Estradiol (Page 8 of 10)

14.4 Women’s Health Initiative Memory Study

The WHIMS estrogen-alone ancillary study of WHI enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age (45 percent were age 65 to 69 years of age; 36 percent were 70 to 74 years of age; 19 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg)-alone 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 to 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 types (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 age 65 to 69 years of age; 35 percent were 70 to 74 years of age; 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 was 2.05 (95 percent CI, 1.21 to 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 2 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 to 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 on 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

How Supplied

Estradiol transdermal system, USP, 0.025 mg per day — each 1.89 cm2 system contains 0.314 mg of estradiol USP for nominal* delivery of 0.025 mg of estradiol, USP per day.

Patient Calendar Pack of 8 Systems………………………………….NDC 69238-1629-7

Estradiol transdermal system, USP, 0.0375 mg per day — each 2.83 cm2 system contains 0.470 mg of estradiol USP for nominal* delivery of 0.0375 mg of estradiol, USP per day.

Patient Calendar Pack of 8 Systems………………………………….NDC 69238-1630-7

Estradiol transdermal system, USP, 0.05 mg per day — each 3.78 cm2 system contains 0.627 mg of estradiol USP for nominal* delivery of 0.05 mg of estradiol, USP per day.

Patient Calendar Pack of 8 Systems………………………………….NDC 69238-1631-7

Estradiol transdermal system, USP, 0.075 mg per day — each 5.66 cm2 system contains 0.940 mg of estradiol USP for nominal* delivery of 0.075 mg of estradiol, USP per day.

Patient Calendar Pack of 8 Systems………………………………….NDC 69238-1632-7

Estradiol transdermal system, USP, 0.1 mg per day — each 7.55 cm2 system contains 1.253 mg of estradiol USP for nominal* delivery of 0.1 mg of estradiol, USP per day.

Patient Calendar Pack of 8 Systems………………………………….NDC 69238-1633-7

[*see DESCRIPTION (11)]

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Do not store unpouched. Apply immediately upon removal from the protective pouch.

17 PATIENT COUNSELING INFORMATION

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

Advise patients to read the Patient Information and Instructions for Use. The complete text of the Patient Information and Instructions for Use is reprinted at the end of this document.

Vaginal Bleeding

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

Possible Serious Adverse Reactions with Estrogen-Alone Therapy

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

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.

Distributed by:
Amneal Pharmaceuticals LLC Bridgewater, NJ 08807

Rev. 08-2018-00

PATIENT INFORMATION

Estradiol ( ess-tra-DYE-ole) Transdermal System

Read this Patient Information before you start using estradiol transdermal system 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 medical condition or your treatment.

What is the most important information I should know about estradiol transdermal system (an estrogen hormone)?
  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb).

    Report any unusual vaginal bleeding right away while you are using estradiol transdermal system. 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.

  • 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 of age or older.
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, 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 of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with estradiol transdermal system.

What is estradiol transdermal system?

Estradiol transdermal system is a prescription medicine patch (Transdermal System) that contains estradiol (an estrogen hormone). When applied to the skin as directed below, estradiol transdermal system releases estrogen through the skin into the bloodstream.

What is estradiol transdermal system used for?

Estradiol transdermal system 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 develop 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 estrogens. In other women, symptoms can be more severe.

  • Treat moderate to severe menopausal changes in and around the vagina

    You and your healthcare provider should talk regularly about whether you still need treatment with estradiol transdermal system to control these problems. If you use estradiol transdermal system only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

  • Treat certain conditions in women before menopause if their ovaries do not produce enough estrogens naturally
  • Help reduce your chances of getting osteoporosis (thin weak bones)

Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use estradiol transdermal system only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

You and your healthcare provider should talk regularly about whether you should continue treatment with estradiol transdermal system.

Who should not use estradiol transdermal system?

Do not start using estradiol transdermal system 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 chances 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 estradiol transdermal system.

  • 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 estradiol transdermal system or any of its ingredients

See the list of ingredients in estradiol transdermal system at the end of this leaflet.

  • think you may be pregnant

    Estradiol transdermal system 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 estradiol transdermal system if the test is positive and talk to your healthcare provider.

    What should I tell my healthcare provider before I use estradiol transdermal system?

    Before you use estradiol transdermal system, 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 unusual 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 estradiol transdermal system.

  • are breastfeeding

    The hormone in estradiol transdermal system 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 estradiol transdermal system works. Estradiol transdermal system may also affect how other medicines work.

    How should I use estradiol transdermal system?

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

  • Use estradiol transdermal system exactly as your healthcare provider tells you to use it.
  • Estradiol transdermal system is for skin use only.
  • Change your estradiol transdermal system patch 2 times a week or every 3 to 4 days.
  • Apply your estradiol transdermal system patch to a clean, dry area of your lower abdomen. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin.
  • Apply your estradiol transdermal system patch to a different area of your abdomen each time. Do not use the same application site 2 times in the same week.
  • Do not apply estradiol transdermal system to your breasts.
  • If you forget to apply a new estradiol transdermal system patch, you should apply a new patch as soon as possible.
  • You and your healthcare provider should talk regularly (every 3 to 6 months) about your dose and whether you still need treatment with estradiol transdermal system.

How to change estradiol transdermal system

  • When changing the patch, peel off the used patch slowly from the skin.
  • After removal of estradiol transdermal system, patients usually have either no adhesive residue or light adhesive residue. If any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with oil or lotion to remove the adhesive from your skin.
  • Keep in mind, the new patch must be applied to a different area of your lower abdomen. This area must be clean, dry, cool and free of powder, oil, or lotion.

What are the possible side effects of estradiol transdermal system?

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 (“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
  • nipple discharge
  • 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
  • swelling
  • rash

Less serious, but common side effects include:

  • headache
  • breast pain
  • irregular vaginal bleeding or spotting
  • painful periods
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection
  • redness and/or irritation at patch placement site

These are not all the possible side effects of estradiol transdermal system. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Amneal Pharmaceuticals (1-877-835-5472).

What can I do to lower my chances of getting a serious side effect with estradiol transdermal system?

  • Talk with your healthcare provider regularly about whether you should continue using estradiol transdermal system.
  • If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
  • See your healthcare provider right away if you get vaginal bleeding while using estradiol transdermal system.
  • 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 higher chances for getting heart disease.

Ask your healthcare provider for ways to lower your chances for getting heart disease.

How should I store and throw away used estradiol transdermal system patches?

  • Store at room temperature 68°F to 77°F (20°C to 25°C)
  • Do not store estradiol transdermal system patches outside of their pouches. Apply immediately upon removal from the protective pouch.
  • Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet.

Keep estradiol transdermal system and all medicines out of the reach of children.

General information about safe and effective use of estradiol transdermal system

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use estradiol transdermal system for conditions for which it was not prescribed. Do not give estradiol transdermal system to other people, even if they have the same symptoms you have. It may harm them.

This leaflet provides a summary of the most important information about estradiol transdermal system. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about estradiol transdermal system that is written for health professionals. For more information, call the toll-free number Amneal Pharmaceuticals (1-877-835-5472).

What are the ingredients in estradiol transdermal system?

Active ingredient: estradiol, USP

Inactive ingredients: a polyester and ethylene vinyl acetate copolymer film, acrylic and silicone adhesives, oleyl alcohol, NF, povidone, USP, dipropylene glycol and a polyester release liner.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 08-2018-00

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