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.

The impact of febrile neutropenia (FN) may be greater than you think

Consequences of FN

FN and its consequences can be debilitating for your patients

More than 80% of patients with FN required hospitalization in the United States1

Study design: Data are from a retrospective cohort study conducted using 2007–2010 data from the Humedica database. The total study population was 2,131 patients, including 401 patients who experienced 458 episodes of FN. An episode of FN was identified based on any of the following criteria: an absolute neutrophil count (ANC) < 1.0 x 109/L, and evidence of infection or fever; inpatient diagnosis of neutropenia, fever, or infection; outpatient diagnosis of neutropenia, and non-prophylactic oral or intravenous antimicrobial use; or mention of FN in the physician’s notes. Primary endpoints were to examine the incidence, treatment, and consequences of chemotherapy-induced FN across inpatient and outpatient care settings.1

Over 100,000 adult patients were hospitalized annually in the United States due to neutropenic complications2

Study design: Estimates are from a cross-sectional study conducted using 1989–2007 hospital discharge data from the Agency for Healthcare Research and Quality Nationwide Inpatient Sample database. The total study population included all hospital discharge records for patients with cancer diagnoses who were ≥ 18 years with no evidence of radiation therapy, estimated at 2.5 million discharges per year. Primary endpoint was to estimate the rate of neutropenic complications.2

See how FN could impact a patient

View case study
Case study—Renee*

What could happen if Renee* misses her next Neulasta® dose?

Hypothetical patient profile picture.

Meet Renee*:
prescribed Neulasta® to help reduce the risk of FN3, 4

  • Age 53
  • Breast cancer
  • Prescribed TC (Q3W)
  • Working mom
  • Leads a choir group
  • Cares for her elderly father

If Renee* misses her Neulasta® dose, she could increase her risk of developing FN

Cycle 1
Chemotherapy Next-day Neulasta®
Day
01
Administered TC
Day
02
Patient recieved Neulasta® dose
Cycle 2
Chemotherapy Missed next-day Neulasta®
Day
01
Administered TC
Day
02
Patient missed Neulasta dose. G-CSF support not administered
Day
07
Patient presented to ER with fever, neutropenia.
Patient hospitalized for 5 days and administered IV antibiotics
Day
12
Patient discharged

Find out how Neulasta® reduced the risk of FN every cycle, for patients like Renee*

See the data

What could happen if a patient misses an ANC-monitoring appointment?

View another case study

*Hypothetical patient.

Case study—George*

What could happen if George* misses his ANC-monitoring appointment?

Hypothetical patient profile picture.

Meet George*:
placed on a wait-and-see treatment plan to manage his FN risk3, 5

  • Age 65
  • Non-Hodgkin’s lymphoma (NHL)
  • Prescribed CHOP + R (Q3W)
  • Part-time museum guide
  • Volunteers at a food bank
  • Enjoys traveling with his wife

If George* misses his ANC-monitoring appointment, he could be at risk of developing FN

Cycle 1
Chemotherapy ANC monitoring
Day
01
CHOP + R administered. ANC at low end of normal. Additional monitoring ordered
Day
06
Patient missed ANC-monitoring appointment and rescheduled for the following week
Day
10
Patient presented to ER with fever, neutropenia.
Patient hospitalized for 9 days and administered IV antibiotics
Day
19
Patient discharged
Day
22
Next chemotherapy cycle scheduled to begin

For patients like George,* Neulasta® EVERY cycle significantly reduced the risk of FN.

Find out how

*Hypothetical patient.

Consider patient risk factors

Assess your patients’ risk of FN EVERY cycle

Patient risk factors for FN (in addition to chemotherapy regimen and cancer type)6
  • Age ≥ 65 years
  • Advanced disease
  • Preexisting neutropenia or bone marrow involvement with tumor
  • Infection
  • Open wounds or recent surgery
  • Poor performance status or poor nutritional status
  • Cardiovascular disease
  • Poor renal function
  • Liver dysfunction, most notably elevated bilirubin
  • Multiple comordid conditions
  • HIV infection
Patient risk factors for poor clinical outcomes resulting from FN or infection6
  • Sepsis syndrome
  • Age > 65 years
  • Profound neutropenia (ANC < 0.1 x 109/L)
  • Neutropenia expected to last > 10 days
  • Pneumonia
  • Invasive fungal infection
  • Other clinically documented infections
  • Hospitalization at time of fever
  • Prior episode of FN

ASCO and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend:

Evaluating first- and subsequent-cycle CSF use for myelosuppressive chemotherapy regimens with an approximate ≥ 20% risk of FN.6,7

"Primary prophylaxis with a CSF starting in the first cycle and continuing through subsequent cycles of chemotherapy is recommended in patients who have an approximately 20% or higher risk for febrile neutropenia on the basis of patient-, disease-, and treatment-related factors."6

— Excerpted from 2015 ASCO guidelines

ASCO, American Society of Clinical Oncology; CSF, colony-stimulating factor; NCCN, National Comprehensive Cancer Network® (NCCN®).

