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Pegfilgrastim-cbqv is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble, 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. During the pegfilgrastim-cbqv manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product. To produce pegfilgrastim-cbqv, a 20 kDa monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-cbqv is approximately 39 kDa.
UDENYCA (pegfilgrastim-cbqv) injection is supplied in 0.6 mL prefilled syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).
Each syringe contains 6 mg pegfilgrastim-cbqv (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.
UDENYCA is indicated 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].
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see DOSAGE AND ADMINISTRATION and Clinical Studies].
The recommended dosage of UDENYCA 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 UDENYCA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
The recommended dose of UDENYCA 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. 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 UDENYCA 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.
UDENYCA is administered subcutaneously via a single-dose prefilled autoinjector, a single-dose prefilled syringe for manual use or for use with the on-body injector (OBI) for UDENYCA, which is co-packaged with a single dose prefilled syringe for OBI. Use of the OBI for UDENYCA is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome. Use of the OBI has not been studied in pediatric patients.
Prior to use‚ remove the carton from the refrigerator and allow UDENYCA to reach room temperature for a minimum of 30 minutes. Discard any UDENYCA left at room temperature for greater than 48 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer UDENYCA if discoloration or particulates are observed.
The needle cap on the prefilled syringe and prefilled autoinjector is not made with natural rubber latex.
The UDENYCA prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks which are necessary to accurately measure doses of UDENYCA less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.
Table 1. Dosing of UDENYCA for pediatric patients weighing less than 45 kg
| Body Weight | UDENYCA Dose | Volume to Administer |
| Less than 10 kg* | See below* | See below* |
| 10 – 20 kg | 1.5 mg | 0.15 mL |
| 21 – 30 kg | 2.5 mg | 0.25 mL |
| 31 – 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 UDENYCA | ||
The UDENYCA prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45 kg. The UDENYCA prefilled autoinjector delivers the entire contents (6 mg in 0.6 mL) in a single injection and is not adjustable.
Only adults can self-administer UDENYCA with the prefilled autoinjector. If subcutaneous injections can be given at home, refer the patient or caregiver to the dose delivery information provided in the INSTRUCTIONS FOR USE. Provide training to patients or caregivers to ensure they understand how to administer UDENYCA via the prefilled autoinjector. Ensure patients or caregivers understand how to identify that a full dose has been administered by listening for the second ‘click’ and checking that the ‘Orange Indicator’ completely blocks the viewing window. Instruct patients or caregivers using the prefilled autoinjector to notify their healthcare provider immediately in order to determine the need for a replacement dose of UDENYCA if they suspect that the full dose may not have been administered.
A healthcare provider must fill the on-body injector (OBI) with UDENYCA using the prefilled syringe and then apply the OBI for UDENYCA 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 UDENYCA. Approximately 27 hours after the OBI for UDENYCA is applied to the patient’s skin, UDENYCA will be delivered over approximately 5 minutes. A healthcare provider may initiate administration with the OBI for UDENYCA on the same day as the administration of cytotoxic chemotherapy, as long as the OBI for UDENYCA delivers UDENYCA no less than 24 hours after administration of cytotoxic chemotherapy.
The prefilled syringe co-packaged in UDENYCA ONBODY must only be used with the OBI for UDENYCA. The prefilled syringe contains additional solution to compensate for liquid loss during filling of the OBI and delivery through the OBI for UDENYCA. If the prefilled syringe co-packaged in UDENYCA ONBODY 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 UDENYCA, the patient may receive less than the recommended dose.
Do not use the OBI for UDENYCA to deliver any other drug product except the UDENYCA prefilled syringe copackaged with the OBI for UDENYCA.
The OBI for UDENYCA should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an OBI for UDENYCA 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 UDENYCA 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 UDENYCA (this includes the 5-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 INSTRUCTIONS FOR USE. Provide training to patients to ensure they understand when the dose delivery of UDENYCA will begin and how to monitor the OBI for UDENYCA for completed delivery. Ensure patients understand how to identify signs of malfunction of OBI for UDENYCA [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended [see WARNINGS AND PRECAUTIONS].
UDENYCA is a clear, colorless, preservative free solution available as:
UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe containing 6 mg pegfilgrastim-cbqv, supplied with a 29-gauge, ½-inch needle with an UltraSafe Passive™ Needle Guard.
The needle cap of the prefilled syringe is not made with natural rubber latex.
UDENYCA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 70114-101-01).
UDENYCA 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. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.
Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard UDENYCA stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard UDENYCA if frozen more than once.
UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose autoinjector containing 6 mg pegfilgrastim-cbqv.
The needle cap of the prefilled autoinjector is not made with natural rubber latex.
UDENYCA is provided in a dispensing pack containing one 6 mg/0.6 mL prefilled autoinjector (NDC 70114-120-01).
The UDENYCA prefilled autoinjector is not suitable for use in pediatric patients weighing less than 45 kg. The UDENYCA prefilled autoinjector delivers the entire contents (6 mg in 0.6 mL) in a single injection and is not adjustable.
Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard UDENYCA stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard UDENYCA if frozen more than once.
UDENYCA ONBODY is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for UDENYCA (NDC 70114-130-01).
The UDENYCA injection single-dose prefilled syringe contains 0.67 mL of a clear, colorless solution that delivers 6 mg/0.6 mL of pegfilgrastim-cbqv when used with the OBI for UDENYCA. The prefilled syringe is supplied with a 29-gauge, 1/2-inch needle. The syringe does not bear graduation marks and is only to be used with the OBI for UDENYCA.
The needle cap of the prefilled syringe is not made with natural rubber latex.
Store UDENYCA ONBODY in the refrigerator at 2°C to 8°C (36°F to 46°F) until 30 minutes prior to use. Because the OBI for UDENYCA is at room temperature during the period of use, UDENYCA ONBODY should not be held at room temperature longer than 12 hours prior to use. Discard UDENYCA ONBODY if stored at room temperature for more than 12 hours.
Do not use the OBI for UDENYCA if its packaging has been previously opened.
Manufactured by: Coherus BioSciences, Inc., Redwood City, California 94065-1442. Revised: Dec 2023
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
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.
Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim 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 pegfilgrastim 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/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg pegfilgrastim (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 pegfilgrastim Patients Compared to Placebo in
Study 3
| Body System Adverse Reaction |
Placebo (N = 461) |
pegfilgrastim 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 x 109/L) was observed in less than 1% of 932 patients with nonmyeloid malignancies receiving pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of pegfilgrastim or of other pegfilgrastim products.
Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.
The following adverse reactions have been identified during post approval use of pegfilgrastim products. 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.
No Information Provided
Included as part of the "PRECAUTIONS" Section
Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving UDENYCA.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving UDENYCA for ARDS. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions. Do not administer UDENYCA to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products.
The on-body injector (OBI) for UDENYCA 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 pegfilgrastim products. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis has occurred in patients receiving pegfilgrastim products. 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 pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of UDENYCA.
White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts.
Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, 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 products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
MDS and AML have been associated with the use of pegfilgrastim products 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 UDENYCA 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 UDENYCA if they suspect that the device may not have performed as intended.
Aortitis has been reported in patients receiving pegfilgrastim products. 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 UDENYCA if aortitis is suspected.
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
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 UDENYCA:
Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim products 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].
Instruct patients who self-administer UDENYCA using the single-dose prefilled syringe of the:
For patients who will use the UDENYCA prefilled autoinjector, tell them that they:
When injection has finished, there will be a second ‘click’ and the ‘Orange Indicator’ will completely block the viewing window.
Advise patients on the use of the on-body injector (OBI) for UDENYCA:
No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products.
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).
Although available data with UDENYCA or pegfilgrastim product 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 embryo lethality 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.
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).
