Idamycin PFS Side Effects

Generic Name: idarubicin

Note: This page contains information about the side effects of idarubicin. Some of the dosage forms included on this document may not apply to the brand name Idamycin PFS.

Not all side effects for Idamycin PFS may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to idarubicin: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by idarubicin (the active ingredient contained in Idamycin PFS). In the event that any of these side effects do occur, they may require medical attention.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

You should check with your doctor immediately if any of these side effects occur when taking idarubicin:

More common
  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • unusual bleeding or bruising
Less common
  • Fast or irregular heartbeat
  • pain at place of injection
  • shortness of breath
  • swelling of feet and lower legs
Rare
  • Stomach pain (severe)

If any of the following side effects occur while taking idarubicin, check with your doctor or nurse as soon as possible:

More common
  • Sores in mouth and on lips
Less common
  • Joint pain
Rare
  • Skin rash or hives

Some of the side effects that can occur with idarubicin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea or stomach cramps
  • headache
  • nausea and vomiting
Less common
  • Darkening or redness of skin (after x-ray treatment)
  • numbness or tingling of fingers, toes, or face

Idarubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is perfectly normal and lasts for only a day or two after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with idarubicin has ended, normal hair growth should return.

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

  • Fast or irregular heartbeat
  • shortness of breath
  • swelling of feet and lower legs

For Healthcare Professionals

Applies to idarubicin: intravenous powder for injection, intravenous solution

Hematologic

Hematologic side effects can be expected after therapeutic doses. Idarubicin (the active ingredient contained in Idamycin PFS) is a potent bone marrow suppressant, and can cause significant reductions in all bone marrow cell lines (leukopenia is most common). Persistent, severe myelosuppression may result in superinfection, hemorrhage, and/or death. Hemorrhage and infection have been observed in up to 63% and 95%, respectively, of patients after induction therapy.[Ref]

For induction therapy for AML, a median WBC nadir of < 500/mm3 (ANC) usually occurs at 10 to 12 days, with recovery at around 15 to 20 days. Idarubicin monotherapy typically induces an absolute neutrophil count of 3000/mm3. Thrombocytopenia is less commonly encountered, with platelet nadirs occurring on days 10 to 15 over a median duration of approximately 25 days. Anemia is rare. Although prolonged myelosuppression is rarely observed, full hematologic recovery is typically observed in all cases.[Ref]

Gastrointestinal

Gastrointestinal side effects including gastrointestinal upset, anorexia, nausea, vomiting, abdominal cramps, and/or diarrhea (all usually mild to moderate) may occur in approximately 80% to 90%, but are severe in less than 5% of patients. Stomatitis or mucositis may occur in 50% to 60% of patients 3 to 7 days after administration. Severe enterocolitis with perforation has been reported rarely.[Ref]

Idarubicin-induced nausea and vomiting can be seen as early as 15 to 30 minutes after IV dosing, and can be easily controlled with appropriate antiemetic therapy.

Mucositis can be severe, especially in patients receiving multiple leukemia induction courses.

Gastrointestinal perforation should be suspected in patients with severe abdominal pain.[Ref]

Dermatologic

Dermatologic side effects have included reversible alopecia or rash in up to 77% and 46% of patients, respectively. Urticaria, hives and a bullous erythrodermatous rash of the palms and soles have been reported, but were attributed to concomitant antimicrobial therapy in some cases. Radiation recall has also been reported.[Ref]

Nervous system

Nervous system side effects include mental status changes in up to 41% of patients after induction therapy. Headache, peripheral nerve problems, and seizures have been reported in 41%, 7%, and 4% of patients, respectively. However, the underlying status of most patients (seriously ill, receiving multiple transfusions and concomitant medications) makes implication of idarubicin (the active ingredient contained in Idamycin PFS) difficult.[Ref]

Cardiovascular

Cardiovascular side effects including toxicity from anthracyclines is associated with cumulative doses and usually presents as congestive heart failure. Early effects of anthracyclines include pericarditis-myocarditis (which can affect patients with no prior history of cardiac disease and which carries a high mortality rate of about 20%), left ventricular dysfunction (which may lead to clinically significant heart failure in patients with limited cardiac reserve), and arrhythmias, the most common of which is sinus tachycardia. Isolated cases of symptomatic supraventricular tachycardia, heart block, and ventricular arrhythmias have also been associated with the use of anthracyclines. Pericarditis has also been reported. Patients over 60 years of age who were undergoing induction therapy experienced congestive heart failure, serious arrhythmias, chest pain, myocardial infarction, and asymptomatic declines in LVEF more frequently than younger patients.[Ref]

Patients with a history of cardiovascular disease, exposure to anthracyclines, or radiation therapy that included the heart or the area around it are at higher risk.

Anthracycline-induced heart failure can present months to years after termination of therapy.

Several studies have revealed that the incidence of decreased left ventricular ejection fraction (as measured by radionuclide cineangiography) associated with the use of idarubicin is significantly less compared to other anthracycline analogues.[Ref]

Local

Intramuscular or subcutaneous administration is NEVER recommended.

In cases of extravasation most experts recommend topical ice packs to the affected area. Topical DMSO has been shown to be useful in cases of extravasation involving other anthracyclines; its usefulness in cases of idarubicin (the active ingredient contained in Idamycin PFS) extravasation is unknown.[Ref]

Local side effects including tissue inflammation, thrombophlebitis, and necrosis following IV site extravasation have been reported.[Ref]

Hepatic

Hepatic side effects including serum transaminase and bilirubin concentration elevations have been transiently observed in 20% to 40% of patients. Severe changes in hepatic function have been reported in less than 5% of patients.[Ref]

Renal

Renal side effects including new or worsened renal insufficiency (perhaps associated with hyperuricemia), concomitant potentially nephrotoxic antimicrobial therapy, and/or dehydration has been reported in less than 5% of patients in large clinical trials. The nephrotic syndrome has been associated with the use of other anthracyclines in patients with acute myelogenous leukemias.[Ref]

Hypersensitivity

Hypersensitivity side effects have rarely been associated with the use of anthracyclines. These reactions can present as fever, chills, rash, or general anaphylaxis.[Ref]

References

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27. Hochster HS, Green MD, Blum RH, Wernz JC, Speyer JL, Muggia FM "Oral 4-demethoxydaunorubicin (idarubicin) in bronchogenic lung cancer; phase II trial." Invest New Drugs 4 (1986): 275-8

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35. Hakes TB, Dougherty JB, Raymond V "Phase II study of idarubicin in advanced cervical carcinoma." Am J Clin Oncol 9 (1986): 262-3

36. Martoni A, Pacciarini MA, Pannuti F "The new anthracycline 4-demethoxydaunorubicin by oral route in advanced pretreated breast cancer and melanoma. A pilot study." Drugs Exp Clin Res 11 (1985): 127-31

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