IMPORTANT SAFETY INFORMATION
What is the most important information I 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 in brain function).
- Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Who should not use 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.
Do not start using BIJUVA if you:
- Have 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.
- 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 (womb). If you have or have had cancer, talk to your healthcare provider about whether you should use BIJUVA.
- Currently have or have had blood clots.
- Had a stroke or heart attack.
- Currently have or have had liver problems.
- Are allergic to BIJUVA or any of its ingredients.
Before you use 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).
- Have any other medical conditions that may become worse while you are using BIJUVA.
- Are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop using BIJUVA.
- Are pregnant or think you may be pregnant.
- Are breastfeeding.
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. BIJUVA may affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine.
What are the possible side effects of BIJUVA?
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
- cancer changes of endometriosis
- 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
Common side effects of BIJUVA include:
- breast tenderness
- headache
- nausea
- vaginal bleeding
- vaginal discharge
- pelvic pain
Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all of the possible side effects of BIJUVA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Mayne Pharma at 1-844-825-8500.
