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Generic Name: estradiol valerate (ess-tra-DIE-ole)
Brand Name: Delestrogen
Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women who receive estrogen-only hormone therapy. Contact your doctor immediately if you experience any unusual vaginal bleeding. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given with another hormone (progestin) for replacement therapy can infrequently cause heart disease (eg, heart attacks), stroke, serious blood clots in the legs or lungs (pulmonary embolism/deep vein thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time Delestrogen is used and the amount of estrogen per dose. Therefore, Delestrogen should be used for the shortest possible length of time at the lowest effective dose so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.
Delestrogen is used for:
Treating certain symptoms of menopause (eg, hot flashes, vaginal itching, burning, or dryness). It is used to treat low levels of estrogen caused by certain conditions. It may be used to treat certain types of prostate cancer (advanced androgen-dependent). It may also be used for other conditions as determined by your doctor.
Delestrogen is a female estrogen hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.It works for advanced prostate cancer by antagonizing male hormones.
Do NOT use Delestrogen if:
- you are allergic to any ingredient in Delestrogen
- you are pregnant or suspect you may be pregnant, or you have vaginal bleeding of abnormal or unknown cause
- you have a history of known or suspected breast cancer (unless your doctor tells you otherwise)
- you have any other estrogen-dependent cancer
- you have the blood disease porphyria, or a history of blood clots or liver problems
- you have had a recent (within the past year) stroke or heart attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using Delestrogen:
Some medical conditions may interact with Delestrogen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have breast lumps or disease, an abnormal mammogram, or a family history of breast cancer or blood clots
- if you have yellowing of the skin or whites of the eyes during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)
- if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)
- if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes
- if you smoke, are overweight, or will be having surgery
- if you have a history of alcohol or other substance abuse or dependence
Some MEDICINES MAY INTERACT with Delestrogen. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and side effects may be increased by Delestrogen
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Delestrogen
- Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), carbamazepine, rifampin, or St. John's wort because they may decrease Delestrogen's effectiveness
- Azole antifungals (eg, ketoconazole) or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Delestrogen's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Delestrogen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Delestrogen:
Use Delestrogen as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Delestrogen. Talk to your pharmacist if you have questions about this information.
- Delestrogen is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Delestrogen at home, a health care provider will teach you how to use it. Be sure you understand how to use Delestrogen. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Delestrogen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Delestrogen, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Delestrogen.
Important safety information:
- Delestrogen may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Delestrogen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Limit alcoholic beverages while you are using Delestrogen.
- Delestrogen may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
- Delestrogen may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
- Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
- Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Delestrogen.
- Follow your doctor's instructions for examining your breasts, and report any lumps immediately.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Delestrogen.
- Diabetes patients - Delestrogen may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Delestrogen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Delestrogen.
- Discuss with your doctor every 3 to 6 months whether treatment with Delestrogen is still appropriate.
- Lab tests, including physical exams and blood pressure, may be performed while you use Delestrogen. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
- Delestrogen has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
- Delestrogen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Delestrogen may cause decreased bone growth in CHILDREN.
- PREGNANCY and BREAST-FEEDING: Do not use Delestrogen if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Delestrogen is found in breast milk. Do not breast-feed while taking Delestrogen.
Possible side effects of Delestrogen:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Abnormal hair growth; breast tenderness; changes in sex drive; cramps; dizziness; flushing; hair loss; headache; lightheadedness; nausea; pain, swelling, or redness at the injection site; reduced tolerance to carbohydrates; stomach bloating and upset; swelling; vaginal infection; weight changes.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf pain or tenderness; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech; chest pain; confusion; coughing of blood; mental/mood changes (eg, depression, memory loss); numbness of an arm or leg; one-sided weakness; pain, swelling, or tenderness in the stomach; problems with contact lenses (eg, changes in fit); severe headache, dizziness, fainting, or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness of an arm or leg; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.Proper storage of Delestrogen:
Delestrogen is usually handled and stored by a health care provider. If you are using Delestrogen at home, store Delestrogen as directed by your pharmacist or health care provider. Keep Delestrogen out of the reach of children and away from pets.
- If you have any questions about Delestrogen, please talk with your doctor, pharmacist, or other health care provider.
- Delestrogen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Delestrogen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Delestrogen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Delestrogen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Delestrogen.