Granix
(Tbo-Filgrastim)By using PrescriberAI, you agree to the AI Terms of Use.
Granix Prescribing Information
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.
GRANIX is a clear, colorless, preservative-free solution available as:
Injection: 300 mcg/0.5 mL solution in single-dose prefilled syringe
Injection: 480 mcg/0.8 mL solution in single-dose prefilled syringe
Injection: 300 mcg/mL solution in single-dose vial
Injection: 480 mcg/1.6 mL (300 mcg/mL) solution in single-dose vial
GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [
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)]
GRANIX (tbo-filgrastim) is a non-glycosylated recombinant methionyl human granulocyte colony-stimulating growth factor (r-metHuG-CSF) manufactured by recombinant DNA technology using the bacterium strain
The product is a sterile, clear, colorless, preservative-free solution containing tbo-filgrastim, glacial acetic acid, sorbitol, polysorbate 80, sodium hydroxide, and Water for Injection. The product is available in single-dose prefilled syringes that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively and single-dose vials that contain either 300 mcg or 480 mcg of tbo-filgrastim at a fill volume of 1 mL or 1.6 mL, respectively. See table below for product composition of each presentation.
Product Composition | ||||
300 mcg/0.5 mL Syringe | 480 mcg/0.8 mL Syringe | 300 mcg/1 mL Vial | 480 mcg/1.6 mL Vial | |
| Tbo-filgrastim | 300 mcg | 480 mcg | 300 mcg | 480 mcg |
Glacial Acetic Acid | 0.3 mg | 0.48 mg | 0.6 mg | 0.96 mg |
Polysorbate 80 | 0.0275 mg | 0.044 mg | 0.055 mg | 0.088 mg |
| Sorbitol | 25 mg | 40 mg | 50 mg | 80 mg |
Sodium Hydroxide | q.s. to pH 4.2 | q.s. to pH 4.2 | q.s. to pH 4.2 | q.s. to pH 4.2 |
Water for Injection | q.s. to 0.5 mL | q.s. to 0.8 mL | q.s. to 1 mL | q.s. to 1.6 mL |
| q.s. = quantity sufficient to make | ||||
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.