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Neulasta Generic Name & Formulations
Legal Class
Rx
General Description
Pegfilgrastim (polyethylene glycol/filgrastim conjugate) 6mg/0.6mL; soln for SC inj; preservative-free.
Pharmacological Class
Granulocyte colony stimulating factor.
How Supplied
Single-dose prefilled syringe—1; Onpro Kit—1 (prefilled syringe + On-body injector)
Manufacturer
Generic Availability
NO
Neulasta Indications
Indications
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia. To increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Neulasta Dosage and Administration
Adults and Children
See full labeling. ≥45kg: Chemotherapy-induced neutropenia: Do not give between 14 days before and 24 hours after chemotherapy. 6mg SC once per chemotherapy cycle. Acute radiation syndrome (use prefilled syringe only): 2 doses, each of 6mg SC; give 1st dose as soon as possible after exposure to radiation levels >2 gray (Gy), then a 2nd dose one week later. Children (<10kg): 0.1mg/kg; (10–20kg): 1.5mg; (21–30kg): 2.5mg; (31–44kg): 4mg. Direct administration of prefilled syringe with doses <6mg is not recommended.
Neulasta Contraindications
Not Applicable
Neulasta Boxed Warnings
Not Applicable
Neulasta Warnings/Precautions
Warnings/Precautions
Monitor for splenomegaly, splenic rupture, acute respiratory distress syndrome (ARDS); evaluate if fever, lung infiltrates, or respiratory distress occurs; discontinue if ARDS diagnosed. Permanently discontinue if serious allergic reactions develop. Sickle cell disorders; discontinue if sickle cell crisis occurs. Monitor for glomerulonephritis; consider dose reduction or interruption if treatment-related. Monitor CBCs, platelet counts during therapy. Discontinue if aortitis is suspected. Myeloid malignancies. Myelodysplasia. Monitor for MDS/AML in those with breast or lung cancer. Possible transient (+) bone imaging changes in nuclear imaging. Latex allergy (needle cap). On-body injector: potential for device failure resulting in missed or partial doses; not recommended for acute radiation syndrome; not studied in children; acrylic adhesive allergy. Pregnancy. Nursing mothers.
Neulasta Pharmacokinetics
See Literature
Neulasta Interactions
Not Applicable
Neulasta Adverse Reactions
Adverse Reactions
Bone or extremity pain; anaphylaxis, ARDS, splenic rupture, glomerulonephritis, leukocytosis, aortitis, thrombocytopenia, capillary leak syndrome (monitor closely if occurs); on-body injector: application-site reactions (eg, hemorrhage, pain, discomfort, bruise, erythema), contact dermatitis, local skin reactions (eg, rash, pruritus, urticaria).
Neulasta Clinical Trials
See Literature
Neulasta Note
Not Applicable
Neulasta Patient Counseling
See Literature