There are no data on the presence of pegfilgrastim products 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 UDENYCA and any potential adverse effects on the breastfed child from UDENYCA or from the underlying maternal condition.
The safety and effectiveness of UDENYCA have been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature.
Use of UDENYCA in pediatric patients for chemotherapy-induced neutropenia is based on UDENYCA’s approval as a biosimilar to pegfilgrastim and evidence from adequate and well controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients with sarcoma [see CLINICAL PHARMACOLOGY and Clinical Studies].
The use of UDENYCA to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on UDENYCA’s approval as a biosimilar to pegfilgrastim and evidence from efficacy studies of pegfilgrastim conducted in animals and clinical data supporting the use of pegfilgrastim in patients with cancer receiving myelosuppressive chemotherapy. Efficacy studies of pegfilgrastim products 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 pegfilgrastim (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, CLINICAL PHARMACOLOGY and Clinical Studies].
Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.
Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see ADVERSE REACTIONS].
UDENYCA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see WARNINGS AND PRECAUTIONS].
Pegfilgrastim products are colony-stimulating factors that act 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 products exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of UDENYCA is based on reducing the duration of severe neutropenia.
The pharmacokinetics of pegfilgrastim were studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim were 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 pegfilgrastim 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 UDENYCA.
No 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].
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]. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of pegfilgrastim 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 pegfilgrastim, 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 pegfilgrastim 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, Table 1] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.
Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were activecontrolled studies that employed doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of pegfilgrastim. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 x 109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of pegfilgrastim was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.
In Study 1, 157 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.
Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of pegfilgrastim-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)].
A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.
Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x109/L) was lower for pegfilgrastim-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the pegfilgrastim-treated patients compared to the placebo-treated patients.
Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics [see CLINICAL PHARMACOLOGY] of pegfilgrastim in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous pegfilgrastim as a single dose of 100 mcg/kg (n= 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n=6) following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the pegfilgrastim and filgrastim groups. The most common adverse reaction reported was bone pain.
Efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval of this indication was based on efficacy studies conducted in animals and data supporting pegfilgrastim’s effect on severe neutropenia in patients with cancer receiving myelosuppressive chemotherapy [see DOSAGE AND ADMINISTRATION].
The recommended dose of UDENYCA is two doses, 6 mg each, administered one week apart for humans exposed to myelosuppressive doses of radiation. For pediatric patients weighing less than 45 kg, dosing of UDENYCA is weight based and is provided in Table 1 [see DOSAGE AND ADMINISTRATION]. This dosing regimen is based on population modeling and simulation analyses. The exposure associated with this dosing regimen is expected to provide sufficient pharmacodynamic activity to treat humans exposed to myelosuppressive doses of radiation [see CLINICAL PHARMACOLOGY]. The safety of pegfilgrastim at a dose of 6 mg has been assessed on the basis of clinical experience in patients with cancer receiving myelosuppressive chemotherapy.
The efficacy of pegfilgrastim for the acute radiation syndrome setting was studied in a randomized, placebocontrolled non-human primate model of radiation injury. Rhesus macaques were randomized to either a control (n = 23) or treated (n = 23) cohort. On study day 0, animals (n = 6 to 8 per irradiation day) were exposed to total body irradiation (TBI) of 7.50 ± 0.15 Gy delivered at 0.8 ± 0.03 Gy/min, representing a dose that would be lethal in 50% of animals by 60 days of follow-up (LD50/60). Animals were administered subcutaneous injections of a blinded treatment (control article [5% dextrose in water] or pegfilgrastim [300-319 mcg/kg/day]) on study day 1 and on study day 8. The primary endpoint was survival. Animals received medical management consisting of intravenous fluids, antibiotics, blood transfusions, and other support as required.
Pegfilgrastim significantly (at 0.0014 level of significance) increased 60-day survival in irradiated non-human primates: 91% survival (21/23) in the pegfilgrastim group compared to 48% survival (11/23) in the control group.
