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FREQUENTLY ASKED QUESTIONS

What is BIJUVA?

BIJUVA is a prescription medicine that contains 2 kinds of hormones, a bio-identical estrogen and a bio-identical progesterone. BIJUVA is used after menopause to reduce moderate to severe hot flashes.

Is BIJUVA a hormone replacement therapy?

Yes, BIJUVA is a once-daily oral capsule that contains an estrogen and a progesterone. It is a bio-identical product, which means that the hormones in BIJUVA are structurally identical to the hormones your body produces naturally. The bio-identical estrogen helps to replenish what’s lost during menopause and treat moderate to severe hot flashes, while the bio-identical progesterone helps to reduce risk to the lining of your uterus.

BIJUVA is not for everyone as there are risks associated with hormone replacement therapy. While there are risks, professional medical guidelines suggest that estrogen therapies, such as BIJUVA, are effective treatments for menopausal symptoms, like hot flashes.

What is the most important information I should know about BIJUVA?

  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
  • Taking estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Taking estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Taking estrogen-alone may increase your chance of getting cancer of the uterus
  • Taking estrogen-alone may increase your chances of getting strokes or blood clots
  • Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with BIJUVA
  • Talk to a Provider

    Does hormone therapy seem like it might be right for you? Ask about BIJUVA.

    Do not take BIJUVA if you:

    • have had your uterus (womb) removed (hysterectomy). BIJUVA contains progesterone to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need progesterone and you should not take BIJUVA
    • have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause
    • currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take BIJUVA
    • currently have or have had blood clots
    • had a stroke or heart attack
    • currently have or have had liver problems
    • have been diagnosed with a bleeding disorder
    • are allergic to BIJUVA or any of its ingredients. See the list of ingredients in BIJUVA here

    Before you take BIJUVA, tell your healthcare provider about all of your medical conditions, including if you:

  • have high levels of fat in your blood (triglycerides)
  • have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause
  • have certain medical conditions that may become worse while you are taking BIJUVA. Your healthcare provider may need to check you more carefully if you have certain conditions, such as:
    • asthma (wheezing)
    • diabetes
    • epilepsy (seizures)
    • migraine
    • a genetic problem called porphyria
    • lupus
    • hypertension (high blood pressure)
    • have high calcium in your blood
    • endometriosis
    • angioedema (swelling of face or tongue)
    • problems with your heart, liver, thyroid or kidneys
  • are going to have surgery or will be on bed rest
  • are pregnant or think you may be pregnant. BIJUVA is not for pregnant women
  • are breastfeeding. The hormones in BIJUVA can pass into your breast milk


  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how BIJUVA works. Some other medicines and food products may increase or decrease the concentrations of the hormones in BIJUVA in the blood. BIJUVA may affect how your other medicines work, and other medicines may affect how BIJUVA works.

    Talk to a Provider

    Questions about BIJUVA or other treatments for hot flashes due to menopause?

    How should I take BIJUVA?

    • Take BIJUVA exactly as your healthcare provider tells you to take it
    • Take 1 capsule by mouth each evening with food
    • If you miss a dose of BIJUVA, take the missed dose as soon as possible with food, unless it is within 2 hours of the next evening dose of BIJUVA
    • Estrogens should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with BIJUVA

    How should I store BIJUVA?

  • Store at room temperature between 68°F to 77°F (20°C to 25ºC)
  • Keep BIJUVA and all medicines out of the reach of children
  • What are the possible side effects for BIJUVA?

    Side effects are grouped by how serious they are and how often they happen when you are treated. Serious but less common side effects include:

    • heart attack
    • stroke
    • blood clots
    • breast cancer
    • cancer of the lining of the uterus (womb)
    • cancer of the ovary
    • dementia
    • gallbladder disease
    • high or low blood calcium levels
    • changes in vision
    • high blood pressure
    • high levels of fat in your blood (triglycerides)
    • liver problems
    • changes in thyroid hormone levels
    • swelling or fluid retention
    • enlargement of benign tumors of the uterus (fibroids)
    • worsening swelling of face or tongue (angioedema) in women who have a history of angioedema
    • changes in laboratory test results, such as bleeding time and high blood sugar levels

    Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

    • new breast lumps
    • unusual vaginal bleeding
    • changes in vision or speech
    • sudden new severe headaches
    • severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue
    • vomiting

    The most common side effects of BIJUVA include:

    • breast tenderness
    • vaginal bleeding
    • pelvic pain
    • headache
    • vaginal discharge

    Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of BIJUVA. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to TherapeuticsMD® at 1-888-228-0150.

    What can I do to lower my chance of serious side effects?

  • Talk with your healthcare provider regularly about whether you should continue taking BIJUVA
  • If you have a uterus, talk with your healthcare provider about whether the addition of a progestogen is right for you
  • The addition of a progestogen is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb)
  • See your healthcare provider right away if you get vaginal bleeding while taking BIJUVA
  • Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year, unless your healthcare provider tells you something else
  • If members of your family have had breast cancer or if you have ever had breast lumps of an abnormal mammogram (breast X-ray), you may need to have breast exams more often
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease
  • Talk to a Provider

    If you have questions about the safety of BIJUVA, connect with a pharmacist or healthcare provider today.

