Pegfilgrastim, a covalent conjugate of filgrastim and monomethoxypolyethylene glycol,1 is a biosynthetic hematopoietic agent that principally affects the proliferation and differentiation of neutrophils within the bone marrow.1, 2, 4, 6, 7, 8
Pegfilgrastim-jmdb, pegfilgrastim-pbbk, pegfilgrastim-apgf, pegfilgrastim-fpgk, pegfilgrastim-cbqv, and pegfilgrastim-bmez are biosimilar to pegfilgrastim (Neulasta®).15, 16, 17, 18, 19, 20 The US Food and Drug Administration (FDA) defines a biosimilar as a biological that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency.170, 171 The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies).171 Therefore, biosimilarity of 2 drugs may be established even when there are formulation or minor structural differences or minor differences in rates of adverse effects between the drugs as long as these differences are not clinically meaningful.171 Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological.171 In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alternation or switch.169 Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.169 None of the available pegfilgrastim biosimilars has interchangeable data at this time.172
In this monograph, unless otherwise stated, the term “pegfilgrastim products” refers to pegfilgrastim (the reference drug) and its biosimilars (pegfilgrastim-jmdb, pegfilgrastim-pbbk, pegfilgrastim-apgf, pegfilgrastim-fpgk, pegfilgrastim-cbqv, and pegfilgrastim-bmez).
Several pegfilgrastim biosimilars are available and biosimilarity of these products has been demonstrated for the ability to decrease infection occurrence in patients with non-myeloid malignancies who are administered myelosuppressive chemotherapeutic agents associated with a clinically significant incidence of febrile neutropenia.1, 15, 16, 17, 18, 19, 20 Biosimilarity of all available pegfilgrastim products has not been demonstrated for use in patients with acute exposure to myelosuppressive doses of radiation; only the reference pegfilgrastim (Neulasta®) and the biosimilars (pegfilgrastim-pbbk, pegfilgrastim-fpgk, pegfilgrastim-cbqv, and pegfilgrastim-bmez) are currently indicated for this use.1, 16, 18, 19, 20 Pegfilgrastim products are not indicated for use in the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.1, 15, 16, 17, 18, 19, 20
Clinical practice guidelines on the use of myeloid growth factors, such as pegfilgrastim, have been published.238, 239 These guidelines focus on recommendations related to the use of these agents in reducing the risk of febrile neutropenia in patients at increased risk for associated complications.238, 239 The American Society of Clinical Oncology (ASCO) guideline specifically states that pegfilgrastim and biosimilars (as they become available) can be used for the prevention of treatment-related febrile neutropenia and that the choice of agent depends on convenience, costs, and clinical situation.238
Chemotherapy-Induced Neutropenia
Pegfilgrastim and its biosimilars (pegfilgrastim-jmdb, pegfilgrastim-pbbk, pegfilgrastim-apgf, pegfilgrastim-fpgk, pegfilgrastim-cbqv, pegfilgrastim-bmez) are used to reduce the incidence of infection, as seen by the presence of febrile neutropenia, in patients with non-myeloid malignancies administered myelosuppressive chemotherapeutic agents associated with a clinically significant incidence of febrile neutropenia.1, 15, 16, 17, 18, 19, 20
