Femseven

The active ingredient in Femseven is estradiol hemihydrate, a form of estrogen. In postmenopausal women, hormone replacement therapy (HRT) is used to replace estrogen to relieve symptoms such as vaginal dryness or hot flashes.

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 Femseven. However, the following is a synopsis of the general guidelines for the use of Femseven:

1. Pick an application site on a clean, dry area of the skin. Recommended sites are the lower abdomen, the buttocks, or the outer hip. Do not use the waistline as tight clothing may rub the system off.

2. Clean and dry the chosen area, then open the package of the HRT patch and remove the protective liner.

3. Place the patch on the area firmly and hold for 10 seconds, ensuring good contact around the edges.

4. If the patch falls off, you can replace the same one.

5. Pick a different area weekly with every new patch, and don’t use the same site within one week of itself.

6. When removing the patch, fold it in half before disposing.

7. You may need to stop using estradiol for 4-6 weeks before a surgery or if you’re on bed rest.

8. If you have a uterus, you may also need a progestin to lower your risk of uterine cancer.

9. Do not drink grapefruit juice while taking this medication.

10. Have a breast exam and mammogram yearly, as this medication may increase your risk of breast cancer.

Some mild or common side effects of Femseven seen in clinical trials as compared to placebo include:

• Breast tenderness/ breast pain.
• Vaginal bleeding.
• Indigestion (dyspepsia).
• Leg cramps.
• Breakthrough bleeding.
• Benign uterine fibroids.
• Application site reactions.

Estradiol can put you at an increased risk of serious side effects. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction presenting with swelling of the face, lips, tongue, or throat, hives, and trouble breathing.
• Signs of a heart attack include chest pain (angina), shortness of breath, and pain radiating to your shoulder, neck, or jaw.
• Signs of a stroke include numbness on one side of your body, a severe headache, or trouble speaking.
• Signs of a blood clot (thromboembolic complication) include severe leg pain, swelling or redness, chest pain, or a fast heart rate.
• Signs of cancer include breast lumps/ pain, swollen lymph nodes, or unusual vaginal bleeding.
• Signs of gallbladder disease such as pain or tenderness in your stomach.

These are not all of the possible side effects of the Femseven patch. 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 Femseven, 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 history, including whether you have:

High triglyceride levels.

High blood pressure.

Reduced liver function or liver disease.

Kidney disease.

Low thyroid levels (hypothyroidism).

Fluid retention/ edema.

Asthma.

Migraine headaches.

Systemic lupus erythematosus.

Epilepsy.

Heart disease.

High cholesterol

High calcium levels.

Endometriosis.

Diabetes.

Undiagnosed vaginal bleeding - endometrial cancer must be ruled out before you can start this medication.

Active blood clot.

Endometrial hyperplasia.

Porphyria.

Breastfeeding.

Active or recent stroke or heart attack.

Liver dysfunction.

History of serious hypersensitivity reaction to estrogens.

Known or suspected pregnancy.

It takes several months to notice a benefit from the estrogen hormone patch.

When Femseven 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:

• Strong liver enzyme inducers such as St John’s Wort, carbamazepine, and rifampin may reduce levels of estrogen in your body and make it less effective.
• Strong liver enzyme inhibitors, such as itraconazole, clarithromycin, ritonavir, and grapefruit juice, increase levels of estrogen and cause more side effects.

Brand-name Femseven is available in Femseven 50mcg/day (each patch containing 1.5mg estradiol hemihydrate), Femseven 75mcg/day (each patch containing 2.25mg estradiol hemihydrate), or Femseven 100mcg/day (each patch containing 3mg estradiol hemihydrate).

It should be stored at room temperature out of the reach of children or pets.

It is manufactured by LTS Lohmann Therapie-Systeme AG and marketed by Theramex.

Yes, it is available from many manufacturers of generic drugs, and under the brand name Estraderm. It is also available as combined HRT containing progesterone under the name Femseven Conti or Evorel Conti.

Barring any serious side effects as listed above, or under the direction of a physician, you should not stop using estradiol suddenly.

Estradiol should not be used during pregnancy.

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.

This medication may reduce the quantity and quality of breast milk and pass into breast milk. It should not be used during lactation.

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.