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Idamycin PFS Side Effects

Generic name: idarubicin

Medically reviewed by Drugs.com. Last updated on Jul 20, 2023.

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

Applies to idarubicin: intravenous solution.

Warning

Intravenous route (Solution)

1. Idarubicin hydrochloride should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.2. As is the case with other anthracyclines the use of idarubicin hydrochloride can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have preexisting cardiac disease.3. As is usual with antileukemic agents, severe myelosuppression occurs when idarubicin hydrochloride is used at effective therapeutic doses.4. It is recommended that idarubicin hydrochloride be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.5. Dosage should be reduced in patients with impaired hepatic or renal function.

Serious side effects of Idamycin PFS

Along with its needed effects, idarubicin (the active ingredient contained in Idamycin PFS) 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 or nurse immediately if any of the following side effects occur while taking idarubicin:

More common

Less common

Rare

Other side effects of Idamycin PFS

Some side effects of idarubicin 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

Less common

For Healthcare Professionals

Applies to idarubicin: intravenous powder for injection, intravenous solution.

Hematologic

Very common (10% or more): Hemorrhage (up to 63%), anemia, severe leukopenia, severe neutropenia, thrombocytopenia

Frequency not reported: Bone marrow depression (dose dependent), pancytopenia[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

Very common (10% or more): Nausea/vomiting (up to 82%), abdominal cramps/diarrhea (up to 73%), burning sensation, mucositis/stomatitis, anorexia

Common (1% to 10%): GI tract bleeding

Uncommon (0.1% to 1%): Dehydration, esophagitis, colitis (including severe enterocolitis/neutropenic enterocolitis with perforation)

Very rare (less than 0.01%): Gastric erosions or ulcerations[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

Very common (10% or more): Alopecia (up to 77%)

Common (1% to 10%): Rash, itch, hypersensitivity of irradiated skin (radiation recall reaction)

Uncommon (0.1% to 1%): Skin and nail hyperpigmentation, urticaria, cellulitis (can be severe), tissue necrosis

Very rare (less than 0.01%): Acral erythema (bullous erythrodermatous rash of the palms and soles)

Frequency not reported: Hives, local toxicity[Ref]

Nervous system

Very common (10% or more): Headache (up to 20%)

Common (1% to 10%): Seizure[Ref]

Cardiovascular

Congestive heart failure (frequently attributed to fluid overload), serious arrhythmias including atrial fibrillation, chest pain, myocardial infarction and asymptomatic declines in LVEF have been reported in patients undergoing induction therapy for acute myeloid leukemia (AML). Myocardial insufficiency and arrhythmias were usually reversible and occurred in the setting of sepsis, anemia, and aggressive IV fluid administration. The events were reported more frequently in patients over age 60 years and in those with preexisting cardiac disease.[Ref]

Common (1% to 10%): Bradycardia, sinus tachycardia, tachyarrhythmias, asymptomatic reduction of left ventricular ejection fraction, congestive heart failure, cardiomyopathies, local phlebitis, thrombophlebitis

Uncommon (0.1% to 1%): ECG abnormalities (e.g., nonspecific ST segment changes), myocardial infarction, shock

Rare (0.01% to 0.1%): Cerebral hemorrhage

Very rare (less than 0.01%): Pericarditis, myocarditis, atrioventricular and bundle branch block

Frequency not reported: Serious arrhythmias including atrial fibrillation, chest pain, myocardial infarction, myocardial insufficiency, asymptomatic declines in LVEF, ECG changes, hot flushes, phlebitis, thrombophlebitis, thromboembolism[Ref]

Local

Frequency not reported: Local skin irritation, extravasation (resulting in inflammation, thrombophlebitis, and/or tissue necrosis)[Ref]

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 extravasation is unknown.[Ref]

Hepatic

Changes in hepatic function tests have been observed. These changes were usually transient and occurred in the setting of sepsis and while patients were receiving potentially hepatotoxic antibiotics and antifungal agents. Severe changes in hepatic function (equivalent to WHO Grade 4) occurred in less than 5% of patients.[Ref]

Very common (10% or more): Bilirubin and serum transaminase elevations (20% to 40%)[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

Very rare (less than 0.01%): Anaphylaxis[Ref]

Genitourinary

Very common (10% or more): Red coloration of the urine for 1 to 2 days after treatment[Ref]

Immunologic

Very common (10% or more): Infection (up to 95%)

Uncommon (0.1% to 1%): Sepsis/septicemia[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperuricamia

Frequency not reported: Tumor lysis syndrome[Ref]

Oncologic

Uncommon (0.1% to 1%): Secondary leukemia (acute myeloid leukemia and myelodysplastic syndrome)[Ref]

Other

Very common (10% or more): Fever (up to 26%), chills[Ref]

Respiratory

Common (1% to 10%): Pulmonary allergy[Ref]

References

1. Product Information. Idamycin (idarubicin). Pharmacia and Upjohn. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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