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® comes home

Bringing patients' needs to the forefront

Dr. Dana Thompson discusses the importance of Neulasta® Onpro®

Watch video

Watch how doctors put Neulasta® Onpro® into practice

 

Neulasta® Onpro®
Apply once per cycle, help protect EVERY cycle

The Neulasta® Onpro® kit includes a single dose of Neulasta® and a single-use On‑body Injector

  • Applied the SAME day as chemotherapy 1
  • Designed to deliver the SAME Neulasta®* the next day over 45 minutes, approximately 27 hours after application, at home or other appropriate setting 1
  • Available at no extra cost beyond that of the Neulasta® prefilled syringe

*The same Neulasta® as in the prefilled syringe for manual injection.

Explore Neulasta® Onpro®:
On-body Injector preparation and application

The Neulasta® Onpro® 3D video features a 360° rotation of the On‑body Injector, and provides a guide to its parts and the application process.

If your Onpro kit contains a needle guard, this video will guide you through the application.

This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.

Offer your patients more scheduling flexibility

  • Patients can receive Neulasta® at home or at another appropriate setting on any day of the week, including weekends or holidays
  • Next-day follow-ups do not need to be coordinated with the timing of Neulasta® delivery

†Patient may need to return if there are concerns that they have received a partial or missed dose of Neulasta® with the On‑body Injector.

160,000 patients have experienced Neulasta® Onpro®2, *

95% of patients would choose Neulasta® Onpro® again if they needed Neulasta®3,†

95% of nurses would choose Neulasta® Onpro® for Neulasta®-appropriate patients3,‡

*Total Onpro® unit demand for the period through December 2016 was calculated using Amgen’s integrated data. A total of 660,742 Onpro® units were sold from launch through December 2016 (Source: integrated customer view data). On average, each patient receives 4.13 units of Neulasta®. Patients undergo around 4.13 chemo cycles with Neulasta® (Source: IMS OSCER data, patients completing therapy January 2016 through December 2016). One unit of Neulasta® is administered per chemo cycle.

Data from interviews with oncology patients who have had experience with Neulasta® (N = 227, PFS n = 150, Neulasta® Onpro® n = 77) conducted in November 2016. Patients who had received Neulasta® via Neulasta® Onpro® were asked to answer the question: Based on your personal experience getting your Neulasta® with Neulasta® Onpro®, if your doctor said you needed to use Neulasta® again in the future, would you request getting it with Neulasta® Onpro® again? Ninety-five percent of patients who had been administered Neulasta® Onpro® responded yes.

Data from interviews with oncology nurses (N = 250) conducted in October 2016. Respondents were asked if they agreed with this statement: Based on my Neulasta® Onpro® experience, when my patients are appropriate for Neulasta®, (PFS or Neulasta® Onpro®), I would choose Neulasta® Onpro®.

Neulasta® Onpro® in practice

Dr. Michael Danso Photo Dr. Michael Danso Photo Dr. Michael Danso Dr. Dana Thompson Photo Dr. Dana Thompson Photo Dr. Dana Thompson

Dr. Michael Danso and Dr. Dana Thompson describe their experiences with prescribing Neulasta® Onpro® and incorporating it into their practices.

4 steps for applying Neulasta® Onpro® 4

1
Prepare the application site
1) Prepare the application site.
2
Fill the On‑body Injector
2) Fill the On‑body Injector.
3
Confirm On‑body Injector activation
3) Confirm On‑body Injector activation.
4
Apply the On‑body Injector
4) Apply the On‑body injector.

The information provided in this guide does not replace the Healthcare Provider Instructions for Use. Prior to use, please review the Instructions for Use.

Watch the full application video

The healthcare provider video provides a detailed overview of the Neulasta® Onpro® kit, the full preparation and application process, and patient instructions upon leaving the clinic.

If your Onpro kit contains a needle guard, this video will guide you through the application.

This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.

Neulasta® Onpro® Resources

Help guide the patient experience

Help your patients understand their Neulasta® medication and Neulasta® Onpro® with educational and support materials.

Patient educational video

Patient Education Video

The patient educational video gives patients an overview of their Neulasta® medication and how the On‑body Injector for Neulasta® works.

This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta® Onpro® kit.

En español

Patient starter brochure

The patient starter brochure helps patients understand the risk of infection and how Neulasta® may help, and gives a detailed explanation of Neulasta® Onpro®.

Download now

Sharps container program

Sharps Container Program

Patients can complete an enrollment form or call 1‑844‑MYNEULASTA ( 1-844-696-3852) 24/7 to order a FREE sharps container for On‑body Injector disposal. Patients should receive their container in 7–10 business days.

24/7 telephone support

Phone Icon
24/7
telephone support

1‑844‑MYNEULASTA ( 1-844-696-3852) offers 24/7 telephone support for general questions on Neulasta® Onpro®.

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).

References: 1. Neulasta® (pegfilgrastim) Prescribing Information, Amgen. 2. Data on file, Amgen; 2016. 3. Data on file, Amgen; 2016. 4. Neulasta® (pegfilgrastim) Onpro® kit Healthcare Provider Instructions for Use, Amgen.

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.