Prescription Hormone Therapies

Find your comfort zone
While there's no way to avoid menopause, there are things you can do to reduce the impact of hot flashes, night sweats, and vaginal dryness. In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. Hormone therapy (HT) such as ANGELIQ^® tablets (drospirenone/estradiol) supplements the body's low estrogen and progesterone levels. The estrogen in ANGELIQ helps to relieve moderate to severe menopausal symptoms. Also, it may not be necessary to raise hormone levels to what they were before menopause. Speak with your healthcare provider about whether the possible benefits of hormone therapy outweigh the potential risks in your case.

Estrogens with or without progestins, including ANGELIQ, should not be used to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your risk of heart attack, strokes, breast cancer, blood clots and dementia.

You and your healthcare provider should talk regularly about whether you still need hormone therapy.

HT is an effective option to help manage menopausal symptoms such as hot flashes, night sweats, and vaginal dryness. Below is an overview of the forms of HT currently available:

• Oral hormone therapies. These medicines are taken at the same time daily and are effective when taken as directed for treating menopausal symptoms. It is important that you take your pills as directed to experience steady treatment of menopausal symptoms. There are different types of estrogens and progestins used in different oral HTs. ANGELIQ^® tablets (drospirenone/estradiol) contain estradiol and the progestin drsp^®, and are used to treat moderate to severe hot flashes, night sweats, and vaginal dryness in women who have a uterus. Ask your healthcare provider what this may mean for you. Estrogens with or without progestins, including ANGELIQ, should not be used to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your risk of heart attack, strokes, breast cancer, blood clots and dementia. drsp may increase potassium or lower the sodium in your blood. You should not take ANGELIQ if you have kidney, liver, or adrenal disease because these conditions may also increase the potassium in your blood.
• Hormone patch therapies. Patch or transdermal HT delivers hormones directly into the bloodstream through the skin. Medicine is delivered continuously for efficient dosing and no spiking. Some patches are designed to last an entire week.
• Hormone gels and vaginal creams. Hormone gels are applied topically to the skin and sometimes can help relieve menopausal symptoms. HT creams containing small amounts of estrogen are applied directly to the vagina to help relieve vaginal soreness, dryness, and itching. Unlike other forms of HT, vaginal creams do not relieve hot flashes or night sweats.
• Vaginal inserts. Vaginal inserts are small rings that release estrogen. They are placed into the vagina and need to be replaced every 3 months.

With so many forms of HT available, you may want to talk with your healthcare provider about these options to determine which one may be right for you.

 

IMPORTANT SAFETY INFORMATION

What is ANGELIQ used for?

ANGELIQ is used after menopause in women who have a uterus to:

• Reduce moderate to severe hot flashes
• Treat moderate to severe dryness, itching, and burning in or around the vagina.
  • If you use ANGELIQ only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

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, 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, are allergic to ANGELIQ or any of its ingredients, or think you may be pregnant, currently have or have had certain cancers. Estrogens may increase the chances of getting cancer of the breast or uterus.

What are possible side effects of ANGELIQ?

ANGELIQ is different from other hormonal medicines for menopausal symptoms because it contains drospirenone, and drospirenone may increase the potassium or lower sodium in your blood.

You should not take ANGELIQ if you have kidney, liver or adrenal disease because these conditions may also increase the potassium in your blood. Some other medicines may also increase potassium. If you regularly take another medicine that increases potassium levels, talk with your healthcare provider about whether ANGELIQ is right for you. In some situations, your healthcare provider may recommend testing your blood for potassium.

What are the less common but serious side effects of ANGELIQ?

Less common but serious side effects of ANGELIQ include: breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease and ovarian cancer.

What are the warning signs of less common but serious side effects of ANGELIQ?

Warning signs of less common but serious side effects of ANGELIQ include breast lumps, unusual vaginal bleeding, dizziness and faintness, changes in speech, severe headaches, chest pain, shortness of breath, pains in your legs, changes in vision, and vomiting. Call you healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

What are common side effects of ANGELIQ?

Common side effects of ANGELIQ include breast pain, upper respiratory infection, stomach/abdominal cramps, headache, irregular vaginal bleeding or spotting, pain in arms, legs or back, flu syndrome, bloating, accidental injury, surgery and sinus infection.

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.