UDENYCA®
(yoo-den-i-kah)
(pegfilgrastim-cbqv) injection, on-body injector for UDENYCA
What is the most important information I need to know about receiving UDENYCA with the on-body injector for UDENYCA?
What is UDENYCA?
UDENYCA is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.
Do not take UDENYCA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.
Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive UDENYCA?
See the INSTRUCTIONS FOR USE for detailed information about how you will receive a dose of UDENYCA with the on-body injector for UDENYCA, and how to remove and dispose of the on-body injector for UDENYCA.
While the on-body injector for UDENYCA is in place you should avoid:
What are the possible side effects of UDENYCA?
UDENYCA may cause serious side effects, including:
If you have an allergic reaction during the delivery of UDENYCA, remove the on-body injector for UDENYCA by grabbing the edge of the adhesive pad and peeling off the on-body injector for UDENYCA. Get emergency medical help right away.
The most common side effect of UDENYCA is pain in your bones, and in your arms, and legs. These are not all the possible side effects of UDENYCA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of UDENYCA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about UDENYCA, talk with your healthcare provider or pharmacist. You can ask your pharmacist for information about UDENYCA that is written for health professionals.
What are the ingredients in UDENYCA?
Active ingredient: pegfilgrastim-cbqv
Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in Water for Injection.
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: December 2023
INSTRUCTIONS FOR USE
UDENYCA [yoo-den-i-kah] ONBODY™
(pegfilgrastim-cbqv)
injection, for subcutaneous use
Guide to Parts
UDENYCA Prefilled Syringe
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On-body Injector for UDENYCA
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Important
READ THE FOLLOWING INSTRUCTIONS BEFORE USING UDENYCA ONBODY
Prescribing Information
Application Information
Environmental Information
Cautions
Storage Information
For all questions, call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692). If a patient calls you regarding any on-body injector problems, call Coherus BioSciences at 1 800-4UDENYCA (1-800-483-3692).
Step 1: Prepare
A| Remove ONBODY from the refrigerator and open carton.
Place the syringe tray and on-body injector tray on a clean, flat, well-lit work surface. Allow to come to room temperature for 30 minutes prior to use. Do not warm the UDENYCA ONBODY components using a heat source.
Check to make sure it contains:
Check the above listed items for damage and check the expiry date on the syringe tray and on-body injector tray.
Do not use the on-body injector:
B| Choose the patient’s injection site.
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Choose the flattest site for the on-body injector application.
Ask the patient about their ability to monitor and remove the on-body injector.
C| Clean an area on the injection site larger than the on-body injector adhesive backing.
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Step 2: Get ready
A| Open on-body injector tray and remove plastic lid.
Wash your hands before use.
Open the on-body injector tray by fully removing the tray cover and removing the plastic lid.
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B| Remove UDENYCA prefilled syringe from tray.
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For safety reasons:
C| Inspect medicine and UDENYCA prefilled syringe. UDENYCA liquid should always be clear and colorless.
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In all the above cases, start again with a new UDENYCA ONBODY. Call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).
D| Remove air bubbles in prefilled syringe.
Injecting air bubbles into the on-body injector could interfere with the full-dose delivery.
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E| Orient the syringe with the needle facing downwards. Center the needle directly over the metal medicine port at a 90-degree angle. Insert the needle all the way into the port, avoiding sides.
Insert needle into metal medicine port at a 90-degree angle only.
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F| Fully depress the plunger rod to expel entire contents of the prefilled syringe into the on-body injector.
After filling completely, you will hear two beeps. The status light will start to flash green.
Remove the needle straight from the metal medicine port and dispose the empty syringe right away into a puncture proof container.
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G| Check to see if the on-body injector is full.
You should see the green status light flashing and a black line next to FULL on the fill indicator. If this is not the case, do not use.
Start again with a new UDENYCA ONBODY, and call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).
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H| Remove on-body injector from tray, then firmly squeeze and lift the green fill guide away from the on-body injector.
