Frequently Asked Questions

If you’re currently experiencing moderate to severe symptoms associated with menopause, have just been prescribed COMBIPATCH®, or are already taking COMBIPATCH, you probably have questions. Below, you’ll find answers to many common questions about COMBIPATCH and hormone therapy.

 

Remember, the best way to get information about treatment is by talking to your doctor. Together, you both can make treatment decisions that are right for you.

Questions About COMBIPATCH®

COMBIPATCH helps to treat moderate to severe hot flashes, night sweats, and vaginal dryness associated with menopause by providing a continuous flow of hormones through the skin directly to the bloodstream. If you use COMBIPATCH only to treat dryness, itching, and burning in or around the vagina, talk with your healthcare professional about whether a topical vaginal product would be better for you.

 

COMBIPATCH is made specifically for women who still have their uterus. If you’ve had your uterus removed, ask your doctor about Minivelle® (estradiol transdermal system), an estrogen-only Delivery Optimized Thermodynamics (DOT) Matrix™ technology patch. For important safety information, including Boxed Warning, about Minivelle, click here.

 

COMBIPATCH should not be used if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers, including cancer of the breast or uterus
  • Had a stroke or heart attack in the recent past (for example, in the past year)
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • May be pregnant

 

Talk to your doctor about what treatment option may be right for you.

COMBIPATCH is the only transdermal combination hormone therapy that utilizes innovative DOT Matrix™ technology. This delivery system releases both estradiol (a form of estrogen like your body’s own) and norethindrone acetate (a progestin) continuously upon application to your skin. This does not mean that COMBIPATCH is safer or more effective than hormone therapy pills. DOT Matrix™ technology allows the medication to be absorbed through your skin and into your bloodstream over 3 to 4 days.

A small transparent patch, COMBIPATCH uses the innovative DOT Matrix™ technology delivery system to allow hormones to be absorbed directly into your bloodstream through your skin. That’s why COMBIPATCH can help to treat moderate to severe symptoms associated with menopause with smaller total doses compared to pills that need to be digested first and then metabolized by the liver before reaching the bloodstream. This does not mean that COMBIPATCH is safer or more effective than hormone therapy pills.

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.

COMBIPATCH was the first patch in the U.S. to deliver both estrogen and progestin. COMBIPATCH was created with an innovative technology called The Delivery Optimized Thermodynamics (DOT) Matrix™ that allows it to be small and transparent for a discreet appearance.

COMBIPATCH is a small transparent round patch that comes sealed in a protective pouch. In clinical studies, COMBIPATCH was shown to have excellent skin adhesion and a low level of skin irritation.

COMBIPATCH is worn on the lower abdomen. (See how.)

If your patch falls off, the same patch can be reapplied to another area of your lower abdomen. If necessary, a new patch can be applied, and the original treatment schedule should be continued. Only one patch should be worn at a time during each half-week time period.

COMBIPATCH should be replaced twice a week, and the new patch should be placed on a different skin area. The areas of application should be rotated, with at least one week allowed between applications to the same spot. COMBIPATCH should be placed on a smooth (fold-free), clean, dry area of the skin. You can choose the days of the week you change patches.

You should remove the old patch and apply a new one to a new area of the lower abdomen as soon as you remember. No matter what day this happens, you should stick to the twice-a-week schedule for the next patch.

Contact with water when bathing, swimming, or showering should not affect the patch as long as it is not rubbed when washing. The patch should not be exposed to the sun for prolonged periods of time.

Women on the Continuous Combined regimen with COMBIPATCH often experience irregular bleeding or spotting during the first year of treatment. This can occur with any combination hormone therapy regimen. 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 treatment plan.

Women on the Continuous Sequential regimen with COMBIPATCH and Minivelle® (estradiol transdermal system) receive a consistent level of estrogen throughout the 4-week schedule, but progestin during only half of the schedule. They often experience regular monthly bleeding, similar to your natural monthly period. Ask your doctor any questions you have about bleeding.

Questions about Hormone Therapy

There are several different forms of hormone therapies, including patches, pills, sprays, and emulsions. While all hormone therapies have similarities, there are differences in dosage strength, delivery (patch, pill, gel, emulsion, or vaginal ring), indication (used for the treatment of menopause symptoms, such as vaginal dryness or hot flashes, and/or for osteoporosis prevention), regimen (combination therapy, estrogen-only therapy) and frequency (every day, twice a week, etc). Some therapies include a combination of hormones, while others may be estrogen or progestin only.

Some women are fine without any therapy. But women who are bothered by moderate to severe symptoms might want to consider treatment. Hormone therapy is the most effective treatment available for hot flashes. It also helps treat night sweats and vaginal dryness.

Clinical studies show that the addition of progestin to an estrogen treatment for at least 12 days per cycle reduces, but does not eliminate, thickening of the lining of the uterus (endometrial hyperplasia) and the potential risk of cancer of the uterus in women with an intact uterus.

Women without a uterus who have moderate to severe symptoms associated with menopause can be treated with estrogen only. Women who still have a uterus should be treated with estrogen plus progestin. Adding progestin helps prevent cancer of the uterus. You and your doctor should discuss treatment options based on your individual needs.

Hormone therapy has not been shown to cause permanent weight gain. Some women experience temporary weight gain due to water retention. Increasing fluid intake, limiting salt consumption and regular exercise help reduce water retention. A slowing metabolism, common as people age, should be accounted for in reduced calorie intake and regular exercise. Hormone therapies are not indicated for the treatment of weight loss.

It is recommended that women who use hormone therapy to help manage their moderate to severe symptoms associated with menopause use the lowest effective dose for the shortest time. Different solutions are right for different women, depending on each woman’s health history, current symptoms, and personal preferences. You and your doctor should regularly discuss if you still need treatment with hormone therapy. Together, you can make the right choice for you.

The recommended storage conditions for COMBIPATCH have been updated.

The recommended storage conditions for COMBIPATCH have been updated.

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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!

*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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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