ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(二)
y reaction to ABRAXANE. (4)
WARNINGS AND PRECAUTIONS
ABRAXANE causes myelosuppression. Monitor CBC and withhold and/or reduce the dose as needed. (5.1)
Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. (5.2)
Sepsis occurred in patients with or without neutropenia who received ABRAXANE in combination with gemcitabine; interrupt ABRAXANE and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm3, then resume treatment at reduced dose levels. (5.3)
Pneumonitis occurred with the use of ABRAXANE in combination with gemcitabine; permanently discontinue treatment with ABRAXANE and gemcitabine. (5.4)
Severe hypersensitivity reactions with fatal outcome have been reported. Do not re-challenge with this drug. (5.5)
Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment; therefore administer with caution. (5.6)
ABRAXANE contains albumin derived from human blood, which has a theoretical risk of viral transmission. (5.7)
Fetal harm may occur when administered to a pregnant woman. Advise women of childbearing potential to avoid becoming pregnant while receiving ABRAXANE. (5.8)
Advise men not to father a child while on ABRAXANE. (5.9)
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea. (6.1)
The most common adverse reactions (≥ 20%) in NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue. (6.2)
The most common (≥ 20%) adverse reactions of ABRAXANE in adenocarcinoma of the pancreas are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. (6.3)
To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Use caution when concomitantly administering ABRAXANE with inhibitors or inducers of either CYP2C8 or CYP3A4. (7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: NEUTROPENIA
1 INDICATIONS AND USAGE
1.1 Metastatic Breast Cancer
1.2 Non-Small Cell Lung Cancer
1.3 Adenocarcinoma of the Pancreas
2 DOSAGE AND ADMINISTRATION
2.1 Metastatic Breast Cancer
2.2 Non-Small Cell Lung Cancer
2.3 Adenocarcinoma of the Pancreas
2.4 Dosage in Patients with Hepatic Impairment
2.5 Dose Reduction/Discontinuation Recommendations
2.6 Preparation and Administration Precautions
2.7 Preparation for Intravenous Administration
2.8 Stability
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hematologic Effects
5.2 Nervous System
5.3 Sepsis
5.4 Pneumonitis
5.5 Hypersensitivity
5.6 Hepatic Impairment
5.7 Albumin (Human)
5.8 Use in Pregnancy
5.9 Use in Men
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience in Metastatic Breast Cancer
6.2 Clinical Trials Experience in Non-Small Cell Lung Cancer
6.3 Clinical Trials Experience in Adenocarcinoma of the Pancreas
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