Upsher-Smith Laboratories, Inc.
Consumer Education Materials Use Agreement
“New Perspectives, New Choices”
NOTICE -- READ THIS BEFORE DOWNLOADING, COPYING OR USING THE CONSUMER EDUCATION MATERIALS
ACCESSING AND USING THE MATERIALS ACCOMPANYING THIS AGREEMENT INDICATES YOUR ACCEPTANCE OF THESE TERMS AND CONDITIONS. READ ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT PRIOR TO ACCESSING OR USING THE MATERIALS. IF YOU DO NOT ACCEPT THESE TERMS, YOU MUST NOT ACCESS OR USE THE MATERIALS.
1. Grant of Use. The consumer education materials “New Perspectives, New Choices” (the “Materials”) are provided, not sold, to you by Upsher-Smith Laboratories, Inc. (“USL”). Subject to the terms of this Agreement, you have a non-exclusive right to use the Materials for non-commercial (e.g. not for resale or rental or the like), educational, evaluation or personal purposes only. You understand and agree that the Materials are intended for use in the United States only. You agree to accurately present and not misrepresent the contents of the Materials and the indications for the products referenced in the Materials. You may not modify the Materials. You may not use USL’s name or other trademarks in the course of using the Materials, except as set forth in the Materials.
2. Copyright. The Materials are copyrighted by USL. You may make copies of the Materials for consumer education and presentation purposes if USL’s copyright notice is included on such copies.
3. Ownership. You agree that the Materials belong to, and are the property of, USL. You agree that you neither own nor hereby acquire any claim or right of ownership to the Materials. All content accessed through the references in the Materials is the property of the applicable content owner and may be protected by applicable copyright law. This Agreement gives you no rights to such content.
4. Term and Termination. This Agreement is effective until terminated. You may terminate this Agreement at any time by destroying all copies of the Materials in your possession. This Agreement automatically terminates if you fail to comply with its terms and conditions and, upon such termination, you will destroy all copies of the Materials and cease any presentation of the Materials.
5. DISCLAIMER OF WARRANTY. USL PROVIDES THE MATERIALS “AS IS” WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD-PARTY INTELLECTUAL PROPERTY RIGHTS.
6. LIMITATION OF REMEDIES. IN NO EVENT WILL USL BE LIABLE FOR ANY DIRECT OR INDIRECT DAMAGES OR OTHER RELIEF ARISING OUT OF YOUR USE OR INABILITY TO USE THE MATERIALS.
7. Applicable Law. This Agreement will be governed by the laws of the State of Minnesota, without reference to conflicts of laws principles.
8. No Other Agreements. This Agreement constitutes the entire agreement between the parties with respect to the Materials, and supersedes any other written or oral agreement.
9. Severability. If any provision of this Agreement is held invalid, the remainder of this Agreement shall continue in full force and effect.
If you have any questions, please contact in writing: Upsher-Smith Laboratories, Inc., 6701 Evenstad Drive, Maple Grove, MN 55369, attention: Women’s Health Marketing
Divigel® is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.
Important Safety Information for Healthcare Providers
Estrogens should not be used in women with undiagnosed abnormal vaginal bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis (DVT) or pulmonary embolism; active or recent arterial thromboembolic disease; liver dysfunction or disease; known hypersensitivity to Divigel® ingredients; or known or suspected pregnancy.
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 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 doses. Long-term continuous administration of estrogen, with or without progestin, has also shown increased risk of breast and ovarian cancers.
Cardiovascular and other risks. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.
The Women's Health Initiative (WHI) studies reported increased risks of stroke and DVT in postmenopausal women (50 to 79) during 6.8 and 7.1 years of treatment, respectively, with daily oral conjugated estrogens (CE) 0.625 mg alone, relative to placebo, and increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79) during 5.6 years of treatment with daily oral CE 0.625 mg and medroxyprogesterone acetate (MPA) 2.5 mg, relative to placebo.
The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women 65 or older during 5.2 years of treatment with daily oral CE 0.625 mg alone and during 4 years of treatment with daily oral CE 0.625 mg and MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
These risks should be assumed to be similar for other combinations and dosage forms of estrogens and progestins.
The less common but serious risks reported with estrogen therapy include certain cardiovascular disorders, certain malignant neoplasms, dementia, gallbladder disease, hypercalcemia and visual abnormalities.
The most frequently reported adverse events in Divigel® clinical trials were nasopharyngitis, upper respiratory tract infection, vaginal mycosis, breast tenderness and metrorrhagia.
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.
This safety information is not all-inclusive. Please see full Prescribing Information, including black box and other warnings.
For more information, call 1-800-654-2299.
UPSHER-SMITH Pharmaceuticals Since 1919
©2012 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369
*Once-daily dosing of estradiol.
