Neulasta

pegfilgrastim · Kit · Subcutaneous

Prescription (Rx) Leukocyte Growth Factor

Uses

Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Neulasta is indicated in adult and pediatric patients 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) ] . Limitations of Use Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Neulasta is indicated to increase survival in adults and pediatric patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] .

Dosage and administration

Patients with cancer receiving myelosuppressive chemotherapy For adult patients of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is 6 mg subcutaneously once per chemotherapy cycle. ( 2.1 ) For pediatric patients weighing less than 45 kg, use weight-based dosing; refer to Table 1. ( 2.1 ) Do not administer between 14 days before and 24 hours after administration of chemotherapy. ( 2.1 ) Patients acutely exposed to myelosuppressive doses of radiation For adults of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is two doses, 6 mg each, subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. ( 2.2 ) For pediatric patients weighing less than 45 kg, use weight-based dosing; refer to Table 1. ( 2.1 ) 2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy 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 For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Neulasta. 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 2.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome 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. 2.3 Preparation and Administration 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: Remove the carton from the refrigerator and allow the Neulasta prefilled syringe or vial to reach room temperature, 20°C to 25°C (68°F to 77°F), for a minimum of 30 minutes. Do not warm in any other way. Discard any prefilled syringe or vial left at room temperature for greater than 48 hours. Neulasta is a clear, colorless, preservative-free solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed. Prefilled Syringe for Manual Use 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. Prefilled Syringe for Use with OBI 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. Vial 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 vials. Do not save unused drug for later administration. 2.4 Special Healthcare Provider Instructions for the On-body Injector for Neulasta 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.

Dosage forms and strengths

Neulasta is a clear, colorless, preservative-free solution available as: Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only. Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta (Neulasta Onpro kit). Injection: 4 mg/0.4 mL in a single-dose vial. Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for manual use only. ( 3 ) Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe co-packaged with the on-body injector for Neulasta. ( 3 ) Injection: 4 mg/0.4 mL solution in a single-dose vial. ( 3 )

Contraindications

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) ] . In patients with a history of serious hypersensitivity reaction to pegfilgrastim or filgrastim. ( 4 )

Warnings and precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in patients with ARDS. ( 5.2 ) Serious hypersensitivity reactions, including anaphylaxis: Permanently discontinue Neulasta in patients with serious hypersensitivity reactions. ( 5.3 ) 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. ( 5.4 ) Fatal sickle cell crises: Discontinue Neulasta if sickle cell crisis occurs. ( 5.5 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Neulasta if causality is likely. ( 5.6 ) Thrombocytopenia: Monitor platelet counts. ( 5.8 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using Neulasta in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. ( 5.11 ) Potential device failures: Instruct patients to notify their healthcare provider if they suspect the on-body injector may not have performed as intended. ( 5.12 ) Large and Medium Vessel Arteritis: Discontinue Neulasta if arteritis is suspected. ( 5.13 ) 5.1 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. 5.2 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. 5.3 Serious Hypersensitivity Reactions 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. 5.4 Allergies to Acrylics 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. 5.5 Use in Patients with Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Discontinue Neulasta if sickle cell crisis occurs. 5.6 Glomerulonephritis 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. 5.7 Leukocytosis White blood cell (WBC) counts of 100 × 10 9 /L or greater have been observed in patients receiving Neulasta. Monitoring of complete blood count (CBC) during Neulasta therapy is recommended. 5.8 Thrombocytopenia Neulasta can cause thrombocytopenia. Monitor platelet counts during Neulasta therapy. 5.9 Capillary Leak Syndrome 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. 5.10 Potential for Tumor Growth Stimulatory Effects on Malignant Cells 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. 5.11 Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer 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. 5.12 Potential Device Failures 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. 5.13 Large and Medium Vessel Arteritis Serious large and medium vessel arteritis, including 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, headache, neck pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider arteritis in patients who develop these signs and symptoms without known etiology.

