Alora contains the active ingredient estradiol hemihydrate in a transdermal system designed for twice-weekly application. It releases estradiol through the skin with dosage strengths ranging from 0.025 to 0.1 mg per day. The system includes inactive ingredients such as silicone adhesive, acrylic adhesive, dipropylene glycol, and oleyl alcohol. Alora is intended to continuously release estradiol when applied to intact skin.

How should I use this medication?

This medication is for external use only. Use it as directed on the prescription label. Apply the patch, sticky side to the skin, to an area that is clean, dry and hairless. Do not cut or trim the patch. Do not wear more than 1 patch at a time. Remove the old patch before using a new patch. Use a different site each time to prevent skin irritation. Keep using it unless your care team tells you to stop. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, apply it as soon as you can. If it is almost time for your next dose, apply only that dose. Do not apply double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original pouch until you are ready to use it. Get rid of any unused medication after the expiration date. Get rid of used patches properly. Since used patches may still contain active medication, fold the patch in half so that it sticks to itself before throwing it away. Put it in the trash where children and pets cannot reach it. It is important to get rid of the medication as soon as you no longer need it, or it is expired. You can do this in two ways: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Breast tissue changes, new lumps, redness, pain, or discharge from the nipple -Gallbladder problems—severe stomach pain, nausea, vomiting, fever -Increase in blood pressure -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Unusual vaginal discharge, itching, or odor -Vaginal bleeding after menopause, pelvic pain Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Bloating -Breast pain or tenderness -Hair loss -Nausea -Stomach pain -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Abnormal vaginal bleeding -Blood vessel disease or blood clots -Breast, cervical, endometrial, ovarian, liver, or uterine cancer -Dementia -Diabetes (high blood sugar) -Gallbladder disease -Heart disease or recent heart attack -High blood pressure -High cholesterol -High levels of calcium in the blood -Hysterectomy -Kidney disease -Liver disease -Low thyroid levels -Lupus -Migraine headaches -Protein C/S deficiency -Stroke -Tobacco use -An unusual or allergic reaction to estrogens, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone This medication may also interact with the following: -Carbamazepine -Certain antibiotics like erythromycin or clarithromycin -Certain antiviral medications for HIV or hepatitis -Certain medications for fungal infections like ketoconazole, itraconazole, or posaconazole -Medications for fungus infections like itraconazole and ketoconazole -Phenobarbital -Raloxifene -Rifampin -St. John's Wort -Tamoxifen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow his or her guidelines for these tests. This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid. If you have any reason to think you are pregnant, stop taking this medication right away and contact your care team. Smoking tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication, especially if you are older than 35 years. If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist. This medication can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone medication, with this medication lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your care team may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your care team to determine the benefits and risks for you. If you are going to need surgery, an MRI, CT scan, or other procedure, tell your care team that you are using this medication. You may need to remove the patch before the procedure. Contact with water while you are swimming, using a sauna, bathing, or showering may cause the patch to fall off. If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area and continue to follow your usual dose schedule.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, or blood clots. Estrogens with progestins may increase your chances of getting breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps. Estrogens with or without progestins may increase your chance of getting dementia based on a study of women 65 years of age or older. If you have a uterus, using estrogens alone (without progestins) may increase your chance of uterine cancer (cancer of the womb).