Download Sample Request Form

Sample Request Form
Fax to 1-877-540-6497
(estradiol transdermal system)
Reference# WEB
Noven Therapeutics, LLC. Women’s Health
MD DO PA NP Other
Practitioner’s Last Name
First Name (required)Professional Designation
State License Number (required)Expiration Date (required)
Office Address
(required-PO boxes are not accepted)
City
State (required)
(required)
Zip (required)
Phone NumberFax NumberEmail
Minivelle® (estradiol transdermal system) Samples
Please check the box for each sample dose requested. You will receive 4 sample boxes per dose
(1 sample box contains 2 patches).
 Minivelle 0.050 mg/day
 Minivelle 0.10 mg/day
NOTE
While supplies last. Only 1 form can be submitted per month.
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.)
Minivelle® (estradiol transdermal system) Indication
MINIVELLE (estradiol transdermal system) is indicated for treatment of moderate to severe vasomotor symptoms due
to menopause. MINIVELLE is also indicated for prevention of postmenopausal osteoporosis. The 0.025 mg/day dose is
only approved for the prevention of postmenopausal osteoporosis.
®
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for
women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
Minivelle® (estradiol transdermal system) Important Safety Information
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.
Estrogen-alone or estrogen plus progestin therapy should not be used for the prevention of cardiovascular
disease or dementia.
Please see additional Boxed WARNING and Important Safety Information on next page.
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Minivelle® (estradiol transdermal system) Important Safety Information (continued)
Boxed WARNING continued
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT). The WHI estrogen plus progestin substudy reported increased risks of
stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) and increased risks of invasive
breast cancer.
The WHI Memory Study (WHIMS) estrogen-alone and estrogen plus progestin ancillary study reported an
increased risk of probable dementia in postmenopausal women 65 years of age and older.
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 re-evaluated periodically as clinically appropriate to determine if treatment is still
necessary.
Estrogens should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history
of breast cancer; known or 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 increase the risk of gallbladder disease. Discontinue estrogen if severe hypercalcemia, vision
abnormalities, 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.
These are not all the side effects of Minivelle.
Click here for the full Prescribing Information, including Boxed WARNING.
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.
MINIVELLE® and the Minivelle Logo are trademarks of Noven Therapeutics, LLC.
VIVELLE® is a registered trademark of Novartis Corporation.
Minivelle® is manufactured by Noven Pharmaceuticals, Inc. and distributed by Noven Therapeutics, LLC.
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