HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NEULASTA safely and effectively.   See full prescribing information for   NEULASTA .
 
NEULASTA ® ( pegfilgrastim ) injection, for subcutaneous use
Initial U.S. Approval: 2002

RECENT MAJOR CHANGES
Indications and Usage (1.2) 11/2015
Dosage and Administration (2.1, 2.2, 2.3)            11/2015
Warnings and Precautions (5.6, 5.7, 5.8) 09/2015
Dosage and Administration (2.4, 2.5) 12/2014
Warnings and Precautions (5.4)  12/2014

INDICATIONS AND USAGE
Neulasta is a leukocyte growth factor 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. (1.1)

Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2)
Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

DOSAGE AND ADMINISTRATION
Patients with cancer receiving myelosuppressive chemotherapy
○ 6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
○ Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1)
○ Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.3)

Patients acutely exposed to myelosuppressive doses of radiation
○ Two doses, 6 mg each, administered subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. (2.2)
○ Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/0.6 mL solution in a single-use prefilled syringe for manual use only. (3)

Injection: 6 mg/0.6 mL solution in a single prefilled syringe co-packaged with the On-body Injector for Neulasta.
CONTRAINDICATIONS
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim. (4)

WARNINGS AND PRECAUTIONS
Fatal splenic rupture: eva luate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. (5.1)

Acute respiratory distress syndrome (ARDS): eva luate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in patients with ARDS. (5.2)

Serious allergic reactions, including anaphylaxis: Permanently discontinue Neulasta in patients with serious allergic reactions. (5.3)

The On-body Injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction (5.4)

Fatal sickle cell crises: Have occurred. (5.5)

Glomerulonephritis: eva luate and consider dose-reduction or interruption of Neulasta if causality is likely. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extre