Indication

Neulasta® is indicated to decrease the incidence of infection, as... Read more

Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia... Read more

Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Help protect your patients at risk of febrile neutropenia (FN) with Neulasta® FIRST and EVERY cycle

Neulasta® EVERY cycle reduced the incidence of FN by 94%

Neulasta® reduced the incidence of neutropenic events across multiple endpoints in a pivotal clinical trial1

Incidence of neutropenic events*1

Incidence of neutropenic events in breast cancer patients treated with Neulasta<sup>®</sup>.

Study design: Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer receiving 100 mg/m2 docetaxel for up to 4 cycles. Included 928 patients initially receiving placebo (n = 465) or Neulasta® (n = 463). Primary endpoint was the percentage of patients who developed FN. Secondary endpoints were the incidence of hospitalization and IV anti-infective use as a result of FN.1

*FN = temperature ≥ 38.2°C and an absolute neutrophil count (ANC) < 0.5 × 109/L on the same day of the fever or the day after.

Neulasta® used EVERY cycle significantly reduced the risk of subsequent-cycle FN

Incidence of FN in patients receiving Neulasta® support in a phase 3 study2

Incidence of neutropenia across cycles in breast cancer patients treated with Neulasta®.

Study design: Open-label, randomized, phase 3 noninferiority study. Patients with breast cancer at risk for FN were randomly assigned to Neulasta® throughout all chemotherapy cycles (n = 84) or Neulasta® in cycles 1 and 2 only (n = 83). A 6 mg fixed dose of Neulasta® was administered 24–30 hours after chemotherapy administration. Primary endpoint was the percentage of patients who developed FN.2

†Fever = body temperature ≥ 38.5°C once or ≥ 38.0°C for > 12 hours. Neutropenia = ANC ≤ 0.5 x 109/L or ANC ≤ 1.0 x 109/L and expected to fall below 0.5 x 109/L within the next 24 hours.

The highest incidence of FN occurred in the third chemotherapy cycle of the experimental arm (24%), which was the first cycle without prophylactic Neulasta® support.2

The authors stated, "We recommend primary G-CSF prophylaxis throughout all chemotherapy cycles in patients at risk for FN."2

G-CSF, granulocyte colony-stimulating factor.

What could happen if a patient missed a subsequent Neulasta® dose?

Neulasta® used EVERY cycle reduced the incidence of FN, more than treatment at physician discretion

Reduction in FN: reactive treatment vs EVERY-cycle Neulasta®3

Incidence of febrile neutropenia in the first cycle and across all cycles in patients with non-Hodgkin’s lymphoma treated with Neulasta<sup>®</sup>.

Study design: Open-label, randomized, phase 4, prospective, multi-center community-based study of patients with solid tumors or non-Hodgkin’s lymphoma (NHL) (N = 852). Patients were randomized to every-cycle Neulasta®, or Neulasta® in any cycle after cycle 1 at the physician’s discretion. Data shown are for a post hoc subset analysis of patients with NHL (n = 73 patients in each study arm). Most NHL patients (82%, n = 120) received CHOP + R. The primary endpoint was the incidence of patients experiencing FN.3

‡FN = ANC < 1.0 x 109/L and temperature ≥ 38°C.

With a reactive approach, what's the risk of a missed
ANC-monitoring appointment?
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References: 1. Vogel C, et al. J Clin Oncol. 2005;23:1178‑1184. 2. Aarts MJ, et al. J Clin Oncol. 2013;31:4290‑4296. 3. Balducci L, et al. Oncologist. 2007;12:1416‑1424.