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Dispose of green fill guide.
A drop of medicine may be visible on the metal medicine port when the green fill guide is removed.
Step 3: Apply
A| 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.
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In all cases, start again with a new UDENYCA ONBODY.
Call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).
B| Securely apply the on-body injector without folding and without wrinkling to the cleaned injection site so it is visible and can be monitored by the patient or caregiver.
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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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Check the quality of adhesion before sending the patient home.
If the adhesive is wrinkled or has folds anywhere that prevent the on-body injector from securely adhering, remove the on-body injector. Start again with a new ONBODY and call Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).
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Step 4: Finish
A| Provide the Instructions for Use Booklet for the patient to take home. Fill in the Dose Delivery information on the Instructions for Use Booklet, and review the following instructions with your patient:
Attention!
What to do if you hear beeping or when you look at status light and it is flashing red?
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If at any time the on-body injector beeps continuously for five 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 UDENYCA ONBODY, and call 1-800- 4UDENYCA (1-800-483-3692).
If the patient reports the red status light is on, they may not have received the full dose. Schedule a follow-up appointment and report the incident to Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).
What to do if the adhesive becomes saturated with fluid or the on-body injector is dripping.
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If the patient reports an on-body injector leak, they may not have received the full dose. Schedule a follow-up appointment and report the incident to Coherus BioSciences at 1-800-4UDENYCA (1-800-483-3692).
Electromagnetic Compatibility
The delivery system is designed to conform to the electromagnetic compatibility (EMC) standard IEC 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments.
To avoid electromagnetic interference (EMI) that may affect the performance of the delivery system [(i) Dose accuracy, (ii) treatment duration, (iii) Injection Depth, (iv) Visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (EMI), such as MRI, ionizing radiation, CT, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. In addition, portable and mobile RF communication equipment, such as RF emitters, cellular telephones, 2-way radios, Bluetooth™ devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness.
If you identify or suspect that external RF sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the EMI source.
Electromagnetic Emissions
The delivery system has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
| The delivery system has been tested for Electromagnetic Emissions | ||
| Emissions Test | Test Level | Compliance Level |
| Radiated Emission per IEC 60601-1-2/ CISPR 11 | Frequency range: 30 - 1000 MHz |
Group 1 Class B, Home Healthcare Environment |
| Radiated Emission per ETSI EN 301 489-1,ETSI EN 301 489-17 and EN 55032 | Frequency range: 30 - 6000 MHz |
Class B, Home Healthcare Environment |
If this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician.
Electromagnetic Immunity
The delivery system has been tested to comply in either a Home Healthcare Environment or Professional Healthcare Environment.
| The delivery system has been tested for Electromagnetic Immunity | ||
| Immunity Test | IEC Test Level | Compliance Level |
| Electrostatic discharge(ESD)per IEC 61000-4-2 | ±8 kV Contact ±2 kV, ±4 kV, ±8 kV, ±15 kV Air |
±8 kV Contact ±15 kV Air |
| Radiated RF EM fields per IEC 61000-4-3 |
10 V / m, 80 MHz- 2.7 GHz, 80 % AM at 1 kHz |
10 V / m, 80 MHz- 2.7 GHz, 80 % AM at 1 kHz |
| Rated Power Frequency (50 / 60 Hz) magnetic fields per IEC 61000-4-8 | 30 A/ m | 30 A/ m |
| Proximity magnetic fields per IEC 61000-4-39 |
8 A/ m, 30kHz, CW; |
8 A/ m, 30kHz, CW; 65 A/ m, 134.2kHz, PM 2.1kHz 50%; 7.5 A/ m, 13.56MHz, PM 50kHz 50% |
Proximity fields from RF wireless communications equipment Immunity
The delivery system is tested per IEC 61000-4-3 at Frequencies and Levels as specified below to ensure Enclosure Port Immunity to RF wireless communications equipment.
