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Estracyt 140 Mg 100 Capsules

DESCRIPTION

Estracyt (Estramustine phosphate sodium), an antineoplastic agent, is an off-white powder readily soluble in water. Estracyt Capsules are white and opaque, each containing Estracyt (Estramustine phosphate sodium) as the disodium salt monohydrate equivalent to 140 mg Estracyt (Estramustine phosphate sodium), for oral administration. Each capsule also contains magnesium stearate, silicon dioxide, sodium lauryl sulfate, and talc. Gelatin capsule shells contain the following pigment: titanium dioxide.

Chemically, Estracyt (Estramustine phosphate sodium) is estra-1,3,5(10)-triene-3,17-diol(17β)-,3-[bis(2-chloroethyl)carbamate] 17-(dihydrogen phosphate), disodium salt, monohydrate. It is also referred to as estradiol 3-[bis(2-chloroethyl)carbamate] 17-(dihydrogen phosphate), disodium salt, monohydrate. Estracyt (Estramustine phosphate sodium) has an empiric formula of C23H30Cl2NNa2O6P•H2O, a calculated molecular weight of 582.4, and the following structural formula:

Chemical Structure

CLINICAL PHARMACOLOGY

Estramustine phosphate (Figure 1) is a molecule combining estradiol and nornitrogen mustard by a carbamate link. The molecule is phosphorylated to make it water soluble.

Chemical Structure

Estramustine phosphate taken orally is readily dephosphorylated during absorption, and the major metabolites in plasma are estramustine (Figure 2), the estrone analog (Figure 3), estradiol, and estrone.

Chemical Structure

Chemical Structure

Prolonged treatment with Estracyt (Estramustine phosphate sodium) produces elevated total plasma concentrations of estradiol that fall within ranges similar to the elevated estradiol levels found in prostatic cancer patients given conventional estradiol therapy. Estrogenic effects, as demonstrated by changes in circulating levels of steroids and pituitary hormones, are similar in patients treated with either Estracyt (Estramustine phosphate sodium) or conventional estradiol.

The metabolic urinary patterns of the estradiol moiety of Estracyt (Estramustine phosphate sodium) and estradiol itself are very similar, although the metabolites derived from Estracyt (Estramustine phosphate sodium) are excreted at a slower rate.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Estracyt 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. Estracyt 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 Tolerance—Because glucose tolerance may be decreased, diabetic patients should be carefully observed while receiving Estracyt.

Elevated Blood Pressure—Because hypertension may occur, blood pressure should be monitored periodically.

PRECAUTIONS

General

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

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

Because Estracyt 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. Estracyt may depress testosterone levels. Abnormalities of hepatic enzymes and of bilirubin have occurred in patients receiving Estracyt. 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 Estracyt.

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 Estracyt are carcinogenic in mice. Carcinogenic studies of Estracyt have not been conducted in man. Although testing by the Ames method failed to demonstrate mutagenicity for Estracyt (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 Estracyt, the patient should be advised to use contraceptive measures.

ADVERSE REACTIONS

In a randomized, double-blind trial comparing therapy with Estracyt Capsules in 93 patients (11.5 to 15.9 mg/kg/day) or diethylstilbestrol (DES) in 93 patients (3.0 mg/day), the following adverse effects were reported:

 

Estracyt
n=93

DES
n=93

CARDIOVASCULAR-RESPIRATORY

   

  Cardiac Arrest

0

2

  Cerebrovascular Accident

2

0

  Myocardial Infarction

3

1

  Thrombophlebitis

3

7

  Pulmonary Emboli

2

5

  Congestive Heart Failure

3

2

  Edema

19

17

  Dyspnea

11

3

  Leg Cramps

8

11

  Upper Respiratory Discharge

1

1

  Hoarseness

1

0

GASTROINTESTINAL

   

  Nausea

15

8

  Diarrhea

12

11

  Minor Gastrointestinal Upset

11

6

  Anorexia

4

3

  Flatulence

2

0

  Vomiting

1

1

  Gastrointestinal Bleeding

1

0

  Burning Throat

1

0

  Thirst

1

0

INTEGUMENTARY

   

