Alora Transdermal

In the U.S.

• Alora
• Climara
• Divigel
• Elestrin
• Esclim
• Estraderm
• Estrasorb
• EstroGel
• Evamist
• Menostar
• Minivelle
• Vivelle
• Vivelle-Dot

In Canada

• Estradot Transdermal
• Estradot Transdermal Therapeutic System
• Estradot Transdermal Therapeutic System
• Oesclim
• Rhoxal-Estradiol Derm 50
• Rhoxal-Estradiol Derm 75
• Roxal-Estradiol Derm 100
• Vivelle 100 Mcg
• Vivelle 25 Mcg
• Vivelle 37.5 Mcg

Available Dosage Forms:

• Patch, Extended Release
• Gel/Jelly
• Spray
• Emulsion

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

Estradiol transdermal gel, patch, and spray are used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen. It is also used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause. This medicine is also used to treat certain conditions in women before menopause if their ovaries do not make enough estrogens naturally, and prevent osteoporosis after menopause.

Estradiol is an estrogen hormone. The hormone from the patch, gel, and spray is absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during menopause.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain estradiol. It may not be specific to Alora. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, breast, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Wash your hands with soap and water before and after using this medicine.

To use the patch:

• Wash your hands with soap and water before and after you use this medicine.
• Carefully tear open the pouch when you are ready to put the patch on your skin. Do not cut it.
• Peel off the backing from the patch and apply the patch to a clean, dry, and hair-free area of the lower stomach or upper buttock area. This area must be free of powder, oil, or lotion for the patch to stick on to your skin.
• Press the patch firmly in place with your hand for about 10 seconds.
• Do not apply the patch on the breast or over any skin folds. Do not apply the patch on oily, broken, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos). Avoid applying the patch on the waistline or other places where tight clothing may rub it off.
• Wear the patch at all times until it is time to put on a new patch. Do not expose it to the sun for long periods of time.
• When replacing your patch, make sure to apply the new patch to a different area of your lower abdomen. Wait at least 1 week before applying a patch to the same area.
• When changing a patch, slowly peel it off from your skin. If you have any patch adhesive left on your skin, allow it to dry for 15 minutes and gently rub the sticky area with oil or lotion to remove it. It is best to change your patch on the same days of each week to help you remember.
• You may take a bath, shower, or swim while using this medicine. Doing so will not affect the patch.
• If a patch falls off, just put it back on a different area. If the patch does not stick completely, put on a new patch but continue to follow your original schedule for changing your patch.
• To throw away a used patch: Fold the patch in half with the sticky side together and place it in a sturdy child-proof container. Throw this container in the trash away from children and pets. Do not flush the patch down the toilet.

To use the spray:

• The spray form of this medicine comes in an applicator that delivers a measured amount of estradiol to the skin with each spray. When using a new spray applicator, prime the pump by holding the spray upright and pumping 3 times. Priming is only necessary the first time you use a new spray applicator; do not prime again.
• Apply the medicine to clean, dry, and unbroken skin on the inside of the forearm between the elbow and the wrist. Do not apply the medicine directly to your breasts or in or around the vagina.
• Allow the medicine to dry for at least 2 minutes before dressing, and at least 1 hour before washing.
• If your doctor tells you to increase your dose, move the applicator to an area of the skin next to your previous application site, before applying the second or third spray.
• Do not rub Evamist® spray into your skin.
• Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid being close with your child, wear clothes with long sleeves to cover the application site.
• If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.
• Do not allow your pets to lick or touch the arm where the medicine was sprayed.
• Always place the protective cover back on the applicator of the spray.
• Do not use the applicator for more than 75 sprays.
• Apply sunscreen at least 1 hour before applying Evamist®.

To use the gel:

• The gel form of this medicine comes in a pump. Each time you press the pump you will get the same amount of medication. You may need to prime the pump by pumping 3 times (EstroGel®) or 10 times (Elestrin™) the first time you use it. Follow the patient instructions for the container you use. After you prime the pump, do not press the pump more than 1 time each time you use it.
• Apply the gel to clean, dry, and unbroken skin. Spread the gel as thinly as possible over the entire area on the inside and outside of your upper arm and shoulder area. Do not apply the medicine directly to your breasts or in or around your vagina.
• Do not allow others to come in contact with the area of skin where you applied the gel for at least 1 hour after you use the medicine. Do not allow others to apply the gel for you. Allow the medicine to dry for at least 5 minutes before you dress.
• Apply sunscreen at least 25 minutes after using the gel. Avoid applying sunscreen on the same application site for 7 days or more.

