Emcyt

Name: Emcyt

How should this medicine be used?

Estramustine 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. Do not take estramustine with milk, milk products, or foods that contain large amounts of calcium. Take estramustine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take estramustine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Estramustine may control the spread of your cancer but does not cure it. It may take up to 3 months before your doctor can tell if this medication is helpful for your condition. Be sure to tell your doctor how you are feeling during your treatment with estramustine. Continue to take estramustine even if you feel well. Do not stop taking estramustine without talking to your doctor.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Estramustine Interactions

Do not take this medication with milk, milk products, calcium supplements, or calcium-rich foods such as ice cream, yogurt, broccoli, and others.

Avoid using antacids or vitamin/mineral supplements that contain calcium. Calcium can make it harder for your body to absorb estramustine.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Other drugs may interact with estramustine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Uses of Emcyt

Emcyt is a prescription medication used to treat prostate cancer that has worsened or has spread to other parts of the body.

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

Emcyt Usage

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. Do not take Emcyt with milk, milk products, or foods that contain large amounts of calcium. Take Emcyt at around the same times every day.

Emcyt Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

The recommended daily dose is 14 mg/kg of body weight, given in 3 or 4 divided doses.

 

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What other drugs will affect Emcyt (estramustine)?

Other drugs may interact with estramustine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Commonly used brand name(s)

In the U.S.

  • Emcyt

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Estrogen

Chemical Class: Nitrogen Mustard

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure.
  • Coughing up blood.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • Very bad dizziness or passing out.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for Emcyt

Emcyt Capsules are indicated in the palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate.

Contraindications

Emcyt Capsules should not be used in patients with any of the following conditions:

1) Known hypersensitivity to either estradiol or to nitrogen mustard. 2) Active thrombophlebitis or thromboembolic disorders, except in those cases where the actual tumor mass is the cause of the thromboembolic phenomenon and the physician feels the benefits of therapy may outweigh the risks.

Warnings

It has been shown that there is an increased risk of thrombosis, including fatal and nonfatal myocardial infarction, in men receiving estrogens for prostatic cancer. Emcyt Capsules should be used with caution in patients with a history of thrombophlebitis, thrombosis, or thromboembolic disorders, especially if they were associated with estrogen therapy. Caution should also be used in patients with cerebral vascular or coronary artery disease.

Glucose ToleranceBecause glucose tolerance may be decreased, diabetic patients should be carefully observed while receiving Emcyt.

Elevated Blood PressureBecause hypertension may occur, blood pressure should be monitored periodically.

Emcyt Dosage and Administration

The recommended daily dose is 14 mg per kg of body weight (ie, one 140 mg capsule for each 10 kg or 22 lb of body weight), given in 3 or 4 divided doses. Most patients in studies in the United States have been treated at a dosage range of 10 to 16 mg per kg per day.

Patients should be instructed to take Emcyt Capsules at least 1 hour before or 2 hours after meals. Emcyt should be swallowed with water. Milk, milk products, and calcium-rich foods or drugs (such as calcium-containing antacids) must not be taken simultaneously with Emcyt.

Patients should be treated for 30 to 90 days before the physician determines the possible benefits of continued therapy. Therapy should be continued as long as the favorable response lasts. Some patients have been maintained on therapy for more than 3 years at doses ranging from 10 to 16 mg per kg of body weight per day.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

References

  1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83–2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC, 20402.
  2. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics, JAMA. 1985; 253 (11):1590–1592.
  3. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
  4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426–428.
  5. Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians. 1983; (Sept/Oct) 258–263.
  6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033–1049.
  7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm. 1986; 43:1193–1204.
  8. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing Society; 1999:32–41.

Rx only

LAB-0088-4.0
June 2007

Estramustine Pregnancy Warnings

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug is not indicated for use in women. US FDA pregnancy category: Not Assigned Comments: -Although testing by the Ames method failed to demonstrate mutagenicity for this drug, it is known that both estradiol and nitrogen mustard are mutagenic. -Some patients who had been impotent while on estrogen therapy have regained potency while taking this drug. -Advise patients to use effective contraceptive measures due to the possibility of mutagenic effects.

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