Duavee

Duavee is a prescription medication used to treat symptoms associated with menopause and prevent postmenopausal osteoporosis.

It is a single product containing 2 medications: conjugated estrogens and bazedoxifine, a selective estrogen receptor modifier.

Duavee belongs to a group of drugs called estrogens and estrogen modifiers. Estrogens work by replacing estrogen that is normally produced by the body. Selective estrogen receptor modifiers work by blocking the action of estrogen on the lining of the uterus.

This medication comes in oral tablet form and is taken once daily, with or without food.

Do not chew, divide, or break  Duavee tablets. Swallow the tablets whole.

Common side effects of Duavee include nausea, heartburn, stomach pain, diarrhea, muscle tightness, neck pain, and sore throat.

Duavee can also dizziness. Do not drive or operate heavy machinery until you know how Duavee affects you.

Duavee is a prescription medication used to treat symptoms associated with menopause, including hot flashes, and prevent postmenopausal osteoporosis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.

Serious side effects have been reported with Duavee. See the “Duavee Precautions” section.

Common side effects of Duavee include the following:

• Nausea
• Heartburn
• Stomach pain
• Diarrhea
• Muscle tightness or spasms
• Neck pain
• Sore throat

This is not a complete list of Duavee side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Any other medication containing estrogens such as estradiol (Estrace, Alora, Climara, Estraderm, Vivelle-Dot) or conjugated estrogens (Premarin)
• Antibiotics including clarithromycin (Biaxin) and erythromycin (E.E.S, E-Mycin)
• Antifungal medications including itraconazole (Sporanox) and ketoconazole (Nizoral)
• Medications for seizures including carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin)
• Thyroid hormone replacement medications including levothyroxine (Levoxyl, Synthroid)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Ritonavir (Norvir, in Kaletra)
• St. John’s Wort

This is not a complete list of Duavee drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Duavee including the following:

• Bulging eyes
• Swelling of the face, mouth, tongue, or throat
• Hoarseness
• Difficulty breathing or swallowing
• Brest tenderness
• Changes in vision
• High blood pressure
• Fluid retention

• Blood clots. Tell your healthcare provider right away if you have some or all of the following symptoms of a blood clot:
  • Severe pains in your chest or legs, with or without shortness of breath, weakness or fatigue.

• Dementia. Women over the age of 65 who take estrogens have a higher risk of developing dementia than women who do not take estrogens. Tell your healthcare provider right away if you have some or all of the following symptoms of dementia:
  • Difficulty thinking, learning, remembering, or understanding information
  • Confusion
  • Changes in language or speech
  • Changes in mood

• Endometrial cancer and breast cancer. Women who take estrogens have a higher risk of developing endometrial and breast cancers than women who do not take estrogens. Tell your healthcare provider right away if you have some or all of the following symptoms of endometrial or breast cancer:
  • Breast lumps or other breast changes
  • Discharge from nipples
  • Abnormal vaginal bleeding

Duavee can cause drowsiness. Do not drive or operate heavy machinery until you know how Duavee affects you.

Do not take Duavee if you:

• are allergic to Duavee or to any of its ingredients
• have abnormal uterine bleeding
• have a known or suspected history of breast cancer
• have a known or suspected history of estrogen-dependent cancer
• have or have had deep vein thrombosis or pulmonary embolism
• have or have had stroke or heart attack
• have liver disease
• have blood coagulation disorders such as protein C, protein S, or antithromin deficiency
• are pregnant or may become pregnant

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duavee, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Duavee, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to conjugated Duavee or to any of its ingredients
• have liver problems
• have heart problems
• have kidney problems
• have thyroid problems
• have high calcium levels in your blood
• have asthma
• have epilepsy or seizure disorders
• have diabetes
• experience migraines
• have endometriosis
• have lupus
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Duavee falls into category X. It has been shown that women taking Duavee during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Duavee should not be used by women who are breastfeeding. Taking estrogen while breastfeeding decreases the quantity and quality of breastmilk.

Take Duavee exactly as prescribed.

Duavee comes in oral tablet form and is taken once daily, with or without food.

Do not chew, divide, or break Duavee tablets. Swallow the tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Duavee at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

The recommended dose of Duavee for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis is 0.45 mg/20 mg once daily. Take the medication at the same time every day.

If you take too much Duavee, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Duavee is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Duavee at room temperature.
• Protect the tablets from moisture.
• Keep this and all medicines out of the reach of children.
• Keep the tablets in the blister pack until you are ready to take them. Do not put the tablets in another pill container or organizer.
• Once the foil pouch is opened, all tablets must be used within 60 days.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA

Women taking DUAVEE should not take additional estrogens.

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. DUAVEE has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. 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.

Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg)-alone, relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. 

In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and other dosage forms of estrogens.

Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.