White blood cell disorders:

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.

FULPHILA 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. Pregnancy. Nursing mothers.

FULPHILA Classification:

Granulocyte colony stimulating factor.

Adverse Reactions:

Bone or extremity pain; anaphylaxis, ARDS, splenic rupture, glomerulonephritis, leukocytosis, capillary leak syndrome (monitor closely if occurs), thrombocytopenia, aortitis.

Generic Drug Availability:

NO

How Supplied:

Single-dose prefilled syringe—1 (w. supplies)