Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established.
When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
The recommended dose of CONBRIZA is one tablet once daily, at any time of day, with or without food (see section 5.2).
Doses higher than 20 mg are not recommended because there is no demonstrable increased efficacy and higher doses may be associated with additional risk (see section 5.1).
Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Bazedoxifene has not been sufficiently evaluated in patients with severe renal impairment; caution should be used in this population (see sections 4.4 and 5.2).
No dose adjustment is required for mild or moderate renally impaired patients.
Safety and efficacy of bazedoxifene have not been evaluated in patients with hepatic impairment; use in this population is not recommended (see sections 4.4 and 5.2).
No dose adjustment is necessary based on age (see section 5.2).
There is no relevant use of bazedoxifene in the paediatric population.
Oral use.
In the case of overdose, there is no specific antidote, and treatment should be symptomatic.
18 months.
Do not store above 25°C.
PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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