About Menopause

Menopause is the point in a woman’s life when the ovaries reduce production of estrogen and progesterone
to the extent where menstruation stops. It’s confirmed when 12 months have passed since a woman’s last
menstrual period. Menopause can also occur when the ovaries are surgically removed.

 

Natural Menopause

For most women, the natural process of menopause usually begins in their early 50s, when periods may become less regular. Declining levels of the hormones estrogen and progesterone cause changes in your periods. These hormones
help keep the vagina and uterus healthy and create menstrual cycles.

Surgical Menopause/Hysterectomy

Some women enter menopause as a result of surgery. Removal of your uterus (hysterectomy) and ovaries (oophorectomy) will initiate menopause at any age. Depending on your age, removal of the uterus alone, although stopping menstruation, does not cause menopause. This is because the ovaries, not the uterus, produce hormones. However, women who have only the uterus removed may experience menopause sooner, depending on ovarian function before the hysterectomy.

Symptoms Associated with Menopause.

Because of the decline in estrogen levels, you may start to experience symptoms. The good news is that you can treat certain moderate to severe symptoms associated with menopause and continue to live your active life. The following symptoms, when moderate to severe, are treatable by hormone therapy:

  • Hot flashes—the most common symptoms associated with menopause
  • Night sweats—hot flashes that occur at night accompanied by heavy perspiration
  • Vaginal dryness (itching, burning, and irritation) and atrophy (narrowing and shortening of the vagina)

 

If you use hormone therapy only to treat dryness, itching, and burning in and around your vagina, talk with your healthcare professional about whether a different treatment or medicine without estrogen might be better for you.

About Menopause

Menopause Resources

Management and Support

No matter where you are in your journey—whether you’re interested in learning more about menopause or looking for a hormone therapy that’s right for you—you have a community of support that’s here to “stick” by you every step of the way.

Visit the following Web sites to find supportive programs, resources, and the tools you need throughout your journey.

The recommended storage conditions for COMBIPATCH have been updated.

The recommended storage conditions for COMBIPATCH have been updated.

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

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.

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!

*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

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

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