Evamist (Page 8 of 8)

14.3 Women’s Health Initiative Memory Study

The WHIMS estrogen-alone ancillary study of the WHI, enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age (45 percent were 65 to 69 years of age, 36 percent were 70 to 74 years of age, and 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) on the incidence of probable dementia (primary outcome) compared to placebo.

After an average follow-up of 5.2 years, the relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent CI, 0.83-2.66). The absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000 women-years. Probable dementia as defined in this study included Alzheimer’s disease (AD), vascular dementia (VaD) and mixed type (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5)].

The WHIMS estrogen plus progestin ancillary study enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were 65 to 69 years of age, 35 percent were 70 to 74 years of age, and 18 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) plus MPA (2.5 mg) on the incidence of probable dementia (primary outcome) compared to placebo.

After an average follow-up of 4 years, the relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.12-3.48). The absolute risk of probable dementia for CE plus MPA versus placebo was 45 versus 22 per 10,000 women-years. Probable dementia as defined in this study included AD, VaD and mixed type (having features of both AD and VaD). The most common classification of probable dementia in the treatment group and the placebo group was AD. Since the ancillary study was conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women [see Warnings and Precautions (5.3) , and Use in Specific Populations (8.5) ].

When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19-2.60). Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women [see Warnings and Precautions (5.3) , and Use in Specific Populations (8.5) ].

15 REFERENCES

1.
Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. JAMA. 2007:297;1465-1477.
2.
Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med. 2006;166:357–365.
3.
Curb JD, et al. Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med. 2006;166:772-780.
4.
Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis. JAMA. 2004:292;1573-1580.
5.
Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women with Hysterectomy. JAMA. 2006;295:1647-1657.
6.
Chlebowski RT, et al. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA. 2003:289;3234-3253.
7.
Anderson GL, et al. Effects of Estrogen Plus Progestin in Gynecologic Cancers and Associated Diagnostic Procedures. JAMA. 2003:290;1739-1748.
8.
Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA. 2004:291;2947-2958.
9.
Jackson RD, et al. Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women with Hysterectomy: Results from the Women’s Health Initiative Randomized Trial. J Bone Miner Res. 2006:21;817-828.
10.
Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women’s Health Initiative. Circulation. 2006:113;2425-2434.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Evamist (NDC 64011-215-41) is supplied as a homogeneous solution of estradiol USP, octisalate USP and alcohol USP. The liquid formulation of Evamist is packaged in a glass vial fitted with a metered-dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered-dose spray. Each metered-dose pump contains 8.1 mL and is designed to deliver 56 sprays of 90 mcL after priming. One spray contains 1.53 mg estradiol.

16.2 Storage and Handling

Keep out of reach of children.

Alcohol and alcohol-based liquids are flammable. Avoid fire, flame or smoking until the spray has dried.

Store at room temperature 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

17.1 Vaginal Bleeding

Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.2) ].

17.2 Unintentional Secondary Exposure to Evamist

Provide the following information about secondary exposure to Evamist:

Apply Evamist as directed and keep children from contacting exposed application site(s). If direct contact with the application site occurs, the contact area should be washed thoroughly with soap and water. Women should cover the Evamist application site, after the 2 minute drying period, with clothing if another person may come in contact with that area of skin. [See FDA-Approved Patient Information Leaflet at the end of the prescribing information.]
Look for signs of unexpected sexual development, such as breast mass or increased breast size in prepubertal children.
If signs of unintentional secondary exposure are noticed:
o
Have children evaluated by a healthcare provider.
o
Discontinue Evamist until the cause(s) is identified for any unexpected sexual development in children under their care.
o
Women should contact their healthcare provider and discuss the appropriate use and handling of Evamist when around children.
o
If conditions for safe use cannot be met, Evamist should be discontinued and alternative treatments for menopausal signs and symptoms should be considered.
Pets may also be unintentionally exposed to Evamist if above precautions are not followed.

17.3 Possible Serious Adverse Reactions with Estrogen-Alone Therapy

Inform postmenopausal women of the possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.1, 5.2, 5.3)].

17.4 Possible Less Serious but Common Adverse Reactions with Estrogen-Alone Therapy

Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting.

P6003-3
Revised 03/2014

Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215

For Ther-Rx Corporation Chesterfield, MO 63005

© 2013 Ther-Rx Corporation 03/2014

Patient Information

EVAMIST (EE-vuh-mist)

(estradiol transdermal spray)

Read this Patient Information before you start using EVAMIST and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

What is the most important information I should know about EVAMIST (an estrogen hormone)?

