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Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.
Neulasta is provided in two presentations:
The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the OBI for Neulasta contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.
Neulasta is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].
Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Neulasta is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)].
The recommended dosage of Neulasta for adults of any weight and pediatric patients weighing at least 45 kg with cancer receiving myelosuppressive chemotherapy is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer Neulasta between 14 days before and 24 hours after administration of chemotherapy.
Table 1. Dosing of Neulasta for Pediatric Patients Weighing Less Than 45 kg
| Body Weight | Neulasta Dose | Volume to Administer |
| Less than 10 kg* | See below* | See below* |
| 10 kg to 20 kg | 1.5 mg | 0.15 mL |
| 21 kg to 30 kg | 2.5 mg | 0.25 mL |
| 31 kg to 44 kg | 4 mg | 0.4 mL |
| * For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Neulasta. | ||
The recommended dosage of Neulasta for adults of any weight and pediatric patients weighing at least 45 kg with hematopoietic subsyndrome of acute radiation syndrome is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1 [see Dosage and Administration (2.1)]. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.
Obtain a baseline complete blood count (CBC). Do not delay administration of Neulasta if a CBC is not readily available. Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.
Neulasta is supplied in single-dose prefilled syringes for manual use or for use with the on-body injector (OBI) for Neulasta, which is co-packaged with a single-dose prefilled syringe for the OBI, and in single-dose vials [see Dosage Forms and Strengths (3)].
Before using any of the Neulasta presentations:
For adult patients of any weight and pediatric patients weighing 45 kg and greater, the single-dose prefilled syringe for manual use is intended for subcutaneous administration of a single 6 mg/0.6 mL dose of Neulasta. The syringe does not bear graduation marks and therefore does not allow for direct administration of doses less than 6 mg/0.6 mL.
The needle cap on the prefilled syringe contains dry natural rubber (derived from latex); persons with latex allergies should not administer this product.
For adult patients of any weight, the single-dose prefilled syringe for use with the OBI for Neulasta, is intended for subcutaneous administration of a single 6 mg/0.6 mL dose of Neulasta. The prefilled syringe co-packaged in the Neulasta Onpro® kit must only be used with the OBI for Neulasta [see Dosage and Administration (2.4)].
Use of the OBI for Neulasta is not recommended for patients with hematopoietic subsyndrome of acute radiation syndrome. Use of the OBI for Neulasta has not been studied in pediatric patients.
The needle cap on the prefilled syringe contains dry natural rubber (derived from latex); persons with latex allergies should not administer this product.
For pediatric patients weighing less than 45 kg, the dose is prepared by withdrawing the required volume from the 4 mg/0.4 mL single-dose vial. A 0.5 mL staked tuberculin syringe with 0.01 mL graduation marks is recommended for preparation and administration for dose accuracy. Only healthcare providers should prepare and administer doses from the vials.
Administer Neulasta subcutaneously.
Discard unused portion of Neulasta in single-dose vials. Do not save unused drug for later administration.
A healthcare provider must fill the on-body injector (OBI) with Neulasta using the prefilled syringe and then apply the OBI for Neulasta 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 OBI for Neulasta. Approximately 27 hours after the OBI for Neulasta is applied to the patient’s skin, Neulasta will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the OBI for Neulasta on the same day as the administration of chemotherapy, as long as the OBI for Neulasta delivers Neulasta no less than 24 hours after administration of chemotherapy.
The prefilled syringe co-packaged in Neulasta Onpro® kit must only be used with the OBI for Neulasta. The prefilled syringe contains additional solution to compensate for liquid loss during delivery through the OBI for Neulasta. If the prefilled syringe co-packaged in Neulasta Onpro kit is used for manual subcutaneous injection, the patient will receive an overdose. If the single-dose prefilled syringe for manual use is used with the OBI for Neulasta, the patient may receive less than the recommended dose.
Do not use the OBI for Neulasta to deliver any other drug product except the Neulasta prefilled syringe co-packaged with the OBI for Neulasta.
The OBI for Neulasta should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an OBI for Neulasta failure or leakage. If the patient misses a dose, a new dose should be administered by single-dose prefilled syringe for manual use, as soon as possible after detection.
Refer to the Healthcare Provider Instructions for Use for the OBI for Neulasta for full administration information.
Advise patients to avoid activities such as traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector (OBI) for Neulasta (this includes the 45-minute delivery period plus an hour post-delivery). Patients should have a caregiver nearby for the first use.
