(idarubicin hydrochloride)
Health Professional Information
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Cardiomyopathy
Inform patients that IDAMYCIN PFS can cause irreversible myocardial damage. Advise patients to immediately contact their healthcare provider during or after treatment with IDAMYCIN PFS for symptoms of heart failure, including new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness, or loss of consciousness [see Warnings and Precautions (5.1)].
Secondary Malignancies
Inform patients that there is an increased risk of secondary malignancies with IDAMYCIN PFS [see Warnings and Precautions (5.2)].
Extravasation and Tissue Necrosis
Inform patients that IDAMYCIN PFS can cause severe injection site reactions. Advise patients to contact a healthcare provider if injection site pain occurs after receiving IDAMYCIN PFS [see Warnings and Precautions (5.3)].
Severe Myelosuppression
Inform patients that IDAMYCIN PFS causes bone marrow suppression at therapeutic doses resulting in an increased risk of infection or hemorrhage. Advise patients to contact their healthcare provider for new onset fever or symptoms of infection or hemorrhage [see Warnings and Precautions (5.4)].
Tumor Lysis Syndrome
Advise patients to contact their healthcare provider promptly to report any signs and symptoms of tumor lysis syndrome (fever, chills, nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle pain, and/or joint discomfort) [see Warnings and Precautions (5.5)].
Alopecia
Inform patients that IDAMYCIN PFS causes alopecia (usually reversible) in most patients [see Adverse Reactions (6.1)].
Red Discoloration of Bodily Fluids
Inform patients that IDAMYCIN PFS may transiently impart a red coloration to bodily fluids, including the urine, after administration.
Gastrointestinal Adverse Reactions
Inform patients that IDAMYCIN PFS can cause nausea, vomiting, diarrhea, and mucositis. Advise patients to contact a healthcare provider if nausea, vomiting, diarrhea, or mucositis occur [see Adverse Reactions (6.1)].
Embryo-Fetal Toxicity
IDAMYCIN PFS can cause fetal harm. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3), and Nonclinical Toxicology (13.1)].
Advise female patients of reproductive potential to use effective contraception during treatment with IDAMYCIN PFS and for 6.5 months after the last dose [see Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3), and Nonclinical Toxicology (13.1)].
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3.5 months after the last dose of IDAMYCIN PFS. [see Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3), and Nonclinical Toxicology (13.1)].
Lactation
Advise women not to breastfeed during treatment with IDAMYCIN PFS and for 14 days after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise male and female patients of reproductive potential that IDAMYCIN PFS may impair fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
LAB-0131-10.0
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