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DUAVIVE is a brand name for Bazedoxifene, supplied as a tablet (immediate and extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, Dosing Considerations). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 75 years of age): DUAVIVE has not been studied in women over 75 years of age, therefore DUAVIVE is not recommended for women over 75 years of age (see 14 CLINICAL TRIALS and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics 2 CONTRAINDICATIONS • Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis.
g. stroke, myocardial infarction, coronary heart disease). • Patients who are hypersensitive (for example, angioedema, anaphylaxis) to estrogens, bazedoxifene or to any ingredient in the formulation or component of the container. For a complete listing, see the
4 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. The most common ADRs that occurred in the conjugated estrogens/bazedoxifene group were abdominal pain, muscle spasms, and vulvovaginal mycotic infection.
5 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the Pr DUAVIVE ™ Product Monograph Page 14 of 44 Unclassified / Non classifié rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates Patient exposure The safety of conjugated estrogens/bazedoxifene was evaluated in 4,158 postmenopausal women who participated in multiple-dose trials.
45 mg/bazedoxifene 20 mg, and 1,069 received placebo. Long-term exposure to DUAVIVE over 2 years was evaluated. There were a total of 699 women exposed to DUAVIVE for at least one year and 297 women exposed to DUAVIVE for 2 years. 0 % of the 1,069 women who received placebo.
8 % of women who received placebo. Table 1 below lists the adverse events (regardless of causality) occurring in >1% of women treated with DUAVIVE in double-blind, placebo-controlled Phase 3 studies of up to 2 years duration. 1 % and <1% but exceeding the placebo rate that occurred in women treated with DUAVIVE in double-blind, placebo- controlled Phase 3 studies of up to 2 years duration.
Blood and lymphatic system disorders:
Anaemia, Thrombocytopenia Cardiac disorders: Angina pectoris Ear and labyrinth disorders: Deafness, Ear discomfort, Motion sickness, Vertigo positional Endocrine disorders: Autoimmune thyroiditis, Goitre, Hypothyroidism Eye disorders: Diplopia, Eye disorder, Eye haemorrhage, Eye pain, Eye pruritus, Eyelid oedema Eyelid ptosis, Photopsia, Vision blurred, Visual impairment Gastrointestinal disorders: Anal pruritus, Colonic polyp, Gingival pain, Haematemesis, Haemorrhoids, Mouth ulceration, Odynophagia, Oral discomfort, Oral pain, Paraesthesia oral, Tooth disorder General disorders and administration site conditions: Axillary pain, Feeling hot, Influenza like illness, Irritability, Oedema, Temperature intolerance Hepatobiliary disorders: Biliary colic, Cholecystitis, Cholelithiasis, Hepatic pain Immune system disorders: Allergy to chemicals, House dust […]
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Carcinogenesis and Mutagenesis Breast cancer In the estrogen-alone arm of the WHI trial, there was no statistically significant difference in the rate of invasive breast cancer in hysterectomized women treated with conjugated equine estrogens versus women treated with placebo.
It is recommended that estrogens not be given to women with existing breast cancer or those with a previous history of the disease (see 2 CONTRAINDICATIONS). There is a need for caution in prescribing estrogens for women with known risk factors associated with the development of breast cancer, such as strong family history of breast cancer (first degree relative) or who present a breast condition with an increased risk (abnormal mammograms and/or atypical Pr DUAVIVE ™ Product Monograph Page 8 of 44 Unclassified / Non classifié hyperplasia at breast biopsy).
Other known risk factors for the development of breast cancer such as nulliparity, obesity, early menarche, late age at first full term pregnancy and at menopause should also be evaluated. It is recommended that women undergo mammography prior to the start of hormone therapy (HT) treatment and at regular intervals during treatment, as deemed appropriate by the treating physician and according to the perceived risks for each patient.
The overall benefits and possible risks of HT should be fully considered and discussed with patients. Instructions for regular self-examination of the breasts should be included in this counselling. Endometrial hyperplasia & endometrial carcinoma An increased risk of endometrial hyperplasia and endometrial carcinoma has been reported with the use of unopposed estrogen therapy in women with a uterus.
