Hormone Therapy

ACTIVELLA^® 0.5 mg/0.1 mg and ACTIVELLA^® 1.0 mg/0.5 mg

Indications and Usage:

Activella® 0.5 mg/0.1 mg (estradiol/norethindrone acetate) tablets is used after menopause in women who have a uterus to reduce moderate to severe hot flashes, and to help reduce your chances of suffering from osteoporosis (thin weak bones). If you use Activella® only to prevent osteoporosis, talk to your health care provider about whether a different treatment or medicine without estrogens might be better for you.

Important Safety Information:

WHAT SHOULD KNOW ABOUT Activella®?

First of all, Activella® isa combination of estrogen and progestin hormones.

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.  Using estrogens with or without progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. 

Do not use estrogens with or without progestins to prevent dementia. Using estrogens with or without progestins may increase your risk of dementia. 

You and your health care provider should talk regularly about whether you still need treatment with Activella®.

Do not take Activella® if you have had your uterus removed (hysterectomy).  Do not start taking Activella® if you have unusual vaginal bleeding, currently have or have had certain cancers (including cancer of the breast or uterus), had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to Activella® or any of its ingredients, think you may be pregnant, or are breast feeding.

In woman with a uterus, the use of estrogen alone may increase the chance of getting cancer of the tissue lining the uterus. You should contact your doctor right away if you have unusual vaginal bleeding.

In a clinical trial, the most commonly reported adverse events (reported at a frequency of ≥5%) were back pain, pain in arms and legs, headache, nausea, diarrhea, upper respiratory tract infection, uterine thickening and vaginal bleeding.

Estrogens and progestins should be used at the lowest dose possible for your treatment and only as long as needed.

Please click here for Activella® 0.5 mg/0.1 mg and Activella® 1.0 mg/0.5 mg Prescribing Information.

Indications and Usage:

Vagifem® (estradiol) vaginal tablet is indicated for the treatment of atrophic vaginitis.

Important Safety Information:

ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA (cancer of the uterus). 

Vagifem® should not be used by women who are pregnant or who think they may be pregnant.  It should not be used immediately after childbirth or while breast-feeding.  It also should not be used by women who have unusual vaginal bleeding, a history of breast or uterine cancer, or a history of blood clots.

Vagifem® may cause some side effects that are generally mild.  Those commonly reported in clinical studies include headache, abdominal pain, back pain, upper respiratory tract infection, vaginal itching, and vaginal yeast infection.  Vagifem® is designed to work only where it is applied in the vagina, and has not been shown to have a significant effect on other organs or tissues (such as the breasts or bones).  If you experience side effects while taking Vagifem®, be sure to tell your doctor.

Remember to check with your doctor to make sure Vagifem® or any other hormone product is right for you.

Please click here for Vagifem® Prescribing Information.