The Benefits of COMBIPATCH®

COMBIPATCH is a transdermal hormone therapy (HT) patch that contains both estrogen and progestin and is designed specifically for postmenopausal women who still have their uterus. When applied just twice a week, COMBIPATCH helps to treat moderate to severe hot flashes, night sweats, and vaginal dryness associated with menopause. You and your healthcare provider should talk regularly about whether you still need treatment with COMBIPATCH to control these problems. If you use COMBIPATCH only to treat menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.


COMIPATCH is a small and discreet patch, and its innovative Delivery Optimized Thermodynamics (DOT) Matrix provides a continuous release of hormones through your skin and directly into your bloodstream. That means you can get effective symptom relief and a smaller daily dose of hormones than with HT pills. This difference does not mean that COMBIPATCH is safer or more effective than hormone therapy pills or other hormone therapies.


COMBIPATCH also provides options for you and your doctor. Learn about two dosing regimens, what bleeding patterns you can expect, and how you and your doctor can work together to meet your changing needs.

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 recommended storage conditions for COMBIPATCH have been updated.

The recommended storage conditions for COMBIPATCH have been updated.

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The recommended storage conditions for COMBIPATCH have been updated.

Please talk to your healthcare provider and see Patient Information.

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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