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Duavee
estrogens, conjugated/ bazedoxifene
Black Box Warnings .
Endometrial Cancer Risk
unopposed estrogen use incr. endometrial CA risk in patients with intact uterus; estrogens, conjugated/bazedoxifene has been shown to decr. risk of endometrial hyperplasia, a possible precursor to endometrial CA; use adequate diagnostic measures such as endometrial sampling to rule out malignancy if undiagnosed persistent or recurrent abnormal genital bleeding; patients should not take additional estrogens during tx
Cardiovascular and Probable Dementia Risks
estrogen should not be used for cardiovascular disease or dementia prevention; incr. risk of stroke and DVT in postmenopausal patients 50-79 yo (WHI estrogen-alone substudy regimen = conjugated estrogens 0.625 mg/day x7y); incr. risk of probable dementia in postmenopausal patients 65 yo and older (WHIMS estrogen-alone substudy regimen = conjugated estrogens 0.625 mg/day x5y); risk unknown in younger postmenopausal patients; other doses of conjugated estrogens or other estrogen-alone products not studied, therefore adverse cardiovascular events and dementia relevance is unknown; weigh risk/benefit; use lowest effective estrogen dose, shortest duration based on individual tx goals and risks
Adult Dosing .
Dosage forms: TAB: 0.45 mg/20 mg
vasomotor symptoms, moderate-severe menopausal
- [1 tab PO qd]
- Info: for patients with intact uterus; use shortest effective tx duration; do not cut/crush/chew tab; D/C tx >4-6wk before surgery with VTE risk
osteoporosis prevention, postmenopausal
- [1 tab PO qd]
- Info: for patients with intact uterus; use shortest effective tx duration; calcium and vitamin D supplementation recommended if inadequate dietary intake; do not cut/crush/chew tab; D/C tx >4-6wk before surgery with VTE risk
renal dosing
- [see below]
- renal disease: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- vaginal bleeding, undiagnosed
- breast CA
- breast CA history
- cancer, estrogen-dependent
- cancer history, estrogen-dependent
- venous thromboembolism
- venous thromboembolism history
- arterial thromboembolism within 12mo
- protein C deficiency
- protein S deficiency
- thrombophilic disorder
- hepatic disease
- hepatic impairment
- pregnancy
- breastfeeding
- caution: patients 65 yo and older
- caution: renal disease
- caution: cardiovascular disease
- caution: vascular disease risk
- caution: HTN
- caution: diabetes mellitus
- caution: smokers
- caution: smoking habit change
- caution: hypertriglyceridemia
- caution: BMI >27 kg/m^2
- caution: surgery
- caution: immobilization, prolonged
- caution: gallbladder disease
- caution: cholestatic jaundice history, estrogen-associated
- caution: cholestatic jaundice history, pregnancy-associated
- caution: hypothyroidism
- caution: sensitivity to fluid retention
- caution: hypocalcemia, severe
- caution: migraine
- caution: chorea
- caution: seizure disorder
- caution: asthma
- caution: porphyria
- caution: SLE
- caution: hepatic hemangioma
- caution: angioedema, hereditary
Drug Interactions .
Overview
bazedoxifene
SERM
- UGT1A1 substrate
- affected by altered enterohepatic circulation
- estrogen modulator
- thrombogenic effects
estrogens, conjugated (hormone replacement)
estrogen
- CYP1A2 substrate
- CYP3A4 substrate
- P-gp substrate
- CYP1A2 inhibitor, moderate
- UGT1A4 inducer
- estrogen
- hyperglycemic effects
- interferes w/ ACTH analog test
- thrombogenic effects
- thyroid hormone synthesis/metabolism effects
Contraindicated
- fezolinetant
Avoid/Use Alternative
- alosetron
- anastrozole
- bazedoxifene
- bendamustine
- clomiphene
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- exemestane
- letrozole
- ospemifene
- pirfenidone
- raloxifene
- tamoxifen
- tizanidine
- toremifene
- tranexamic acid
- vaccinia immune globulin
- vorasidenib
Monitor/Modify Tx
- abemaciclib
- abrocitinib
- acarbose
- aflibercept
- alogliptin
- aminocaproic acid
- aminophylline
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- asciminib
- asparaginase
- atidarsagene autotemcel
- avatrombopag
- axitinib
- baricitinib
- bevacizumab
- bexagliflozin
- binimetinib
- botulism immune globulin
- brolucizumab
- bromocriptine
- C1 esterase inhibitor
- cabozantinib
- caffeine citrate
- calaspargase
- canagliflozin
- carbamazepine
- carfilzomib
- celecoxib
- chorionic gonadotropin
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- colesevelam
- concizumab
- cosyntropin
- cytomegalovirus immune globulin
- danazol
- dapagliflozin
- darbepoetin alfa
- deflazacort
- desogestrel (contraceptive)
