NEULASTA- pegfilgrastim kit NEULASTA- pegfilgrastim injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PEGFILGRASTIM (UNII: 3A58010674) (PEGFILGRASTIM - UNII:3A58010674)

Available from:

Amgen Inc

INN (International Name):

PEGFILGRASTIM

Composition:

PEGFILGRASTIM 6 mg in 0.6 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . Limitations of Use Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)] . Neulasta is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)] . Risk Summary Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outc

Product summary:

Neulasta single-dose prefilled syringe for manual use Neulasta injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard. The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex). Neulasta is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 55513-190-01). Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe. Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once. Neulasta Onpro® kit Neulasta Onpro kit is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for Neulasta (NDC 55513-192-01). The Neulasta injection single-dose prefilled syringe contains 0.64 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the OBI for Neulasta. The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle. The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta. The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex). Store Neulasta Onpro kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until 30 minutes prior to use. Because the OBI for Neulasta is at room temperature during the period of use, Neulasta Onpro kit should not be held at room temperature longer than 12 hours prior to use. Discard Neulasta Onpro kit if stored at room temperature for more than 12 hours. Do not use the OBI for Neulasta if its packaging has been previously opened.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NEULASTA- PEGFILGRASTIM
NEULASTA- PEGFILGRASTIM INJECTION
AMGEN INC
----------
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
Warnings and Precautions, Thrombocytopenia (5.8)
01/2021
Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute
Myeloid Leukemia
(AML) (5.11)
01/2021
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)
Limitations of Use
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-dose prefilled syringe for
manual use only. (3)
Injection: 6 mg/0.6 mL solution in