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Plicamycin Side Effects

For the Consumer

Applies to plicamycin: intravenous powder for solution

Along with its needed effects, plicamycin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking plicamycin:

Less common
  • Muscle and abdominal cramps
Symptoms of overdose
  • Bloody or black, tarry stools
  • flushing or redness or swelling of face
  • nosebleed
  • skin rash or small red spots on skin
  • sore throat and fever
  • unusual bleeding or bruising
  • vomiting of blood
  • yellow eyes or skin

Some side effects of plicamycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • irritation or soreness of mouth
  • loss of appetite
  • nausea or vomiting—may occur 1 to 2 hours after the injection is started and continue for 12 to 24 hours
Less common
  • Drowsiness
  • fever
  • headache
  • mental depression
  • pain, redness, soreness, or swelling at place of injection
  • unusual tiredness or weakness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Bloody or black, tarry stools
  • nosebleed
  • sore throat and fever
  • unusual bleeding or bruising
  • vomiting of blood

For Healthcare Professionals

Applies to plicamycin: intravenous powder for injection

Hematologic

The hemorrhagic syndrome may start with an episode of hematemesis which may progress to more widespread hemorrhage in the gastrointestinal tract or to a more generalized bleeding tendency. This may be due to abnormalities in multiple clotting factors. The hemorrhagic syndrome has been dose related.

If severe thrombocytopenia occurs, infusion of platelet concentrates of platelet-rich plasma may of help in elevating the platelet count.

Laboratory abnormalities have generally been upon discontinuation of therapy.[Ref]

Hematologic effects including a bleeding syndrome which usually begins with an episode of epistaxis, comprise the major form of toxicity associated with the use of plicamycin. Thrombocytopenia which is sometime rapid in onset, may occur at any time during therapy or within several days following the last dose. Depression of platelet count, white count, hemoglobin, and prothrombin time, elevation of clotting and bleeding times, and abnormal clot retraction have been reported. Leukopenia (6%) has been reported. Depression in levels of serum calcium, phosphorus, and potassium have also been reported.[Ref]

Gastrointestinal

Gastrointestinal effects including anorexia, nausea, vomiting, diarrhea, and stomatitis are among the most common effects reported with the use of plicamycin.[Ref]

General

General effects including fever, weakness, lethargy, malaise, and drowsiness have been reported.[Ref]

Nervous system

Nervous system effects including headache have been reported.[Ref]

Psychiatric

Psychiatric effects including depression have been reported.[Ref]

Cardiovascular

Cardiovascular effects including phlebitis have been reported. A case has also been reported of multiple arterial occlusive episodes in association the courses of drug therapy.[Ref]

Dermatologic

Dermatologic effects including facial flushing an skin rash have been reported. A case of toxic epidermal necrolysis have also been reported.[Ref]

Hepatic

Laboratory abnormalities have generally been reported to be reversible upon discontinuation of therapy.[Ref]

Hepatic effects including increased levels of serum glutamic oxalacetic transaminase, serum glutamic pyruvic transaminase, lactic dehydrogenase, alkaline phosphatase, serum bilirubin, ornithine carbamyl transferase, isocitric dehydrogenase, an increased retention of bromsulphalein have been reported.[Ref]

Genitourinary

Genitourinary effects including increased blood urea nitrogen, increased serum creatinine, and proteinuria have been reported.[Ref]

Laboratory abnormalities have generally been reported to be reversible upon discontinuation of therapy.[Ref]

References

1. Ahr DJ, Scialla SJ, Kimbali DB Jr "Acquired platelet dysfunction following mithramycin therapy." Cancer 41 (1978): 448-54

2. "Product Information. Mithracin (plicamycin)." Bayer, West Haven, CT.

3. Yamreudeewong W, Henann NE, Fazio A, Rangaraj U "Possible severe thrombocytopenia associated with a single dose of plicamycin." Ann Pharmacother 26 (1992): 1369-73

4. Margileth DA, Smith FE, Lane M "Sudden arterial occlusion associated with mithramycin therapy." Cancer 31 (1973): 708-12

5. Purpora D, Ahern MJ, Silverman N "Toxic epidermal necrolysis after mithramycin [letter]." N Engl J Med 299 (1978): 1412

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

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