Healthcare Professionals

    COMBIPATCH® Dosing Regimens

    There are two hormone therapy regimens that use COMBIPATCH: The Continuous Combined regimen and Continuous Sequential regimen.

    •  In this regimen, Minivelle is applied for the first two weeks of the month, followed by COMBIPATCH during weeks 3 and 4
    • You may experience regular monthly bleeding

    More about the Continuous Sequential regimen

    This calendar is just an example. You will be able to choose the days of the week you change patches based on when you begin treatment.

    Continuous Combined Regimen

    COMBIPATCH® offers two dosing options to treat certain moderate to severe symptoms of menopause.
    To decide which treatment plan may work for you, talk to your doctor about the following:

    • Your preference for a predictable monthly bleed vs. the potential for occasional spotting
    • Your personal history of menstruation
    • How far along you are in your menopause journey

    Depending on your personal preferences, history, and time since you started menopause (among other considerations), your doctor can recommend a dosing regimen that might be right for you.

    If your doctor has prescribed COMBIPATCH for a Continuous Combined regimen, your body will receive a consistent level of hormones throughout the month. The calendar to the right shows an example of when you’ll apply a new transdermal patch to your lower abdomen throughout a 4-week schedule. You’ll remove your patch and apply a new one every 3 to 4 days, according to your schedule.

    While following a Continuous Combined regimen, you may experience irregular bleeding (spotting) in the first year.

    • Women prescribed continuous combined treatment may experience spotting, particularly in the first six months, but it generally decreases with time
    • Over the course of a one-year study with COMBIPATCH, this bleeding and spotting stopped in the majority of women
    • Women who experienced bleeding usually characterized it as light (1.3 on an intensity scale of 1 [light] to 4 [heavy])
     

    Talk to your doctor about any issues you have with spotting. He or she may be able to help by adjusting your dosing regimen

    Keep your doctor regularly informed about your bleeding patterns and other issues related to your hormone therapy. It’s important to schedule follow-up visits with your doctor every 3 to 6 months to discuss your symptoms, health risks, and treatment goals. All of these are important, and all can change over time. Communicate openly with your physician about your treatment with COMBIPATCH, how it’s affecting your daily routine, and whether or not switching to a Continuous Sequential regimen might be better for you. COMBIPATCH offers options to help you and your doctor address your needs now and in the future. It’s important that you take your medication as prescribed. Never start or stop any treatment plan without talking to your doctor first.

    This calendar is just an example. You will be able to choose the days of the week you change patches based on when you begin treatment.

    This calendar is just an example. You will be able to choose the days of the week you change patches based on when you begin treatment.

    Continuous Sequential Regimen

    COMBIPATCH® offers two dosing options to treat certain moderate to severe symptoms of menopause.
    To decide which treatment plan may work for you, talk to your doctor about the following:

    • Your preference for a predictable monthly bleed vs. the risk of occasional spotting
    • Your personal history of menstruation
    • How far along you are in your menopause journey

    Depending on your personal preferences, history, and time since you started menopause (among other considerations), your doctor can recommend a dosing regimen that might be right for you.

     

    If you and your doctor have selected a Continuous Sequential regimen:

    • Apply Minivelle® (estradiol transdermal system) for the first two weeks of your monthly schedule and COMBIPATCH for the second two weeks
    • Remove one patch and apply a new one every 3 to 4 days, according to your schedule
    • A predictable monthly bleed will most likely occur
     

    The calendar to the right shows an example of when you’ll apply a new transdermal patch to your lower abdomen throughout the 4-week schedule.

     

    The Continuous Sequential regimen with COMBIPATCH and Minivelle provides a consistent level of estrogen throughout the 
4-week schedule, but progestin during only half of the schedule. This plan is similar to a natural menstrual cycle, and women prescribed the Continuous Sequential regimen often experience regular monthly bleeding.

     

    Keep your doctor regularly informed about your bleeding patterns and other issues related to your hormone therapy. It’s important to schedule follow-up visits with your doctor every 3 to 6 months to discuss your symptoms, health risks, and treatment goals. All of these are important, and all can change over time. Communicate openly with your physician about your treatment with COMBIPATCH, how it’s affecting your daily routine, and when it might be time to consider switching to a Continuous Combined regimen. COMBIPATCH offers options to help you and your doctor address your needs now and in the future. It’s important that you take your medication as prescribed. Never start or stop any treatment plan without talking to your doctor first.

     

    Please Click Here for Full Product Information, including Boxed WARNING, for COMBIPATCH.
    Please Click Here for Full Product Information, including Boxed WARNING, for Minivelle.

     

    This calendar is just an example. You will be able to choose the days of the week you change patches based on when you begin treatment.

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    The recommended storage conditions for COMBIPATCH have been updated.

    Please click here to see full announcement >

    The recommended storage conditions for COMBIPATCH have been updated.

    Please click here to see full announcement >

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    Click continue if you are a U.S. healthcare professional

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    Leaving the COMBIPATCH® Web Site

    You are now leaving the CombiPatch Web Site and moving to an external Web site independently operated and not managed by Noven Pharmaceuticals. Noven assumes no responsibility for the content of the site.

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    Pay as little as $25 on each COMBIPATCH® prescription*†

    Copay Savings Offer

    Eligible patients pay as little as $25 on each prescription for up to 6

     

    COMBIPATCH® (estradiol/norethindrone acetate transdermal system) prescriptions.*†

    To get started, just follow these steps:

    Click on the savings offer button to download your offer.

     

    1. Take the printout to your doctor.
    2. If you and your doctor have decided that CombiPatch® may be right for you, ask your doctor for a prescription for COMBIPATCH®.
    3. Take your COMBIPATCH® prescription, along with your savings card printout,to a pharmacy to fill your prescription and to start saving!
    Download and print your offer

    *On copays up to $80, pay as little as $25 for a 1-month supply. On copays in excess of $80, or non-covered prescriptions, you may qualify for up to $55 in savings for a 1-month supply.

    †For eligible patients only. Restrictions apply. See offer for the full terms and conditions

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    Click continue if you are a U.S. healthcare professional

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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