8. 4 Pediatric Use
The safety and effectiveness of ABRAXANE in pediatric patients have not
8. 5 Geriatric Use
Of the 229 patients in the randomized study who received ABRAXANE for
the treatment of metastatic breast cancer, 13% were at least 65 years of
age and < 2% were 75 years or older. No toxicities occurred notably
more frequently among patients who received ABRAXANE.
Of the 514 patients in the randomized study who received ABRAXANE
and carboplatin for the first-line treatment of non-small cell lung
cancer, 31% were 65 years or older and 3.5% were 75 years or older.
Myelosuppression, peripheral neuropathy, and arthralgia were more
frequent in patients 65 years or older compared to patients younger than
65 years old. No overall difference in effectiveness, as measured by
response rates, was observed between patients 65 years or older
compared to patients younger than 65 years old.
Of the 431 patients in the randomized study who received ABRAXANE
and gemcitabine for the first-line treatment of pancreatic adenocarcinoma,
41% were 65 years or older and 10% were 75 years or older. No overall
differences in effectiveness were observed between patients who were
65 years of age or older and younger patients. Diarrhea, decreased
appetite, dehydration and epistaxis were more frequent in patients 65
years or older compared with patients younger than 65 years old. Clinical
studies of ABRAXANE did not include sufficient number of patients with
pancreatic cancer who were 75 years and older to determine whether
they respond differently from younger patients.
8. 6 Patients with Hepatic Impairment
Because the exposure and toxicity of paclitaxel can be increased in patients
with hepatic impairment, the administration of ABRAXANE should be
performed with caution in patients with hepatic impairment [see Dosage
and Administration ( 2. 4), Warnings and Precautions ( 5. 6) and Clinical
Pharmacology( 12. 3)]. Abraxane has not been studied in combination
with gemcitabine for the treatment of pancreatic cancer in patients with a
bilirubin greater than the upper limit of normal.
8. 7 Patients with Renal Impairment
The use of ABRAXANE has not been studied in patients with renal
There is no known antidote for ABRAXANE overdosage. The primary
anticipated complications of overdosage would consist of bone marrow
suppression, sensory neurotoxicity, and mucositis.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Product No.: 103450
NDC No.: 68817-134-50 100 mg of paclitaxel in a single-use vial,
individually packaged in a carton.
16. 2 Storage
Store the vials in original cartons at 20°C to 25°C ( 68° F to 77°F). Retain
in the original package to protect from bright light.
16. 3 Handling and Disposal
Procedures for proper handling and disposal of anticancer drugs should
be considered. Several guidelines on this subject have been published
[see References ( 15)]. There is no general agreement that all of the
procedures recommended in the guidelines are necessary or appropriate.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling
• ABRAXANE injection may cause fetal harm. Advise patients to avoid
becoming pregnant while receiving this drug. Women of childbearing
potential should use effective contraceptives while receiving
ABRAXANE [see Warnings and Precautions ( 5. 8) and Use in Specific
Populations ( 8.1)].
• Advise men not to father a child while receiving ABRAXANE [see
Warnings and Precautions ( 5. 9)].
• Patients must be informed of the risk of low blood cell counts and
severe and life-threatening infections and instructed to contact their
physician immediately for fever or evidence of infection. [see Warnings
and Precautions ( 5.1), ( 5. 3)].
• Patients should be instructed to contact their physician for persistent
vomiting, diarrhea, or signs of dehydration.
• Patients must be informed that sensory neuropathy occurs frequently
with ABRAXANE and patients should advise their physicians of
numbness, tingling, pain or weakness involving the extremities [see
Warnings and Precautions ( 5. 2)].
• Explain to patients that alopecia, fatigue/asthenia, and myalgia/arthralgia
occur frequently with ABRAXANE
• Instruct patients to contact their physician for signs of an allergic
reaction, which could be severe and sometimes fatal [see Warnings
and Precautions ( 5. 5)].
• Instruct patients to contact their physician immediately for sudden
onset of dry persistent cough, or shortness of breath [see Warnings
and Precautions ( 5. 4)].
Manufactured for: Celgene Corporation
Summit, NJ 07901
ABRAXANE® is a registered trademark of Abraxis BioScience, LLC.
©2005-2013 Abraxis BioScience, LLC.
All Rights Reserved.
Abraxis BioScience, LLC is a wholly owned subsidiary of Celgene Corporation.
U.S. Patent Numbers: See www.celgene.com.