therapy cycle. Neulasta® should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy (see PRECAUTIONS).
The 6 mg fixed-dose formulation should not be used in infants, children, and smaller adolescents weighing less than 45 kg.
No dosing adjustment is necessary for renal dysfunction (see CLINICAL PHARMACOLOGY, Special Populations).
Neulasta® should be visually inspected for discoloration and particulate matter before administration. Neulasta® should not be administered if discoloration or particulates are observed.
For method of administration please see patient package insert.
Storage
Neulasta® should be stored refrigerated at 2° to 8°C (36° to 46°F); syringes should be kept in their carton to protect from light until time of use. Shaking should be avoided. Before injection‚ Neulasta® may be allowed to reach room temperature for a maximum of 48 hours but should be protected from light. Neulasta® left at room temperature for more than 48 hours should be discarded. Freezing should be avoided; however, if accidentally frozen, Neulasta® should be allowed to thaw in the refrigerator before administration. If frozen a second time, Neulasta® should be discarded.
HOW SUPPLIED
Neulasta® is supplied as a preservative‑free solution containing 6 mg (0.6 mL) of pegfilgrastim (10 mg/mL) in a single‑dose syringe with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.
The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex).
Neulasta® is provided in a dispensing pack containing one syringe
(NDC 55513‑190‑01).
Rx Only
This product, its production, and/or its use may be covered by one or more US Patents, including US Patent Nos. 5,824,784; 4,810,643; 4,999,291; 5,582,823; 5,580,755 as well as other patents or patents pending.
REFERENCES
Morstyn G, Dexter T, Foote M. Filgrastim (r‑metHuG‑CSF) in clinical practice. 2nd ed. 1998;3:51‑71.
Valerius T, Elsasser D, Repp R, et al. HLA Class‑II antibodies recruit G‑CSF activated neutrophils for treatment of B‑cell malignancies. Leukemia and Lymphoma. 1997;26, 261‑269.
Heil G, Hoelzer D, Sanz MA, et al. A randomized, double‑blind, placebo‑controlled, phase III study of Filgrastim in remission induction and consolidation therapy for adults with de novo Acute Myeloid Leukemia. Blood. 1997;90:4710‑4718.
Manufactured by:
Amgen Manufacturing, Limited, a subsidiary of Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
© 2002-2006 Amgen Inc. All rights reserved.
3;v6.1
Neulasta®
(pegfilgrastim)
INFORMATION FOR PATIENTS AND CAREGIVERS
This patient package insert provides information and instructions for people who will be receiving Neulasta® or their caregivers. This patient package insert does not tell you everything about Neulasta®. You should discuss any questions you have about treatment with Neulasta® with your doctor.
What is Neulasta®?
Neulasta® is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria E coli. G-CSF is a substance naturally produced by the body. It stimulates the growth of neutrophils (nu-tro-fils), a type of white blood cell important in the body’s fight against i |
