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.

Neulasta® dosing and clinical pharmacology

See dosing information and learn how Neulasta® works in the body

Dosing and administration

Two delivery methods for Neulasta® support

The Neulasta® Onpro® kit with the On‑body Injector for Neulasta®, and the prefilled syringe for manual injection.

On-body Injector for Neulasta®, part of the Neulasta®
Onpro® Kit, and the prefilled syringe for manual injection. See how to use Neulasta® Onpro®
  • Both options deliver a single 6 mg fixed dose of Neulasta® with a half-life of 15–80 hours 1
  • Do not administer Neulasta® between 14 days before and 24 hours after administration of cytotoxic chemotherapy 1
  • The Neulasta® prefilled syringe for manual injection is not designed to allow for direct administration of doses less than 0.6 mL (6 mg), as the syringe does not bear graduation marks
  • Direct administration to pediatric patients weighing less than 45 kg is not recommended due to the potential for dosing errors
    • Use of the On‑body Injector for Neulasta® has not been studied in pediatric patients

For more information regarding dosing, please see the Neulasta® full Prescribing Information.

The On‑body Injector delivers the same Neulasta®

Comparable Neulasta® pharmacokinetics shown with the prefilled syringe (PFS) for manual injection and On‑body Injector.

Neulasta® pharmacokinetics data.

Study design: Phase 1, randomized, open-label study of Neulasta® pharmacokinetics in healthy subjects at 5 controlled study centers. Subjects were randomized to receive a single, 6 mg dose of Neulasta® by hand using the PFS for manual injection (n = 128) or automatically using the On‑body Injector (n = 125). Primary endpoints were the maximum Neulasta® concentration and area under the concentration curve from time 0 to infinity after dosing. 2

Special Instructions for the On‑body Injector for Neulasta®

  • A healthcare provider must fill the On‑body Injector with Neulasta® using the co‑packaged prefilled syringe and then apply the On‑body Injector to the patient’s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the On‑body Injector. Approximately 27 hours after the On‑body Injector is applied to the patient’s skin, Neulasta® will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the On‑body Injector on the same day as the administration of cytotoxic chemotherapy, as long as the On‑body Injector delivers Neulasta® no less than 24 hours after the administration of cytotoxic chemotherapy.
  • The prefilled syringe co‑packaged in the Neulasta® Onpro® kit contains additional solution to compensate for liquid loss during delivery through the On‑body Injector. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the On‑body Injector, the patient may receive less than the recommended dose.
  • Do not use the On‑body Injector to deliver any other drug product except the Neulasta® prefilled syringe co‑packaged with the On‑body Injector. Use of the On‑body Injector for Neulasta® has not been studied in pediatric patients.
  • The On‑body Injector should be applied to intact, non‑irritated skin on the arm or abdomen.
  • A missed dose could occur due to an On‑body Injector failure or leakage. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection.
  • Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.
  • Refer to the Instructions for Use for the On‑body Injector for full administration information.
  • For any On‑body Injector problems, call Amgen at 1‑800‑772‑6436 or 1‑844‑MYNEULASTA (1‑844‑696‑3852).

Neulasta® and neutrophil nadirs

Once-per-cycle Neulasta® provided neutrophil support throughout the nadir

Absolute neutrophil count (ANC)

Self-regulating clearance allowed Neulasta® to remain in the blood until the neutrophil count returned to normal3, 4

Neulasta® serum level vs ANC after a single 6 mg Neulasta® dose (n = 73) 3

Chart showing Neulasta® serum concentration vs ANC.

Study design: Phase 3, randomized, double-blind, multicenter study of patients with breast cancer (N = 157) receiving 4 cycles of doxorubicin (60 mg/m2) and docetaxel (75 mg/m2). Data shown are from patients (n = 73) who received a single 6 mg dose of Neulasta® approximately 24 hours after cycle 1 chemotherapy. Primary endpoint was the duration of grade 4 neutropenia (ANC < 0.5 x 109/L) in cycle 1. 3

Neulasta® can help reduce the duration of neutropenic events

See how
Duration of neutropenia

Chemotherapy-induced ANC nadir occurred earlier with Neulasta® support 5

Mean ANC: Neulasta® compared with no granulocyte colony-stimulating factor (G-CSF) support 5

Chemotherapy-induced nadir chart in patients receiving
Neulasta®.

The recovery of mean ANC to > 1.0 × 109/L was 16 to 18 days in the arm without Neulasta® support, whereas the recovery was 9 days in the Neulasta® arm. 5

Study design: Phase 2, open-label, randomized trial of patients (N = 60) with breast cancer (aged ≥ 65 years), who received up to 6 cycles of adjuvant fluorouracil, epirubicin, and cyclophosphamide (FEC). Patients were prospectively randomized to receive primary prophylaxis with Neulasta® on day 2 of all cycles (n = 31, of which 30 received Neulasta® in cycle 1) or secondary prophylaxis on day 2 of all cycles after a neutropenic event (n = 29), with no reactive G-CSF support being given in cycle 1. Primary endpoint was the proportion of patients with at least 1 neutropenic event (defined as grade 3* or 4 neutropenia and fever, an infectious complication requiring the use of systemic anti-infectives, or a dose reduction or delay resulting from hematological toxicity) in cycle 1. Secondary endpoint was the ANC profile during cycle 1. 5

*Grade 3 = ANC < 1.0 x 109/L.

†Grade 4 = ANC < 0.5 x 109/L.

The duration of neutropenia was shortened with once-per-cycle Neulasta®

See Neulasta® mechanism of action below

Neulasta® mechanism of action

Neulasta® is a recombinant G-CSF that acts on hematopoietic cells by binding to specific cell surface receptors 1

Next Help your patients access Neulasta® and Neulasta® Onpro®

References: 1. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 2. Yang BB, et al. Cancer Chemother Pharmacol. 2015;75:1199‑1206. 3. Green MD, et al. Ann Oncol. 2003;14:29‑35. 4. Yang BB, Kido A. Clin Pharmacokinet. 2011;50:295‑306. 5. Brugger W, et al. Crit Rev Oncol Hematol. 2009;72:265‑269.

Important Safety Information

Contraindication

Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic Rupture

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

Acute Respiratory Distress Syndrome

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

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® 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

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis

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

Leukocytosis

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.

Capillary Leak Syndrome

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including 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.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The G-CSF receptor, through which pegfilgrastim and filgrastim act, 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, diseases for which pegfilgrastim is not approved, cannot be excluded.

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

Please see full Prescribing Information.

Important Safety Information

Contraindication

Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic Rupture

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

Acute Respiratory Distress Syndrome

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

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® 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

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis

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

Leukocytosis

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.

Capillary Leak Syndrome

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including 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.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The G-CSF receptor, through which pegfilgrastim and filgrastim act, 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, diseases for which pegfilgrastim is not approved, cannot be excluded.

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

Please see 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.