Efficacy of pegfilgrastim has been evaluated in 3 randomized, double-blind, controlled studies.1 Studies 1 and 2 were active-controlled studies involving patients with metastatic breast cancer receiving doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 every 21 days for up to 4 cycles.1, 12, 13 Based on evidence from studies of filgrastim indicating that a correlation exists between duration of severe neutropenia and incidence of febrile neutropenia, efficacy of pegfilgrastim was demonstrated by establishing comparability between pegfilgrastim and filgrastim therapy with respect to the mean number of days of severe neutropenia.1 In Study 1 and 2, the incidence, severity, and duration of severe neutropenia (absolute neutrophil count [ANC] <500/mm3) were similar in patients receiving a single fixed (6 mg) or weight-adjusted (100 mcg/kg) subcutaneous dose of pegfilgrastim on day 2 of each chemotherapy cycle or daily subcutaneous injections of filgrastim (5 mcg/kg) starting on day 2 of each chemotherapy cycle and continuing for up to 14 days.1, 10, 11, 12, 13 In these studies, the mean duration of severe neutropenia during the first chemotherapy cycle was 1.7 to 1.8 or 1.6 days in patients receiving pegfilgrastim or filgrastim, respectively, and febrile neutropenia occurred in 10 to 20% of patients receiving either pegfilgrastim or filgrastim.12, 13 In the absence of growth factor support, febrile neutropenia or severe neutropenia has been reported in 30 to 40 or 100%, respectively, of patients receiving similar chemotherapy regimens, with severe neutropenia having a mean duration of 5 to 7 days.1
Study 3 was a randomized, double-blind, placebo-controlled study involving 928 patients with breast cancer who were treated with docetaxel 100 mg/m2 every 21 days for up to 4 cycles.1, 240 Patients were randomly assigned to pegfilgrastim 6 mg as a single subcutaneous injection or placebo on day 2 of each 21-day cycle.1, 240 Results revealed that the incidence of febrile neutropenia for all cycles was substantially reduced among patients administered pegfilgrastim as compared to placebo (1% versus 17%).1, 240 Patients administered pegfilgrastim also experienced a reduced incidence of hospitalization (1% versus 14%) and IV antibiotic use (2% versus 10%).1, 240
The efficacy of pegfilgrastim was also evaluated in a multicenter, randomized, open-label study in 43 pediatric and young adult patients (0 to 21 years of age) with sarcoma administered dose-intensive vincristine-doxorubicin-cyclophosphamide/ifosfamide-etoposide (VDC/IE) chemotherapy.1, 241 Patients were randomly assigned to pegfilgrastim 100 mcg/kg as a single subcutaneous dose or filgrastim 5 mcg/kg/day following myelosuppressive chemotherapy.1, 241 Overall recovery of neutrophil counts was similar in both treatment groups.1, 241
The product labeling of all available pegfilgrastim biosimilars references the above clinical data in their respective clinical studies sections.15, 16, 17, 18, 19, 20
Acute Exposure to Myelosuppressive Doses of Radiation
The reference pegfilgrastim product (Neulasta®) and the biosimilars (pegfilgrastim-pbbk, pegfilgrastim-fpgk, pegfilgrastim-cbqv, and pegfilgrastim-bmez) are used to improve survival in patients acutely exposed to myelosuppressive radiation doses.1, 16, 18, 19, 20
Due to ethical and feasibility issues, efficacy studies evaluating pegfilgrastim in humans with acute radiation syndrome could not be performed.1, 16, 18, 19, 20 The administration of pegfilgrastim for this indication is based on studies conducted in animals and data from studies evaluating the impact of pegfilgrastim on severe neutropenia in patients with cancer receiving myelosuppressive chemotherapy.1, 16, 18, 19, 20 The approved dosage regimen is based on population modeling and simulation analyses.1, 16, 18, 19, 20
Dispensing and Administration Precautions
Administer pegfilgrastim products by subcutaneous injection via a single-dose prefilled syringe.1, 15, 16, 17, 18, 19, 20
Pegfilgrastim (Neulasta Onpro® kit) and pegfilgrastim-cbqv (Udenyca Onbody®) are also administered subcutaneously via an on-body injector (OBI), co-packaged with a single-dose prefilled syringe.1, 19 These products are not recommended for use in patients acutely exposed to myelosuppressive doses of radiation and not evaluated in pediatric patients.1, 19