| Test Frequency (MHz) |
Band (MHz) |
Service | Modulation | Immunity Test Level (V / m) |
| 385 | 380 to 390 | TETRA 400 | Pulse modulation 18 Hz | 27 |
| 450 | 430 to 470 | GMRS 460, FRS 460 | FM± 5 kHz deviation 1 kHz sine | 28 |
| 710, 745, 780 | 704 to 787 | LTE Band 13, 17 | Pulse modulation 217 Hz | 9 |
| 810, 870, 930 | 800 to 960 | GSM 800 / 900, TETRA 800, | Pulse modulation 18 Hz | 28 |
| 1720, 1845, 1970 | 1 700 to 1 900 | GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS |
Pulse modulation 217 Hz | 28 |
| 2450 | 2 400 to 2 570 | Bluetooth, WLAN, 802.11 b/ g/ n, RFID 2450,LTE Band 7 | Pulse modulation 217 Hz | 28 |
| 5240, 5500, 5785 | 5 100 to 5 800 | WLAN 802.11 a/ n | Pulse modulation 217 Hz | 9 |
| If necessary to achieve the immunity test level, the distance between the transmitting antenna and the me equipment or me system may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. | ||||
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Delivery System. Otherwise, degradation of the performance of this equipment could result.
WARNING: Use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Symbols Glossary
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INSTRUCTIONS FOR USE
UDENYCA [yoo-den-i-kah] ONBODYTM
(pegfilgrastim-cbqv)
injection, for subcutaneous use
Dose Delivery Information
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| Your On-body injector was applied: | ||
| _______________________________________________________ | ||
| Day | Time | AM / PM |
| Injection of your dose (delivery) will start around: | ||
| _______________________________________________________ | ||
| Day | Time | AM / PM |
| Healthcare Provider Name: | ||
| _______________________________________________________ | ||
| Healthcare Provider contact number: | ||
| _______________________________________________________ | ||
| On-body injector lot number: | ||
Get to Know Your On-body Injector
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Important Information
On-body Injector for UDENYCA Description
Warnings
Wearing the On-body Injector
Environmental Precautions
A healthcare provider who is familiar with UDENYCA should answer your questions. For general questions or support call 1-800-4UDENYCA (1-800-483-3692) or visit www.udenyca.com.
Step 1: Monitor On-body Injector
A| For the next 27 hours, occasionally check the status light for at least 10 seconds. If the status light is flashing green, it is okay.
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Step 2: Observe Dose Delivery
A| After about 27 hours, your on-body injector will begin to deliver your dose of UDENYCA.
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Check your on-body injector often for leaks during the 5-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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Step 3: Verify Dose Complete
A| After the beep, check the color of the status light.
Check to see if the status light is SOLID GREEN or has switched off. This means the dose is complete.
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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.
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Call your healthcare provider right away, as you may need a replacement dose.
B| Grab the edge of the adhesive pad. Slowly peel off the on-body injector.
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Step 4: Finish
Check to see if your on-body injector is empty.
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A| Check off the box below to record how your on-body injector looks after use.
B| Properly dispose of the on-body injector.
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Frequently Asked Questions
How do I know it is safe to remove the on-body injector?
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It is safe to remove the on-body injector after checking the following:
What to do if you hear beeping or when you look at status light and it is flashing red?
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What do I do if the on-body injector comes off before the full dose is delivered?
Call your healthcare provider right away if the on-body injector at any time comes away from your skin before your full dose delivery, as you may need a replacement dose.
Do not reapply it. Caution the needle may be exposed. Dispose of the on-body injector into a sharps disposal container right away.
What if there is blood at my application site after the on-body injector has been removed?
If there is blood, press a clean cotton ball or gauze pad on the application site. Apply an adhesive bandage if needed.
What if my application site is red or tender after on-body injector removal?
Call your healthcare provider right away if you experience persistent or worsening redness or tenderness at the application site, as this can be a sign of infection.
