Approved Drug Label (PDF)
Boxed Warning
Total revision;
now reads:
WARNING: CARDIAC TOXICITY,
SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE
MYELOSUPPRESSION
See full prescribing information for complete boxed
warning.
Cardiac Toxicity:
Myocardial damage, including acute left ventricular failure, can occur with
ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure
with incidence rates from 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700
mg/m2, and 3.3% at 900 mg/m2. The risk of cardiomyopathy is further increased
with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction
(LVEF) before and regularly during and after treatment with ELLENCE.
Secondary
Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic
syndrome (MDS) occur at a higher incidence in patients treated with
anthracyclines, including ELLENCE.
Extravasation and
Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue
injury and necrosis requiring wide excision of the affected area and skin
grafting. Immediately terminate the drug and apply ice to the affected area.
Severe
myelosuppression resulting in serious infection, septic shock, requirement for
transfusions, hospitalization, and death may occur.
4
Contraindications
Additions
and/or revisions underlined:
ELLENCE is contraindicated
in patients with:
Severe myocardial insufficiency
Recent
myocardial infarction or severe arrhythmias, or previous treatment with maximum
cumulative dose of anthracyclines
Severe persistent drug-induced myelosuppression
Severe hepatic impairment (defined as Child-Pugh Class
C or serum bilirubin level greater than 5 mg/dL)
Severe hypersensitivity to ELLENCE, other
anthracyclines, or anthracenediones
5
Warnings and Precautions
Subsection
titles may have been revised with extensive changes to content; please refer to
label for complete information:
5.1
Cardiac Toxicity
5.2
Secondary Malignancies
5.3
Extravasation and Tissue Necrosis
5.4
Severe Myelosuppression
5.5
Use in Patients with Hepatic Impairment
5.6
Use in Patients with Renal Impairment
5.7
Tumor-Lysis Syndrome
5.8 Immunosuppressant
Effects/Increased Susceptibility to Infections
5.9
Thrombophlebitis and Thromboembolic Events
5.10
Potentiation of Radiation Toxicity and Radiation Recall
5.11
Embryo-Fetal Toxicity
6
Adverse Reactions
Addition
of bulleted line listing:
The following
clinically significant adverse reactions are described elsewhere in the
labeling:
Cardiac
Toxicity
Secondary
Malignancies
Extravasation
and Tissue Necrosis
Severe
Myelosuppression
Tumor-Lysis Syndrome
Thrombophlebitis
and Thromboembolic Events
Potentiation
of Radiation Toxicity and Radiation Recall
7
Drug Interactions
7.1 Cardiotoxic Agents
Additions and/or revisions underlined:
Closely monitor cardiac function when ELLENCE is used in combination with other cardiotoxic agents. Patients
receiving ELLENCE after stopping treatment with other cardiotoxic
agents, especially those with long half-lives such as trastuzumab, may be at an
increased risk of developing cardiotoxicity. Trastuzumab may persist in the
circulation for up to 7 months. Therefore, avoid anthracycline-based therapy
for up to 7 months after stopping trastuzumab when possible. Monitor the
patient’s cardiac function closely if anthracyclines are used before this time.
Concomitant use of ELLENCE …
8
Use in Specific Populations
8.4 Pediatric Use
‘or
late cardiovascular dysfunction’ replaces ‘and for chronic CHF’
8.5 Geriatric Use
Additions
and/or revisions underlined:
Clinical
experience in patients who were 65 years of age and older who received ELLENCE chemotherapy
regimens for primary breast cancer showed no overall differences in safety
and effectiveness compared with younger patients.
In elderly female
patients, closely monitor for increased toxicity due to the
risk of decreased clearance of epirubicin.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Extensively
changed; please refer to label for complete information.
Approved Drug Label (PDF)
Boxed Warning
Total revision;
now reads:
WARNING: CARDIAC TOXICITY,
SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE
MYELOSUPPRESSION
See full prescribing information for complete boxed
warning.
Cardiac Toxicity:
Myocardial damage, including acute left ventricular failure, can occur with
ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure
with incidence rates from 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700
mg/m2, and 3.3% at 900 mg/m2. The risk of cardiomyopathy is further increased
with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction
(LVEF) before and regularly during and after treatment with ELLENCE.
Secondary
Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic
syndrome (MDS) occur at a higher incidence in patients treated with
anthracyclines, including ELLENCE.
Extravasation and
Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue
injury and necrosis requiring wide excision of the affected area and skin
grafting. Immediately terminate the drug and apply ice to the affected area.
Severe
myelosuppression resulting in serious infection, septic shock, requirement for
transfusions, hospitalization, and death may occur.
4
Contraindications
Additions
and/or revisions underlined:
ELLENCE is contraindicated
in patients with:
Severe myocardial insufficiency
Recent
myocardial infarction or severe arrhythmias, or previous treatment with maximum
cumulative dose of anthracyclines
Severe persistent drug-induced myelosuppression
Severe hepatic impairment (defined as Child-Pugh Class
C or serum bilirubin level greater than 5 mg/dL)
Severe hypersensitivity to ELLENCE, other
anthracyclines, or anthracenediones
5
Warnings and Precautions
Subsection
titles may have been revised with extensive changes to content; please refer to
label for complete information:
5.1
Cardiac Toxicity
5.2
Secondary Malignancies
5.3
Extravasation and Tissue Necrosis
5.4
Severe Myelosuppression
5.5
Use in Patients with Hepatic Impairment
5.6
Use in Patients with Renal Impairment
5.7
Tumor-Lysis Syndrome
5.8 Immunosuppressant
Effects/Increased Susceptibility to Infections
5.9
Thrombophlebitis and Thromboembolic Events
5.10
Potentiation of Radiation Toxicity and Radiation Recall
5.11
Embryo-Fetal Toxicity
6
Adverse Reactions
Addition
of bulleted line listing:
The following
clinically significant adverse reactions are described elsewhere in the
labeling:
Cardiac
Toxicity
Secondary
Malignancies
Extravasation
and Tissue Necrosis
Severe
Myelosuppression
Tumor-Lysis Syndrome
Thrombophlebitis
and Thromboembolic Events
Potentiation
of Radiation Toxicity and Radiation Recall
8
Use in Specific Populations
PLLR conversion for following 3
subsections; please refer to label for complete information.
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive
Potential
8.4
Pediatric Use
‘or
late cardiovascular dysfunction’ replaces ‘and for chronic CHF’
8.5
Geriatric Use
Additions
and/or revisions underlined:
Clinical
experience in patients who were 65 years of age and older who received ELLENCE chemotherapy
regimens for primary breast cancer showed no overall differences in safety
and effectiveness compared with younger patients.
In elderly female
patients, closely monitor for increased toxicity due to the
risk of decreased clearance of epirubicin.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Extensively
changed; please refer to label for complete information.
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