Idamycin PFS Side Effects

Generic name: idarubicin

Medically reviewed by Drugs.com. Last updated on Sep 4, 2024.

Note: This document provides detailed information about Idamycin PFS Side Effects associated with idarubicin. Some dosage forms listed on this page may not apply specifically to the brand name Idamycin PFS.

Applies to idarubicin: intravenous solution.

Important warnings This medicine can cause some serious health issues

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 side effects

• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain or discomfort
• coughing up blood
• cough or hoarseness
• difficulty with breathing or swallowing
• dizziness
• fainting
• fast or irregular heartbeat
• fever or chills
• increased menstrual flow or vaginal bleeding
• lower back or side pain
• nosebleeds
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools
• sores in the mouth and on the lips
• sweating
• trouble breathing
• unusual bleeding or bruising
• vomiting

Less common side effects

• joint pain
• redness, pain, or swelling at the injection site
• swelling of the feet and lower legs

Rare side effects

• skin rash or hives
• stomach pain (severe)

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 side effects

• cracked lips
• diarrhea
• difficulty in swallowing
• hair loss, thinning of hair
• headache
• nausea and vomiting
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach cramps

Less common side effects

• darkening or redness of the skin
• numbness or tingling of the fingers, toes, or face

For healthcare professionals

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

Hematologic adverse events

• 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 (the active ingredient contained in Idamycin PFS) 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

• 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]

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]

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

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

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]

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]

Further information

Idamycin PFS side effects can vary depending on the individual. 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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