Dosing Considerations
DUAVIVE contains conjugated estrogens and bazedoxifene. Women taking DUAVIVE should not be taking progestins, additional estrogens or selective estrogen receptor modulators (SERMs).
DUAVIVE may be given at any time of day, without regard to meals. Tablets should be swallowed whole.
DUAVIVE should be used at the lowest effective dose and for a duration consistent with treatment goals and the benefits and risks for the individual woman. Women should be re-evaluated periodically as clinically appropriate. The safety and efficacy of DUAVIVE have been evaluated in clinical trials of up to 2 years in duration.
Recommended Dose and Dosage Adjustment
DUAVIVE should be taken as a single oral tablet, once daily. DUAVIVE should be taken at the same time each day.
Special Populations
Use in patients with renal impairment
The pharmacokinetics of DUAVIVE have not been adequately evaluated in women with renal impairment (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency), therefore use in this population is not recommended.
Use in patients with hepatic impairment
DUAVIVE has not been studied in women with impaired liver function or past history of cholestatic jaundice. Women with hepatic impairment [i.e. Child-Pugh Class A, B, and C] treated with 20 mg bazedoxifene showed up to a 4.3-fold increase in AUC compared with controls (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency). Due to the increase in bazedoxifene exposure in women with hepatic impairment, use of DUAVIVE in patients with known liver dysfunction or disease is contraindicated (see CONTRAINDICATIONS).
Use in elderly patients
DUAVIVE has not been studied in women over 75 years of age, therefore DUAVIVE is not recommended for women over 75 years of age. In 224 women included in clinical trials, between 65 and 75 years of age, no dosage adjustment was required (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics and CLINICAL TRIALS, Geriatrics).
Use in children
DUAVIVE is not indicated for pediatric use.
Missed Dose
If a patient misses a dose, advise them to take the dose as soon as possible. If it is almost time for the patient’s next dose, advise the patient to skip the missed dose and go back to their normal schedule. Patients should not take 2 doses at the same time.
Administration
DUAVIVE contains conjugated estrogens and bazedoxifene. Women taking DUAVIVE should not be taking progestins, additional estrogens or selective estrogen receptor modulators (SERMs).
DUAVIVE should be taken as a single oral tablet, once a day. DUAVIVE should be taken at the same time each day.