Recommended Topic Related To:

Mithracin

"Two researchers at the National Institutes of Health discovered a new genetic link between the rapid growth of healthy fetuses and the uncontrolled cell division in cancer. The findings shed light on normal development and on the genetic under"...

Mithracin

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

Mithracin

WARNINGS

IT IS RECOMMENDED THAT MITHRACIN (plicamycin) BE ADMINISTERED ONLY TO HOSPITALIZED PATIENTS BY OR UNDER THE SUPERVISION OF A QUALIFIED PHYSICIAN WHO IS EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS, BECAUSE OF THE POSSIBILITY OF SEVERE REACTIONS. FACILITIES FOR THE DETERMINATION OF NECESSARY LABORATORY STUDIES MUST BE AVAILABLE.

SEVERE THROMBOCYTOPENIA, A HEMORRHAGIC TENDENCY AND EVEN DEATH MAY RESULT FROM THE USE OF MITHRACIN (plicamycin) . ALTHOUGH SEVERE TOXICITY IS MORE APT TO OCCUR IN PATIENTS WHO HAVE FAR-ADVANCED DISEASE OR ARE OTHERWISE CONSIDERED POOR RISKS FOR THERAPY, SERIOUS TOXICITY MAY ALSO OCCASIONALLY OCCUR EVEN IN PATIENTS WHO ARE IN RELATIVELY GOOD CONDITION.

IN THE TREATMENT OF EACH PATIENT, THE PHYSICIAN MUST WEIGH CAREFULLY THE POSSIBILITY OF ACHIEVING THERAPEUTIC BENEFIT VERSUS THE RISK OF TOXICITY WHICH MAY OCCUR WITH MITHRACIN (plicamycin) THERAPY. THE FOLLOWING DATA CONCERNING THE USE OF MITHRACIN (plicamycin) IN THE TREATMENT OF TESTICULAR TUMORS, HYPERCALCEMIC AND/OR HYPERCALCIURIC CONDITIONS ASSOCIATED WITH VARIOUS ADVANCED MALIGNANCIES, SHOULD BE THOROUGHLY REVIEWED BEFORE ADMINISTERING THIS COMPOUND.

 

PRECAUTIONS

General:   Mithracin (plicamycin) should be administered only to patients who are hospitalized and who can be observed carefully and frequently during and after therapy.

Severe thrombocytopenia, a hemorrhagic tendency and even death may result from the use of Mithracin (plicamycin) . Although severe toxicity is more apt to occur in patients who have far-advanced disease or are otherwise considered poor risks for therapy, serious toxicity may also occasionally occur even in patients who are in relatively good condition.

Electrolyte imbalance, especially hypocalcemia, hypokalemia, and hypophosphatemia, should be corrected with appropriate electrolyte therapy prior to treatment with Mithracin (plicamycin) .

Mithracin (plicamycin) should be used with extreme caution in patients with significant impairment of renal or hepatic function.

Mithracin (plicamycin) should not normally be administered to patients who are pregnant or to mothers who are breast feeding.

In the treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit versus the risk of toxicity which may occur with Mithracin (plicamycin) therapy.

Laboratory Tests:   The following laboratory studies should be obtained frequently during therapy and for several days following the last dose: platelet count, prothrombin time, bleeding time. The occurrence of thrombocytopenia or a significant prolongation of prothrombin time or bleeding time is an indication for the termination of therapy.

Carcinogenesis, mutagenesis, impairment of fertility:   No long-term studies in animals have been performed to evaluate the carcinogenic potential of Mithracin (plicamycin) . Histologic evidence of inhibition of spermatogenesis was observed in a substantial number of male rats receiving doses of 0.6 mg/ kg/day and above.

Pregnancy Category X:   See "Contraindications" section.

Nursing Mothers:   It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Mithracin (plicamycin) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.

Health Resources
Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations