ENJUVIA<sup>®</sup>


Rules, regulations, and other information of interest

Acceptance of Terms
Welcome to the Teva Women’s Health, Inc., Web sites (the “Sites”). These Terms of Use constitute an Agreement (“Agreement”) between Teva Women’s Health, Inc., and its affiliates (collectively “Teva”), and you (“you” or “user”). By accessing and using the Sites, you agree to the following terms of use and any amendments in effect at the time of your visit. This Agreement expressly incorporates by reference and includes the Teva Privacy Policy, and any guidelines, rules, or disclaimers that may be posted and updated on specific Sites. You understand that your right to use the Sites is derived solely from, and is expressly limited by, this Agreement.

Teva reserves the right to amend these Terms of Use from time to time. We encourage you to review these Terms of Use upon each visit to the Sites because any changes will be binding on you.

Information Provided on the Site
PLEASE CONSULT WITH YOUR PHYSICIAN OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED HERE OR WITHIN ANY OF OUR OTHER SITES. Promptly see a qualified healthcare professional if you have, or suspect that you have, a medical condition. This Site may contain information related to various health, medical, and fitness conditions and their treatment. However, we do not offer individualized medical diagnosis or patient-specific treatment advice. You should not use the information contained herein for diagnosing or treating a medical condition or disease. You should always consult a qualified healthcare professional before initiating use of any medicine or other treatment. Only a qualified healthcare professional can determine if a product described here, or within any of our other Sites, would be appropriate for you to use. Your qualified healthcare professional is in the best position to discuss with you the risks and benefits of any treatment, including prescription drugs, specific to your own medical condition.

Teva provides the Sites and the information available on the Sites (hereinafter referred to as “Information”) for the convenience of its users. This Information is presented in good faith and is believed to be correct. TEVA MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, REGARDING ANY INFORMATION, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OR FITNESS FOR A PARTICULAR PURPOSE. Information is supplied on the condition that the persons receiving the Information will make their own determinations as to its suitability.

Information provided on the Sites may only be used, copied, or distributed in unmodified form for informational purposes and without responsibility on the part of Teva.

Teva’s Site Content
Teva’s Sites and the Content (as defined below) thereon are owned by Teva, and all rights are exclusively reserved to Teva. You acknowledge that the Sites may contain Information, communications, software, photos, text, video, graphics, music, sounds, images, and other material (“Content”), which are provided by Teva. You agree and acknowledge that the Content and its use or the use of these Sites are protected by copyright, trademark, and other intellectual property laws, that these rights are valid and protected in all media now existing or later developed, and that your use of the Content shall be governed and constrained by applicable copyright, trademark, and other intellectual property laws. In addition, the Sites are protected by copyright as a collective work and/or compilation, pursuant to U.S. Copyright laws, international conventions, and other copyright laws. You may not modify, adapt, translate, exhibit, publish, transmit, participate in the transfer or sale of, reproduce, create derivative works from, distribute, perform, display, reverse engineer, decompile or dissemble, or in any way exploit, any of the Content, materials, or Sites, in whole or in part. Teva reserves the right to add, change, or delete Site Content, without notice, at its sole discretion.

Links
Teva may provide links to third-party Web sites. These links are provided only as a convenience. Linked Web sites are not reviewed, controlled, or examined by Teva and Teva is not responsible for the information, advertising, products, resources, or other material of any linked site or any link contained in a linked site. The inclusion of any link does not imply endorsement by Teva. In addition, please be aware that your use of any linked site is subject to the terms and conditions applicable to that site. Please direct any questions regarding linked sites to the Webmaster of that site.

Disclaimer
Your use of these Sites, the Content, and the Information provided on the Sites is solely at your own risk and is provided on an “as is” and “as available” basis. Teva expressly disclaims all other guarantees, warranties, conditions, and representations of any kind, either express or implied, whether arising under any statute, law, commercial usage, or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title, and non-infringement.

Limitation of Liability
In no event shall Teva or any of its officers, directors, employees, agents, or affiliates be liable, directly or indirectly, to anyone for any claims, losses, or damages, direct, indirect, special, incidental, or consequential, including, without limitation, loss of profits, resulting from or occasioned by the creation, use, or reliance of or on its Sites or any third-party Web sites or the information, advertising, products, resources, or material accessed through any such Web sites, regardless of the nature or cause of any such damages or losses and whether or not a claim thereof is based in contract, tort, negligence, or otherwise.

IMPORTANT SAFETY INFORMATION

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

The estrogen alone substudy of the Women’s Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo.

The estrogen-plus-progestin substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of oral conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

 

ENJUVIA® tablets should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active or recent (eg, within the past year) arterial thromboembolic disease (eg, stroke, myocardial infarction); liver dysfunction or disease; known hypersensitivity to the ingredients of ENJUVIA® tablets; or known or suspected pregnancy. There is no indication for ENJUVIA® in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

The most common side effects in clinical trials were headache, pain, nausea, and breast pain.

In a clinical trial, adverse events that occurred at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, included: headache, breast pain, nausea, pain, flu syndrome, bronchitis, rhinitis, sinusitis, abdominal pain, accidental injury, flatulence, vaginitis, dizziness, paresthesia, and dysmenorrhea.

ENJUVIA® tablets are taken orally, once daily, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the treatment of moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause.

When prescribing solely for the treatment of moderate-to-severe vaginal dryness and pain during intercourse, topical vaginal products should be considered. Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA® daily. Dosage should be periodically reassessed by the healthcare provider and adjustments made based upon the individual patient response.

Please click here for full prescribing information, including Boxed Warning.