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Duavive is a brand name for Bazedoxifene. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DUAVIVE is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. The experience treating women older than 65 years is limited.
Verbatim from this product's EMA label. Tap a section to expand.
4). 45 mg conjugated oestrogens (CE) and 20 mg bazedoxifene (BZA) taken as a single oral tablet, once daily. If a tablet is forgotten, it should be taken as soon as the patient remembers. Therapy should then be continued as before. If more than one tablet has been forgotten, only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets.
Special populations Elderly CE/BZA has not been studied in women over 75 years of age. 2). The experience treating women older than 65 years is limited. 3 Renal impairment The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairment.
2). Hepatic impairment The safety and efficacy of CE/BZA have not been evaluated in patients with hepatic impairment. 2). Paediatric population There is no relevant use of CE/BZA in the paediatric population. Method of administration Oral use.
2). Tablets should be swallowed whole.
Summary of the safety profile The most commonly reported adverse reaction is abdominal pain, occurring in more than 10% of patients in clinical trials. Serious venous thromboembolic events may occur rarely (less than 1 case per 1,000 patients).
Tabulated list of adverse reactions The table below lists the adverse reactions observed with CE/BZA (n = 3,168) in placebo-controlled clinical trials. Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) or rare ( 1/10,000 to < 1/1,000).
10 System organ class Frequency of occurrence of adverse reactions Very common Common Uncommon Rare Infections and infestations Vulvovaginal candidiasis Vascular disorders Venous thromboembolic events (including, pulmonary embolism, retinal vein thrombosis, deep vein thrombosis and thrombophlebitis) Gastrointestinal disorders Abdominal pain Constipation; diarrhoea; nausea Hepatobiliary disorders Cholecystitis Musculoskeletal and connective tissue disorders Muscle spasms Investigations Blood triglycerides increased Description of selected adverse reactions Breast cancer risk Breast cancer risk associated with the use of oestrogens alone is represented by several studies.
The increased risk to users of oestrogen-only therapy is lower than that seen in users of oestrogen– progestagen combinations. 4). Absolute risk estimations based on the results of the largest randomised placebo-controlled trial (WHI-study) and the largest meta-analysis of prospective epidemiological studies are presented.
7 * Taken from baseline incidence rates in England in 2015 in women with BMI 27 Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
1 * Taken from baseline incidence rates in England in 2015 in women with BMI 27 Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
For the treatment of postmenopausal symptoms, CE/BZA should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and treatment should only be continued as long as the benefit outweighs the risk.
Women taking CE/BZA should not be taking progestins, additional oestrogens or selective oestrogen receptor modulators (SERMs). DUAVIVE (CE/BZA) has not been studied in the treatment of premature menopause. Medical examination/follow-up Before initiating or reinstituting treatment with CE/BZA, a complete personal and family medical history should be taken.
Physical (including pelvic and breast) examination should be guided by this 4 and by the contraindications and precautions for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below). , mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. , venous thromboembolism, stroke, and pregnancy) and in the following situations: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache Endometrial hyperplasia and carcinoma In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.
The reported increase in endometrial cancer risk among oestrogen-only users varies from 2- to 12-fold greater compared with non-users, depending on duration of treatment and oestrogen dose. After stopping treatment, risk may remain elevated for at least 10 years.
1. - Known, suspected, or past history of breast cancer. , endometrial cancer). - Undiagnosed genital bleeding. - Untreated endometrial hyperplasia. , deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis). 4). , myocardial infarction, stroke).
- Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal. 3). - Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1,000 women with a uterus not using HRT. 4). Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from 5 to 55 extra cases diagnosed in every 1,000 women between the ages of 50 and 65 years.
4). Endometrial hyperplasia may be a precursor to endometrial cancer. 4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2,000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period.
56 in the placebo group. 36 in the placebo group. 4). The occurrence of such a reaction is more likely in the first year of treatment. 5 fold increased relative risk of ischaemic stroke. 4). The additional risk of ischaemic stroke over five years of use was assessed in the largest randomised trial in women without a uterus (WHI) from 50-59 years of age.
WHI Studies combined – Additional risk of ischaemic stroke* over 5 years use Age […]
Women taking CE/BZA should not take additional oestrogens as this may increase the risk of endometrial hyperplasia and endometrial carcinoma. The addition of bazedoxifene in CE/BZA reduces the risk of endometrial hyperplasia, which may be a precursor of endometrial carcinoma.
Break-through bleeding and spotting may occur during treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
5 Breast cancer The overall evidence shows an increased risk of breast cancer in women taking oestrogen-only HRT that is dependent on the duration of taking HRT. The Women’s Health Initiative (WHI) trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only therapy.
8). Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
An observational study with an average follow-up time of 22 months showed that the risk of breast cancer among users of CE/BZA might be in the same range as among users of oestrogen-progestin combination hormone therapy. 1). Ovarian cancer Ovarian cancer is much rarer than breast cancer.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only Hormone Replacement Therapy (HRT), which becomes apparent within 5 years of use and diminishes over time after stopping.
8). The effect of CE/BZA on the risk of ovarian cancer is unknown. 8). Should a VTE event occur or be suspected, CE/BZA should be discontinued immediately. 8). 3-3 fold risk of developing VTE. 8). Patients with known thrombophilic states have an increased risk of VTE and hormone therapy may add to this risk.
3). Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and […]