Side effects

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Allergies to Acrylics [see Warnings and Precautions (5.4) ] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.5) ] Glomerulonephritis [see Warnings and Precautions (5.6) ] Leukocytosis [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.10) ] Myelodysplastic syndrome [see Warnings and Precautions (5.11) ] Acute myeloid leukemia [see Warnings and Precautions (5.11) ] Large and Medium Vessel Arteritis [see Warnings and Precautions (5.13) ] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles. The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m 2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American, or other. The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo-controlled clinical trials are bone pain and pain in extremity. Table 2. Adverse Reactions with ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3 Body System Adverse Reaction Placebo (N = 461) Neulasta 6 mg SC on Day 2 (N = 467) Musculoskeletal and connective tissue disorders Bone pain 26% 31% Pain in extremity 4% 9% Leukocytosis In clinical studies, leukocytosis (WBC counts > 100 × 10 9 /L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Splenic rupture and splenomegaly (enlarged spleen) [see Warnings and Precautions (5.1) ] Acute respiratory distress syndrome (ARDS) [see Warnings and Precautions (5.2) ] Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria, generalized erythema, and flushing [see Warnings and Precautions (5.3) ] Sickle cell crisis [see Warnings and Precautions (5.5) ] Glomerulonephritis [see Warnings and Precautions (5.6) ] Leukocytosis [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] Injection site reactions Sweet's syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis Application site reactions (including events such as application site hemorrhage, application site pain, application site discomfort, application site bruise, and application site erythema) have been reported with the use of the on-body injector for Neulasta. Contact dermatitis and local skin reactions such as rash, pruritus, and urticaria have been reported with the use of the on-body injector for Neulasta, possibly indicating a hypersensitivity reaction to the adhesive. Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy [see Warnings and Precautions (5.11) ] Large and medium vessel arteritis, including aortitis [see Warnings and Precautions (5.13) ] Alveolar hemorrhage

Use in specific populations

8.1 Pregnancy Risk Summary Although available data with Neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). 8.2 Lactation Risk Summary There are no data on the presence of pegfilgrastim in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neulasta and any potential adverse effects on the breastfed child from Neulasta or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of Neulasta for chemotherapy-induced neutropenia and hematopoietic subsyndrome of acute radiation syndrome have been established in pediatric patients. Use of Neulasta in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 8 months and older with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . The use of Neulasta to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in animals and clinical data supporting the use of Neulasta in patients with cancer receiving myelosuppressive chemotherapy. Efficacy studies of Neulasta could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Results from population modeling and simulation indicate that two doses of Neulasta (Table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.1 , 2.2) , Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] . 8.5 Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Pregnancy

Pediatric use

8.4 Pediatric Use The safety and effectiveness of Neulasta for chemotherapy-induced neutropenia and hematopoietic subsyndrome of acute radiation syndrome have been established in pediatric patients. Use of Neulasta in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 8 months and older with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1) ] . The use of Neulasta to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in animals and clinical data supporting the use of Neulasta in patients with cancer receiving myelosuppressive chemotherapy. Efficacy studies of Neulasta could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Results from population modeling and simulation indicate that two doses of Neulasta (Table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see Dosage and Administration (2.1 , 2.2) , Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] .

Geriatric use

8.5 Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Overdosage

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.

Description

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 (pegfilgrastim) is a sterile, clear, colorless, preservative-free solution with a pH of 4.0, 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, or in single-dose vials. Prefilled Syringe for Manual Use or for Use with OBI Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). On-body injector (OBI) for Neulasta is supplied with a prefilled syringe containing 0.64 mL of Neulasta in solution that delivers 0.6 mL of Neulasta in solution when used with the OBI for Neulasta. The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta. The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the OBI for Neulasta contains pegfilgrastim (6 mg based on protein weight), acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP. Vial Neulasta for subcutaneous injection is supplied in 4 mg/0.4 mL single-dose vials. Each 0.4 mL vial contains pegfilgrastim (4 mg based on protein weight), acetate (0.24 mg), polysorbate 20 (0.02 mg), sodium (0.01 mg), and sorbitol (20 mg) in Water for Injection, USP.

Mechanism of action

12.1 Mechanism of Action 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.

How supplied

Neulasta single-dose prefilled syringe for manual use 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 at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light or physical damage. 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. Do not shake. Neulasta Onpro ® kit 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 refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. 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. Do not shake the prefilled syringe. Do not use the OBI for Neulasta if its packaging has been previously opened. Neulasta single-dose vial Neulasta injection is a clear, colorless, solution, supplied in a vial containing 4 mg pegfilgrastim. Neulasta is provided in a carton containing one 4 mg/0.4 mL vial (NDC 55513-099-01). Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Discard vials stored at room temperature for more than 48 hours. Do not shake.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Discard vials stored at room temperature for more than 48 hours. Do not shake.

