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    What Makes COMBIPATCH® Different?

    Effective Symptom Relief with Smaller Daily Doses Compared to Pills*
    A small transparent patch, COMBIPATCH uses the innovative DOT Matrix™ delivery system. Upon application to your skin, the patch continuously releases both estradiol (a form of estrogen) and norethindrone acetate (a progestin) directly into your bloodstream. That’s why COMBIPATCH can help to treat certain moderate to severe symptoms associated with menopause with smaller daily doses compared to pills that need to be digested first and then processed through the liver.*

     

    *This does not mean that COMBIPATCH is safer or more effective than hormone therapy (HT) pills or other hormone therapies.

     

    Learn more about how COMBIPATCH works.

     

    Dosing Options

    COMBIPATCH offers the convenience of two dosage options in a small and discreet combination HT patch.

    Designed to Provide a Choice of Dosing and Regimen Options

    COMBIPATCH can be used in one of two ways—based on what you and your doctor decide:

    • The Continuous Combined regimen means you will use only COMBIPATCH continuously throughout the month. Women prescribed a Continuous Combined regimen with COMBIPATCH receive a consistent level of progestin and may experience spotting, particularly in the first six months, but it generally decreases with time
    • The Continuous Sequential regimen means you will be alternating treatment with COMBIPATCH and Minivelle® (estradiol transdermal system) over the month. Women prescribed a Continuous Sequential regimen with COMBIPATCH and Minivelle receive progestin during only half of the month and usually experience a regular monthly bleed

     

    There are many important things to consider when choosing a COMBIPATCH dosing regimen. Talk to your healthcare provider about your preference for a predictable monthly bleed vs. the potential for occasional spotting, your history of menstruation, and how far along you are in your menopause journey. Depending on your personal preferences, history, and time since you started menopause, your doctor can recommend an appropriate dosing regimen.

     

    COMBIPATCH is available in two dosage options (reflected in two patch sizes). This allows your doctor to make adjustments to your treatment (specifically your progestin level) according to your symptoms and any side effects you may be experiencing. For example, many women experience irregular bleeding (spotting) during the first year on a Continuous Combined regimen with the kind of hormones contained in COMBIPATCH (estrogen and progestin). Spotting usually decreases during the first year of using COMBIPATCH, but your doctor can also make adjustments to your treatment plan or dose based on your personal experience. Make sure you schedule follow-up visits with your doctor every 3 to 6 months to discuss your progress, your concerns, and whether you still need treatment with COMBIPATCH. Never start or stop any treatment without talking to your doctor first.

    Read more about dosing regimens and what to expect while using COMBIPATCH.

    Designed to Provide a Choice of Dosing and Regimen Options Cont’d

    Click here

    Dosing Options
    COMBIPATCH offers the convenience of two dosage options in a small and discreet combination HT patch.
    For important safety information about Minivelle, click here.

    Petite and Discreet
    Small and transparent—COMBIPATCH is a small transparent patch that uses the innovative DOT Matrix™ technology delivery system to allow hormones to be absorbed directly into your bloodstream through your skin.

    Simple-to-Use Option
    COMBIPATCH has been shown to have a low level of skin irritation and excellent skin adhesion. The patch is designed to stay on as you go about your busy life. It sticks with you while showering, bathing, and even in the pool, so you can go about your active life while wearing the patch.

    Twice Weekly
    COMBIPATCH is changed twice a week according to a schedule that you set based on when you begin.

    Hormones in COMBIPATCH
    COMBIPATCH is a transdermal hormone therapy (HT) patch that contains both estrogen (estradiol) and progestin (norethindrone acetate). The progestin in COMBIPATCH may help to reduce the risk of certain types of uterine cancers and is specifically designed for postmenopausal women who still have their uterus.

    Find out how COMBIPATCH works.

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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 >

    The site you are about to enter is intended specifically for U.S. healthcare professionals

    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

    Minivelle® (estradiol transdermal system)

    INDICATION

    Minivelle® (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). Minivelle is used to reduce moderate to severe hot flashes due to menopause and to help prevent postmenopausal osteoporosis (thin weak bones). The 0.025 mg/day dose is only approved for the prevention of postmenopausal osteoporosis. If you use Minivelle only to prevent osteoporosis from menopause, talk with your healthcare provide about whether a different treatment or medicine without estrogens might be better for you.

    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 developing probable dementia in postmenopausal women 65 years of age or 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 DVT, pulmonary embolism (PE), stroke 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 developing probable dementia in postmenopausal women 65 years of age or older

    Minivelle should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Minivelle or any of its ingredients, or think you may be pregnant.

    Before you take Minivelle, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.

    Minivelle should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. You and your healthcare professional should talk regularly about whether you still need treatment with Minivelle.

    The most common side effects that may occur with Minivelle are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting.

    These are not all the possible effects of Minivelle. Please read the Patient Information section within the full Prescribing Information before taking Minivelle. For more information ask your healthcare provider or pharmacist for advice about side effects.

    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.

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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