Divigel^® is a medicine that contains an estrogen hormone estradiol.  Divigel^® is a clear, colorless, smooth gel that is applied to the skin.  Divigel^® offers the lowest approved estradiol dose (0.25 mg), compared to any other available gel or lotion estrogen product. 

The estrogen hormone in Divigel^® is estradiol, a synthetic estrogen that is derived from a plant source. Estradiol is a bioidentical estrogen. This means that it is identical to estrogen produced by the ovaries.

Divigel^® is approved by the Food and Drug Administration (FDA) to be safe and effective after menopause to reduce moderate to severe hot flashes.  

As with all estrogen products, it will take some time before the full effect of Divigel^® is seen.

In a clinical study, significant reduction in the number of hot flashes was first noted after 2 weeks of treatment with the highest dose of Divigel^® and after 5 weeks of treatment with the lowest dose of Divigel^®. 

The maximal effect of Divigel^® on hot flashes is typically reached after 8 to 12 weeks of treatment.

In a clinical study, patients also noticed that the severity of their hot flashes was reduced along with the number of hot flashes that they experienced each day.

Divigel^® should be applied to the skin once a day, around the same time each day.  Because Divigel^® should be applied to clean and dry skin, many women choose to apply it after their daily bath or shower.  The application site should be completely dry before dressing. 

With once-a-day application of Divigel^® to the skin, after a couple of weeks a stable level of estrogen will be maintained in the body throughout the day.

Divigel^® should be applied once daily on the skin of either the right or left upper thigh.  The application area should be about 5 by 7 inches.  To avoid potential irritation of the skin, Divigel^® should be applied to the right or left upper thigh on alternating days. 

Because it has not been tested in clinical studies, the application of Divigel^® to other areas of the body such as the skin on the arms or abdomen cannot be recommended.

Do not apply Divigel^® to your face, breasts, or irritated skin.  Never apply Divigel^® in or around the vagina.  Contact of the gel with the eyes should be avoided. 

The skin where Divigel^® has been applied should not be washed for at least 1 hour. Washing the skin where Divigel^® has been applied 1 hour after application will remove Divigel^® from the surface of the skin.  This will also decrease the amount of estrogen that is absorbed into the body that day by about one third. 

Divigel^® is very skin-friendly.  Less than 1% of all the patients in a clinical trial experienced some form of skin irritation from Divigel^®.

Divigel^® should be applied to a small area of clean, dry skin. 

It is possible that the application of other lotions or creams, such as sunscreens, to the same area of skin where Divigel^® has been applied has not been studied and could change the amount of estrogen that is absorbed from the skin into the body.

Estrogen therapies such as Divigel^® should be used for the shortest amount of time necessary for each individual woman.  You and your healthcare provider should talk regularly, for example, every 3 to 6 months, about whether you still need treatment with Divigel^®.

Every woman is different.  Divigel^® is available in three different doses, 0.25 mg, 0.5 mg, and 1.0 mg of estradiol, so doctors can adjust the dose to meet each woman’s individual needs.

Generally, women should be started on the lowest dose of Divigel^®, 0.25 mg of estradiol, per day.  Your healthcare provider will recommend the appropriate starting dose for you.  He or she may adjust the dose depending on each woman’s individual response. 

Divigel^® should be used at the lowest dose possible for treatment.  

If you have not had a hysterectomy, taking estrogen increases the chance of getting cancer of the uterus (also known as uterine cancer). When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be started to reduce the risk of this type of cancer.  Your healthcare provider will recommend the appropriate dose of progestin for you.  A woman without a uterus does not need a progestin. 

Always 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.  Your healthcare provider should check any unusual vaginal bleeding to find out the cause. 

Less common but serious side effects of estrogen are blood clots.  So, if feasible, estrogens, such as Divigel^®, should be stopped at least 4 to 6 weeks before surgeries of the type that may be associated with an increased risk of blood clots, or during times of prolonged immobilization.

Divigel^® should be stored at room temperature, between 68°-77°F. 

Estrogen are broken down or metabolized by certain enzymes in the liver.  Other medicines, which are metabolized by the same liver enzymes, may interact with estrogen products such as Divigel^®.  Examples of medicines that may interact with estrogen therapies such as Divigel^® include some antibiotics (eg, erythromycin and clarithromycin), some herbal supplements (eg, St. John’s Wort), and some epilepsy medications (eg, phenobarbital and carbamazepine). 

Other medicines that are not listed here may also affect how Divigel^® works.  Likewise, Divigel^® may affect how some other medicines work.  Make sure you tell your healthcare provider about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Do not use estrogens, such as Divigel^®, 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, such as Divigel®, with or without progestins, to prevent dementia.  Using estrogens, with or without progestins, may increase your risk of dementia. 

Divigel^® has not been studied as a drug to prevent osteoporosis.  Therefore, Divigel^® is not approved by the FDA for the prevention of osteoporosis. 

A PATIENT INFORMATION leaflet is included in each box of Divigel^®.  Read this information before you start using Divigel^® and each time you refill your Divigel^® prescription. There may be new information.  If you would like to view the PATIENT INFORMATION leaflet now, click on the link below.  

Click here to view the PATIENT INFORMATION leaflet now.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not start using Divigel^® if you:

• Have unusual vaginal bleeding
• Currently have or have had certain cancers.  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
• Think you may be pregnant

In Divigel^® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness, and vaginal bleeding. 

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss.  The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer. 

Call your healthcare provider right away if you have any symptoms that concern you, especially 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, or vomiting.  These can be warning signs of serious side effects.