Fill the OBI with pegfilgrastim or pegfilgrastim-cbqv using the prefilled syringe and apply to intact, non-irritated skin on the abdomen or back of arm (only if a caregiver is available).1, 19 Administration with the OBI can be initiated on the same day as chemotherapy, as long as the OBI delivers the drug no <24 hours after administration of chemotherapy.1, 19
Only use the co-packaged prefilled syringe with the OBI.1, 19 If the co-packaged prefilled syringe is used for manual subcutaneous injection, an overdose will occur.1, 19 Conversely, if the prefilled syringe for manual use is used with the OBI, the patient may receive less than the recommended dose.1, 19
Refer to the pegfilgrastim (Neulasta®) and pegfilgrastim-cbqv (Udenyca®) product labeling for more detailed instructions on the use of the OBI.1, 19
Pegfilgrastim-cbqv (Udenyca®) is also administered subcutaneously via a single-dose prefilled autoinjector.19 This product is not suitable for use in pediatric patients who weigh <45 kg.19 Provide training to ensure that patients understand how to use and identify that a full dose has been administered.19
Refer to the pegfilgrastim-cbqv product labeling for more detailed instructions on the use of the prefilled autoinjector.19
Store the prefilled syringe under refrigeration (2-8°C) and protect from light; do not shake.1, 15, 16, 17, 18, 19, 20 Prior to administration, remove from refrigeration and allow the prefilled syringe to reach room temperature for at least 30 minutes (at least 15 to 30 minutes for pegfilgrastim-bmez).1, 15, 16, 17, 18, 19, 20 Avoid freezing the prefilled syringe.1, 15, 16, 17, 18, 19, 20 If frozen, thaw in the refrigerator before use.1, 15, 16, 17, 18, 19, 20 Discard the prefilled syringe if frozen more than once.1, 15, 16, 17, 18, 19, 20 Refer to the product labeling of each pegfilgrastim product for specific information on when to dispose a prefilled syringe left at room temperature as time periods vary among the products.1, 15, 16, 17, 18, 19, 20
Store the pegfilgrastim (Neulasta Onpro®) kit and pegfilgrastim-cbqv (Udenyca Onbody®) under refrigeration (2-8°C) until 30 minutes prior to administration.1, 19 Do not keep at room temperature for >12 hours prior to use.1, 19 Discard the kit if stored at room temperature for >12 hours.1 Do not use if packaging has been opened prior.1, 19
Store the pegfilgrastim-cbqv (Udenyca®) single-dose prefilled autoinjector under refrigeration (2-8°C), protect from light, and do not shake.19 Discard if left at room temperature for >48 hours.19 Do not freeze; however, if frozen, thaw in the refrigerator prior to use.19 Throw away if frozen more than one time.19
Visually inspect any pegfilgrastim products for particulate matter and discoloration prior to administration.1, 15, 16, 17, 18, 19, 20 Do not administer pegfilgrastim products if particulate matter or discoloration is observed.1, 15, 16, 17, 18, 19, 20
Chemotherapy-induced Neutropenia
The recommended dosage of pegfilgrastim or biosimilars (pegfilgrastim-jmdb, pegfilgrastim-pbbk, pegfilgrastim-apgf, pegfilgrastim-fpgk, pegfilgrastim-cbqv, pegfilgrastim-bmez) is a single 6 mg subcutaneous injection given once per chemotherapy cycle.1, 15, 16, 17, 18, 19, 20
Do not administer pegfilgrastim products between 14 days before and 24 hours after administration of cytotoxic chemotherapy.1, 15, 16, 17, 18, 19, 20
Acute Exposure to Myelosuppressive Doses of Radiation
The recommended subcutaneous dosage of pegfilgrastim (Neulasta®), pegfilgrastim-pbbk (Fylnetra®), pegfilgrastim-fpgk (Stimufend®), pegfilgrastim-cbqv (Udenyca®), and pegfilgrastim-bmez (Ziextenzo®) is 2 doses (6 mg each) given one week apart.1, 16, 18, 19, 20 Give the first dose as soon as possible after suspected or confirmed exposure to radiation doses >2 Gray.1, 16, 18, 19, 20 Administer the second dose 1 week after the initial dose.1, 16, 18, 19, 20
Obtain a baseline CBC; do not delay therapy if a CBC is not readily available.1, 16, 18, 19, 20
Estimate the level of radiation exposure via clinical findings (e.g., time to vomiting onset, lymphocyte depletion kinetics), biodosimetry (if available), and information from public health authorities.1, 16, 18, 19, 20