Patient information

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: Splenic rupture and splenomegaly Acute Respiratory Distress Syndrome Serious hypersensitivity reactions Sickle cell crisis Glomerulonephritis Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive Neulasta in conjunction with chemotherapy and/or radiation therapy Capillary Leak Syndrome Arteritis, including aortitis 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 prefilled syringe of the: Importance of following the Instructions for Use. Dangers of reusing syringes. Importance of following local requirements for proper disposal of used syringes. Advise patients on the use of the on-body injector (OBI) for Neulasta: Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient. Refer the patient to the dose delivery information written on the Patient Instructions for Use. Tell the patient when their dose delivery of Neulasta will begin and when their dose delivery should be completed. Advise the patient that serious hypersensitivity reactions can happen with Neulasta. Patients should have a caregiver nearby for the first use. Patients should plan to be in a place where they can appropriately monitor the OBI for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery. Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26 to 29 following application of the OBI for Neulasta. If the OBI for Neulasta is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the OBI for Neulasta. If a patient calls the healthcare provider regarding any OBI for Neulasta problems, the healthcare provider is advised to call Amgen at 1-800-772-6436. Advise the patient: to call their healthcare provider immediately if the status light on the OBI for Neulasta is flashing red (see the Patient Instructions for Use) . to inform their healthcare provider if the adhesive on the OBI for Neulasta becomes saturated with fluid, or there is dripping, as this may be evidence of significant product leakage, resulting in inadequate or missed dose (see the Patient Instructions for Use) . to keep the OBI for Neulasta dry for approximately the last 3 hours prior to the dose delivery start to better enable potential leak detection. that the OBI for Neulasta should only be exposed to temperatures between 5°C to 40°C (41°F and 104°F). to keep the OBI for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves, and other common appliances. Failure to keep the OBI for Neulasta at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta. that if the needle is exposed after OBI for Neulasta removal, place the used OBI for Neulasta in a sharps disposal container to avoid accidental needle stick and call their healthcare provider immediately. to remove the OBI for Neulasta after the green light shines continuously and to place the used OBI for Neulasta in a sharps disposal container (see the Patient Instructions for Use) . Advise the patient: do not reapply the OBI for Neulasta if the OBI for Neulasta comes off before full dose is delivered and instead call their healthcare provider immediately, as they may need a replacement dose. avoid bumping the OBI for Neulasta or knocking the OBI for Neulasta off the body. do not use other materials to hold the on-body injector in place that could cover audio/visual indicators or compress the on-body injector against the patient's skin, as this could dislodge the cannula and lead to a missed dose or incomplete dose of Neulasta. do not expose the OBI for Neulasta to medical imaging studies (e.g., X-ray scan, MRI, CT scan and ultrasound), radiation treatment, and oxygen rich environments such as hyperbaric chambers to avoid OBI for Neulasta damage and patient injury. Advise the patient to avoid: airport X-ray scans and request a manual pat down instead; remind patients who elect to request a manual pat down to exercise care to avoid having the OBI for Neulasta dislodged during the pat down process. sleeping on the OBI for Neulasta or applying pressure on the OBI for Neulasta as this may affect OBI for Neulasta performance. getting body lotions, creams, oils, and cleaning agents near the OBI for Neulasta as these products may loosen the adhesive. use of lotions, creams, or oils on their arms and abdomen prior to their next scheduled OBI for Neulasta dose (to help with device adherence to the skin). using bath tubs, hot tubs, whirlpools, or saunas and avoid exposing the OBI for Neulasta to direct sunlight as these may affect the drug. peeling off or disturbing the OBI for Neulasta adhesive before delivery of full dose is complete.

Label text from the FDA structured product label by Amgen, Inc (revised Aug 10, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Pegfilgrastim in 2 products

Neulasta NDC products (3)

NDC	Strength & form	Labeler	Type
55513-099	Pegfilgrastim 4 mg/.4mL Solution	Amgen, Inc	BLA
55513-190	Pegfilgrastim 6 mg/.6mL Injection	Amgen, Inc	BLA
55513-192	Kit	Amgen, Inc	BLA