Help protect your patients at risk of FN

About neutrophil nadirs

Myelosuppressive chemotherapy decreases ANC, resulting in neutropenia and a neutrophil nadir

Duration and depth of chemotherapy-induced neutropenia has an associated nadir8

Neutrophil nadir chart.

Study design: Phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients (N = 210) with small-cell lung cancer receiving up to 6 cycles of chemotherapy with cyclophosphamide, doxorubicin, and etoposide. Patients were randomized to receive either placebo (n = 104) or NEUPOGEN® (filgrastim) (n = 95) 24 hours post-chemotherapy (beginning on day 4 and continuing through day 12 and up to day 17 of a 21-day cycle unless the postnadir neutrophil count after day 12 exceeded 10.0 × 109/L, in which case growth factor support was discontinued for the remainder of the cycle). Primary endpoint was the incidence of fever (≥ 38°C) associated with an ANC < 1.0 x 109/L.8

†Severe neutropenia (Grade 4) = ANC < 0.5 × 109/L.

Risk associated with severe neutropenia

A longer duration of severe neutropenia is directly related to an increased risk of FN

Incidence of FN by duration of severe neutropenia in cycle 1 in patients with cancer receiving granulocyte colony-stimulating factor (G-CSF) support9

Incidence of FN by duration of severe neutropenia in cycle 1 in patients with cancer receiving G-CSF support.

Study design: Retrospective analysis combining 2 randomized phase 3 clinical trials comparing Neulasta® to NEUPOGEN® (filgrastim). Patients received myelosuppressive chemotherapy (docetaxel 75 mg/m2 and doxorubicin 60 mg/m2) on day 1; on day 2, patients received either once-per-cycle Neulasta® or once-daily NEUPOGEN®. Data are from cycle 1. Primary endpoint of this retrospective analysis was to characterize the relationship between the duration of severe neutropenia and FN.9

‡Severe neutropenia = ANC < 0.5 x 109/L.

Next See Neulasta® efficacy in patients with breast cancer or NHL

References: 1. Weycker D, et al. J Oncol Pharm Pract. 2014;20:190‑198. 2. Kozma CM, et al. J Oncol Pract. 2012;8:149‑155. 3. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 4. Kosaka Y, et al. Support Care Cancer. 2015;23:1137‑1143. 5. Pettengell R, et al. Support Care Cancer. 2012;20:647‑652. 6. Smith TJ, et al. J Clin Oncol. 2015;33:3199‑3212. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloid Growth Factors V.2.2016. National Comprehensive Cancer Network, Inc. 2016. All rights reserved. Accessed September 9, 2016. To view the most recent and complete version of the guideline, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. 8. Crawford J, et al. N Engl J Med. 1991;325:164‑170. 9. Meza L, et al. Proc Am Soc Clin Oncol. 2002;21:Abstract 2840.

NEUPOGEN® is administered by subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

Important Safety Information

Contraindication

Do not administer Neulasta® or NEUPOGEN® to patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G‑CSF), such as pegfilgrastim or filgrastim.

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta®, and has been reported following the administration of NEUPOGEN®. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®, and has been reported in patients receiving NEUPOGEN®. Evaluate patients who develop fever, and lung infiltrates or respiratory distress for ARDS. Discontinue Neulasta® or NEUPOGEN® in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®, and have been reported in patients receiving NEUPOGEN®. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® or NEUPOGEN® in patients with serious allergic reactions.

Allergies to Acrylics

The On-body Injector for Neulasta® uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Use in Patients with Sickle Cell Disorders

Sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®, and has been reported with the use of NEUPOGEN® in patients with sickle cell trait or sickle cell disease.

Glomerulonephritis

Glomerulonephritis has occurred in patients receiving NEUPOGEN® and Neulasta®. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of NEUPOGEN® and Neulasta®. If causality is likely, consider dose-reduction or interruption of NEUPOGEN® or Neulasta®.

Capillary Leak Syndrome

Capillary leak syndrome (CLS) has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including NEUPOGEN® and Neulasta®, 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 capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Thrombocytopenia

Thrombocytopenia has been reported in patients receiving NEUPOGEN®. Monitor platelet counts.

Leukocytosis

White blood cell counts of ≥ 100,000/mm3 were observed in about 2% of patients with cancer receiving myelosuppressive chemotherapy who received NEUPOGEN® at dosages > 5 mcg/kg/day. It is recommended to monitor CBCs at least twice weekly, and adjust NEUPOGEN® dosing as clinically indicated to help mitigate risk of leukocytosis. Dosages of NEUPOGEN® that increase the absolute neutrophil count (ANC) beyond 10‚000/mm3 may not result in any additional clinical benefit. Discontinuation of NEUPOGEN® therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.