Important Safety Information

Contraindication

  • Neulasta® is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim
  • Reactions have included anaphylaxis

Splenic Rupture

  • Splenic rupture, including fatal cases, can occur following the administration of Neulasta®
  • Evaluate for an enlarged or ruptured spleen in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

  • ARDS has occurred in patients receiving Neulasta®
  • Evaluate patients who develop a fever and lung infiltrates or respiratory distress after receiving Neulasta®
  • Discontinue Neulasta® in patients with ARDS

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulasta®
  • Majority of events occurred upon initial exposure and can recur within days after discontinuation of initial anti‐allergic treatment
  • Permanently discontinue Neulasta® in patients with serious allergic reactions

Allergies to Acrylics

  • On‐body injector (OBI) for Neulasta® uses acrylic adhesives
  • Patients who are allergic to acrylic adhesives may have a significant reaction

Use in Patients With Sickle Cell Disorders

  • In patients with sickle cell trait or disease, sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®

Glomerulonephritis

  • Has occured in patients receiving Neulasta®
  • Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
  • Generally events resolved after dose reduction or discontinuation of Neulasta®
  • If suspected, evaluate for cause and if cause is likely, consider dose‐reduction or interruption of Neulasta®

Leukocytosis

  • Increased white blood cell counts of 100 x 109/L have been observed
  • Monitoring CBCs is recommended

Capillary Leak Syndrome (CLS)

  • CLS has been reported after G‐CSF administration, including Neulasta®
  • Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
  • Episodes vary in frequency, severity, and may be life‐threatening if treatment is delayed
  • Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

  • G‐CSF receptor has been found on tumor cell lines
  • The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded

Potential Device Failures

  • Missed or partial doses have been reported in patients receiving pegfilgrastim via the on‐body injector (OBI) due to the device not performing as intended
  • In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
  • Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended

Most common adverse reactions

  • Bone pain
  • Pain in extremity

Please see Neulasta® full Prescribing Information.

Important Safety Information

Contraindication

  • Neulasta® is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim
  • Reactions have included anaphylaxis

Splenic Rupture

  • Splenic rupture, including fatal cases, can occur following the administration of Neulasta®
  • Evaluate for an enlarged or ruptured spleen in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

  • ARDS has occurred in patients receiving Neulasta®
  • Evaluate patients who develop a fever and lung infiltrates or respiratory distress after receiving Neulasta®
  • Discontinue Neulasta® in patients with ARDS

Serious Allergic Reactions

  • Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulasta®
  • Majority of events occurred upon initial exposure and can recur within days after discontinuation of initial anti‐allergic treatment
  • Permanently discontinue Neulasta® in patients with serious allergic reactions

Allergies to Acrylics

  • On‐body injector (OBI) for Neulasta® uses acrylic adhesives
  • Patients who are allergic to acrylic adhesives may have a significant reaction

Use in Patients With Sickle Cell Disorders

  • In patients with sickle cell trait or disease, sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®

Glomerulonephritis

  • Has occured in patients receiving Neulasta®
  • Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
  • Generally events resolved after dose reduction or discontinuation of Neulasta®
  • If suspected, evaluate for cause and if cause is likely, consider dose‐reduction or interruption of Neulasta®

Leukocytosis

  • Increased white blood cell counts of 100 x 109/L have been observed
  • Monitoring CBCs is recommended

Capillary Leak Syndrome (CLS)

  • CLS has been reported after G‐CSF administration, including Neulasta®
  • Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
  • Episodes vary in frequency, severity, and may be life‐threatening if treatment is delayed
  • Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

  • G‐CSF receptor has been found on tumor cell lines
  • The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded

Potential Device Failures

  • Missed or partial doses have been reported in patients receiving pegfilgrastim via the on‐body injector (OBI) due to the device not performing as intended
  • In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
  • Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended

Most common adverse reactions

  • Bone pain
  • Pain in extremity

Please see Neulasta® full Prescribing Information.

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Instructions for Use
Enhanced Neulasta® Onpro®Kit
Instructions for Use

Recent updates to Neulasta® Onpro® include approximately 35% smaller packaging,1 an updated fill symbol on the adhesive backing, and a co-packaged prefilled syringe without a needle guard.

1. Data on file, Amgen; 2016.