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 and older (45% were age 65 to 69 years of age; 36% were 70 to 74 years of age; 19% 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% 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% were age 65 to 69 years of age; 35% were 70 to 74 years of age; 18% 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% 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 two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95% 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

16.1 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)]

16.2 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.

Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

17 PATIENT COUNSELING INFORMATION

Advise women to read the FDA-approved patient labeling (Patient Information and Instructions for Use)

Vaginal Bleeding

Inform postmenopausal women to report any 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, 5.3)].

Possible 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. 11-2021-01

PATIENT INFORMATION

Estradiol ( es” tra dye’ ol) 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 menopausal symptoms 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 and older.
  • Do not use estrogens with progestogens to prevent heart disease, heart attacks, strokes, or dementia.
  • Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.
  • Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia.Because other products and doses have not been studied in the same way, it is not known how the use of estradiol transdermal system will affect your chances of these conditions. 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 the estrogen hormone estradiol. When applied to the skin, estradiol is absorbed 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 estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden intense 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.

  • 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 due to 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.

  • have been diagnosed with a bleeding disorder
  • 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 (womb). 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
  • are allergic to estradiol transdermal system or any of the ingredients in it.

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

Before you use estradiol transdermal system, tell your healthcare provider about all of your medical conditions, including 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 that may become worse while you are using estradiol transdermal system

    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); 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 pregnant or think you may be pregnant.

    Estradiol transdermal system is not for pregnant women.

  • 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 over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol transdermal system works. Estradiol transdermal system 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 new medicine.

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 on 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, 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 if any adhesive residue remains on your skin, allow the area to dry for 15 minutes. Then, gently rub the area with oil or lotion to remove the adhesive from your skin.
  • Apply the new patch 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
  • high blood pressure
  • stroke
  • high levels of fat (triglyceride) in your blood
  • blood clots
  • liver problems
  • breast cancer
  • changes in your thyroid hormone levels
  • cancer of the lining of the uterus (womb)
  • fluid retention
  • cancer of the ovary
  • cancer changes of endometriosis
  • dementia
  • enlargement of benign tumors of the uterus (“fibroids”)
  • high or low blood calcium
  • gallbladder disease
  • worsening of swelling of face and tongue (angioedema) in women with a history of angioedema
  • visual abnormalities

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
  • swelling of face and tongue with or without red, itchy bumps

Common side effects of estradiol transdermal system include:

  • headache
  • nausea and vomiting
  • breast pain
  • hair loss
  • irregular vaginal bleeding or spotting
  • fluid retention
  • painful periods
  • vaginal yeast infection
  • stomach or abdominal cramps, bloating
  • 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. Tell your healthcare provider if you have any side effects that bother you or do not go away.

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 progestogen is right for you. In general, the addition of a progestogen is 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 estradiol transdermal system at room temperature 68° to 77°F (20° 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 purposes other than those listed 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.

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

This Patient Information has been approved by the U.S. Food and Drug Administration.

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