  Rash

1

4

  Pruritus

2

2

  Dry Skin

2

0

  Pigment Changes

0

3

  Easy Bruising

3

0

  Flushing

1

0

  Night Sweats

0

1

  Fingertip—Peeling Skin

1

0

  Thinning Hair

1

1

BREAST CHANGES

   

  Tenderness

66

64

  Enlargement

   

    Mild

60

54

    Moderate

10

16

    Marked

0

5

MISCELLANEOUS

   

  Lethargy Alone

4

3

  Depression

0

2

  Emotional Lability

2

0

  Insomnia

3

0

  Headache

1

1

  Anxiety

1

0

  Chest Pain

1

1

  Hot Flashes

0

1

  Pain in Eyes

0

1

  Tearing of Eyes

1

1

  Tinnitus

0

1

LABORATORY ABNORMALITIES

   

  Hematologic

   

    Leukopenia

4

2

    Thrombopenia

1

2

  Hepatic

   

    Bilirubin Alone

1

5

    Bilirubin and LDH

0

1

    Bilirubin and SGOT

2

1

    Bilirubin, LDH and SGOT

2

0

    LDH and/or SGOT

31

28

  Miscellaneous

   

    Hypercalcemia—Transient

0

1

OVERDOSAGE

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 Estracyt Capsules.

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 Estracyt Capsules at least 1 hour before or 2 hours after meals. Estracyt 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 Estracyt.

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.

HOW SUPPLIED

White opaque capsules, each containing Estracyt (Estramustine phosphate sodium) as the disodium salt monohydrate equivalent to 140 mg Estracyt (Estramustine phosphate sodium)—bottle of 100 (NDC 0013-0132-02).

NOTE

Estracyt Capsules should be stored in the refrigerator at 36° to 46°F (2° to 8°C).

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

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LAB-0088-4.0
June 2007

PRINCIPAL DISPLAY PANEL - 140 mg Capsule Bottle Label

NDC 0013-0132-02
100 Capsules
Rx only

Emcyt® 
Estracyt (Estramustine phosphate sodium)
sodium capsules

140 mg*

Store in refrigerator at 36° to 46°F (2° to 8°C).

Pfizer 
Distributed by 
Pharmacia & Upjohn Co 
Division of Pfizer Inc, NY, NY 10017

 

Estracyt 
Estracyt (Estramustine phosphate sodium) capsule

Product Information

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Item Code (Source)

NDC:0013-0132

Route of Administration

ORAL

DEA Schedule

    

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

Estracyt (Estramustine phosphate sodium) (estramustine)

Estracyt (Estramustine phosphate sodium)

140 mg

Inactive Ingredients

Ingredient Name

Strength

magnesium stearate

 

silicon dioxide

 

sodium lauryl sulfate

 

talc

 

titanium dioxide

 

Product Characteristics

Color

WHITE (opaque)

Score

no score

Shape

CAPSULE

Size

19mm

Flavor

 

Imprint Code

PHARMACIA;AND;UPJOHN;Estracyt;140MG

Contains

    

   

Packaging

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0013-0132-02

100 in 1 BOTTLE

   
 

Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

NDA

NDA018045

01/01/1992

 

 

Labeler - Pharmacia and Upjohn Company (829076566)

 

Establishment

Name

Address

ID/FEI

Business Operations

Pfizer Cork Limited

 

988786778

API MANUFACTURE

 

Establishment

Name

Address

ID/FEI

Business Operations

Pfizer Italia S.r.l.

 

431227388

MANUFACTURE

 

Establishment

Name

Address

ID/FEI

Business Operations

Valdepharm

 

260128560

API MANUFACTURE

 

Establishment

Name

Address

ID/FEI

Business Operations

Excella GmbH

 

329809800

API MANUFACTURE

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Estracyt 140 Mg 100 Capsules

  • Brand: Pfizer
  • Product Code: Estramustine
  • Availability: In Stock
  • $171.00

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