Refer the patient to the dose delivery information written on the Patient Instructions for Use. Provide training to patients to ensure they understand when the dose delivery of Neulasta will begin and how to monitor the OBI for Neulasta for completed delivery. Ensure patients understand how to identify signs of malfunction of OBI for Neulasta [see Warnings and Precautions (5.12) and Patient Counseling Information (17)]. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of Neulasta if they suspect that the device may not have performed as intended [see Warnings and Precautions (5.12)].
Neulasta is a clear, colorless, preservative-free solution available as:
Neulasta injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).
Neulasta is provided in a carton containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 55513-190-01).
Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration.
Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
Neulasta Onpro kit is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for Neulasta (NDC 55513-192-01).
The Neulasta injection single-dose prefilled syringe contains 0.64 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the OBI for Neulasta. The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle. The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).
Store Neulasta Onpro kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until 30 minutes prior to use. Because the OBI for Neulasta is at room temperature during the period of use, Neulasta Onpro kit should not be held at room temperature longer than 12 hours prior to use. Discard Neulasta Onpro kit if stored at room temperature for more than 12 hours. Do not freeze the kit. Keep in the carton until use to protect from light.
Do not shake the prefilled syringe.
Do not use the OBI for Neulasta if its packaging has been previously opened.
Neulasta injection is a clear, colorless, solution, supplied in a single-dose vial containing 4 mg pegfilgrastim.
Neulasta is provided in a carton containing one 4 mg/0.4 mL single-dose vial (NDC 55513-099-01).
Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Do not freeze. Discard unused vials stored at room temperature for more than 48 hours.
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080
Patent: https://pat.amgen.com/onpro
© 2002-2025 Amgen Inc. All rights reserved. www.neulasta.com
1-800-77-AMGEN (1-800-772-6436)
v29
Included as part of the PRECAUTIONS section.
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 (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 hypersensitivity reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Hypersensitivity reactions, including anaphylaxis, can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue Neulasta in patients with serious hypersensitivity reactions. Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim.
The on-body injector (OBI) for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Discontinue Neulasta if sickle cell crisis occurs.
Glomerulonephritis has occurred in patients receiving 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 Neulasta. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta.
White blood cell (WBC) counts of 100 × 109/L or greater have been observed in patients receiving Neulasta. Monitoring of complete blood count (CBC) during Neulasta therapy is recommended.
Neulasta can cause thrombocytopenia. Monitor platelet counts during Neulasta therapy.
Capillary leak syndrome has been reported after 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.
The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that Neulasta acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.
MDS and AML have been associated with the use of Neulasta in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Missed or partial doses have been reported in patients receiving Neulasta 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 using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of Neulasta if they suspect that the device may not have performed as intended.
Aortitis has been reported in patients receiving Neulasta. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta if aortitis is suspected.
Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including Neulasta, has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim.
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).
Overdosage of Neulasta may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered Neulasta on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)]. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Animal data and clinical data in humans suggest a correlation between pegfilgrastim exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of Neulasta is based on reducing the duration of severe neutropenia.
The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection. In healthy volunteers, the pharmacokinetics of pegfilgrastim were comparable when delivered subcutaneously via a manual prefilled syringe versus via the on-body injector (OBI) for Neulasta.
Specific PopulationsNo gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5)].
In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim.
The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies (14.1)]. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of Neulasta after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13). The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively.
The pharmacokinetics of pegfilgrastim is not available in patients acutely exposed to myelosuppressive doses of radiation. Based on limited pharmacokinetic data in irradiated non-human primates, the area under the concentration-time curve (AUC), reflecting the exposure to pegfilgrastim in non-human primates following a 300 mcg/kg dose of Neulasta, appears to be greater than in humans receiving a 6 mg dose. Results from population modeling and simulation indicate that two 6 mg doses of Neulasta administered one week apart in adults result in clinically relevant effects on duration of grade 3 and 4 neutropenia. In addition, weight-based dosing in pediatric patients weighing less than 45 kg [see Dosage and Administration (2.1, Table 1 and 2.2)] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Advise patients of the following risks and potential risks with Neulasta:
Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of Neulasta for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)].
Instruct patients who self-administer Neulasta using the single-dose prefilled syringe of the:
Advise patients on the use of the on-body injector (OBI) for Neulasta:
Neulasta® (pegfilgrastim)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080
Patent: https://pat.amgen.com/onpro/
© 2002-2025 Amgen Inc. All rights reserved. www.neulasta.com
1-800-77-AMGEN (1-800-772-6436)
v29
INSTRUCTIONS FOR USE
NEULASTA®(nu-las-tah)
(pegfilgrastim)
Guide to Parts
Neulasta Prefilled Syringe
On-body Injector for Neulasta
Important
Prescribing Information
For all questions, or if a patient calls you regarding any injector problems, call Amgen at 1-800-772-6436.
Place the syringe tray and the on-body injector tray on a clean, well-lit work surface.
Allow the syringe and on-body injector to come naturally to room temperature for 30 minutes prior to activating. Do not warm the kit components using a heat source.
Choose the patient’s injection site.
Ask the patient about their ability to monitor and remove the on-body injector.
Clean an area on the injection site larger than the on-body injector adhesive backing.
Thoroughly clean the site with alcohol to enhance on-body adherence to the skin.
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Remove Neulasta prefilled syringe from tray.
For safety reasons:
Inspect Neulasta prefilled syringe. Neulasta liquid should always be clear and colorless.
Remove air bubbles in prefilled syringe.
Injecting air bubbles could interfere with proper operation of the on-body injector.
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Center the needle directly over the medicine port and insert all the way into the port, avoiding sides.
Medicine port
Insert needle into medicine port at a 90 degree angle only.
Push the plunger rod to empty entire syringe contents into the on-body injector.
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Check to see if the on-body injector is full and the amber light is flashing. You should see a black line next to FULL on the fill indicator.
Firmly lift and remove the blue needle cover away from the on-body injector
Peel away both pull tabs to show the adhesive. Never touch hands or gloves to the adhesive.
Make sure skin is dry prior to applying the on-body injector.
Before the cannula inserts, securely apply the on-body injector so it is visible and can be monitored by the patient or caregiver.
You now have time to carefully apply the on-body injector without folding or wrinkling the adhesive.
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| Back of upper arm (triceps) Vertical with the light facing down toward the elbow |
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| Abdomen Horizontal with the light facing up and visible to the patient |
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 |
Do not worry if the on-body injector is quiet. When 3 minutes are up, the on-body injector will beep telling you the cannula is about to insert. |
Wait for the status light to turn green. This means the cannula has been inserted.
Do not remove the on-body injector during cannula insertion to avoid needle stick injury to you or to the patient.
|
Check the quality of adhesion before sending the patient home. |
If the adhesive is wrinkled in front of the cannula window or has folds anywhere that prevent the on-body injector from securely adhering, remove the on-body injector. Start again with a new kit and call Amgen at 1-800-772-6436.
Provide the Patient IFU Booklet for the patient to take home.
Fill in the Dose Delivery information on the booklet, and review the following instructions with your patient:
What to do if you hear beeping or when you look at status light and it is flashing red.
If at any time the on-body injector beeps continuously for 5 minutes, and the status light is flashing red, take the on-body injector off of the patient.
In all cases, do not use. Start over with a new Neulasta Onpro kit, and call Amgen at 1-800-772-6436.
What to do if your patient reports the status light is flashing red.
If the patient reports the status light is flashing red, they may not have received the full dose. Schedule a follow-up appointment with your patient.
What to do if your patient reports the adhesive is saturated with fluid or the on-body injector is dripping.
If the patient reports an on-body injector leak, they may not have received the full dose. Schedule a follow-up appointment with your patient.
In all cases report the incident to Amgen at 1-800-772-6436.
Neulasta® (pegfilgrastim)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080
Patent: https://pat.amgen.com/onpro/
© 2002-2025 Amgen Inc. All rights reserved. www.neulasta.com
1-800-77-AMGEN (1-800-772-6436)
v29
|
The following is an overview of on-body injector preparation steps. Read this section first |
|
To prepare and apply the on-body injector, you will use a pre- filled syringe to fill and activate it. As part of this process, the on-body injector uses lights and sounds as signals to help guide you through the preparation and application process. As you fill the on-body injector, the status light flashes amber and the on-body injector beeps 3 times. When the status light flashes amber and the on-body injector beeps, this means it has been properly filled and activated. After the on-body injector activates, you will have 3 full minutes to remove the blue needle guard and adhesive backing, and then apply the on-body injector to your patient.
When the status light flashes green, this means the on-body injector has successfully inserted the cannula. For all questions, or if a patient calls you regarding any on-body injector problems, call Amgen at 1-800-772-6436.  Turn over to continue with the Instructions for Use |
 |
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Symbol |
Meaning |
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Do not reuse this on-body injector. Single-use only |
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Refer to Instructions for Use |
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Do not use if packaging is damaged |
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Temperature limitation |
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Humidity limitation |
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Expiration date (use by date) |
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Reference/model number |
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Lot number |
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Type BF medical device (protection from electrical shock) |
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Sterilized by ethylene oxide |
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Waterproof up to 8 feet for 1 hour |
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Prescription use only |
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MR Unsafe |
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On-body injector for Neulasta® (pegfilgrastim) |
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Neulasta® (pegfilgrastim) prefilled syringe |
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Pressure Limitation |
Do not expose the on-body injector for Neulasta to the following environments as the on-body injector may be damaged and the patient could be injured:
Electromagnetic Compatibility
The information contained in this section (such as separation distances) is, in general, specifically written in regard to the on-body injector for Neulasta. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.
General Notes:
Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC), and needs to be installed and put into service according to the EMC information provided in this document.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Cables and accessories not specified within the instructions for use are not authorized. Using cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity).
Care should be taken if the on-body injector for Neulasta is used adjacent to other electrical equipment; if adjacent use is inevitable, the on-body injector for Neulasta should be observed to verify normal operation in this setting.
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Electromagnetic Emissions |
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The on-body injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of the on-body injector for Neulasta should ensure that it is used in such an environment. |
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Emissions |
Compliance according to |
Electromagnetic environment |
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RF Emissions (CISPR 11) |
Group 1 |
The on-body injector for Neulasta uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely tocause any interference in nearby equipment. |
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CISPR B Emissions Classification |
Class B |
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Electromagnetic Immunity |
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The on-body injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of this equipment should ensure that it is used in such an environment. |
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Immunity Test |
IEC 60601 Test Level |
Compliance Level |
Electromagnetic Environment-Guidance |
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ESD |
±8 kV Contact |
±8 kV Contact |
Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%. |
|
Power Frequency 50/60 Hz |
30 A/m |
30 A/m |
Power frequency magnetic fields should be that of typical commercial or hospital environment. |
|
Radiated RF Fields 61000-4-3 |
3 V/m |
(E1)=3 V/m |
Portable and mobile communications equipment should be separated from the on-body injector for Neulasta by no less than the distances calculated/listed below: |
| Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment | ||||||
| The on-body injector for Neulasta is intended for use in the radio frequency environment specified below. The user of this equipment should ensure that it is used in such an environment. | ||||||
| Test Frequency (MHz) |
Band a) (MHz) |
Service a) | Modulation b) | Maximum Power (W) | Distance (m) | Immunity Test Level (V/m) |
| 385 | 380-390 | TETRA 400 | Pulse modulationb) 18 Hz |
1.8 | 0.3 | 27 |
| 450 | 430-470 | GMRS 460,FRS 460 | FM c) ± 5 kHz deviation 1 kHz sine | 2 | 0.3 | 28 |
| 710 | 704-787 | LTE Band 13,17 | Pulse modulationb) 217 Hz |
0.2 | 0.3 | 9 |
| 745 | ||||||
| 780 | ||||||
| 810 | 800-960 | GSM 800/900,TETRA 800,iDEN 820,CDMA 850, LTE Band 5 | 18 Hz Pulse modulationb) | 2 | 0.3 | 28 |
| 870 | ||||||
| 930 | ||||||
| 1720 | 1700-1990 | GSM 1800;CDMA 1900;GSM 1900;DECT; LTE Band 1, 3,4, 25; UMTS | Pulse modulationb) 217 Hz |
2 | 0.3 | 28 |
| 1845 | ||||||
| 1970 | ||||||
| 2450 | 2400-2570 | Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | Pulse modulationb) 217 Hz |
2 | 0.3 | 28 |
| 5240 | 5100-5800 | WLAN 802.11 a/n | Pulse modulationb) 217 Hz | 0.2 | 0.3 | 9 |
| 5500 | ||||||
| 5785 | ||||||
| NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT OF ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. | ||||||
| a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. |
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| Recommended separation distances between portable and mobile RF communications equipment and the on-body injector for Neulasta | |||
| You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the on-body injector for Neulasta, as recommended below, according to the maximum power of the communication equipment. | |||
| Rated maximum output power of transmitter, in watts | Separation distance according to frequency of transmitter, in meters | ||
| 150 kHz to 80 MHz D=(3.5/V1)(√P) |
80 MHz to 800 MHz D=(3.5/E1)(√P) |
800 MHz to 2.5 GHz D=(7/E1)(√P) |
|
| 0.01 | 0.11667 | 0.11667 | 0.23333 |
| 0.1 | 0.36894 | 0.36894 | 0.73785 |
| 1 | 1.1667 | 1.1667 | 2.3333 |
| 10 | 3.6894 | 3.6894 | 7.3785 |
| 100 | 11.667 | 11.667 | 23.333 |
INSTRUCTIONS FOR USE
Neulasta® Onpro® (nu-las-tah)
(pegfilgrastim) injection
Single-Use On-body Injector
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Your On-body injector was applied: |
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| Injection of your dose (delivery) will start around: | |
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| Healthcare Provider name: | |
| Healthcare Provider contact number: | |
| On-body Injector lot number: | |
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| Parts and Signals | ||
| Status Light | ||
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Flashing Green:The on-body injector is working properly. Do not remove the on-body injector if the status light is flashing green. |
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Solid Green (or off): Signals dose delivery is complete. Check to see if fill indicator reads empty. | |
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Flashing Red: On-body injector error. If you hear beeping at any time, check the status light. If it is flashing red, call your healthcare provider right away as you may need a replacement dose. | |
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Fill Indicator:Black line shows how much Neulasta is in the on-body injector. | |
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Contents |
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IMPORTANT INFORMATION Learn about your Neulasta On-body Injector. |
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STEP 1: MONITOR What to expect from your device for most of the day. |
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STEP 2: OBSERVE What to watch for during dose delivery and what to do if there is an issue. |
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STEP 3: VERIFY Understand when delivery is complete and when you may remove the device. |
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STEP 4: FINISH Confirm the dose was delivered and dispose of the device. |
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FAQ When it is safe to remove your on-body injector and answers to frequently asked questions. |
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Check your on-body injector often for leaks during the 45-minute dose delivery. If the on-body injector was placed on the back of your arm, a caregiver must be available to check your on-body injector. |
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Check to see if the status light is SOLID GREEN or has switched off. This means the dose is complete. If the dose is complete, go to the next step. Do not remove the on-body injector if the status light is flashing green. |
If you see the status light is FLASHING RED, and your on-body injector is beeping, your on- body injector is not functioning properly. Call your healthcare provider right away, as you may need a replacement dose. |
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Check to see if your on-body injector is empty. |
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What to do if you hear beeping or when you look at the status light and it is flashing red?
What do I do if the on-body injector comes off before the full dose is delivered?
What if there is blood at my application site after the on-body injector has been removed?
What if my application site is red or tender after on-body injector removal?
Neulasta® (pegfilgrastim)
Manufactured by:
Amgen Inc
One Amgen Center Drive
Thousand Oaks, California 91320-1799 US License No. 1080
Patent: https://pat.amgen.com/onpro/
© 2002 to 2025 Amgen Inc. All rights reserved. https://www.neulasta.com
1-844-MYNEULASTA (1-844-696-3852)
Revised: 08/2025 V11
INSTRUCTIONS FOR USE
Neulasta (nu-las-tah) (pegfilgrastim)
injection, for subcutaneous use
Single-Dose Prefilled Syringe
Important: The needle is covered by the gray needle cap before use.
ImportantRead the Patient Information for important information you need to know about Neulasta before using these Instructions for Use.
Before you use a Neulasta prefilled syringe, read this important information. Storing the prefilled syringe
Using the prefilled syringe
Check the expiration date.
Important: Do not use if the expiration date has passed.
Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature, 68°F to 77°F (20°C to 25°C), for 30 minutes before you give an injection.
Open the tray by peeling away the cover. Grab the blue safety guard to remove the prefilled syringe from the tray.
For safety reasons:
Make sure the medicine in the prefilled syringe is clear and colorless. It is normal to see air bubbles in the syringe.
In all cases, use a new prefilled syringe and call your healthcare provider.
You can use:
Clean the injection site with an alcohol wipe. Let the skin dry.
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Before you finish! |
For your safety, pull the blue safety guard until it clicks and covers the needle.
Once extended, the blue safety guard will lock into position and will not slide back over the needle.
Keep your hands away from the needle at all times.
Important: Always keep the sharps disposal container out of the reach of children.
If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080
Patent: https://pat.amgen.com/onpro/
Ó 2002-2025 Amgen Inc. All rights reserved. 1xxxxxx
Revised: 08/2025 v4
