Information about ANGELIQ®
IMPORTANT SAFETY INFORMATION
What is ANGELIQ® used for?
ANGELIQ (0.25 mg drsp/0.5 mg estradiol E2) tablets and ANGELIQ (0.5 mg drsp/1.0 mg E2) tablets are used after menopause in women who have a uterus to reduce moderate to severe hot flashes.
In addition, ANGELIQ (0.5 mg drsp/1.0 mg E2) is used after menopause in women who have a uterus to treat moderate to severe dryness, itching, and burning in or around the vagina. If you use ANGELIQ (0.5 mg drsp/1.0 mg E2) only to treat dryness, itching, and burning in or around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
What is the most important information I should know about ANGELIQ (combination of estrogen and progestin hormones)?
- Do not use estrogens with progestins, or estrogen-alone, to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins, or estrogen-alone, may increase your chance of getting dementia, based on a study of women 65 years of age or older
- Using estrogen-alone may increase your chance of getting strokes, blood clots or cancer of the uterus (womb)
- You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ
Who should not use ANGELIQ?
Do not use ANGELIQ if you have had your uterus removed (hysterectomy). ANGELIQ contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use ANGELIQ.
Do not start taking ANGELIQ if you have unusual vaginal bleeding; currently have or have had certain cancers, such as cancer of the breast or uterus; had a stroke or heart attack in the past year; currently have or have had blood clots; have kidney disease, liver disease, or disease of your adrenal glands; have been diagnosed with a bleeding disorder; are allergic to ANGELIQ or any of its ingredients; or are pregnant or plan to become pregnant.
What are the most serious risks of taking ANGELIQ?
ANGELIQ may increase the risk of heart attack; stroke; blood clots; dementia; cancer of the breast, ovary, or lining of the uterus (womb); high blood pressure; high blood sugar; gallbladder disease; liver problems; or enlargement of benign tumors of the uterus (fibroids).
In addition, ANGELIQ contains drospirenone which may increase the potassium level in your blood. Do not take ANGELIQ if you have kidney, liver or adrenal disease because these conditions may also increase the potassium level in your blood. Tell your healthcare provider about all the medicines you take because some other medicines may increase potassium. In some situations, your healthcare provider may recommend testing your blood for potassium level.
Call your healthcare provider right away if you have:
- New breast lumps; changes in vision or speech; sudden new severe headaches; severe pain in your chest or legs with or without shortness of breath, weakness and fatigue; vaginal bleeding while taking ANGELIQ
What are the most common side effects in ANGELIQ clinical trials?
The most common side effects were stomach and abdominal pain, vaginal bleeding or spotting, breast pain/discomfort, headache, vaginal yeast infection, nausea, diarrhea, and fluid retention.
ANGELIQ is available by prescription only.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information about ANGELIQ, please see the full Prescribing Information.