Tbo-Filgrastim (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- GRANIX
Indications and Usage
GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Contraindications
GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [see Warnings and Precautions (5.3) ].
Adverse Reactions
The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1)] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] Serious Allergic Reactions [see Warnings and Precautions (5.3)] Sickle Cell Disorders [see Warnings and Precautions (5.4)] Glomerulonephritis [see Warnings and Precautions (5.5)] Capillary Leak Syndrome [see Warnings and Precautions (5.6)] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.7)] Myelodysplastic Syndrome and Acute Myeloid Leukemia [see Warnings and Precautions (5.8)] Leukocytosis [see Warnings and Precautions ( 5.9 ) ] Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended [see Warnings and Precautions ( 5.10 ) ] Aortitis [see Warnings and Precautions ( 5.12 ) ] Alveolar Hemorrhage [see Warnings and Precautions (5.13)]
Mechanism of Action
Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.