Estrogen Injection

IMPORTANT WARNING:

Estrogen increases the risk that you will develop endometrial cancer (cancer of the lining of the uterus [womb]). The longer you use estrogen, the greater the risk that you will develop endometrial cancer. If you have not had a hysterectomy (surgery to remove the uterus), you should be given another medication called a progestin to take with estrogen injection. This may decrease your risk of developing endometrial cancer, but may increase your risk of developing certain other health problems, including breast cancer. Before you begin using estrogen injection, tell your doctor if you have or have ever had cancer and if you have unusual vaginal bleeding. Call your doctor immediately if you have abnormal or unusual vaginal bleeding during your treatment with estrogen injection.Your doctor will watch you closely to help ensure you do not develop endometrial cancer during or after your treatment.

In a large study, women who took estrogen with progestins by mouth had a higher risk of heart attacks, strokes,blood clots in the lungs or legs, breast cancer, and dementia (loss of ability to think, learn, and understand). Women who use estrogen injection alone or with progestins may also have a higher risk of developing these conditions. Tell your doctor if you smoke or use tobacco, if you have had a heart attack or a stroke in the past year, and if you or anyone in your family has or has ever had blood clots or breast cancer. Also tell your doctor if you have or have ever had high blood pressure, high blood levels of cholesterol or fats, diabetes, heart disease, lupus (a condition in which the body attacks its own tissues causing damage and swelling), breast lumps, or an abnormal mammogram (x-ray of the breast used to find breast cancer).

The following symptoms can be signs of the serious health conditions listed above. Call your doctor immediately if you experience any of the following symptoms while you are using estrogen injection: sudden, severe headache; sudden, severe vomiting; speech problems; dizziness or faintness; sudden complete or partial loss of vision; double vision; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; difficulty thinking clearly, remembering, or learning new things;breast lumps or other breast changes; discharge from nipples; or pain, tenderness, or redness in one leg.

You can take steps to decrease the risk that you will develop a serious health problem while you are using estrogen injection. Do not use estrogen injection alone or with a progestin to prevent heart disease, heart attacks, strokes, or dementia. Use the lowest dose of estrogen that controls your symptoms and only use estrogen injection as long as needed. Talk to your doctor every 3-6 months to decide if you should use a lower dose of estrogen or should stop using the medication.

You should examine your breasts every month and have a mammogram and a breast exam performed by a doctor every year to help detect breast cancer as early as possible. Your doctor will tell you how to properly examine your breasts and whether you should have these exams more often than once a year because of your personal or family medical history.

Tell your doctor if you are having surgery or will be on bedrest. Your doctor may tell you to stop using estrogen injection 4-6 weeks before the surgery or bedrest to decrease the risk that you will develop blood clots.

Talk to your doctor regularly about the risks and benefits of using estrogen injection.

WHY is this medicine prescribed?

The estradiol cypionate and estradiol valerate forms of estrogen injection are used to treat hot flushes (hot flashes; sudden strong feelings of heat and sweating) and/or vaginal dryness, itching, and burning in women who are experiencing menopause (change of life; the end of monthly menstrual periods). However, women who need a medication only to treat vaginal dryness, itching, or burning should consider a different treatment. These forms of estrogen injection are also sometimes used to treat the symptoms of low estrogen in young women who do not produce enough estrogen naturally. The estradiol valerate form of estrogen injection is also sometimes used to relieve the symptoms of certain types of prostate (a male reproductive organ) cancer. The conjugated estrogens form of estrogen injection is used to treat abnormal vaginal bleeding that a doctor has decided is caused only by a problem with the amounts of certain hormones in the body. Estrogen injection is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The estradiol cypionate and estradiol valerate forms of long acting estrogen injection come as a liquid to inject into a muscle. These medications are usually injected by a health care professional once every 3 to 4 weeks. When the estradiol valerate form of estrogen injection is used to treat the symptoms of prostate cancer, it is usually injected by a health care professional once every 1 to 2 weeks.

The conjugated estrogens form of estrogen injection comes as a powder to mix with sterile water and inject into a muscle or vein. It is usually injected by a health care professional as a single dose. A second dose may be injected 6 to 12 hours after the first dose if it is needed to control vaginal bleeding.

If you are using estrogen injection to treat hot flushes, your symptoms should improve within 1 to 5 days after you receive the injection. Tell your doctor if your symptoms do not improve during this time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using estrogen injection,

• tell your doctor and pharmacist if you are allergic to estrogen injection, any other estrogen products, any other medications, or any of the ingredients in estrogen injection. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients in the brand of estrogen injection you plan to use.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral);aprepitant (Emend); carbamazepine (Carbatrol, Epitol, Tegretol);cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); dexamethasone (Decadron, Dexpak); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E.E.S, Erythrocin);fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); griseofulvin (Fulvicin, Grifulvin, Gris-PEG); lovastatin (Altocor, Mevacor); medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); medications for thyroid disease; nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate);sertraline (Zoloft); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had yellowing of the skin or eyes during pregnancy or during your treatment with an estrogen product, endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body), uterine fibroids (growths in the uterus that are not cancer), asthma, migraine headaches, seizures, porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system), very high or very low levels of calcium in your blood, or thyroid, liver, kidney, gallbladder, or pancreatic disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using estrogen injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medicine.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of estrogen injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Estrogen injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• breast pain or tenderness
• upset stomach
• vomiting
• weight gain or loss
• dizziness
• nervousness
• depression
• irritability
• changes in sexual desire
• hair loss
• unwanted hair growth
• spotty darkening of the skin on the face
• difficulty wearing contact lenses
• leg cramps
• swelling, redness, burning, itching, or irritation of the vagina
• vaginal discharge

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• bulging eyes
• pain, swelling, or tenderness in the stomach
• loss of appetite
• weakness
• yellowing of the skin or eyes
• joint pain
• movements that are difficult to control
• rash or blisters
• hives
• itching
• swelling of the eyes, face, tongue, throat, hands, arms, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Estrogen may increase your risk of developing cancer of the ovaries or gallbladder disease that may need to be treated with surgery. Talk to your doctor about the risks of using estrogen injection.

Estrogen may cause growth to slow or stop early in children who receive large doses for a long time. Estrogen injection may also affect the timing and speed of sexual development in children.Your child's doctor will monitor him or her carefully during his or her treatment with estrogen. Talk to your child's doctor about the risks of giving this medication to your child.

Estrogen injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Your doctor will store the medication in his or her office.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• upset stomach
• vomiting
• vaginal bleeding

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using estrogen injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.