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You don't have to lose your cool over hot flashes

BIJUVA is proven to reduce moderate to severe hot flashes while reducing risk to the lining of the uterus.1-3 BIJUVA is the FIRST AND ONLY AVAILABLE FDA-approved combination of bio-identical estradiol and bio-identical progesterone in a single daily oral capsule.1


Treat The Heat

What's got you
hot and bothered?

Understand how your body changes during
menopause and how menopausal
symptoms may affect you.


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Important Risk Information

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER

See full prescribing information for complete boxed warning.


Estrogen Plus Progestin Therapy

  • The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, and myocardial infarction (MI)
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
  • The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
  • Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia

Estrogen-Alone Therapy

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT
  • The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
  • Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia

The WHI estrogen-alone and estrogen plus progestin substudies evaluated only daily oral conjugated estrogens (CE) [0.625 mg] and medroxyprogesterone acetate (MPA) [2.5 mg]. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE and MPA doses, other routes of administration, or other estrogen-alone or estrogen plus progestogen products is not known, and cannot be definitively excluded or determined.

Most important information you should know about BIJUVA (a combination of estrogen and progestogen):

  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.
  • Using estrogen-alone may increase your chance of getting cancer of the uterus.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Using estrogen-alone may increase your chances of getting strokes or blood clots.
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and 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 a progestogen to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestogen and you should not use 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.
  • Have been diagnosed with a bleeding disorder.
  • Have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use BIJUVA.
  • Have or have had blood clots.
  • Had a stroke or heart attack.
  • Have or have had liver problems.
  • 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 any other medical conditions that may become worse while you are using BIJUVA, such as: asthma (wheezing); diabetes; a genetic problem called porphyria; lupus; hypertension (high blood pressure); have high calcium in your blood; epilepsy (seizures); migraine; 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
  • Nausea
  • 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, an estrogen and a progestogen. 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 here


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.