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using EVAMIST. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function).
Using estrogen-alone may increase your chances of getting strokes or blood clots.
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years or older.
Do not use estrogens with progestins to prevent heart disease, heart attack, strokes, or dementia.
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years and older.
The estrogen in EVAMIST spray can transfer from the area of skin where it was sprayed to other people. Do not allow others, especially children, to come into contact with the area of your skin where you sprayed EVAMIST. Young children who are accidentally exposed to estrogen through contact with women using EVAMIST may show signs of puberty that are not expected (for example, breast budding).
You and your healthcare provider should talk regularly about whether you still need treatment with EVAMIST.

What is EVAMIST?

EVAMIST is a prescription medicine spray that contains estradiol (an estrogen hormone).

What is EVAMIST used for?

EVAMIST spray is used after menopause to:

Reduce moderate to severe hot flashes
Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with EVAMIST.

Who should not use EVAMIST?

Do not start using EVAMIST if you:

have unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use EVAMIST.
had a stroke or heart attack
currently have or have had blood clots
currently have or have had liver problems
have been diagnosed with a bleeding disorder
are allergic to EVAMIST or any of its ingredients
See the list of ingredients in EVAMIST at the end of this leaflet
think you may be pregnant
EVAMIST is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use EVAMIST if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before I use EVAMIST?

Before you use EVAMIST, tell your healthcare provider if you:

have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any vaginal bleeding to find out the cause.
have any other medical conditions
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop using EVAMIST.
are breast feeding The hormone in EVAMIST can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect how EVAMIST works. EVAMIST may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use EVAMIST?

For detailed instructions, see the step-by-step instructions for using EVAMIST at the end of this Patient Information.

Use EVAMIST exactly as your healthcare provider tells you to use it.
EVAMIST is for skin use only.
Apply EVAMIST at the same time each day.
If you use sunscreen 1 hour after you use EVAMIST, it may reduce the amount of EVAMIST absorbed by your skin.
The estrogen in EVAMIST spray can transfer from the area of skin where it was sprayed to other people or pets. Do not allow other people, especially children to come into contact with the area of your skin where you have sprayed EVAMIST.
If another person accidentally touches the area of your skin where you have sprayed EVAMIST, that area of their skin should be washed with soap and water right away.
Do not let pets lick or touch your arm where you have sprayed EVAMIST, especially small pets. EVAMIST may harm them. Cover your skin with clothing where you have sprayed EVAMIST if you think a pet could come in contact with that area of your skin.
If a pet accidentally comes in contact with the area of your skin where you have sprayed EVAMIST, the area of the pet’s skin should be washed with soap and water right away.
Young children who are accidentally exposed to estrogen through contact with women using EVAMIST may show signs and symptoms of puberty that are not expected. Signs and symptoms in children of exposure to EVAMIST may include:
o
breast budding or breast lumps
o
other signs of abnormal sexual development
If a child shows signs and symptoms of accidental exposure to EVAMIST:
o
have the child checked right away by their healthcare provider.
o
stop using EVAMIST and call your healthcare provider right away.
o
talk to your healthcare provider about the correct use of EVAMIST when around children.
Talk to your healthcare provider about other treatments for your menopause symptoms if accidental exposure to EVAMIST cannot be avoided.
You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with EVAMIST.

What should I avoid while using EVAMIST?

Do not allow others to make contact with the area of skin where you have applied the EVAMIST spray.
EVAMIST contains alcohol, which is flammable. Avoid fire, flame, or smoking until the area of your skin where you have applied EVAMIST has dried.

What are the possible side effects of EVAMIST?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

heart attack
stroke
blood clots
dementia
breast cancer
cancer of the lining of the uterus (womb)
cancer of the ovary
high blood pressure
high blood sugar
gallbladder disease
liver problems
changes in your thyroid hormone levels
enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

new breast lumps
unusual vaginal bleeding
changes in vision or speech
sudden new severe headaches
severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

headache
breast pain
irregular vaginal bleeding or spotting
stomach or abdominal cramps, bloating
nausea and vomiting
hair loss
fluid retention
vaginal yeast infection

These are not all the possible side effects of EVAMIST. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to Ther-Rx at 1-877-567-7676 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with EVAMIST?

Talk with your healthcare provider regularly about whether you should continue using EVAMIST.
If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
See your healthcare provider right away if you get vaginal bleeding while using EVAMIST.
Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease.
Ask your healthcare provider for ways to lower your chances of getting heart disease.

How should I store EVAMIST?

