Divigel

The active ingredient in Divigel is estradiol. Estradiol is one of the more potent estrogen hormones in the female body and plays an important role in women’s health. Total estrogen levels tend to decline during menopause which results in hot flashes, night sweats, and uncomfortable vaginal symptoms. Using estradiol during menopause as hormone replacement therapy replaces the decline in the body’s natural estrogen produced by the ovaries.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Divigel. However, the following is a synopsis of the general guidelines for the use of Divigel:

• Use Divigel exactly as prescribed. Estrogen therapy should be used at the lowest dose possible needed for symptom relief. Do not exceed the daily recommended dose or duration of use.
• Typically, Divigel is applied once a day, around the same time, to clean, dry, and unbroken skin on the upper thigh. Once applied, let the medication dry completely before dressing. Alternate between the left and right upper thigh each day to minimize the risk of skin irritation.
• If you take a bath or shower, let the skin dry completely before applying Divigel.
• After applying, wash your hands with soap and water to prevent transfer to other people. Do not allow others to come in contact with the application site for at least 1 hour after applying. Do not have another person apply the gel unless they are wearing a disposable plastic glove.
• Do not apply Divigel to the face, breast, or vagina.
• Sunscreen can affect how much estradiol is absorbed. Generally, you should not apply them at the same time, but consult your healthcare provider. They will know or recommend what is best for you.
• Divigel contains alcohol and is flammable. Keep the medication away from open flame and avoid fire, flame, or smoking until the application site has dried.
• You should have a pelvic exam, breast exam, and mammogram yearly unless your healthcare provider recommends something else.
• If you miss a dose and it is less than 12 hours away from your next dose, skip the missed dose and continue with your regular dosing schedule the following day. If your next dose is more than 12 hours away, apply the missed dose and continue with your regular dosing schedule the next day.

The most common side effects of Divigel seen in clinical trials as compared to placebo include:

• Irregular vaginal bleeding or spotting
• Breast tenderness
• Breast pain
• Bloating
• Vaginal yeast infections
• Common cold symptoms
• Upper respiratory tract infections

Some individuals may experience serious side effects while using Divigel. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a heart attack such as chest pain or discomfort that radiates to the back, arm, neck, or jaw, shortness of breath, nausea, vomiting, and lightheadedness
• Signs of a stroke such as facial drooping, one-sided numbness or weakness of the arms, sudden and severe headache, sudden change in vision, and slurred speech.
• Signs of a blood clot such as severe leg pain, swollen legs, chest pain, and shortness of breath.
• New breast lumps. This could be a sign of breast cancer.
• Unusual vaginal bleeding or vaginal discharge. This could be a sign of uterine or ovarian cancer.
• Dementia
• Elevations in triglyceride levels, which could lead to pancreatitis.
• Signs of hypercalcemia (high calcium levels) such as nausea, vomiting, constipation, fatigue, and muscle weakness
• Signs of gallbladder disease such as severe pain in the upper right abdomen, nausea, vomiting, and a change in stool or urine color.
• Vision changes
• High blood pressure
• Signs of a liver problem such as right-sided abdominal pain, nausea, vomiting, loss of appetite, and yellowing of the skin or eyes (jaundice).
• Fluid retention
• Signs of angioedema such as swelling of the lips, face, eyes, and tongue.

These are not all of the possible side effects of Divigel. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Divigel, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Unusual vaginal bleeding
• Asthma
• Epilepsy
• Diabetes
• Migraines
• Endometriosis
• Lupus
• History of angioedema
• Heart disease
• Liver problems
• High cholesterol levels
• Thyroid problems, such as hypothyroidism
• Kidney problems
• Hypercalcemia or high blood calcium levels
• Plans for surgery
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• The use of estrogen alone can increase the risk of endometrial cancer in those without a hysterectomy. Adding a progestogen to estrogen therapy can reduce endometrial hyperplasia or abnormal overgrowth.
• A study looking at the effects of estrogen-alone therapy reported an increased risk of dementia in postmenopausal women 65 years of age or older. The same study also reported an increased risk of stroke and deep vein thrombosis (DVT).
• The same study also looked at the effects of estrogen plus progestin therapy and found increased risks of pulmonary embolism, DVT, stroke, heart attack, breast cancer, and dementia in postmenopausal women 65 years of age or older.
• Neither estrogen alone nor estrogen plus progestin therapy should be used for preventing cardiovascular disease or dementia.

Do not use Divigel if you have:

• Unusual vaginal bleeding
• Bleeding disorder
• Personal or family history of cancer, especially uterine cancer (cancer of the uterus) or breast cancer
• History of stroke or heart attack
• History of blood clots
• History of liver problems
• An allergy to estradiol or any of the other ingredients in Divigel

It can take a couple of weeks of regular use to see the full effects of Divigel in treating symptoms of menopause.

When Divigel is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• St. John’s Wort
• Phenobarbital
• Carbamazepine
• Rifampin
• Erythromycin
• Clarithromycin
• Ketoconazole
• Itraconazole
• Ritonavir
• Grapefruit juice

Divigel is available as a gel in single-dose foil packets in the following strengths:

• 0.25 mg
• 0.5 mg
• 0.75 mg
• 1 mg
• 2.5 mg

Estradiol is also available in other dosage forms such as patches or vaginal creams. Speak to your healthcare provider about which option is best for you.

Divigel should be stored at room temperature, away from light and moisture, and out of reach of children.

Divigel is manufactured by the pharmaceutical company Vertical Pharmaceuticals.

Yes, there is a generic available for the brand-name Divigel.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Divigel.

Divigel should not be used in pregnancy. It is only approved for use in postmenopausal women. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Divigel can pass into the breast milk and may cause harm to the unborn child. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.