Idamycin Side Effects

Generic name: idarubicin

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

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

For the Consumer

Applies to idarubicin: intravenous solution

If you experience any of the following serious side effects from idarubicin (the active ingredient contained in Idamycin) contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

• congestive heart failure (difficulty breathing, fluid retention, chest pain);

• irregular heartbeats;

• tissue or vein reactions near the site of administration;

• liver damage (abdominal pain, yellowing of the skin or eyes);

• severe nausea, vomiting, diarrhea, and loss of appetite;

• inflamation and sores inside the mouth, throat, or intestines;

• fever, chills, or other signs of infection;

• numbness, tingling, or difficult movement of a body part;

• seizures; or

• increased levels of uric acid in the body (joint pain and stiffness).

Other, less serious side effects may be more likely to occur. Continue taking idarubicin and talk to your doctor if you experience:

• facial flushing during administration;

• eye irritation or tearing;

• darkening of the nail beds and skin folds;

• temporary hair loss; or

• red colored urine for 1 or 2 days following a dose.

Some breast cancer patients developed a second cancer (leukemia) after treatment with idarubicin. Idarubicin may cause premature menopause.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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) 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.

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.

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.

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.

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.

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) difficult.

Cardiovascular

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 (the active ingredient contained in Idamycin) is significantly less compared to other anthracycline analogues.

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.

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) extravasation is unknown.

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

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.

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.

Hypersensitivity

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

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