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GRANIX® is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Safety Information: Contraindication: GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim or pegfilgrastim products.

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Teva’s short-acting G-CSF was first introduced in Europe in 2008 and is approved in 51 countries*2

*As of October 2016.

GRANIX was approved through the traditional FDA approval pathway for biologics

Highlights of 351(a) Biologics Licensing Application (BLA) pathway process3

  • Demonstrate safety and efficacy for intended use
  • Demonstrate that the product, manufacturing process, and manufacturing facilities meet applicable requirements to ensure the continued safety, purity, and potency of the product
  • Assessments must also consider the storage and testing of cell substrates and a potency assay
  • Data evidence: pre-clinical and clinical (human) studies

Experience with GRANIX in the US

Hospital growth

  • GRANIX has already gained ~40% share of the short-acting G-CSF hospital market in the first 34 months since the product was introduced in the US1

National coverage

  • More than 97% of lives assessed nationwide have coverage for GRANIX†4

  • Covered lives is defined as those under plans with a universal status of covered and/or restricted (PA/ST) for the medical and/or pharmacy benefit as of 11/12/2015. Managed Markets Insight and Technology, LLC™, a trademark of MMIT.

Indication

  • GRANIX® is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Safety Information

  • Contraindication: GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim or pegfilgrastim products.
  • Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of filgrastim products. Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX.
  • Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving filgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.
  • Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving GRANIX. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.
  • Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving filgrastim products. 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.
  • Glomerulonephritis: Glomerulonephritis can occur in patients receiving filgrastim products. The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of the filgrastim product. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of GRANIX.
  • Capillary leak syndrome (CLS): CLS can occur in patients receiving filgrastim products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
  • Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating 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 Full Prescribing Information.

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References: 1. This information is an estimate derived from the use of information under license from the following IMS Health Information Service: IMS National Sales Perspective, GRANIX® (tbo-filgrastim) injection micrograms by non-federal hospital channel September 2016. IMS expressly reserves all rights, including rights of copying, distribution, and republication (micrograms calculated as eaches x strength). 2. Data on file. Teva Pharmaceuticals: Filgrastim MA Approvals Worldwide. October 2016.
3.
US Food and Drug Administration. Frequently asked questions about therapeutic biological products. http://www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/ucm113522.htm. Updated July 7, 2015. Accessed February 28, 2017. 4. Data on file. Teva Pharmaceuticals: Managed Markets Reporting for monitored or called upon accounts November 2015.