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).

The recommended dosage of Neulasta^® is a single subcutaneous injection of 6 mg administered once per chemotherapy 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.

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.

Neulasta^® is provided in a dispensing pack containing one syringe (NDC 55513-190-01).

REFERENCES

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