NOVEN THERAPEUTICS, LLC. WOMEN’S HEALTH MINIVELLE (ESTRADIOL TRANSDERMAL SYSTEM) SAMPLE REQUEST FORM

Transcription

NOVEN THERAPEUTICS, LLC. WOMEN’S HEALTH MINIVELLE (ESTRADIOL TRANSDERMAL SYSTEM) SAMPLE REQUEST FORM
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
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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.
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