Conjugated estrogens/bazedoxifene

What is Conjugated estrogens/bazedoxifene?

• Conjugated estrogens/bazedoxifene (Duavee) is a combination of conjugated estrogens with an estrogen agonist/antagonist used for hormone replacement purposes.

Bazedoxifene 2

Bazedoxifene-3D-balls

What are the uses of this medicine?

• Conjugated estrogens/bazedoxifene (Duavee) is a prescription medicine that contains a mixture of estrogens and bazedoxifene.

Conjugated estrogens/bazedoxifene (Duavee) is used after menopause for women with a uterus to:

• reduce moderate to severe hot flushes
• help reduce your chances of developing osteoporosis (thin, weak bones)
• Duavee should be taken for the shortest time possible and only for as long as treatment is needed.

limitations of use:

• It is not known if Duavee is safe and effective in people with kidney problems.

How does this medicine work?

• A combination preparation of conjugated estrogens and the selective estrogen receptor modulator (SERM) bazedoxifene that can be used for hormone replacement purposes.
• The conjugated estrogens increase the diminishing levels of estrogen in menopausal and postmenopausal women by binding to and activating estrogen receptors (ERs), which, in turn, bind to estrogen response elements (EREs) in target genes; this results in the transcription of estrogen-regulated genes.
• Maintaining adequate estrogen levels decreases symptoms such as hot flashes, night sweats, irregular menstruation, fat redistribution, mood swings, sleep disorders, vaginal dryness and osteoporosis.
• Bazedoxifene specifically binds to and activates ERs in certain tissues, including liver, bone, breast, and endometrium, and also promotes the transcription of estrogen-regulated genes in these tissues.
• However, bazedoxifene acts as an estrogen antagonist in uterine and breast tissue, thereby blocking the proliferative effects of estrogen-binding to ER-positive cells in these tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• currently have or have had blood clots
• are allergic to estrogens or bazedoxifene, the active ingredients in Duavee, or any of its ingredients.
• have unusual vaginal bleeding
• currently have or have had certain cancers
• currently have or have had liver problems
• have been diagnosed with a bleeding disorder
• are pregnant

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• certain antibiotics including clarithromycin (Biaxin) and erythromycin (E.E.S, E-Mycin)
• certain antifungal medications including itraconazole (Sporanox) and ketoconazole (Nizoral)
• certain medications for seizures including carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin)
• thyroid hormone replacement medications
• rifampin (Rifadin, Rimactane, in Rifamate), and ritonavir (Norvir, in Kaletra)
• St John's wort

Is this medicine FDA approved?

• The combination was approved for medical use in the United States in October 2013, and in the European Union in December 2014.

How should this medicine be used?

Recommended dosage: Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause:

• The recommended dosage is one Duavee tablet daily.

Prevention of Postmenopausal Osteoporosis:

• The recommended dosage is one Duavee tablet daily.

Recommendations for Calcium and Vitamin D Supplementation:

• Women taking Duavee for prevention of postmenopausal osteoporosis should add supplemental calcium and/or vitamin D to their diet if daily intake is inadequate.

• Use in patients with renal impairment is not recommended.

Administration:

• Estrogen and bazedoxifene combination comes as a tablet to take by mouth.
• Take Duavee once daily, without regard to meals.
• Tablets should be swallowed whole.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg

This medicine is available in fallowing brand namesː

• Duavee

What side effects can this medication cause?

The most common side effects of this medicine include:

• muscle spasms
• nausea
• diarrhea
• upset stomach
• abdominal pain
• throat pain
• dizziness
• neck pain

Duavee may cause serious side effects include:

• blood clots
• stroke
• heart attack
• cancer of the lining of the uterus
• breast cancer
• cancer of the ovary
• dementia
• gallbladder problems
• loss of vision
• high blood pressure
• increased fats in your blood
• liver problems
• thyroid problems
• fluid retention
• low calcium
• swelling of your mouth or tongue
• worsening of other medical problems such as asthma, diabetes, epilepsy, migraines, a genetic problem called porphyria, lupus and liver problems

What special precautions should I follow?

• Duavee contains conjugated estrogens and bazedoxifene, an estrogen agonist/antagonist. Women taking Duavee should not take progestins, additional estrogens or additional estrogen agonist/antagonists.
• Estrogen agonist/antagonists (including bazedoxifene, a component of Duavee) and estrogens individually are known to increase the risk of cardiovascular disorders, including venous thromboembolism, pulmonary embolism, stroke, and retinal vascular thrombosis.
• An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in women with a uterus. Women taking Duavee should not take additional estrogens as this may increase the risk of endometrial hyperplasia. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
• The effect of treatment with Duavee on the risk of breast cancer is unknown. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.
• The risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.
• Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine.
• In a small number of case reports in women receiving estrogens, substantial increases in blood pressure.
• In women with pre-existing hypertriglyceridemia, treatment with estrogens may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of Duavee if pancreatitis occurs.
• Duavee has not been studied in women with impaired liver function or past history of cholestatic jaundice.
• Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. These women should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.
• Estrogens may cause some degree of fluid retention. Use of Duavee in patients with renal impairment is not recommended.
• Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.
• Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.
• Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
• There is no indication for premenopausal use of Duavee. The efficacy and safety of Duavee in premenopausal women have not been established, and its use is not recommended.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding

Management of overdosage:

• In case of overdosage, there is no specific antidote, and the treatment should be symptomatic.

Can this medicine be used in pregnancy?

• Duavee is contraindicated for use in pregnant women and is not indicated for use in females of reproductive potential.

Can this medicine be used in children?

• Duavee is not indicated for use in children.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: conjugated estrogens and bazedoxifene. Conjugated estrogens are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components, including sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin.

• Inactive Ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, ascorbic acid, sucrose palmitic acid ester, hydroxyethylcellulose, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, povidone, polydextrose, maltitol, poloxamer 188, propylene glycol, isopropyl alcohol.

Who manufactures and distributes this medicine?

Distributed by:

• Wyeth pharmaceuticals Inc.

What should I know about storage and disposal of this medication?

• Store Duavee at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Duavee in the blister until you are ready to take it to protect the tablet from moisture.
• Do not place Duavee in pill boxes or pill organizers.
• After opening the foil pouch the Duavee blisters come in, Duavee must be used within 60 days.

• Dailymed label info on Conjugated estrogens/bazedoxifene
• FDA Conjugated estrogens/bazedoxifene

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