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Fulphila Generic Name & Formulations
Legal Class
Rx
General Description
Pegfilgrastim-jmdb 6mg/0.6mL; soln for SC inj; preservative-free.
Pharmacological Class
Granulocyte colony stimulating factor.
How Supplied
Single-dose prefilled syringe—1 (w. supplies)
Manufacturer
Generic Availability
NO
Fulphila 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.
Limitations of Use
Not for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Fulphila Dosage and Administration
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 Contraindications
Not Applicable
Fulphila Boxed Warnings
Not Applicable
Fulphila 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. Pregnancy. Nursing mothers.
Fulphila Pharmacokinetics
See Literature
Fulphila Interactions
Not Applicable
Fulphila Adverse Reactions
Adverse Reactions
Bone or extremity pain; anaphylaxis, ARDS, splenic rupture, glomerulonephritis, leukocytosis, capillary leak syndrome (monitor closely if occurs), thrombocytopenia, aortitis.
Fulphila Clinical Trials
See Literature
Fulphila Note
Not Applicable
Fulphila Patient Counseling
See Literature