    Active ingredients: estradiol and progesterone

    Inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di-glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide.

    BIJUVA is supplied in blister cartons of 30 capsules.

    IMPORTANT RISK INFORMATION

    Most important information you should know about BIJUVA (estradiol and progesterone) capsules:

    • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
    • Taking estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
    • Taking estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age or older.
    • Taking estrogen-alone may increase your chance of getting cancer of the uterus.
    • Taking estrogen-alone may increase your chances of getting strokes or blood clots.
    • Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
    • You and your healthcare provider should talk regularly about whether you still need treatment with BIJUVA.

    DO NOT USE BIJUVA IF YOU:

    • Have had your uterus (womb) removed (hysterectomy). BIJUVA contains progesterone to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need progesterone and you should not take BIJUVA.
    • Have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
    • Currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take BIJUVA.
    • Currently have or have had blood clots.
    • Had a stroke or heart attack.
    • Currently have or have had liver problems.
    • Have been diagnosed with a bleeding disorder.
    • Are allergic to BIJUVA or any of its ingredients.

    WARNINGS

    Ask a doctor before use if you:

    • Have high levels of fat in your blood (triglycerides).
    • Have any unusual vaginal bleeding.
    • Have certain medical conditions that may become worse while you are taking BIJUVA, such as: asthma (wheezing); diabetes; epilepsy (seizures); migraine; a genetic problem called porphyria; lupus; hypertension (high blood pressure); have high calcium in your blood; endometriosis; angioedema (swelling of face or tongue); problems with your heart, liver, thyroid or kidneys.
    • Are going to have surgery or will be on bed rest.
    • Are pregnant or think you may be pregnant. BIJUVA is not for pregnant women.
    • Are breastfeeding.

    Tell your doctor or pharmacist about all the medicines you take,

    including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    WHEN USING BIJUVA, YOU MAY HAVE

    • Breast tenderness
    • Headache
    • Vaginal bleeding
    • Vaginal discharge
    • Pelvic pain

    Call your doctor right away if you get any of the following warning signs:

    • New breast lumps
    • Unusual vaginal bleeding
    • Changes in vision or speech
    • Sudden new severe headaches
    • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
    • Vomiting

    USE

    BIJUVA is a prescription medicine that contains two hormones, estrogen and progesterone. BIJUVA is used after menopause to reduce moderate to severe hot flashes in women with a uterus.

    The risk information provided here is not complete. To learn more, review the BIJUVA Patient Information and talk about BIJUVA with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at www.BIJUVA.com.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. You may also report side effects to TherapeuticsMD® at 1-888-228-0150.

    IMPORTANT RISK INFORMATION

    Most important information you should know about BIJUVA (estradiol and progesterone) capsules:

    • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
    • Taking estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
    • Taking estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age or older.
    • Taking estrogen-alone may increase your chance of getting cancer of the uterus.
    • Taking estrogen-alone may increase your chances of getting strokes or blood clots.
    • Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
    • You and your healthcare provider should talk regularly about whether you still need treatment with BIJUVA.

    DO NOT USE BIJUVA IF YOU:

    • Have had your uterus (womb) removed (hysterectomy). BIJUVA contains progesterone to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need progesterone and you should not take BIJUVA.
    • Have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
    • Currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take BIJUVA.
    • Currently have or have had blood clots.
    • Had a stroke or heart attack.
    • Currently have or have had liver problems.
    • Have been diagnosed with a bleeding disorder.
    • Are allergic to BIJUVA or any of its ingredients.

    WARNINGS

    Ask a doctor before use if you:

    • Have high levels of fat in your blood (triglycerides).
    • Have any unusual vaginal bleeding.
    • Have certain medical conditions that may become worse while you are taking BIJUVA, such as: asthma (wheezing); diabetes; epilepsy (seizures); migraine; a genetic problem called porphyria; lupus; hypertension (high blood pressure); have high calcium in your blood; endometriosis; angioedema (swelling of face or tongue); problems with your heart, liver, thyroid or kidneys.
    • Are going to have surgery or will be on bed rest.
    • Are pregnant or think you may be pregnant. BIJUVA is not for pregnant women.
    • Are breastfeeding.

    Tell your doctor or pharmacist about all the medicines you take,

    including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    WHEN USING BIJUVA, YOU MAY HAVE

    • Breast tenderness
    • Headache
    • Vaginal bleeding
    • Vaginal discharge
    • Pelvic pain

    Call your doctor right away if you get any of the following warning signs:

    • New breast lumps
    • Unusual vaginal bleeding
    • Changes in vision or speech
    • Sudden new severe headaches
    • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
    • Vomiting

    USE

    BIJUVA is a prescription medicine that contains two hormones, estrogen and progesterone. BIJUVA is used after menopause to reduce moderate to severe hot flashes in women with a uterus.

    The risk information provided here is not complete. To learn more, review the BIJUVA Patient Information and talk about BIJUVA with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at www.BIJUVA.com.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. You may also report side effects to TherapeuticsMD® at 1-888-228-0150.