GRANIX

Tbo-filgrastim exhibits nonlinear pharmacokinetics. Increasing the dose of subcutaneous GRANIX from 5 to 10 mcg/kg resulted in an approximate 2.5-fold increase in the maximum serum concentration (C max ) and 3.0-fold increase in the area under the curve (AUC). In adult patients enrolled across three studies, subcutaneous GRANIX 5 mcg/kg resulted in median time to maximal serum tbo-filgrastim concentrations (T max ) within 4 to 6 hours. Geometric mean [coefficient of variation (CV%)] serum C max ...

The efficacy of GRANIX was evaluated in a multinational, multicenter, randomized and controlled Phase 3 study in 348 chemotherapy-naive patients with high-risk stage II, stage III, or stage IV breast cancer receiving doxorubicin (60 mg/m 2 ) and docetaxel (75 mg/m 2 ) comparing GRANIX to placebo and a non-U.S.-approved filgrastim product as controls. The median age of the patients was 50 years (range 25 to 75 years) with 99% female and 86% Caucasian. GRANIX, placebo, and the non-U.S.-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after che...

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 f...

GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [see Warnings and Precautions (5.3) ]. Patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products. ( 4 )

Splenic Rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture ( 5.1 ) Acute Respiratory Distress Syndrome (ARDS): Monitor for and manage immediately. Discontinue GRANIX if suspected ( 5.2 ) Serious Allergic Reactions Including Anaphylaxis: Permanently discontinue GRANIX in patients with serious allergic reactions ( 5.3 ) Sickle Cell Disorders: Severe and sometimes fatal crisis can occur. Discontinue GRANIX if suspected ( 5.4 ) Glome...