Generic Name and Formulations:
Pegfilgrastim-jmdb 6mg/0.6mL; soln for SC inj; preservative-free.
Indications for FULPHILA:
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.
Limitations Of use:
Not for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Adults and Children:
See full labeling. ≥45kg: Do not give between 14 days before and 24 hours after chemotherapy. 6mg SC once per chemotherapy cycle. 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 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. Myeloid malignancies. Myelodysplasia. Pregnancy. Nursing mothers.
Granulocyte colony stimulating factor.
May cause transient (+) changes in bone-imaging test results.
Bone or extremity pain; anaphylaxis, ARDS, splenic rupture, glomerulonephritis, leukocytosis, capillary leak syndrome (monitor closely if occurs).
Single-dose prefilled syringe—1 (w. supplies)
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