FDA

Idarubicin Hydrochloride

Approved 17 Feb 1997IntravenousSolution

The FDA lists this product in 23 strengths and forms.

Indications

IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1)

Contraindications

None. None. (4)

Warnings and precautions

Myelosuppression : Severe myelosuppression resulting in severe infection, septic shock, hemorrhage, or death may occur. Obtain complete blood counts prior to each treatment and closely monitor patients during treatment for possible clinical complications due to myelosuppression. (5.4)
Tumor Lysis Syndrome : During treatment, monitor blood chemistries and manage promptly. Treat as clinically indicated. (5.5)
Hypersensitivity : Monitor patients for hypersensitivity reactions and manage as clinically indicated. (5.6)
Renal Impairment : Assess renal function prior to and during treatment. Reduce the dose in patients on dialysis or those with GFR <30 mL/min. ( 2.3 , 5.7 , 8.6 )
Hepatic Impairment : Obtain liver tests prior to and during therapy. Reduce dose in patients with serum bilirubin levels of 2.6 to 5 mg/dL. Avoid use in patients with serum bilirubin greater than 5 mg/dL. ( 2.4 , 5.8 , 8.7 )
Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.9 , 8.1 , 8.3 )

5.1Cardiomyopathy IDAMYCIN

PFS can cause myocardial damage, including left ventricular failure, or congestive heart failure (CHF). In pediatric patients, anthracycline-induced cardiomyopathy included impaired left ventricular systolic performance, reduced contractility, congestive heart failure, or death. Cardiomyopathy may develop during treatment with IDAMYCIN PFS or up to several years after completion of treatment. Cases of pericarditis and myocarditis have also been reported at a lower incidence and may not be dose related.

Indications

Warnings and precautions

Myelosuppression : Severe myelosuppression resulting in severe infection, septic shock, hemorrhage, or death may occur. Obtain complete blood counts prior to each treatment and closely monitor patients during treatment for possible clinical complications due to myelosuppression. (5.4)
Tumor Lysis Syndrome : During treatment, monitor blood chemistries and manage promptly. Treat as clinically indicated. (5.5)
Hypersensitivity : Monitor patients for hypersensitivity reactions and manage as clinically indicated. (5.6)
Renal Impairment : Assess renal function prior to and during treatment. Reduce the dose in patients on dialysis or those with GFR <30 mL/min. ( 2.3 , 5.7 , 8.6 )
Hepatic Impairment : Obtain liver tests prior to and during therapy. Reduce dose in patients with serum bilirubin levels of 2.6 to 5 mg/dL. Avoid use in patients with serum bilirubin greater than 5 mg/dL. ( 2.4 , 5.8 , 8.7 )
Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.9 , 8.1 , 8.3 )

5.1Cardiomyopathy IDAMYCIN

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling:

Cardiomyopathy [see Warnings and Precautions (5.1) ]
Secondary Malignancies [see Warnings and Precautions (5.2) ]
Severe Local Tissue Necrosis with Extravasation [see Warnings and Precautions (5.3) ]
Severe Myelosuppression [see Warnings and Precautions (5.4) ]
Tumor Lysis Syndrome [see Warnings and Precautions (5.5) ]
Hypersensitivity [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥30%) are infection, nausea/vomiting, alopecia, abdominal pain/diarrhea, hemorrhage, mucositis, dermatologic, mental status changes, and pulmonary disorders. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials and Postmarketing Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of IDAMYCIN PFS in combination with cytarabine has been evaluated in four controlled clinical studies with 823 patients with AML randomized to receive idarubicin hydrochloride (n=401) or daunorubicin (n=422) [see Clinical Studies (14) ] .

Southeastern Cancer Study Group (SEG) Table 3 below lists the adverse reactions that occurred in patients with AML who received idarubicin hydrochloride in the Southeastern Cancer Study Group (SEG) study. Table 3: Adverse Reactions (≥5%) in Patients with AML Who Received Idarubicin Hydrochloride as Induction Therapy in the SEG Trial Adverse Reactions Idarubicin with Cytarabine (N=110) Daunorubicin with Cytarabine (N=118) All Grades % All Grades % Infection 95 97 Nausea/Vomiting 82 80 Alopecia 77 72 Abdominal Pain/Diarrhea 73 68 Hemorrhage 63 65 Mucositis 50 55 Dermatologic 46 40 Mental Status Changes 41 34 Pulmonary Disorders 39 39 Fever 26 28 Headache 20 24 Cardiac Disorder 16 24 Peripheral Neuropathy 7 9 Clinically relevant adverse reactions in <5% of patients who received idarubicin hydrochloride included pulmonary allergy, seizure, and cerebellar adverse reactions.

Other Clinical Trials The following additional adverse reactions associated with the use of idarubicin hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac

Asymptomatic declines in Left Ventricular Ejection Fraction (LVEF)
Chest pain
Congestive heart failure
Myocardial infarction
Serious arrhythmias including atrial fibrillation Dermatologic
Bullous erythrodermatous rash (palms and soles)
Generalized rash
Radiation recall (skin reaction)
Urticaria Gastrointestinal
Severe enterocolitis with perforation Hepatic
Increased ALT/AST Renal
Renal impairment

Idarubicin Hydrochloride

Indications

Contraindications

Warnings and precautions

5.1Cardiomyopathy IDAMYCIN

Two medicines in one question?

Idarubicin Hydrochloride

Indications

Contraindications

Warnings and precautions

5.1Cardiomyopathy IDAMYCIN

Two medicines in one question?

5.2Secondary Malignancies

5.4Severe Myelosuppression

5.5Tumor Lysis Syndrome IDAMYCIN

5.6Hypersensitivity IDAMYCIN

5.7Use in Patients with Renal Impairment

5.8Use in Patients with Hepatic Impairment

5.9Embryo-Fetal Toxicity Based

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.1Clinical Trials and Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance