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

Dr. Michael Danso describes his experience with prescribing Neulasta® Onpro®

Watch video
 
Recent modifications to the Neulasta® Onpro® kit include approximately 35% smaller packaging,2 an updated fill symbol on the adhesive backing, and a co-packaged prefilled syringe without a needle guard. Prior to use, please review the Instructions for Use.

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 chemotherapy1
  • Designed to deliver the SAME Neulasta®* the next day, approximately 27 hours after application, at home or other appropriate setting1
  • Available at no extra cost beyond that of the Neulasta® prefilled syringe

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

Explore in 3D:
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.

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 other 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.

Approximately 44,000 patients received Onpro® in 20153

Neulasta® Onpro® has been put into practice by over 2,900 accounts§3

‡Data from Amgen integrated customer view data for all of 2015 and Oncology Services Comprehensive Electronic Records (OSCER) electronic health record database from January to November 2015. Estimated number of patients prescribed Neulasta® Onpro® (n = 43,731) was extrapolated by dividing the total number of Neulasta® Onpro® units sold (166,177, based on Amgen integrated customer view data) by the average number of prefilled syringes for manual injection used per patient (3.8, based on OSCER database information).3

§Data from Amgen integrated customer view data from January to December 2015. Calculation for the estimated number of accounts that ordered Neulasta® Onpro® (n = 2,981) included all accounts that ordered at least one unit of Neulasta® Onpro® in 2015.3

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 here is an abbreviated summary and does not replace the Healthcare Provider Instructions for Use. Prior to use, please review the Instructions for Use.

Note: The Instructions for Use do not require gloves to be worn for application of the On‑body Injector.

Watch the full application video

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

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 Neulasta® and Neulasta® Onpro® with educational and support materials.

Patient educational video

Patient educational 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

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

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. 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.

Indication

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.

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.

Indication

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.

See More Close
Back to top
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.