"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
(estradiol gel) 0.1%
Read this PATIENT INFORMATION leaflet before you start using Divigel® and read what you get each time you refill your Divigel® prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT Divigel® (AN ESTROGEN HORMONE)?
- Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.
- Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.
You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.
What is Divigel®?
Divigel® is a medicine that contains an estrogen hormone (estradiol). Divigel® is a clear, colorless, smooth gel that is odorless when dry.
What is Divigel® used for?
Divigel® is used after menopause to:
- Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.
Who should not use Divigel®?
Do not start using Divigel® if you:
- Have unusual vaginal bleeding
- Currently have or have had
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Divigel®.
- Had a stroke or heart attack in the past year
- Currently have or have had blood clots
- Currently have or have had liver problems
- Are allergic to Divigel® or any
of its ingredients
See the next section of this leaflet for a list of ingredients in Divigel®.
- Think you may be pregnant
Tell your healthcare provider:
- If you are breastfeeding
The hormone in Divigel® can pass into your milk.
- About all of your medical
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing); epilepsy (seizures); migraine; endometriosis; lupus; problems with your heart, liver, thyroid, or kidneys; or have high calcium levels in your blood.
- About all the medicines you
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Divigel® works. Divigel® may also affect how your other medicines work.
- If you are going to have
surgery or will be on bedrest
You may need to stop using Divigel®.
What are the ingredients in Divigel®?
The active ingredient in Divigel® is estradiol.
The inactive ingredients are carbomer, ethanol, propylene glycol, purified water, and triethanolamine.
How should I use Divigel®?
- Divigel® should be used once daily.
- Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you
- Divigel® should be used at the lowest dose possible for your treatment and only as long as needed.
You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Divigel®.
Important things to remember when using Divigel®
- Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people.
- Allow the gel to dry before dressing. Try to keep the area dry for as long as possible.
- Do not allow others to come in contact with the area of skin where you applied the gel for at least one hour after you apply Divigel®.
- You should not allow others to apply the gel for you. However, if this is necessary, the individual should wear a disposable plastic glove to avoid direct contact with Divigel®
- Do not apply Divigel® to your face, breast, or irritated skin
- Never apply Divigel® in or around the vagina
- Divigel® contains alcohol. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.
What should I do if I miss a dose?
If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day. Do not apply Divigel® more than once each day. If you accidentally spill some of the contents of a Divigel® packet, do not open a new packet. Wait and apply your normal dose the next day.
What should I do if someone else is exposed to Divigel®?
Once you have applied Divigel®, it has dried, and you have washed your hands, there is little risk of transfer to another person. If someone else is exposed to Divigel® by direct contact with the wet gel, that person should wash the area of contact with soap and water as soon as possible. This is especially important for men and children. The longer the gel is in contact with the skin before washing, the chance is greater that the other person will absorb some of the estrogen hormone.
What should I do if I get Divigel® in my eyes?
If you get Divigel® in your eyes, flush your eyes right away with lukewarm tap water. If you have concerns, contact your healthcare provider.
What are the possible side effects of estrogens?
Less common but serious side effects include:
- Breast cancer
- Cancer of the uterus
- Heart attack
- Blood clots
- Gallbladder disease
- Ovarian cancer
Some of the warning signs of serious side effects include:
- Breast lumps
- Unusual vaginal bleeding
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
Common side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
Other side effects include:
- High blood pressure
- Liver problems
- High blood sugar
- Fluid retention
- Enlargement of benign tumors of the uterus (“fibroids”)
- Vaginal yeast infection
These are not all the possible side effects of Divigel®. For more information, ask your healthcare provider or pharmacist.
What can I do to lower my chances of a serious side effect with Divigel®?
Talk with your healthcare provider regularly about whether you should continue taking Divigel®. If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while taking Divigel®. Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you otherwise. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.
Have an annual gynecological exam.
General information about safe and effective use of Divigel®
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Divigel® for conditions for which it was not prescribed. Do not give Divigel® to other people, even if they have the same symptoms you have. It may harm them.
Keep Divigel® out of the reach of children.
This leaflet provides a summary of the most important information about Divigel®. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Divigel® that is written for health professionals. You can get more information by calling the toll free number 1-800-654-2299.
How should Divigel® be applied?
- Divigel® should be applied once a day, around the same time each day.
- Apply Divigel® to clean, dry, and unbroken (without cuts or scrapes) skin. If you take a bath or shower, be sure to apply your Divigel® after your skin is dry. The application site should be completely dry before dressing or swimming.
- Apply Divigel® to either your left or right upper thigh. Change between your left and right upper thigh each day to help prevent skin irritation.
1. Wash and dry your hands thoroughly.
2. Sit in a comfortable position.
3. Cut or tear the Divigel® packet as shown in Diagram 1.
4. Using your thumb and index finger, squeeze the entire contents of the packet onto the skin of the upper thigh as shown in Diagram 2.
5. Gently spread the gel in a thin layer on your upper thigh over an area of about 5 by 7 inches, or two palm prints as shown in Diagram 3. It is not necessary to massage or rub in Divigel®.
6. Allow the gel to dry completely before dressing.
7. Dispose of the empty Divigel® packet in the trash.
8. Wash your hands with soap and water immediately after applying Divigel® to remove any remaining gel and reduce the chance of transferring Divigel® to other people.
HOW IS Divigel® SUPPLIED?
Divigel® is supplied in individual foil packets, each one containing a single day's dose.
Store Divigel® packets at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.]
Last reviewed on RxList: 6/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Divigel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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