′ to 25’C (68′ to 77’F) [see USP ]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20′ to 25’C (68′ to 77’F); that results in a mean kinetic temperature calculated to be not more than 25’C; and that allows for excursions between 15′ and 30’C (59′ and 86’F) that are experienced in pharmacies, hospitals, and warehouses. Marketed by: Lilly USA, LLC, Indianapolis , IN 46285, USA. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to EVISTA in 8429 patients who were enrolled in placebocontrolled trials, including 6666 exposed for 1 year and 5685 for at least 3 years. Osteoporosis Treatment Clinical Trial (MORE) The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene hydrochloride (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar among groups: 23 (0, deca-instabolin 50 mg injectable steroids $78.00 deca durabolin, deca. Therapy was discontinued due to an adverse reaction in 10. Venous Thromboembolism : The most serious adverse reaction related to EVISTA was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis). During an average of study-drug exposure of 2. Twenty-six EVISTA-treated women had a VTE compared to 11 placebo-treated women, the hazard ratio was 2. Common adverse reactions considered to be related to EVISTA therapy were hot flashes and leg cramps. Hot flashes occurred in about one in 10 patients on EVISTA and were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter. Leg cramps occurred in about one in 14 patients on EVISTA. Placebo-Controlled Osteoporosis Prevention Clinical Trials. The safety of raloxifene has been assessed primarily in 12 Phase 2 and Phase 3 studies with placebo, estrogen, and estrogen-progestin therapy control groups. The duration of treatment ranged from 2 to 30 months, and 2036 women were exposed to raloxifene HCl (371 patients received 10 to 50 mg/day, 828 received 60 mg/day, and 837 received from 120 to 600 mg/day). Therapy was discontinued due to an adverse reaction in 11. Discontinuation rates due to hot flashes did not differ significantly between EVISTA and placebo groups (1.
Table 7: Updated Adjuvant Study Results – Monotherapy Arms Analysis (Median Follow-up 73 Months) Censored analysis censors follow-up at the date of selective crossover in 632 patients who crossed to Letrozole tablets or another aromatase inhibitor after the tamoxifen arms were unblinded in 2005, deca-instabolin 50 mg injectable steroids $78.00 deca durabolin, deca.
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