ELLENCE® (epirubicin HCl) 17 PATIENT COUNSELING INFORMATION

(epirubicin HCl)

Prescribing Information

17 PATIENT COUNSELING INFORMATION

Cardiac Toxicity

Inform patients that there is a risk of irreversible myocardial damage associated with treatment with ELLENCE. Advise patients to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness [see Warnings and Precautions (5.1)].

Secondary Malignancies

Inform patients that there is an increased risk of treatment-related leukemia from ELLENCE [see Warnings and Precautions (5.2)].

Extravasation and Tissue Necrosis

Inform patients that ELLENCE can cause severe injection site reactions. Advise patients to contact a healthcare provider if injection site pain occurs after receiving ELLENCE [see Warnings and Precautions (5.3)].

Severe Myelosuppression

Inform patients that ELLENCE can cause leukopenia, thrombocytopenia, or anemia. Advise patients to contact a healthcare provider for new onset fever or symptoms of infection [see Warnings and Precautions (5.4)].

Nausea and Vomiting

Inform patients that ELLENCE can cause nausea or vomiting. Advise patients to contact a healthcare provider should they develop any severe symptoms [see Adverse Reactions (6.1)].

Common Adverse Reactions

Inform patients of the expected adverse effects of ELLENCE, including diarrhea, stomatitis, and alopecia [see Adverse Reactions (6.1)].

Red Coloration of Urine

Advise patients that their urine may appear red for 1 to 2 days after administration of ELLENCE and that they should not be alarmed [see Adverse Reactions (6.2)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)].
Advise female patients of reproductive potential to use effective contraception during treatment with ELLENCE and for 6 months after the last dose [see Warnings and Precautions (5.11) and Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ELLENCE. Advise male patients with pregnant partners to use condoms during treatment and for at least 7 days after the last dose of ELLENCE [see Use in Specific Populations (8.3)].

Lactation

Advise female patients not to breastfeed during treatment with ELLENCE and for at least 7 days after the last dose [see Use in Specific Populations (8.2)].

Infertility

Women treated with ELLENCE may develop irreversible amenorrhea, or premature menopause. Advise patients that ELLENCE may impair female and male fertility [see Use in Specific Populations (8.3)].

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