The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in nonusers and appears dependent on duration of treatment and on estrogen dose. DUAVIVE contains a SERM. This component reduces the risk of endometrial hyperplasia that can occur with the conjugated estrogens component of DUAVIVE.
• Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis. g. stroke, myocardial infarction, coronary heart disease). • Patients who are hypersensitive (for example, angioedema, anaphylaxis) to estrogens, bazedoxifene or to any ingredient in the formulation or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • Undiagnosed abnormal genital bleeding. • Known, suspected, or past history of breast cancer. g. endometrial cancer).
• Liver dysfunction or disease as long as liver functions tests have failed to return to normal • Endometrial hyperplasia. • Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. • Known or suspected pregnancy, women who may become pregnant, and nursing mothers.
• Partial or complete loss of vision due to ophthalmic vascular disease. Pr DUAVIVE ™ Product Monograph Page 5 of 44 Unclassified / Non classifié
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Endometrial hyperplasia may be a precursor to endometrial cancer. Women taking DUAVIVE should not take additional estrogens as this may increase the risk of endometrial hyperplasia. 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. The investigation may include endometrial biopsy to exclude endometrial malignancy.
Ovarian cancer Some recent epidemiologic studies have found that the use of estrogen-alone therapies, in particular for five or more years, has been associated with an increased risk of ovarian cancer. Cardiovascular Stroke The results of the WHI trial indicate that the use of estrogen-alone is associated with an increase in the risk of stroke in postmenopausal women.
WHI trial findings In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period, there were/was: • 12 more cases of stroke (44 on estrogen-alone therapy versus 32 on placebo) • no statistically significant difference in the rate of CHD.
Should a stroke occur or be suspected, DUAVIVE should be discontinued immediately (see 2 CONTRAINDICATIONS). Pr DUAVIVE ™ Product Monograph Page 9 of 44 Unclassified / Non classifié Blood pressure Women using HT sometimes experience increased blood pressure.
Blood pressure should be monitored with HT use. Elevation of blood pressure in previously normotensive or hypertensive patients should be investigated and HT may have to be discontinued. Ear/Nose/Throat Otosclerosis Estrogens should be used with caution in patients with otosclerosis.
Endocrine and Metabolism Glucose and lipid metabolism A worsening of glucose tolerance and lipid metabolism has been observed in a significant percentage of peri- and post-menopausal patients. Therefore, diabetic patients, or those with a predisposition to diabetes, should be observed closely to detect any alterations in carbohydrate or lipid metabolism, especially in triglyceride blood levels.
Women with familial hyperlipidemias need special surveillance. Lipid-lowering measures are recommended additionally, before treatment is started. 4 mmol/L). Bazedoxifene may increase serum triglyceride levels; therefore, caution should be exercised in women with known hypertriglyceridemia.
4 mmol/L). In women with pre-existing hypertriglyceridemia, treatment with estrogens alone may be associated with further elevations of plasma triglycerides leading to pancreatitis and other complications. Consider discontinuation of DUAVIVE if pancreatitis occurs.
Heme metabolism Women with porphyria need special surveillance. Calcium and phosphorus metabolism Because the prolonged use of estrogens influences the metabolism of calcium and phosphorus, estrogens should be used with caution in patients with metabolic and malignant bone diseases associated with hypercalcemia and in patients with renal insufficiency.
Hypothyroidism Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients who require thyroid hormone replacement therapy and who are also taking estrogen may require increased doses of their thyroid replacement therapy.
These women should have their thyroid function monitored in order to maintain their free thyroid hormone levels remain in an acceptable range (see 9 DRUG INTERACTIONS Drug-Laboratory Test Interactions). Pr DUAVIVE ™ Product Monograph Page 10 of 44 Unclassified / Non classifié Other conditions DUAVIVE contains lactose.
In patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption, the severity of the condition should be […]