Chemotherapy-induced Neutropenia
The recommended dosage of pegfilgrastim or biosimilars (pegfilgrastim-jmdb, pegfilgrastim-pbbk, pegfilgrastim-apgf, pegfilgrastim-fpgk, pegfilgrastim-cbqv, pegfilgrastim-bmez) is a single 6 mg subcutaneous injection given once per chemotherapy cycle.1, 15, 16, 17, 18, 19, 20 Table 1 lists dosing recommendations for pediatric patients weighing <45 kg.1, 15, 16, 17, 18, 19, 20 The pegfilgrastim product prefilled syringes are not designed to allow for direct administration of doses <0.6 mL.1, 15, 16, 17, 18, 19, 20
Do not administer pegfilgrastim products between 14 days before and 24 hours after administration of cytotoxic chemotherapy.1, 15, 16, 17, 18, 19, 20
Acute Exposure to Myelosuppressive Doses of Radiation
The recommended subcutaneous dosage of pegfilgrastim (Neulasta®), pegfilgrastim-pbbk (Fylnetra®), pegfilgrastim-fpgk (Stimufend®), pegfilgrastim-cbqv (Udenyca®), and pegfilgrastim-bmez (Ziextenzo®) is 2 doses (6 mg each) given one week apart.1, 16, 18, 19, 20 Give the first dose as soon as possible after suspected or confirmed exposure to radiation doses >2 Gray.1, 16, 18, 19, 20 Administer the second dose 1 week after the initial dose.1, 16, 18, 19, 20 For pediatric patients weighing <45 kg, see dosing information in Table 1.1, 16, 18, 19, 20
Obtain a baseline CBC; do not delay therapy if a CBC is not readily available.1, 16, 18, 19, 20
Estimate the level of radiation exposure via clinical findings (e.g., time to vomiting onset, lymphocyte depletion kinetics), biodosimetry (if available), and information from public health authorities.1, 16, 18, 19, 20
The manufacturer makes no specific dosage recommendations for patients with hepatic impairment.1, 15, 16, 17, 18, 19, 20
The manufacturer makes no specific dosage recommendations for patients with renal impairment.1, 15, 16, 17, 18, 19, 20
The manufacturer makes no specific dosage recommendations for geriatric patients.1, 15, 16, 17, 18, 19, 20
Splenic rupture, including fatal cases, has been reported with therapy.1, 15, 16, 17, 18, 19, 20 Monitor patients for left upper abdominal pain or shoulder pain as these symptoms may be suggestive of an enlarged spleen or splenic rupture.1, 15, 16, 17, 18, 19, 20
Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) has been reported with therapy.1, 15, 16, 17, 18, 19, 20 Monitor patients for the development of fever and lung infiltrates or respiratory distress as these signs and symptoms may be suggestive of ARDS.1, 15, 16, 17, 18, 19, 20 Discontinue pegfilgrastim products in patients with ARDS.1, 15, 16, 17, 18, 19, 20
Serious allergic reactions, including anaphylaxis, have been reported with therapy.1, 16, 15, 17, 18, 19, 20 Most of these reactions occur upon initial exposure to pegfilgrastim products.1, 15, 16, 17, 18, 19, 20 Serious allergic reactions, including anaphylaxis, can recur within days after discontinuing treatment for the initial reaction.1, 15, 16, 17, 18, 19, 20 Permanently discontinue pegfilgrastim products in patients with serious allergic reactions.1, 15, 16, 17, 18, 19, 20 Do not administer pegfilgrastim products to patients with a history of serious allergic reactions to these products or filgrastim.1, 15, 16, 17, 18, 19, 20
Severe sickle cell crises, including fatal cases, have been reported in patients with sickle cell disorders administered pegfilgrastim products; discontinue therapy if a sickle cell crisis occurs.1, 15, 16, 17, 18, 19, 20
Glomerulonephritis has been reported with therapy.1, 15, 16, 17, 18, 19, 20 If glomerulonephritis is suspected, assess for the underlying etiology.1, 15, 16, 17, 18, 19, 20 If a pegfilgrastim product is the likely cause, reduce the dose or interrupt therapy.1, 15, 16, 17, 18, 19, 20
Leukocytosis (WBC ≥100,000/mm3) has been reported with therapy; monitor complete blood count (CBC) during treatment.1, 15, 16, 17, 18, 19, 20
