Menostar is a skin patch that contains estradiol, a form of estrogen. Estradiol is a female sex hormone produced by the ovaries that regulates many processes in the body.

Menostar skin patches are used to prevent postmenopausal osteoporosis.

Menostar may also be used for purposes not listed in this medication guide.

You should not use Menostar if you have: liver disease, a bleeding disorder, unusual vaginal bleeding, history of a hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer), or if you have ever had a heart attack, stroke, a blood clot, or if you will be having major surgery.

Do not use Menostar if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Using Menostar can increase your risk of blood clots, stroke, heart attack, or cancer of the breast, uterus, or ovaries. Estradiol should not be used to prevent heart disease, stroke, or dementia.

Your doctor should check your progress on a regular basis to determine whether you should continue treatment with Menostar.

Before taking this medicine

You should not use Menostar if you are allergic to estradiol, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• liver disease;

• a bleeding or blood-clotting disorder;

• a recent history of heart attack or stroke;

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• if you have ever had a blood clot (especially in your lung or your lower body).

Menostar should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Menostar is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

• a history of jaundice caused by pregnancy or birth control pills;

• hereditary angioedema (an immune system disorder);

• a thyroid disorder;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• gallbladder disease;

• high or low levels of calcium in your blood; or

• if you have had your uterus removed (hysterectomy).

Using estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Menostar long term.

FDA pregnancy category X. Do not use Menostar if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using Menostar.

Estradiol can pass into breast milk. Menostar may slow breast milk production. Do not use if you are breast-feeding a baby.

Use Menostar patches exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to help lower this risk. Report any unusual vaginal bleeding right away.

Menostar comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The adhesive side of Menostar should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock.

• Menostar should not be applied to or near the breasts.
• The sites of application must be rotated, with an interval of at least 1-week allowed between applications to a same site.
• The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off.
• Application to areas where sitting would dislodge Menostar should also be avoided.

Application

• Menostar should be applied immediately after opening the pouch and removing the protective liner.
• Menostar should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
• If the system lifts, apply pressure to maintain adhesion.
• In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval.
• Only one system should be worn at any one time during the 7-day dosing interval.
• Swimming, bathing, or using a sauna while using Menostar has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.

Removal of the Menostar Transdermal System

• Removal of the system should be done carefully and slowly to avoid irritation of the skin.
• Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.
• Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.

If you need surgery or medical tests or if you will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Menostar.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms while using Menostar.

Store Menostar patches at room temperature away from moisture and heat. Keep each patch in its pouch until you are ready to use it.

You should not use Menostar if you are allergic to estradiol, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;

• liver disease;

• a bleeding or blood-clotting disorder;

• a recent history of heart attack or stroke;

• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or

• if you have ever had a blood clot (especially in your lung or your lower body).

Menostar should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure Menostar is safe for you, tell your doctor if you have:

• heart disease;

• risk factors for coronary artery disease (such as diabetes, lupus, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or if you have had a hysterectomy);

• a history of jaundice caused by pregnancy or birth control pills;

• hereditary angioedema (an immune system disorder);

• a thyroid disorder;

• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• lupus;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• endometriosis or uterine fibroid tumors;

• gallbladder disease;

• high or low levels of calcium in your blood; or

• if you have had your uterus removed (hysterectomy).

Using estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Menostar long term.

FDA pregnancy category X. Do not use Menostar if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using Menostar.

Estradiol can pass into breast milk. Menostar may slow breast milk production. Do not use if you are breast-feeding a baby.

If you forget to change your patch, change it as soon as you remember or wait until your next scheduled patch change. Do not apply two patches at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction to the Menostar patch: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• swelling or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding, pelvic pain;

• a breast lump;

• memory problems, confusion, unusual behavior; or

• high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common Climara side effects may include:

• headache, back pain;

• stuffy nose, sinus pain, sore throat;

• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;

• bloating, stomach cramps, nausea, vomiting;

• breast pain;

• redness or irritation where the patch was worn;

• thinning scalp hair; or

• fluid retention (swelling, rapid weight gain).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with estradiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.