Deep Dive brainstorming technique, an innovative process for organizational development. Deep Dive brainstorming technique for business and organizations of all forms. EzineArticles.com allows expert authors in hundreds of niche fields to get massive levels of exposure in exchange for the submission of their quality original articles. FDA prescribing information, side effects and uses. Osphena is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. DOSAGE AND ADMINISTRATIONOsphena is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin . Postmenopausal women should be re- evaluated periodically as clinically appropriate to determine if treatment is still necessary. Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause. Take one 6. 0 mg tablet with food once daily. DOSAGE FORMS AND STRENGTHSOsphena tablets are white to off- white, oval, biconvex, film coated tablets containing 6. CONTRAINDICATIONSOsphena is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Known or suspected estrogen- dependent neoplasia. Active DVT, pulmonary embolism (PE), or a history of these conditions. Active arterial thromboembolic disease . Osphena may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo- fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo- fetal lethal in rabbits at 1. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus. WARNINGS AND PRECAUTIONSCardiovascular Disorders. Risk factors for cardiovascular disorders, arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus), should be managed appropriately. Stroke. In the WHI estrogen- alone substudy, a statistically significant increased risk of stroke was reported in women 5. CE (0. 6. 25 mg)- alone compared to women in the same age group receiving placebo (4. The increase in risk was demonstrated in year 1 and persisted. In the clinical trials for Osphena (duration of treatment up to 1. Osphena 6. 0 mg treatment group and 1. Should thromboembolic or hemorrhagic stroke occur or be suspected, Osphena should be discontinued immediately. Research Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up. The Nuclear Family - The nuclear family is comprised of the parents and the siblings. Learn how birth order affects children and the challenges facing only children. Coronary Heart Disease. In the WHI estrogen- alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen- alone compared to placebo. In the Osphena clinical trials, a single MI occurred in a woman receiving 6. Venous Thromboembolism. In the WHI estrogen- alone substudy, the risk of VTE (DVT and PE), was increased for women receiving daily CE (0. DVT reached statistical significance (2. The increase in VTE risk was demonstrated during the first 2 years. In the Osphena clinical trials, the incidence of DVT was 1. Osphena 6. 0 mg treatment group and 1. Should a VTE occur or be suspected, Osphena should be discontinued immediately. If feasible, Osphena should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. Malignant Neoplasms. Endometrial Cancer. Osphena is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, Osphena has agonistic effects. In the Osphena clinical trials (6. There was a single case of simple hyperplasia without atypia. Endometrial thickening equal to 5 mm or greater was seen in the Osphena treatment groups at a rate of 6. The incidence of any type of proliferative (weakly plus active plus disordered) endometrium was 8. Osphena vs. 1. 3. Uterine polyps occurred at an incidence of 5. An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 1. Most studies show no significant increased risk associated with the use of estrogens for less than 1 year. The greatest risk appears to be associated with prolonged use, with increased risks of 1. This risk has been shown to persist for at least 8 to 1. Studies show the prevalence of mistaken identifications, while experts try to advise juries of the relevant factors to consider in evaluating a given ID. InformationWeek.com: News, analysis and research for business technology professionals, plus peer-to-peer knowledge sharing. Engage with our community. Adding a progestin to postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen- alone regimens. These include an increased risk of breast cancer. The use of progestins with Osphena therapy was not evaluated in the clinical trials. Clinical surveillance of all women using Osphena is important. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Breast Cancer. Osphena 6. Severe Hepatic Impairment. Osphena should not be used in women with severe hepatic impairment . ADVERSE REACTIONSThe following serious adverse reactions are discussed elsewhere in the labeling: Clinical Trials Experience. Because clinical trials 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 safety of Osphena has been assessed in nine phase 2/3 trials (N=1. The duration of treatment in these studies ranged from 6 weeks to 1. Most women (N=1. 37. The incidence rates of thromboembolic and hemorrhagic stroke were 0. Osphena 6. 0 mg treatment group and 1. The incidence of deep vein thrombosis (DVT) was 1. Osphena 6. 0 mg treatment group (2 reported cases of DVT) and 1. DVT) in placebo. Table 1 lists adverse reactions occurring more frequently in the Osphena 6. Placebo. Ospemifene 6. N=1. 24. 2)%Placebo(N=9. Vascular Disorders Hot flush. Reproductive System and Breast Disorders Vaginal discharge. Genital discharge. Musculoskeletal and Connective Tissue Disorders Muscle spasms. Skin and Subcutaneous Tissue Disorders Hyperhidrosis. Postmarketing Experience. The following adverse reactions have been identified during post- approval use of ospemifene. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: allergic conditions including hypersensitivity, angioedema. Skin and Subcutaneous Tissue Disorders: rash, rash erythematous, rash generalized, pruritus, urticaria. DRUG INTERACTIONSOsphena is primarily metabolized by CYP3. A4 and CYP2. C9. CYP2. C1. 9 and other pathways contribute to the metabolism of ospemifene. Estrogens and estrogen agonist/antagonist. Osphena should not be used concomitantly with estrogens and estrogen agonists/antagonists. The safety of concomitant use of Osphena with estrogens and estrogen agonists/antagonists has not been studied. Fluconazole. Fluconazole, a moderate CYP3. A / strong CYP2. C9 / moderate CYP2. C1. 9 inhibitor, should not be used with Osphena. Fluconazole increases the systemic exposure of ospemifene by 2. Administration of fluconazole with ospemifene may increase the risk of Osphena- related adverse reactions . Therefore, co- administration of Osphena with drugs such as rifampin which induce CYP3. A4, CYP2. C9 and/or CYP2. C1. 9 activity would be expected to decrease the systemic exposure of ospemifene, which may decrease the clinical effect . Administration of ketoconazole chronically with ospemifene may increase the risk of Osphena- related adverse reactions . No study was conducted with multiple doses of warfarin. The effect of ospemifene on clotting time such as the International Normalized Ratio (INR) or prothrombin time (PT) was not studied . Use of Osphena with other drug products that are highly protein bound may lead to increased exposure of either that drug or ospemifene . USE IN SPECIFIC POPULATIONSPregnancy. Teratogenic effects: Pregnancy Category X . Adverse findings at maternally toxic doses included embryofetal lethality in rats and rabbits, and neonatal mortality and difficult labor in rats. The reproductive effects observed are consistent with and are considered to be related to estrogen receptor activity of Osphena. Animal Data. The effects of Osphena on embryo- fetal development were studied in rats (0. In rabbits, there was an increase in the incidence of total resorptions at 3. Drug- induced malformations were not observed in either rats or rabbits. The effects of Osphena on pre- and postnatal development were studied in pregnant rats (0. Pregnant rats given 0. Osphena (0. 8% to 4% the human exposure based on surface area mg/m. Osphena did not induce adverse effects in the surviving offspring of pregnant rats at drug exposures up to 4% the human exposure. Nursing Mothers. It is not known whether Osphena is excreted in human breast milk. In a nonclinical study, ospemifene was excreted in rat milk and detected at concentrations higher than that in maternal plasma. Pediatric Use. Osphena is not indicated in children. Clinical studies have not been conducted in the pediatric population. Geriatric Use. Of the 1. Osphena- treated women enrolled in the nine phase 2/3 trials of Osphena, > 1. No clinically meaningful differences in safety or effectiveness were observed between these women and younger women less than 6. Renal Impairment. The pharmacokinetics of ospemifene in women with severe renal impairment (Cr. CL < 3. 0 m. L/min) was similar to those in women with normal renal function . OVERDOSAGEThere is no specific antidote for Osphena. DESCRIPTIONOsphena is an estrogen agonist/antagonist.
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