The gel and spray contain alcohol and are flammable. Avoid using it near an open flame or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hot flashes and other symptoms caused by menopause:
  • For transdermal dosage form (gel):
    • Adults—
      • Elestrin™: Apply one dose (0.87 grams) of the gel to the upper arm once a day. Your doctor may adjust your dose as needed.
      • EstroGel®: Apply one dose (1.25 grams) of the gel to the arm once a day. Your doctor may adjust your dose as needed.
    • Children—Use is not recommended.
  • For transdermal dosage form (patch):
    • Adults—
      • Climara®: At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttocks area once a week. Your doctor may adjust your dose as needed.
      • Minivelle®: At first, apply one patch (0.0375 milligrams (mg)) to the lower stomach or upper buttocks area two times a week (every 3 to 4 days). Your doctor may adjust your dose as needed.
    • Children—Use is not recommended.
  • For transdermal dosage form (spray):
    • Adults—At first, one spray once a day, usually in the morning. Your doctor may adjust your dose as needed.
    • Children—Use is not recommended.
• For prevention of osteoporosis after menopause:
  • For transdermal dosage form (patch):
    • Adults—
      • Climara®: At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttock area once a week. Your doctor may adjust your dose as needed.
      • Minivelle®: At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttock area two times a week (every 3 to 4 days). Your doctor may adjust your dose as needed.
    • Children—Use is not recommended.
• For the treatment of low estrogen levels:
  • For transdermal dosage form (patch):
    • Adults—At first, apply one patch (0.025 milligrams (mg)) to the lower stomach or upper buttock area once a week. Your doctor may adjust your dose as needed.
    • Children—Use is not recommended.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not use Evamist® spray if it has been more than 12 hours since you missed your last dose.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach cramps or pain
• acid or sour stomach
• anxiety
• backache
• belching
• blistering, peeling, or loosening of the skin
• bloating
• blurred vision
• breast tenderness, enlargement, pain, or discharge
• change in vaginal discharge
• changes in skin color
• changes in vision
• chest pain or discomfort
• chills
• clay-colored stools
• clear or bloody discharge from the nipple
• confusion
• constipation
• convulsions
• cough
• darkening of the urine
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• dimpling of the breast skin
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• fever
• fluid-filled skin blisters
• full or bloated feeling or pressure in the stomach
• headache
• headache, severe and throbbing
• heartburn
• indigestion
• inverted nipple
• irregular heartbeat
• itching of the vagina or genital area
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• loss of bladder control
• lump in the breast or under the arm
• migraine headache
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasm or jerking of all extremities
• nausea
• noisy breathing
• numbness and tingling around the mouth, fingertips, or feet
• pain during sexual intercourse
• pain in the ankles or knees
• pain or discomfort in the arms, jaw, back, or neck
• pain or feeling of pressure in the pelvis
• pain, redness, or swelling in the arm, foot, or leg
• painful, red lumps under the skin, mostly on the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• persistent crusting or scaling of the nipple
• poor insight and judgment
• problems with memory or speech
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash, hives, or itching
• red, irritated eyes
• redness or swelling of the breast
• sensitivity to the sun
• skin thinness
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach discomfort, upset, or pain
• sudden loss of consciousness
• sudden shortness of breath or troubled breathing
• sweating
• swelling
• swelling of the abdominal or stomach area
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• tremor
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• unexpected or excess milk flow from the breasts
• unpleasant breath odor
• unusual tiredness or weakness
• unusually heavy or unexpected menstrual bleeding
• vaginal bleeding or spotting
• vomiting
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• difficulty with moving
• muscle aches
• muscle pain or stiffness
• stuffy or runny nose

• Decreased interest in sexual intercourse
• heavy bleeding
• hives or welts
• inability to have or keep an erection
• increased hair growth, especially on the face
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• irritability
• leg cramps
• loss in sexual ability, desire, drive, or performance
• loss of scalp hair
• mental depression
• mood disturbances
• patchy brown or dark brown discoloration of the skin
• redness of the skin
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also Warning section.

Skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels, obesity, lupus, underactive thyroid (hypothyroidism), mineral imbalance (low or high level of calcium in the blood), a certain hormone problem (hypoparathyroidism), uterus problems (such as fibroids, endometriosis), gallbladder disease, asthma, seizures, migraine headaches, a certain blood disorder (porphyria), mental/mood disorders (such as dementia, depression).

Do not smoke or use tobacco. Estrogens combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking an estrogen product. You may need to stop this medication for a time or take special precautions.

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

Children may be more sensitive to the side effects of this drug. It may affect their growth/development. Discuss the possible effects of this medication with the doctor, and monitor your child's growth periodically.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.