(estradiol)

Prescribing Information
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ADVERSE REACTIONS

ADVERSE REACTIONS

See WARNINGS and PRECAUTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two ESTRING controlled studies, discontinuation of treatment due to an adverse event was required by 5.4 percent of patients receiving ESTRING and 3.9 percent of patients receiving conjugated estrogens vaginal cream. The most common reasons for withdrawal from ESTRING treatment due to an adverse event were vaginal discomfort and gastrointestinal symptoms.

The adverse events reported with a frequency of 3 percent or greater in the two pivotal controlled studies by patients receiving ESTRING or conjugated estrogens vaginal cream are listed in Table 3.

TABLE 3: Adverse Events Reported by 3 Percent or More of Patients Receiving Either ESTRING or Conjugated Estrogens Vaginal Cream in Two Pivotal Controlled Studies
ADVERSE EVENTESTRING
(n = 257)
%		Conjugated Estrogens Vaginal Cream
(n = 129)
%

Musculoskeletal

  Back Pain

6

8

  Arthritis

4

2

  Arthralgia

3

5

  Skeletal Pain

2

4

CNS/Peripheral Nervous System

  Headache

13

16

Psychiatric

  Insomnia

4

0

Gastrointestinal

  Abdominal Pain

4

2

  Nausea

3

2

Respiratory

  Upper Respiratory Tract Infection

5

6

  Sinusitis

4

3

  Pharyngitis

1

3

Urinary

  Urinary Tract Infection

2

7

Female Reproductive

  Leukorrhea

7

3

  Vaginitis

5

2

  Vaginal Discomfort/Pain

5

5

  Vaginal Hemorrhage

4

5

  Asymptomatic Genital Bacterial Growth

4

6

  Breast Pain

1

7

Resistance Mechanisms

  Genital Moniliasis

6

7

Body as a Whole

  Flu-Like Symptoms

3

2

  Hot Flushes

2

3

  Allergy

1

4

Miscellaneous

  Family Stress

2

3

Postmarketing Experience

Cases of toxic shock syndrome (TSS) have been reported in women using vaginal rings. TSS is a rare, but serious disease that may cause death. Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body.

Vaginal erosion, vaginal ulceration, adherence of the vaginal ring to the vaginal wall:

•
Cases of ring adherence to the vaginal wall, making ring removal difficult, have occurred. Some cases have required surgical removal of vaginal rings.
•
Cases of vaginal erosion and vaginal ulceration that may manifest as vaginal irritation, erythema. abrasion or spotting have occurred.

Vaginal wall ulceration or erosion should be carefully evaluated. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete in order to prevent the ring from adhering to the healing tissue.

Cases of bowel obstruction and vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.

Cases of hypersensitivity have been reported.

The following additional adverse events were reported at least once by patients receiving ESTRING in the worldwide clinical program, which includes controlled and uncontrolled studies. A causal relationship with ESTRING has not been established.

Body as a Whole: allergic reaction

CNS/Peripheral Nervous System: dizziness

Gastrointestinal: enlarged abdomen, vomiting

Metabolic/Nutritional Disorders: weight decrease or increase

Musculoskeletal: arthropathy (including arthrosis)

Psychiatric: depression, decreased libido, nervousness

Reproductive: breast engorgement, breast enlargement, intermenstrual bleeding, genital edema, vulval disorder

Skin/Appendages: pruritus, pruritus ani

Urinary: micturition frequency, urethral disorder

Vascular: thrombophlebitis

Vision: abnormal vision

Medication Guide
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PATIENT INFORMATION

PATIENT INFORMATION

ESTRING
(estradiol vaginal system)

Read this Patient Information before you start using ESTRING 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 ESTRING?

ESTRING (estradiol vaginal system) is an off-white, soft, flexible ring with a center that contains 2 mg of estradiol (an estrogen hormone). ESTRING releases estradiol into the vagina in a consistent, stable manner for 90 days. The soft, flexible ring is placed in the upper third of the vagina (by the physician or the patient). ESTRING should be removed after 90 days of continuous use. If continuation of therapy is indicated, the flexible ring should be replaced.

What is ESTRING used for?

ESTRING is used after menopause to 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 ESTRING to control these problems.

Who should not use ESTRING?

Do not start using ESTRING 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. If you have or had an estrogen-dependent cancer, talk with your healthcare provider about whether you should use ESTRING.
•
had a stroke or heart attack
•
currently have or have had blood clots
•
currently have liver problems
•
have been diagnosed with a bleeding disorder
•
are allergic to ESTRING or any of its ingredients
 
See the list of ingredients in ESTRING at the end of this leaflet.
•
think you may be pregnant
 
ESTRING 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 ESTRING if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before I use ESTRING?
Before you use ESTRING, 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 ESTRING.
•
are breast feeding
 
The hormone in ESTRING 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 ESTRING works. ESTRING may also affect how your other medicines work.

What are the possible side effects of ESTRING?

If you experience any of the following side-effects, immediately remove ESTRING if possible and contact your healthcare provider. If you experience difficulty or pain when trying to remove the ring please do not continue and contact your healthcare provider:

•
Cases of toxic shock syndrome (TSS) have been reported in women using vaginal rings. Toxic shock syndrome is a rare but serious illness caused by a bacterial infection. Symptoms of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-like rash on face and body.
•
Cases of the vaginal ring becoming attached to the vaginal wall, making ring removal difficult, have occurred. Some women have needed surgery to remove vaginal rings.
•
Cases of erosion (wearing away) and ulceration (holes) of the vaginal lining have also occurred. Symptoms of vaginal erosion and ulceration can include vaginal pain or soreness, vaginal bleeding, and redness, swelling, or scrapes in the vagina.
•
Cases of bowel obstruction have been reported.
•
Severe allergic reactions have been reported including skin rash, giant hives, swelling of the eyelids, face, lips, tongue or throat.

The most frequently reported side effect with ESTRING use is increased vaginal secretions. Many of these vaginal secretions are like those that occur normally prior to menopause and indicate that ESTRING is working. Vaginal secretions that are associated with a bad odor, vaginal itching, or other signs of vaginal infection are NOT normal and may indicate a risk or a cause for concern. Other side effects may include vaginal discomfort, abdominal pain, or genital itching.

What are the possible side effects of estrogens?

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
•
memory loss or confusion

Less serious, but common side effects include:

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

These are not all the possible side effects of ESTRING. 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 healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Pfizer at 1-800-438-1985.

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

•
Follow carefully the instructions for use.
•
Talk with your healthcare provider regularly about whether you should continue using ESTRING.
•
See your healthcare provider right away if you get vaginal bleeding while using ESTRING.
•
If you have fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-like rash on face and body, remove ESTRING and contact your healthcare provider.
•
Contact your healthcare provider if you have difficulty removing the vaginal ring.
•
Have a 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 examinations 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.

General information about safe and effective use of ESTRING

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

Keep ESTRING out of the reach of children.

This leaflet provides a summary of the most important information about ESTRING. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ESTRING that is written for health professionals. You can get more information by calling the toll free number 1-888-691-6813.

What are the ingredients in ESTRING?

ESTRING (estradiol vaginal system) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol (an estrogen hormone). Estradiol, silicone polymers, barium sulfate and silicone fluid (as dispersing agent) are combined to form the ring.

Storage: Store at controlled room temperature 15° to 25 °C (59 °F to 77 °F).

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.