Alora

1 What is Alora?

Brand: Alora, Climara, Divigel, Elestrin, Esclim, Estraderm, Estrasorb, EstroGel, Evamist, Menostar, Minivelle, Vivelle, Vivelle-Dot Canada: Estradot Transdermal, Estradot Transdermal Therapeutic System, Oesclim, Rhoxal-Estradiol Derm 50, Rhoxal-Estradiol Derm 75, Rhoxal-Estradiol Derm 100, Vivelle 100Mcg, Vivelle 25Mcg, Vivelle 375Mcg

Generic: Estradiol

Alora 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 medication is also used to treat certain conditions in women before menopause if their ovaries do not make enough natural estrogen and prevent osteoporosis after menopause.

Alora is an estrogen hormone. The hormone is absorbed through the skin into your body (transdermal). 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 medication is only available with your doctor’s prescription. This medication is available in the following forms:

  • Extended-release patch
  • Gel/Jelly
  • Spray
  • Emulsion

2 What to Know Before Using

Before using Alora, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies: Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.

Geriatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in the elderly. Safety and efficacy have not been established.

Pregnancy: This medication is listed as Pregnancy Category X. This means that studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant, as they risk obviously outweighs any benefits.

Breastfeeding: Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, monitor the infant for side effects and adequate milk intake.

Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.

When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive. 

Using this medication with any of the following is not recommended. Your doctor may decide not to treat you with this medication, or change some of the other medications you take Tranexamic Acid.

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take.

  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Crizotinib
  • Dabrafenib
  • Darunavir
  • Dasabuvir
  • Donepezil
  • Eliglustat
  • Fentanyl
  • Idelalisib
  • Isotretinoin
  • Lumacaftor
  • Nilotinib
  • Piperaquine
  • Pixantrone
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topotecan

Using this medication with any of the following medications may increase your risk of side effects. However, using both medications may be the best treatment for you. If both medications are prescribed together, your doctor may change the dose or how often you take one or both medications.

  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Ginseng
  • Griseofulvin
  • Ketoconazole
  • Lamotrigine
  • Levothyroxine
  • Licorice
  • Modafinil
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Tacrine
  • Telaprevir
  • Tipranavir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Voriconazole
  • Warfarin

Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Using this medication with any of the following is not normally recommended, but may be unavoidable. If used together, your doctor may change the dose or how often you take your medication or give you special instructions about the use of food, alcohol or tobacco: Caffeine.

Other Medical Problems: Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially: 

  • Abnormal or unusual vaginal bleeding 
  • Blood clots (i.e. deep vein thrombosis, pulmonary embolism)
  • Breast cancer, known or suspected, or history of 
  • Heart attack, active or recent (within the past 12 months) 
  • Liver disease 
  • Protein C or protein S deficiency, or other known blood clotting disorders
  • Stroke, active or recent (within the past 12 months) 
  • Surgery with a long period of inactivity 
  • Tumors (estrogen-dependent), known or suspected - Should not be used in patients with these conditions.
  • Asthma 
  • Cancer
  • Diabetes 
  • Edema (fluid retention or body swelling) 
  • Endometriosis 
  • Epilepsy (seizures) 
  • Gallbladder disease
  • Heart disease
  • Hereditary angioedema (swelling of the face, lips, tongue, or throat)
  • Hypercalcemia (high calcium in the blood)
  • Hypertension (high blood pressure)
  • Hypertriglyceridemia (high triglycerides or fats in the blood)
  • Hypocalcemia (low calcium in the blood)
  • Hypothyroidism (an underactive thyroid)
  • Jaundice during pregnancy or from using hormonal therapy in the past
  • Liver tumors
  • Migraine headache
  • Porphyria (an enzyme problem)
  • Systemic lupus erythematosus (SLE) - Use with caution. May make these conditions worse.

3 Proper Usage

Proper usage of Alora requires strict adherence to your doctor’s orders. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

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

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

To use the patch:

  • Wash your hands with soap and water before and after using this medication.
  • 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 (i.e. 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 use 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 medication 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.
  • Apply the medication to clean, dry, and unbroken skin on the inside of the forearm between the elbow and the wrist. Do not apply directly to your breasts or in or around the vagina.
  • Allow the medication 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 the 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 immediately 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 this medication.

