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    Provide a Simple-To-Use, Effective Hormone Therapy With COMBIPATCH®

    Request samples of COMBIPATCH

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    COMBIPATCH – a discreet transdermal patch indicated for the treatment of moderate to severe vasomotor symptoms and moderate to severe vulvar and vaginal atrophy in postmenopausal women with an intact uterus.

    Please see Important Safety Information below, including BOXED WARNING, and link to Full Prescribing Information.

    Two Discreet Dosing Options

    2 Dosing Regimens + 2 Dosing Options = A Patch Designed With Choice in Mind

    COMBIPATCH enables you to respond to the needs of individual patients with a choice of 2 dosing options (0.05/0.25 or 0.05/0.14 mg/day) and 2 FDA-approved regimens:

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    Continuous Combined Regimen:

    • Significantly reduces moderate to severe hot flashes as well as vulvar and vaginal atrophy
    • Helps to achieve amenorrhea
    • Patients should be educated about the possibility of breakthrough bleeding1

    Continuous Sequential Regimen:

    • Significantly reduces moderate to severe hot flashes as well as vulvar and vaginal atrophy
    • Helps achieve a predictable monthly bleed
    • Patients should be educated that monthly withdrawal bleeding often occurs1

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    1COMBIPATCH (estradiol/norethindrone acetate) transdermal system [prescribing information]. Miami, FL: Noven Therapeutics, LLC; 2015

    Transdermal Delivery Avoids 1st Pass Metabolism

    COMBIPATCH continuously releases estrogen via skin into the bloodstream, therefore avoiding first-pass liver metabolism, thus achieving effective hormone levels with smaller total doses compared to oral estrogen in pills.1 This does not imply differences in safety or efficacy with other hormone therapies.

    Keep Pace With Busy Lifestyles

    COMBIPATCH has been shown to have a low level of skin irritation. The patch is designed to stay on as your patients go about their daily activities, even when bathing, swimming, or exercising.1

     

    1COMBIPATCH (estradiol/norethindrone acetate) transdermal system [prescribing information]. Miami, FL: Noven Therapeutics, LLC; 2015
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    July 2022

    IMPORTANT PRESCRIBING INFORMATION

    Subject: New Packaging Reflecting Updated Storage Conditions for CombiPatch®
    (estradiol/ norethindrone acetate transdermal system)
    Dear Health Care Provider,
     
    In December 2021, Noven Pharmaceuticals Inc., announced a change in the storage conditions for CombiPatch® (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg/day and 0.05/0.25 mg/day, approved by the U.S Food and Drug Administration (FDA).
     
    The new storage condition only allows to “store CombiPatch in the refrigerator at 2°C to 8°C (36°F to 46°)”. Previous CombiPatch storage conditions allowed for the product to be stored as follows: “Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing to the patient, CombiPatch can be stored at room temperature between 20°C to 25°C (66°F to 77°F) for up to 6 months”.
     
    The change in the storage condition for CombiPatch from up to 6 months at room temperature between 20°C to 25°C (66°F to 77°F) to fully refrigerated between 2°C to 8°C (36°F to 46°F), is not due to a product change. Recent analyses of test results showed that storage of CombiPatch in refrigerated conditions of 2°C to 8°C (36°F to 46°F) lead to improvement of product adhesion.
     
    Please note that the earliest patients will see changes to the outer packaging of CombiPatch reflecting these storage condition changes is September 2022. We advise you to please continue to proactively inform any patients receiving CombiPatch of its updated storage conditions.
     
    Prescriber Action:
    Continue to counsel all patients about the risks and benefits of CombiPatch, including:
    • The new storage requirements to ensure optimal adhesion of the product.
    • Patients should store all sealed CombiPatch in the refrigerator (2°C to 8°C (36°F to 46°F)) until they are ready to apply the transdermal system. Allow the transdermal system to reach room temperature before application.
     
    Note: All commercially available CombiPatch stored at previous storage recommendations are still safe and effective for use and, can continue to be used by patients.
     
    Please ensure your staff and any provider in your institution who may be involved in the handling, storage and dispensing of CombiPatch, receives a copy of this letter and specifically reviews the updated storage conditions
     
    Reporting Adverse Events
    Noven encourages the reporting of adverse events expeditiously. To report adverse events, product quality complaints or to request medical information related to CombiPatch please contact Noven Medical Information at (800) 455-8070 (9 a.m- 5 p.m EST, Mon-Fri).

    Adverse events or quality problems experienced with the use of this product may also be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail, telephone, or fax.
     

     

    This letter is not intended as a complete description of the benefits and risks related to the use of CombiPatch. Please refer to the full prescribing information including patient information available on www.combipatch.com. For additional information, please call Noven at 1-800- 455-8070.
     
    We will continue to work diligently to provide a consistent supply of CombiPatch. We appreciate your assistance in this matter and apologize for any inconvenience.
     
    Sincerely,
     
    Joel S. Lippman, MD
    COO & CMO