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Mithracin

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Mithracin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

Mithracin (plicamycin) is a potent antineoplastic agent which has been shown to be useful in the treatment of carefully selected hospitalized patients with malignant tumors of the testis in whom successful treatment by surgery and/or radiation is impossible. Also, on the basis of limited clinical experience to date, it may be considered in the treatment of certain symptomatic patients with hypercalcemia and hypercalciuria associated with a variety of advanced neoplasms.

The use of Mithracin (plicamycin) in other types of neoplastic disease is not recommended at the present time.

DOSAGE AND ADMINISTRATION

The daily dose of Mithracin (plicamycin) is based on the patient's body weight. If a patient has abnormal fluid retention such as edema, hydrothorax or ascites, the patient's ideal weight rather than actual body weight should be used to calculate the dose.

Treatment of Testicular Tumors:   In the treatment of patients with testicular tumors the recommended daily dose of Mithracin (plicamycin) is 25 to 30 mcg (0.025-0.030 mg) per kilogram of body weight. Therapy should be continued for a period of 8 to 10 days unless significant side effects or toxicity occur during therapy. A course of therapy consisting of more than 10 daily doses is not recommended. Individual daily doses should not exceed 30 mcg (0.030 mg) per kilogram of body weight.

In those patients with responsive tumors, some degree of tumor regression is usually evident within 3 or 4 weeks following the initial course of therapy. If tumor masses remain unchanged following an initial course of therapy, additional courses of therapy at monthly intervals are warranted.

When a significant tumor regression is obtained, it is suggested that additional courses of therapy be given at monthly intervals until a complete regression of tumor masses is achieved or until definite tumor progression or new tumor masses occur in spite of continued courses of therapy.

Treatment of Hypercalcemia and Hypercalciuria:   Reversal of hypercalcemia and hypercalciuria can usually be achieved with Mithracin (plicamycin) at doses considerably lower than those recommended for use in the treatment of testicular tumors.

In hypercalcemia and hypercalciuria associated with advanced malignancy the recommended course of treatment with Mithracin (plicamycin) is 25 mcg (0.025 mg) per kilogram of body weight per day for 3 or 4 days.

If the desired degree of reversal of hypercalcemia or hypercalciuria is not achieved with the initial course of therapy, additional courses of therapy may then be administered at intervals of one week or more to achieve the desired result or to maintain serum calcium and urinary calcium excretion at normal levels. It may be possible to maintain normal calcium balance with single, weekly doses or with a schedule of 2 or 3 doses per week.

NOTE : BECAUSE OF THE DRUG'S TOXICITY AND THE LIMITED CLINICAL EXPERIENCE TO DATE IN THESE INDICATIONS, THE FOLLOWING RECOMMENDATIONS SHOULD BE KEPT IN MIND BY THE PHYSICIAN.

  1. CONSIDER CASES OF HYPERCALCEMIA AND HYPERCALCIURIA NOT RESPONSIVE TO CONVENTIONAL TREATMENT.
  2. APPLY SAME CONTRAINDICATIONS AND PRECAUTIONARY MEASURES AS IN ANTITUMOR TREATMENT.
  3. RENAL FUNCTION SHOULD BE CAREFULLY MONITORED BEFORE, DURING, AND AFTER TREATMENT.
  4. BENEFITS OF USE DURING PREGNANCY OR IN WOMEN OF CHILDBEARING AGE SHOULD BE WEIGHED AGAINST POTENTIAL TOXICITY TO EMBRYO OR FETUS.

ADMINISTRATION

By IV administration only. The appropriate daily dose of Mithracin (plicamycin) should be diluted in one liter of 5% Dextrose Injection, USP or Sodium Chloride Injection, USP and administered by slow intravenous infusion over a period of 4 to 6 hours. Rapid direct intravenous injection of Mithracin (plicamycin) should be avoided as it may be associated with a higher incidence and greater severity of gastrointestinal side effects. Extravasation of solutions of Mithracin (plicamycin) may cause local irritation and cellulitis at injection sites. Should thrombophlebitis or perivascular cellulitis occur, the infusion should be terminated and reinstituted at another site. The application of moderate heat to the site of extravasation may help to disperse the compound and minimize discomfort and local tissue irritation. The use of antiemetic compounds prior to and during treatment with Mithracin (plicamycin) may be helpful in relieving nausea and vomiting.

Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published. 3 - 8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

 

HOW SUPPLIED

Mithracin (plicamycin) is available in vials as a freeze-dried preparation for intravenous administration. Each vial contains 2500 mcg (2.5 mg) of Mithracin (plicamycin) with 100 mg of mannitol and sufficient disodium phosphate to adjust to pH 7. These vials should be stored at refrigerator temperatures between 2°C to 8°C (36°F to 46°F).

To reconstitute, add aseptically 4.9 mL of Sterile Water for Injection to the contents of the vial and shake to dissolve. Each mL of the resulting solution will then contain 500 mcg (0.5 mg) of Mithracin (plicamycin) . NOTE: 1 mg (milligram)=1000 mcg (micrograms). AFTER REMOVAL OF THE APPROPRIATE DOSE, THE REMAINING UNUSED SOLUTION MUST BE DISCARDED, FRESH SOLUTIONS MUST BE PREPARED IN THE ABOVE MANNER EACH DAY OF THERAPY.

REFERENCES

  1. Kennedy, B.D., et al: Cancer Res. 27  :1534, 1967.
  2. Ransohoff, J., et al: Cancer Chemother. Rep. 49  :51, 1965.
  3. 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, D.C. 20402.
  4. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15, 1985.
  5. National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street, Providence, Rhode Island 02902.
  6. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1  :426-428, 1983.
  7. Jones, R.B., et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. Ca A Cancer Journal for Clinicians, Sept/Oct. 258-263, 1983.
  8. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic drugs in hospitals. Am J Hosp Pharm 42  :131-137, 1985.

 

Manufactured for
Bayer Corporation
Pharmaceutical Division
400 Morgan Lane
West Haven, CT 06516

by Ben Venue Laboratories
Bedford, Ohio 44146

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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