ASH Clinical News December 2014 | Page 45

GRANIX is another option
in short-acting G-CSF therapy
TM

» GRANIX demonstrated a 71% reduction in duration of severe neutropenia (DSN) vs placebo1
– GRANIX significantly reduced DSN when compared to placebo (1.1 days vs 3.8 days; p<0.001)1
– Efficacy was evaluated in a multinational, multicenter, randomized, controlled, Phase III
study of chemotherapy-naïve patients with high-risk breast cancer receiving doxorubicin
(60 mg/m2 IV bolus)/docetaxel (75 mg/m2)1

» Safety was evaluated in 3 Phase III clinical trials1

Important Safety Information (continued)
» Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in
patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior
to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients
undergoing a sickle cell crisis.

» Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colonystimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines.
The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies
and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.

» Most common treatment-emergent adverse reaction: The most common treatment-emergent
adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an
incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain.

Please see brief summary of Full Prescribing Information on adjacent page.
For more information, visit GRANIXhcp.com.
Reference: 1. GRANIX TM (tbo-filgrastim) Injection Prescribing Information. North Wales, PA: Teva Pharmaceuticals; 2013.

©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical
Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd.
All rights reserved. GRX-40138 January 2014.