Thrombocytopenia has been reported with therapy; monitor platelet counts.1, 15, 16, 17, 18, 19, 20
Symptoms of capillary leak syndrome (e.g., hypotension, hypoalbuminemia, edema, hemoconcentration) may occur with therapy.1, 15, 16, 17, 18, 19, 20 The syndrome may be life-threatening if treatment is delayed; closely monitor patients who develop capillary leak syndrome and initiate symptomatic treatment.1, 15, 16, 17, 18, 19, 20
Tumor Growth Stimulatory Effects
Pegfilgrastim products may potentially act as growth factors for any tumor type.1, 15, 16, 17, 18, 19, 20
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
Patients with breast and lung cancer who receive pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy may potentially develop MDS and AML.1, 15, 16, 17, 19, 20 Monitor these patients for signs and symptoms of MDS/AML.1, 15, 16, 17, 18, 19, 20
Signs and symptoms of aortitis (e.g., fever, abdominal pain, malaise, back pain, and increased inflammatory markers) have been reported with therapy and may occur as soon as the initial week of treatment; discontinue pegfilgrastim products if aortitis is suspected.1, 15, 16, 17, 18, 19, 20
Transient positive bone imaging changes may occur due to the increased hematopoietic bone marrow activity observed with growth factor therapy.1, 15, 16, 17, 18, 19, 20 These changes should be taken into consideration when interpreting bone imaging results.1, 15, 16, 17, 18, 19, 20
The pegfilgrastim and pegfilgrastim-cbqv on-body injectors (OBIs) use acrylic adhesive.1, 19 Use of these products may result in a significant allergic reaction in patients with sensitivity to acrylic adhesives.1, 19
The pegfilgrastim and pegfilgrastim-cbqv OBI may not perform as intended, resulting in missed or partial doses.1, 19 This may lead to an increased risk of neutropenia, febrile neutropenia, and/or infection.1, 19 If it is suspected that the OBI has not performed as intended, patients should notify their healthcare provider immediately in order to determine the need for a replacement dose.1, 19
Anti-drug antibodies have been detected with pegfilgrastim product use.1, 15, 16, 17, 18, 19, 20 Of 849 patients with metastatic breast cancer, 51 (6%) had pre-existing binding antibodies.1, 15, 16, 17, 18, 19, 20 In another evaluation of 521 pegfilgrastim-treated patients, 4 patients who were negative for binding antibodies at baseline developed antibodies following treatment, but none had evidence of neutralizing antibodies.1, 15, 16, 17, 18, 19, 20
There are insufficient data involving the use of pegfilgrastim products in pregnant women; however, there are data from published studies in pregnant women exposed to filgrastim products.1, 15, 16, 17, 18, 19, 20 These studies have not established a link between filgrastim product use during pregnancy and adverse maternal or fetal outcomes.1, 15, 16, 17, 18, 19, 20
In studies involving pregnant rats, no evidence of reproductive or developmental toxicity was noted with administration of cumulative doses of pegfilgrastim approximately 10 times the recommended human dose.1, 15, 16, 17, 18, 19, 20 However, in pregnant rabbits, increased embryolethality and spontaneous abortions were seen with administration of pegfilgrastim at approximately 4 times the recommended human dose.1, 15, 16, 17, 18, 19, 20
It is not known whether pegfilgrastim products are distributed into milk, affect milk production, or affect the breast-fed infant.1, 15, 16, 17, 18, 19, 20 Other filgrastim products secrete poorly into breast milk and are not absorbed orally by neonates.1, 15, 16, 17, 18, 19, 20 Weigh the developmental and health benefits of breastfeeding along with the clinical need for pegfilgrastim products against any potential adverse effects of therapy on the breast-fed child.1, 15, 16, 17, 18, 19, 20
