Emcyt

Estramustine is used to treat prostate cancer that has worsened or has spread to other parts of the body. Estramustine is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of cancer cells.

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

Unless your doctor tells you otherwise, continue your normal diet.

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

• nausea
• diarrhea
• breast tenderness and enlargement
• leg cramps
• tiredness
• difficulty falling asleep or staying asleep
• impotence (inability to have or maintain an erection)

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing
• shortness of breath
• chest pain
• dizziness or faintness
• speech problems
• sudden, severe headache
• sudden partial or complete loss of vision
• weakness or numbness of an arm or a leg
• pain, redness or swelling of an arm or leg

Estramustine 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).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to estramustine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

Emcyt is a prescription medication used to treat prostate cancer that has worsened or has spread to other parts of the body. Emcyt belongs to a group of drugs called antimicrotubule agents. It works by stopping the growth and spread of cancer cells.

Emcyt comes as a capsule to take by mouth. It is usually taken with water 3 to 4 times a day at least one hour before or two hours after meals. Take Emcyt at around the same times every day.

Common side effects include nausea, diarrhea, and leg cramps.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep this medication in the container it came in, tightly closed, and out of reach of children.
• Store Emcyt capsules in the refrigerator.
• Throw away any medication that is outdated or no longer needed.
• Talk to your pharmacist about the proper disposal of your medication.

You should not use this medicine if you have a blood clot, swelling of a vein caused by a blood clot, or if you have ever had an allergic reaction to estradiol or nitrogen mustard.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of estramustine in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Epilepsy or
• Mental depression (or history of) or
• Migraine headaches or
• Kidney disease—Fluid retention sometimes caused by estramustine may worsen these conditions

• Blood clots (or history of) or
• Stroke (or history of) or
• Recent heart attack or stroke—May be worsened because of blood vessel problems caused by estramustine

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Diabetes mellitus (sugar diabetes)—Estramustine may change the amount of antidiabetic medicine needed

• Gallbladder disease (or history of)—May be worsened by estramustine

• Heart or blood vessel disease—Estramustine can cause circulation problems

• Jaundice or hepatitis (or history of) or other liver disease—Effects, including liver problems, may be increased

• Stomach ulcer—May be aggravated by estramustine

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Do not take estramustine within 1 hour before or 2 hours after meals or after the time you take milk, milk formulas, or other dairy products, since they may keep the medicine from working properly.

This medicine commonly causes nausea and sometimes causes vomiting. However, it may have to be taken for several weeks to months to be effective. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of estramustine, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• It is used to treat prostate cancer.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to estramustine or any other part of Emcyt (estramustine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a blood clot, have ever had a blood clot, or have been told you are at risk of getting a blood clot.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Emcyt with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Emcyt as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Take with a full glass of water.
• Do not eat or drink dairy products or take calcium at the same time as this medicine. They may make Emcyt not work as well. If you have questions, talk with your doctor or pharmacist.
• If the capsule is opened or broken, do not touch the contents. If the contents are touched or they get in the eyes, wash hands or eyes right away.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Breast soreness.
• Enlarged breasts.
• Change in sex ability.
• Leg cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

General

Fluid Retention. Exacerbation of preexisting or incipient peripheral edema or congestive heart disease has been seen in some patients receiving therapy with Emcyt Capsules. Other conditions which might be influenced by fluid retention, such as epilepsy, migraine, or renal dysfunction, require careful observation.

Emcyt may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients.

Because Emcyt may influence the metabolism of calcium and phosphorus, it should be used with caution in patients with metabolic bone diseases that are associated with hypercalcemia or in patients with renal insufficiency. Patients with prostate cancer and osteoblastic metastases are at risk for hypocalcemia and should have calcium levels closely monitored.

Gynecomastia and impotence are known estrogenic effects.

Allergic reactions and angioedema at times involving the airway have been reported.

Information for the Patient

Because of the possibility of mutagenic effects, patients should be advised to use contraceptive measures.

Laboratory Tests

Certain endocrine and liver function tests may be affected by estrogen-containing drugs. Emcyt may depress testosterone levels. Abnormalities of hepatic enzymes and of bilirubin have occurred in patients receiving Emcyt. Such tests should be done at appropriate intervals during therapy and repeated after the drug has been withdrawn for two months.

Food/Drug Interaction

Milk, milk products, and calcium-rich foods or drugs may impair the absorption of Emcyt.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term continuous administration of estrogens in certain animal species increases the frequency of carcinomas of the breast and liver. Compounds structurally similar to Emcyt are carcinogenic in mice. Carcinogenic studies of Emcyt have not been conducted in man. Although testing by the Ames method failed to demonstrate mutagenicity for estramustine phosphate sodium, it is known that both estradiol and nitrogen mustard are mutagenic. For this reason and because some patients who had been impotent while on estrogen therapy have regained potency while taking Emcyt, the patient should be advised to use contraceptive measures.

Although there has been no experience with overdosage to date, it is reasonable to expect that such episodes may produce pronounced manifestations of the known adverse reactions. In the event of overdosage, the gastric contents should be evacuated by gastric lavage and symptomatic therapy should be initiated. Hematologic and hepatic parameters should be monitored for at least 6 weeks after overdosage of Emcyt Capsules.

Applies to estramustine: oral capsule

Endocrine

Very common (10% or more): Breast tenderness (66%), breast enlargement (60%), gynecomastia
Frequency not reported: Erectile dysfunction[Ref]

Hepatic

Very common (10% or more): Abnormal LDH and/or AST (31%), abnormal hepatic function
Common (1% to 10%): Abnormal bilirubin[Ref]

Other

Very common (10% or more): Edema (19%)
Common (1% to 10%): Chest pain
Frequency not reported: Injection site thrombosis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (15%), diarrhea (12%), minor gastrointestinal upset (11%), vomiting
Common (1% to 10%): Flatulence, gastrointestinal bleeding[Ref]

Respiratory

Very common (10% or more): Dyspnea (11%)
Common (1% to 10%): Pulmonary emboli, upper respiratory discharge, hoarseness, burning throat
Frequency not reported: Larynx edema[Ref]

Cardiovascular

Very common (10% or more): Congestive heart failure
Common (1% to 10%): Myocardial infarction, thrombophlebitis
Frequency not reported: Myocardial ischemia, hypertension[Ref]

Hematologic

Very common (10% or more): Anemia, leukopenia
Common (1% to 10%): Thrombocytopenia[Ref]

Metabolic

Very common (10% or more): Fluid retention
Common (1% to 10%): Anorexia, thirst[Ref]

Dermatologic

Common (1% to 10%): Pruritus, dry skin, rash, easy bruising, flushing, peeling skin on fingertip, thinning hair[Ref]

Musculoskeletal

Common (1% to 10%): Leg cramps
Frequency not reported: Muscular weakness[Ref]

Nervous system

Common (1% to 10%): Lethargy, cerebrovascular accident, headache[Ref]

Ocular

Common (1% to 10%): Tearing of eyes[Ref]

Psychiatric

Common (1% to 10%): Insomnia, emotional lability, anxiety
Frequency not reported: Confusional state, depression[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions, allergic reactions, angioedema, allergic dermatitis[Ref]

Some side effects of Emcyt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.