NOVEN THERAPEUTICS, LLC. WOMEN’S HEALTH MINIVELLE (ESTRADIOL TRANSDERMAL SYSTEM) SAMPLE REQUEST FORM FAX TO 1-877-540-6497 ® PRACTITIONER INFORMATION REFERENCE #: BW First Name: Designation: (circle one) Last Name: MD DO PA NP Other State License #: Expiration Date: _ _ / _ _ / _ _ _ _ Street Address: (PO Boxes are not accepted) City: State: Zip Code: Telephone: ( __ __ __ ) __ __ __ - __ __ __ __ Fax: ( __ __ __ ) __ __ __ - __ __ __ __ Email: MINIVELLE® PRODUCT SAMPLES Please check the box for each sample dose requested. You will receive 2 packer boxes (1 packer contains 2 boxes, which contain 4 total patches). Product Description NDC Code and Quantity Product Description NDC Code and Quantity Minivelle 0.0375 mg/day 68968-6637-4 (1 packer = 2 boxes) Minivelle 0.05 mg/day 68968-6650-4 (1 packer = 2 boxes) Minivelle 0.075 mg/day 68968-6675-4 (1 packer = 2 boxes) Minivelle 0.1 mg/day 68968-6610-4 (1 packer = 2 boxes) This form must be filled out completely before your sample request can be processed. You should expect samples to arrive within 2 weeks from the date your fax request is received. If you have any questions regarding your request, please call 1 877-540-6498 (M-F 8am–5pm EST). Practitioner Certification I, a licensed practitioner, certify that all the information on this form is correct and that I am licensed with the appropriate state authorities and eligible under state law to request, receive, prescribe, and dispense the above samples. I have requested the packaged quantities shown on this document for the product indicated. I understand and agree that the samples are subject to the requirements of the Prescription Drug Marketing Act and cannot be sold, traded, bartered, billed, returned for credit or utilized to seek reimbursement. Date: _ _ /_ _ / _ _ _ _ Practitioner’s Signature (Request cannot be fulfilled unless this form is signed and dated in ink. Must be original, no signature stamps accepted.) INDICATION MINIVELLE® (estradiol transdermal system) is indicated for treatment of moderate to severe vasomotor symptoms due to menopause. IMPORTANT SAFETY INFORMATION WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Estrogen Plus Progestin Therapy Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Estrogens should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or Page 1 of 2 MINI-2106-14 NOVEN THERAPEUTICS, LLC. WOMEN’S HEALTH MINIVELLE (ESTRADIOL TRANSDERMAL SYSTEM) SAMPLE REQUEST FORM FAX TO 1-877-540-6497 ® suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or history of arterial thromboembolic disease (e.g., stroke or MI); known anaphylactic reaction or angioedema with MINIVELLE; liver dysfunction or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy. 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. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine if treatment is still necessary. Estrogens increase the risk of gallbladder disease. Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs. Monitor thyroid function in women on thyroid replacement therapy. In clinical trials with Vivelle® (estradiol transdermal system), the most common side effects (≥5%) were headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, and intermenstrual bleeding. To report SUSPECTED ADVERSE REACTIONS, contact Noven Therapeutics, LLC at 1-800-455-8070 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch These are not all the possible side effects of Minivelle. Please read the full Prescribing Information and Medication Guide. Please see full Prescribing Information, including Boxed WARNING for Minivelle® at www.minivelle.com. Minivelle® is manufactured by Noven Pharmaceuticals, Inc. and distributed by Noven Therapeutics, LLC. Page 2 of 2 MINI-2106-14
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