Store EVAMIST at room temperature 68°F to 77°F (20°C to 25°C )
Do not freeze.
Safely throw away medicine that is out of date or no longer needed.

Keep EVAMIST and all medicines out of the reach of children.

General information about the safe and effective use of EVAMIST.

Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. Do not use EVAMIST for conditions for which it was not prescribed. Do not give EVAMIST to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about EVAMIST. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about EVAMIST that is written for health professionals.

For more information, go to www.Evamist.com or call Ther-Rx at 1-877-567-7676.

What are the ingredients in EVAMIST?

Active ingredient: estradiol

Inactive ingredients: octisalate, alcohol

Instructions for Use

EVAMIST (EE-vuh-mist)

(estradiol transdermal spray)

Read this Instructions for Use before you start using EVAMIST and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms of your treatment.

The parts of your EVAMIST applicator

EVAMIST comes in a spray applicator that delivers a measured amount of estradiol to your skin with each spray (see Figure A).

Figure A
(click image for full-size original)
Figure A
Step 1. Priming your EVAMIST
Before you use your EVAMIST applicator for the first time, the applicator must be primed.
Hold the EVAMIST applicator upright. Keep the cover on. Fully press down the pump button 3 times with your thumb or index finger (see Figure B). After priming, the EVAMIST applicator is ready to use.
The EVAMIST applicator should be primed only 1 time when you first start using a new applicator. Do not prime the EVAMIST applicator before your dose each day.
Figure B
(click image for full-size original)

Figure B

Step 2. Using your EVAMIST

Remove the plastic cover.
Apply EVAMIST to a clean, dry, unbroken skin area on the inside of your forearm between the elbow and the wrist (see Figure C). This area must be clean, dry, and the skin must be without open wounds, cuts, abrasions, or rashes.
Hold the EVAMIST applicator upright and rest the plastic cone flat against your skin. You may need to change the position of your arm or the position of the cone on your arm so that the cone is flat against your skin and there are no gaps between the cone and your skin (see Figure C).
Press the pump button down fully 1 time (see Figure C).
Figure C
(click image for full-size original)
Figure C
If your healthcare provider tells you to increase your dose to 2 or 3 sprays, move the cone before applying the second or third spray to an area of your skin next to but not touching the area of the previous spray (see Figure D).
Figure D
(click image for full-size original)
Figure D
Do not apply EVAMIST to your breasts or in and around your vagina.
Do not massage or rub EVAMIST into your skin.
Let EVAMIST spray dry on your skin for at least:
o
2 minutes before you cover your skin with clothing.
o
1 hour before you wash your skin.

Step 3. After you use EVAMIST

Place the plastic cover back on the EVAMIST applicator cone.
EVAMIST is flammable until dry. Avoid fire, flame, or smoking until the area of your skin where you have applied EVAMIST has completely dried.

Step 4. Throwing away used EVAMIST applicators
Your EVAMIST applicator contains enough medicine to allow for initial priming of the pump with 3 sprays and application of 56 sprays.
Do not use your EVAMIST applicator for more than 56 application sprays even though the bottle may not be completely empty. You may not get the correct dose.
Always replace the cover over the cone of your EVAMIST applicator before you throw it away to prevent accidental exposure to other people or pets.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

P0000
Revised 03/2014

Manufactured by
DPT Laboratories. Ltd
San Antonio, TX 78215

For
Ther-Rx CorporationChesterfield, MO 63005

© 2013 Ther-Rx Corporation 03/14

PRINICPAL DISPLAY PANEL

NDC 64011-215-41 FOR TOPICAL USE ONLY

Evamist ®

(estradiol transdermal spray)

Each spray contains 1.53 mg of estradiol

0.27 fl oz. (8.1 mL) Rx Only

Carton Label
(click image for full-size original)

Carton Label

EVAMIST estradiol spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64011-215
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
estradiol (estradiol) estradiol 1.53 mg
Inactive Ingredients
Ingredient Name Strength
octisalate
alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64011-215-41 56 SPRAY, METERED in 1 VIAL, MULTI-DOSE None
2 NDC:64011-215-42 56 SPRAY, METERED in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022014 07/08/2009
Labeler — Ther-Rx Corporation (055041706)
Registrant — KV Pharmaceutical (006291405)
Establishment
Name Address ID/FEI Operations
DPT Laboratories Ltd. 832224526 MANUFACTURE (64011-215), ANALYSIS (64011-215)
Establishment
Name Address ID/FEI Operations
DPT Laboratories Ltd. 832224690 MANUFACTURE (64011-215)

Revised: 03/2014 Ther-Rx Corporation

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