Generic Name and Formulations:
Pegfilgrastim (polyethylene glycol/filgrastim conjugate) 6mg/0.6mL; soln for SC inj; preservative-free.
Indications for NEULASTA:
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.
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. Pediatrics weighing 31–44kg: 4mg; 21–30kg: 2.5mg; 10–20kg: 1.5mg; <10kg: 0.1mg/kg. Direct administration of prefilled syringe with doses <6mg is not recommended.
Monitor CBC and platelets before and during therapy. Monitor for splenomegaly, splenic rupture, acute respiratory distress syndrome (ARDS); evaluate if fever, lung infiltrates, or respiratory distress occurs; discontinue if ARDS diagnosed. Monitor for glomerulonephritis; consider dose reduction or interruption if treatment-related. Permanently discontinue if serious allergic reactions develop. Sickle cell disease: may cause severe sickle cell crises (discontinue if occurs). Monitor for signs/symptoms of aortitis; discontinue if suspected. Myeloid malignancies. Myelodysplasia. 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.
Granulocyte colony stimulating factor.
Bone or extremity pain; anaphylaxis, ARDS, splenic rupture, glomerulonephritis, leukocytosis, 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).
Single-use prefilled syringe—1; Onpro Kit—1 (prefilled syringe + On-body injector)
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