The efficacy and safety of pegfilgrastim products have been established in pediatric patients.1, 15, 16, 17, 18, 19, 20 Based on postmarketing data and a review of the scientific literature, no safety differences between adult and pediatric patients have been identified.1, 15, 16, 17, 18, 19, 20
The use of pegfilgrastim products in pediatric patients for chemotherapy-induced neutropenia is based on studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma.1, 15, 16, 17, 18, 19, 20 The use of pegfilgrastim in pediatric patients who experienced acute exposure to myelosuppressive radiation is based on studies conducted in animals and clinical data supporting use in patients with cancer administered myelosuppressive chemotherapy.1, 16, 18, 19, 20
In clinical studies of pegfilgrastim, 139 (15%) of 932 patients with cancer were ≥65 years of age and 18 (2%) were ≥75 years of age.1, 15, 16, 17, 18, 19, 20 There were no differences in effectiveness or safety observed between patients ≥65 years of age and younger patients.1, 15, 16, 17, 18, 19, 20
Renal impairment, including end stage renal disease, had no effect on the pharmacokinetics of pegfilgrastim in a study involving 30 subjects with varying degrees of renal dysfunction.1, 15, 16, 17, 18, 19, 20
The most common (≥5% difference in incidence as compared to placebo) adverse reactions include bone pain and pain in extremity.1, 15, 16, 17, 18, 19, 20
No formal drug interaction studies involving the pegfilgrastim products have been performed.1, 15, 16, 17, 18, 19, 20
Pegfilgrastim, a covalent conjugate of filgrastim (a human granulocyte colony-stimulating factor [G-CSF]) and monomethoxypolyethylene glycol (PEG),1, 10, 12 is a biosynthetic hematopoietic agent that principally affects the proliferation and differentiation of neutrophils within the bone marrow.1, 2, 4, 6, 7, 8, 10, 11 Filgrastim used in the manufacture of pegfilgrastim is produced using recombinant DNA technology and cultures of Escherichia coli that have been genetically modified to incorporate the human G-CSF gene1, 10, 11 and is identical to that contained in commercially available filgrastim (recombinant DNA origin) (Neupogen®). Studies on cellular proliferation, receptor binding, and neutrophil function demonstrate that filgrastim and pegfilgrastim have the same mechanism of action.1, 10, 11
As a result of conjugation with PEG, renal clearance of the drug is delayed and the plasma half-life is increased from about 3.5 hours (reported for filgrastim) to about 15-80 hours, and the PEG-conjugated drug can be administered once per chemotherapy cycle.1, 10, 11 Pegfilgrastim exhibits nonlinear, dose-dependent pharmacokinetics in cancer patients.1, 11 The level of circulating neutrophils in the body affects serum clearance of pegfilgrastim, resulting in a rapid decline in serum concentrations of the drug with resolution of neutropenia; the mechanism of this effect involves receptor binding.1, 11
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 6 mg/0.6 mL | Fulphila® (available in prefilled disposable syringes) |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 6 mg/0.6 mL | Fylnetra® (available in prefilled disposable syringes) |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 6 mg/0.6 mL | Nyvepria® (available in prefilled disposable syringes) |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 6 mg/0.6 mL | Stimufend® (available in prefilled disposable syringes) |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 6 mg/0.6 mL | Udenyca® (available in prefilled disposable syringes) | |
6 mg/0.6 mL | Udenyca® (available in prefilled autoinjector) | |||
6 mg/0.6 mL | Udenyca Onbody® (available in prefilled syringe co-packaged with on-body injector) |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for subcutaneous use | 6 mg/0.6 mL | Ziextenzo® (available in prefilled disposable syringes) |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions August 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Amgen Inc. Neulasta® (pegfilgrastim) injection prescribing information. Thousand Oaks, CA; 2025 Jan.