- deuruxolitinib
- dexamethasone
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- dulaglutide
- eltrombopag
- empagliflozin
- epirubicin
- epoetin alfa
- ertugliflozin
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- everolimus
- exenatide
- factor XIII concentrate
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- fibrinogen (human)
- fitusiran
- flurbiprofen
- follitropin
- fruquintinib
- glimepiride
- glipizide
- glyburide
- hepatitis B immune globulin
- hydrocortisone
- ibuprofen
- immune globulin
- indomethacin
- insulin
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- ketoprofen
- ketorolac
- lamotrigine
- lazertinib
- lenalidomide
- lenvatinib
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- levothyroxine
- lidocaine
- linagliptin
- liothyronine
- liraglutide
- lixisenatide
- luspatercept
- lusutrombopag
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- menotropins
- metformin
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- metyrapone
- miglitol
- momelotinib
- nabumetone
- naproxen
- nateglinide
- necitumumab
- nintedanib
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- obinutuzumab
- olaparib
- oxaprozin
- pacritinib
- pazopanib
- pegaspargase
- phenytoin
- pioglitazone
- piroxicam
- pomalidomide
- ponatinib
- porfimer
- pramlintide
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- propranolol
- prothrombin complex concentrate (human)
- ramucirumab
- ranibizumab
- rasagiline
- repaglinide
- Rho(D) immune globulin
- ritlecitinib
- romiplostim
- ropinirole
- rosiglitazone
- ruxolitinib
- ruxolitinib topical
- salsalate
- saxagliptin
- segesterone (contraceptive)
- semaglutide
- sipuleucel-T
- sitagliptin
- sodium tetradecyl sulfate
- somapacitan
- somatrogon
- somatropin
- sotatercept
- sulindac
- tesamorelin
- testosterone
- thalidomide
- theophylline
- thyroid
- tirzepatide
- tivozanib
- tofacitinib
- tolmetin
- trametinib
- tretinoin
- triclabendazole
- upadacitinib
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- varicella zoster immune globulin
- von Willebrand factor
- vorinostat
- warfarin
- ziv-aflibercept
- zopapogene imadenovec
Caution Advised
- apalutamide
- betamethasone
- butalbital
- caffeine
- charcoal, activated
- cholestyramine
- colestipol
- cortisone
- cyclosporine
- danshen
- dantrolene
- dicloxacillin
- duloxetine
- efavirenz
- elacestrant
- elagolix
- encorafenib
- enzalutamide
- fosphenytoin
- fulvestrant
- grapefruit
- icosapent ethyl
- imlunestrant
- ivosidenib
- lorlatinib
- lumacaftor/ivacaftor
- melatonin
- meropenem
- methylprednisolone
- mitapivat
- mitotane
- oxcarbazepine
- pentobarbital
- phenobarbital
- prednisolone
- prednisone
- primidone
- ramelteon
- relugolix
- rifabutin
- rifampin
- rifapentine
- riluzole
- ritonavir
- roflumilast
- roflumilast topical
- romidepsin
- selegiline
- St. John's wort
- tipranavir
- turmeric
- ursodiol
- vaborbactam
- zolmitriptan
Adverse Reactions .
Serious Reactions
- thromboembolism
- retinal thrombosis
- stroke
- dementia
- hypersensitivity reaction
- anaphylaxis
- erythema multiforme
- pancreatitis
- cholestatic jaundice
- gallbladder disease
- breast CA risk
- ovarian CA risk
Common Reactions
- muscle spasms
- nausea
- diarrhea
- dyspepsia
- abdominal pain
- oropharyngeal pain
- neck pain
- dizziness
Safety/Monitoring .
Monitoring Parameters
breast exam q12mo; mammography; BP; free T4, free T3 if hypothyroidism tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
N/A; drug unlikely to be used during pregnancy based on indication
Lactation
Clinical Summary
N/A; drug unlikely to be used while breastfeeding based on indication
Pharmacology .
Metabolism: for estrogen: liver; CYP450: 3A4 (partial) substrate; Info: enterohepatically recirculated; converted to active estrogen metabolites including estradiol, estrone; for bazedoxifene: liver, GI tract; CYP450: minimal; UGT: 1A1, 1A8, 1A10 substrate; Info: undergoes enterohepatic recycling
Excretion: for estrogen: urine; Half-life: 17h (estrone); for bazedoxifene: feces 85%, urine <1%; Half-life: 30h
Subclass: Estrogen Receptor Modulators, Selective (SERMs) ; Estrogens, Non-oncologic ; Osteoporosis: Estrogenic Agents
Mechanism of Action
for estrogen: binds to estrogen receptors, developing and maintaining female sex characteristics and reproductive systems; for bazedoxifene: selectively binds to estrogen receptors, producing estrogenic and anti-estrogenic effects (estrogen receptor modulator); estrogen antagonist in uterus, decr. endometrial hyperplasia risk
Formulary .
No Formulary Selected
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