To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)

Nursing Mothers: Caution should be exercised when administered to a nursing woman. (8.3)
See 17 for PATIENT COUNSELING INFORMATION, PATIENT COUNSELING INFORMATION and PATIENT COUNSELING INFORMATION.

Revised: 11/2015
 
FULL PRESCRIBING INFORMATION: CONTENTS*
1       INDICATIONS AND USAGE
1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome 2       DOSAGE AND ADMINISTRATION
2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy 2.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome 2.3 Administration 2.4 Special Healthcare Provider Instructions for the On-body Injector for Neulasta 2.5 Advice to Give to Patients Regarding Administration via the On-body Injector for Neulasta 3       DOSAGE FORMS AND STRENGTHS
4       CONTRAINDICATIONS
5       WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture 5.2 Acute Respiratory Distress Syndrome 5.3 Serious Allergic Reactions 5.4 Allergies to Acrylics 5.5 Use in Patients with Sickle Cell Disorders 5.6 Glomerulonephritis 5.7 Leukocytosis 5.8 Capillary Leak Syndrome 5.9 Potential for Tumor Growth Stimulatory Effects on Malignant Cells 6       ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Postmarketing Experience 7       DRUG INTERACTIONS
8       USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 10       OVERDOSAGE
11       DESCRIPTION
12       CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13       NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.3 Reproductive and Developmental Toxicology 14       CLINICAL STUDIES
14.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy 14.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome 16       HOW SUPPLIED/STORAGE AND HANDLING
17       PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1       INDICATIONS AND USAGE

1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].

Neulasta is not indicated for the mobilization of peripheral blood progen