2. Amgen. Neupogen (filgrastim) prescribing information. Thousand Oaks, CA; 2021 Feb.
4. Hollinad LM, Goa KL. Recombinant granulocyte colony-stimulating factor (rG-CSF): a review of its pharmacological properties and prospective role in neutropenic conditions. Drugs . 1991; 42:300-30. [PubMed 1717226]
6. Lieschke GJ, Burgess AW. Granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor. (First of two parts.) N Engl J Med . 1992; 327:28-35.
7. Welte K, Bonilla MA, Gabrilove JL et al. Recombinant human granulocyte-colony stimulating factor: in vitro and in vivo effects on myelopoiesis. Blood Cells . 1987; 13:17-30. [PubMed 3311216]
8. Cohen AM, Zsebo KM, Inoue H et al. In vivo stimulation of granulopoiesis by recombinant human granulocyte colony-stimulating factor. Proc Natl Acad Sci USA . 1987; 84:2484-8. [PubMed 3550811]
10. Anon. Pegfilgrastim (Neulasta) for prevention of febrile neutropenia. Med Lett Drugs Ther 2002; 44:44-5.
11. Curran MP, Goa KL. Pegfilgrastim. Drugs . 2002; 62:1207-13. [PubMed 12010086]
12. Holmes FA, O'Shaughnessy JA, Vukelja S et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol . 2002; 20:727-31. [PubMed 11821454]
13. Green M, Koelbl H, Baselga J et al. A randomized, double-blind, phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol . 2003;14:29-35.
15. Mylan Pharmaceuticals Inc. Fulphila® (pegfilgrastim-jmdb) injection prescribing information. Morgantown, WV; 2021 Oct.
16. Amneal Pharmaceuticals LLC. Fylnetra® (pegfilgrastim-pbbk) injection prescribing information. Bridgewater, NJ; 2025 April.
17. Hospira Inc. Nyvepria® (pegfilgrastim-apgf) injection prescribing information. Lake Forest, IL; 2021 Oct.
18. Fresenius Kabi USA, LLC. Stimufend® (pegfilgrastim-fpgk) injection prescribing information. Lake Zurich, IL; 2025 Mar.
19. Coherus Biosciences, Inc. Udenyca® (pegfilgrastim-cbqv) injection prescribing information. Redwood City, CA; 2023 Dec.
20. Sandoz Inc. Ziextenzo® (pegfilgrastim-bmez) injection prescribing information. Princeton, NJ; 2024 Feb.
21. Institute for Safe Medication Practices. ISMP's list of confused drug names. ISMP website. Accessed 2023 Mar 7.
169. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Considerations in demonstrating interchangeability with a reference product guidance for industry. Guidance for industry. From FDA website. [Web]
170. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Guidance for industry. From FDA website. [Web]
171. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. From FDA website. [Web]
172. Food and Drug Administration. FDA Purple Book Database of Licensed Biological Products. Rockville, MD. From FDA website. Accessed 2023 Mar 6. [Web]
238. Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2015;33:3199-212.
239. Crawford J, Becker PS, Armitage JO, et al. Myeloid growth factors. Version 2.2017. Clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2017;15:1520-41.
240. Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005;23:1178-84.
241. Spunt SL, Irving H, Frost J, et al. Phase II, randomized, open-label study of pegfilgrastim-supported VDC/IE chemotherapy in pediatric sarcoma patients. J Clin Oncol. 2010;28:1329-36.