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DELESTROGEN®
(estradiol valerate injection, USP)

Read this Patient Information before you start taking DELESTROGEN (estradiol valerate) and read what you get each time you refill DELESTROGEN (estradiol valerate) . 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 DELESTROGEN (estradiol valerate) ?

DELESTROGEN (estradiol valerate) is a medicine that contains estrogen hormones.

What is DELESTROGEN (estradiol valerate) used for?

DELESTROGEN (estradiol valerate) 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 to 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 feeling 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. You and your healthcare provider should talk regularly about whether you still need treatment with DELESTROGEN (estradiol valerate) .
• treat moderate to severe dryness, itching, and burning in and around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with DELESTROGEN (estradiol valerate) to control these problems. If you use DELESTROGEN (estradiol valerate) only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

Who should not take DELESTROGEN (estradiol valerate) ?

Do not start taking DELESTROGEN (estradiol valerate) if you:

• have unusual vaginal bleeding.
• 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 had cancer, talk with your healthcare provider about whether you should take DELESTROGEN (estradiol valerate) .
• had a stroke or heart attack in the past year.
• currently have or have had blood clots.
• currently have or have had liver problems.
• are allergic to DELESTROGEN (estradiol valerate) or any of its ingredients. See the end of this leaflet for a list of ingredients in DELESTROGEN (estradiol valerate) .
• think you may be pregnant.

Tell your healthcare provider:

• if you are breastfeeding. The hormone in DELESTROGEN (estradiol valerate) can pass into your milk.
• about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometrio-sis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how DELESTROGEN (estradiol valerate) works. DELESTROGEN (estradiol valerate) may also affect how your other medicines work.
• if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.

How should I take DELESTROGEN (estradiol valerate) ?

DELESTROGEN (estradiol valerate) should be injected deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration. By virtue of the low viscosity of the vehicles, the various preparations of DELESTROGEN (estradiol valerate injection, USP) may be administered with a small gauge needle. Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose.

DELESTROGEN (estradiol valerate) should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to pale yellow. Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming.

NOTE: A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material.

1. Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
2. Estrogens should be used at the lowest dose possible for your treatment only as long as needed. The lowest effective dose of DELESTROGEN (estradiol valerate) has not been determined. 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 DELESTROGEN (estradiol valerate) .

What are the possible side effects of estrogens?

Less common but serious side effects include:

• Breast cancer
• Cancer of the uterus
• Stroke
• Heart attack
• Blood clots
• Dementia
• Gallbladder disease
• Ovarian cancer

These are some of the warning signs of serious side effects:

• Breast lumps
• Unusual vaginal bleeding
• Dizziness and faintness
• Changes in speech
• Severe headaches
• Chest pain
• Shortness of breath
• Pains in your legs
• Changes in vision
• Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach/abdominal cramps, bloating
• Nausea and vomiting
• Hair loss

Other side effects include:

• High blood pressure
• Liver problems
• High blood sugar
• Fluid retention
• Enlargement of benign tumors of the uterus ("fibroids")
• Vaginal yeast infection

These are not all the possible side effects of DELESTROGEN (estradiol valerate) . For more information, ask your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with DELESTROGEN (estradiol valerate) ?

Talk with your healthcare provider regularly about whether you should continue taking DELESTROGEN (estradiol valerate) . If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. See your healthcare provider right away if you get vaginal bleeding while taking DELESTROGEN (estradiol valerate) . 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 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.

General information about safe and effective use of DELESTROGEN (estradiol valerate)

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

Keep DELESTROGEN (estradiol valerate) out of the reach of children.

This leaflet provides a summary of the most important information about DELESTROGEN (estradiol valerate) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about DELESTROGEN (estradiol valerate) that is written for health professionals. You can get more information by calling the toll free number 1-866-923-2547.

What are the ingredients in DELESTROGEN (estradiol valerate) ?

DELESTROGEN (estradiol valerate) is supplied in three 5 mL multiple dose vials; 10 mg/mL, 20 mg/mL, and 40 mg/mL strengths. The 10 mg/mL strength contains 10 mg estradiol valerate in a solution of chlorobutanol and sesame oil. The 20 mg/mL strength contains 20 mg estradiol valerate in a solution of benzyl benzoate, ben-zyl alcohol, and castor oil. The 40 mg/mL strength contains 40 mg estradiol valerate in a solution of ben-zyl benzoate, benzyl alcohol, and castor oil.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.