ENJUVIA<sup>®</sup>

ENJUVIA® begins working as early as 4 weeks, even at lowest dose1
ENJUVIA® can help you solve the estrogen puzzle. In clinical studies, ENJUVIA® has been demonstrated to reduce the frequency and intensity of moderate-to-severe:

  • Hot flashes, including night sweats2,3
  • Vaginal dryness1
  • Pain with sex4

...all at the lowest approved dose of 0.3 mg.

In one study, women taking the lowest dose of ENJUVIA® (0.3 mg) experienced a 55% reduction in hot flashes after 4 weeks, and a 72% reduction in hot flashes by week 12.2,a

In a separate study, women taking the lowest dose of ENJUVIA® experienced a 68% reduction in severity of vaginal dryness and a 66% reduction in severity of pain with intercourse by week 12.1,b

ENJUVIA® comes in a range of dosage strengths
ENJUVIA® offers 5 strengths allowing for dosing flexibility consistent with treatment guidelines that estrogen therapy should be limited to the lowest effective dose for the shortest amount of time possible.1

Several dosage strengths means that you and your healthcare professional have the flexibility to initiate or change your treatment regimen with the dose that meets your needs. It is important for you to continue to talk with your healthcare professional about how well your ENJUVIA® treatment and dosage strength are working.

aBased on a 12-week, randomized, double-blind, placebo-controlled, multicenter study of 281 naturally or surgically postmenopausal women conducted to evaluate the safety and effectiveness of 3 different doses of ENJUVA® for the treatment of vasomotor symptoms. At baseline, patients experienced a minimum of 7 moderate-to-severe hot flashes per day or 50 per week.1

bBased on a 12-week, randomized, double-blind, placebo-controlled, multicenter study of 248 naturally or surgically postmenopausal women conducted to evaluate the safety and effectiveness of ENJUVIA® 0.3 mg for the treatment of symptoms of vulvar and vaginal atrophy. Patients were assessed for improvement in 3 co-primary efficacy variables including most bothersome symptom (identified by the patient as most bothersome to her at baseline); percentage of vaginal superficial cells and percentage of vaginal parabasal cells; and vaginal pH.1

ENJUVIA® (synthetic conjugated estrogens, B) Tablets is a medicine that contains estrogen hormones. It is prescribed to help relieve moderate-to-severe vasomotor symptoms, including hot flashes and night sweats, and moderate-to-severe vaginal dryness and pain with sex, symptoms associated with menopause.


IMPORTANT SAFETY INFORMATION

Important health information you should know when taking estrogens like ENJUVIA®: Estrogens increase the risk for cancer of the uterus (womb). If you experience persistent or recurring vaginal bleeding while taking estrogens let your doctor know right away, as this could be a warning sign for cancer. Your doctor should check for the cause of any unusual vaginal bleeding after menopause.

Estrogens (alone or in combination with progestins) should not be used to prevent heart disease, heart attacks, strokes, or dementia.

Estrogens (alone or in combination with progestins) may increase the risk of heart attack, stroke, blood clots, and breast cancer. Estrogens (alone or in combination with progestins) may increase your risk of dementia, based on a study of women age 65 or older. Because of these risks, estrogens should be used at the lowest dose for the shortest period of time. You and your doctor should talk regularly to determine whether you still need treatment with ENJUVIA®.


Who should not use ENJUVIA®?
Do not use ENJUVIA® if you:

  • May be pregnant
  • Have had a stroke or heart attack in the past year
  • Have unusual vaginal bleeding
  • Are allergic to ENJUVIA® or any of its components
  • Have a history of certain cancers, blood clots, or liver problems

What are the common side effects with ENJUVIA®?
You may experience headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, or hair loss.

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.

Please see the Patient Information section of the full prescribing information, including Boxed Warning.

References: 1. ENJUVIA® [package insert]. Sellersville, PA: Teva Women’s Health, Inc; 2010. 2. Utian WH, Lederman SA, Williams BM, Vega RY, Koltun WD, Leonard TW. Relief of hot flushes with new plant-derived 10-component synthetic conjugated estrogens. Obstet Gynecol. 2004;103(2):245-253. 3. Portman D, Margolis M, Reape K. Low-dose synthetic conjugated estrogens, B exhibits early onset of action in the treatment of vasomotor symptoms and vulvovaginal atrophy associated with menopause. Poster presented at: the North American Menopause Society Annual Meeting; September 30-October 3, 2009; San Diego, CA. 4.Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008;90(4):1132-1138.