To use the gel:

  • The gel form of this medication comes with 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 for EstroGel or 10 times for 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 medication 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 medication. Do not allow others to apply the gel for you. Allow it to dry for at least 5 minutes before you dress.
  • Apply sunscreen at least 25 minutes after using the gel. Avoid applying sunscreen to 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: Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For hot flashes:

  • Gel:
    • Adults: 
      • Elestrin: Apply 1 dose (0.87g) to the upper arm once a day. Your doctor may adjust the dose as needed.
      • EstroGel: Apply 1 dose (1.25g) to the arm once a day. Your doctor may adjust the dose as needed.
    • Children - Use is not recommended.
  • Patch:
    • Adults:
      • Climara: Start with 1 patch (0.025mg) to the lower stomach or upper buttocks twice a week. Your doctor may adjust the dose as needed.
      • Minivelle: Start with 1 patch (0.0375mg) to the lower stomach or upper buttocks twice a week. Your doctor may adjust the dose as needed.
    • Children - Use is not recommended.
  •  Spray:
    • Adults: Start with 1 spray once a day. Your doctor may adjust the dose as needed.
    • Children - Use is not recommended.

For prevention of osteoporosis after menopause:

  • Patch:
    • Adults: 
      • Climara: Start with 1 patch (0.025mg) to the lower stomach or upper buttocks once a week. Your doctor may adjust the dose as needed.
      • Minivelle: Start with 1 patch (0.0375mg) to the lower stomach or upper buttocks once a week. Your doctor may adjust the dose as needed.
    • Children - Use is not recommended.

For treatment of low estrogen levels:

  • Patch:
    • Adults: 
      • Climara: Start with 1 patch (0.025mg) to the lower stomach or upper buttocks once a week. Your doctor may adjust the dose as needed.
    • Children - Use is not recommended.

Missed Dose: If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule.

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

Storage: Store this medication in a closed container at room temperature. Keep it away from heat, moisture, and direct light. Do not freeze. Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

4 Precautions to Take

Before using Alora, there are some precautions you must take. It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly. Do not take other prescription or over-the-counter medications without asking your doctor.

Using this medication while pregnant can harm your unborn child. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant, inform your doctor immediately.

Using this medication may increase your risk of blood clots, strokes or heart attacks. This risk may continue even after you stop using the medication. Your risk is even greater if you have hypertension (high blood pressure), high cholesterol, diabetes or if you are overweight or smoke cigarettes.

Call your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscles or an inability to speak.

Using this medication for extended periods of time may increase your risk of breast cancer, endometrial cancer or uterine cancer. Talk with your doctor about these risks. If you still have your uterus, ask your doctor if you should use a progestin medication. Inform your doctor if you have unusual vaginal bleeding.

Using this medication may increase your risk of dementia, especially in women 65 years of age or older. Using this medication may increase your risk of gallbladder disease. Ask your doctor about this risk.

If you are having surgery, inform the doctor or dentist in charge that you are using this medication. This medication may affect the results of certain medical tests.

Inform your doctor immediately if you have a severe headache or sudden loss of vision, or any other change in vision while using this medication.

This medication may cause a serious type of allergic reaction called anaphylaxis, which is life-threatening and requires immediate emergency medical help. Inform your doctor immediately if you have a rash, itching, hoarseness, difficulty breathing or swallowing or any swelling of the hands, face or mouth while using this medication.

Inform your child’s doctor immediately if your child has nipple or breast swelling or tenderness (females) or breast enlargement (males). Your child may have been exposed to this medication.

Do not allow pets to lick or touch the area of skin this medication has been applied to. Small pets may be sensitive to this medication. Call your veterinarian if your pet has nipple or breast enlargement, swelling of the vulva or any signs of illness.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Alora. Although not all of these side-effects may occur, if they do occur, they may need medical attention.

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less Common:

  • Back pain
  • Difficulty moving
  • Muscle aches
  • Muscle pain or stiffness
  • Stuffy or a runny nose

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects. Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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