Cutaneous Vasculitis

Cutaneous vasculitis has been reported in patients treated with NEUPOGEN®. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with severe chronic neutropenia (SCN) receiving long-term NEUPOGEN® therapy. Hold NEUPOGEN® therapy in patients with cutaneous vasculitis. NEUPOGEN® may be started at a reduced dose when the symptoms resolve and the ANC has decreased.

Potential Effect on Malignant Cells

The G-CSF receptor through which filgrastim acts has also been found on tumor cell lines. The possibility that Neulasta® or NEUPOGEN® acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded.

Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended

The safety and efficacy of NEUPOGEN® given simultaneously with cytotoxic chemotherapy have not been established. Do not use NEUPOGEN® in the period 24 hours before or after the administration of cytotoxic chemotherapy. The safety and efficacy of NEUPOGEN® have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of NEUPOGEN® with chemotherapy and radiation therapy.

Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results.

The most common adverse reactions in patients taking NEUPOGEN® (≥ 5% difference in incidence, compared to placebo) are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, peripheral edema, decreased hemoglobin, decreased appetite, oropharyngeal pain, and alopecia.

The most common adverse reactions in patients taking Neulasta® (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

Please refer to the full Prescribing Information for Neulasta® and the full Prescribing Information for NEUPOGEN®.

Indication

Neulasta® and NEUPOGEN® are 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.

Important Safety Information

Contraindication

Do not administer Neulasta® or NEUPOGEN® to patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G‑CSF), such as pegfilgrastim or filgrastim.

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta®, and has been reported following the administration of NEUPOGEN®. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®, and has been reported in patients receiving NEUPOGEN®. Evaluate patients who develop fever, and lung infiltrates or respiratory distress for ARDS. Discontinue Neulasta® or NEUPOGEN® in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®, and have been reported in patients receiving NEUPOGEN®. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® or NEUPOGEN® in patients with serious allergic reactions.

Allergies to Acrylics

The On-body Injector for Neulasta® uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Use in Patients with Sickle Cell Disorders

Sickle cell crisis, in some cases fatal, can occur in patients receiving Neulasta®, and has been reported with the use of NEUPOGEN® in patients with sickle cell trait or sickle cell disease.

Glomerulonephritis

Glomerulonephritis has occurred in patients receiving NEUPOGEN® and Neulasta®. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of NEUPOGEN® and Neulasta®. If causality is likely, consider dose-reduction or interruption of NEUPOGEN® or Neulasta®.

Capillary Leak Syndrome

Capillary leak syndrome (CLS) has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including NEUPOGEN® and Neulasta®, 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 capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Thrombocytopenia

Thrombocytopenia has been reported in patients receiving NEUPOGEN®. Monitor platelet counts.

Leukocytosis

White blood cell counts of ≥ 100,000/mm3 were observed in about 2% of patients with cancer receiving myelosuppressive chemotherapy who received NEUPOGEN® at dosages > 5 mcg/kg/day. It is recommended to monitor CBCs at least twice weekly, and adjust NEUPOGEN® dosing as clinically indicated to help mitigate risk of leukocytosis. Dosages of NEUPOGEN® that increase the absolute neutrophil count (ANC) beyond 10‚000/mm3 may not result in any additional clinical benefit. Discontinuation of NEUPOGEN® therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.

Cutaneous Vasculitis

Cutaneous vasculitis has been reported in patients treated with NEUPOGEN®. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with severe chronic neutropenia (SCN) receiving long-term NEUPOGEN® therapy. Hold NEUPOGEN® therapy in patients with cutaneous vasculitis. NEUPOGEN® may be started at a reduced dose when the symptoms resolve and the ANC has decreased.

Potential Effect on Malignant Cells

The G-CSF receptor through which filgrastim acts has also been found on tumor cell lines. The possibility that Neulasta® or NEUPOGEN® acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, cannot be excluded.

Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended

The safety and efficacy of NEUPOGEN® given simultaneously with cytotoxic chemotherapy have not been established. Do not use NEUPOGEN® in the period 24 hours before or after the administration of cytotoxic chemotherapy. The safety and efficacy of NEUPOGEN® have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of NEUPOGEN® with chemotherapy and radiation therapy.

Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results.

The most common adverse reactions in patients taking NEUPOGEN® (≥ 5% difference in incidence, compared to placebo) are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, peripheral edema, decreased hemoglobin, decreased appetite, oropharyngeal pain, and alopecia.

The most common adverse reactions in patients taking Neulasta® (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

Please refer to the full Prescribing Information for Neulasta® and the full Prescribing Information for NEUPOGEN®.

Indication

Neulasta® and NEUPOGEN® are 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.

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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.