UDENYCA pegfilgrastim-cbqv 6 mg/.6mL Injection, Solution, 1 syringe — NDC 69448-025-63 (Billing 69448-0025-63)
This is a package of 1 syringe of UDENYCA pegfilgrastim-cbqv 6 mg/.6mL Injection, Solution from Accord BioPharma, Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 079223
- GCN: 45679
- GPI-14 (Medi-Span): 8240157010E520
- HICL (First Databank): 045445
- AHFS class code: 20:16.00.00
- RxCUI (RxNorm): 2102703
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Leukocyte Growth Factor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It helps lower the risk of serious infection with fever in people with non-myeloid cancers getting chemotherapy. Neulasta is also used to improve survival after exposure to dangero...
- For chemotherapy, Neulasta is given once per cycle. It is not given in the 14 days before or the 24 hours after chemotherapy. Your care team will set the exact timing.
- Bone pain and pain in the arms or legs are the most common. Rash, flushing and injection site reactions can also happen.
- Get help for trouble breathing, facial swelling, or hives. Also report pain in the left upper belly or shoulder, fever with breathing problems, or a sickle cell crisis.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $2,644.36 | $1,586.62 / 0.6 ml |
| Medicare drug plans payPart D · Q2 2026 | $6,917.98 | $4,150.79 / 0.6 ml |
| Medicare Part B allowsASP · Q5111 | $149.133 / Q5111 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Sep 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 69448-0025-63 You're viewing this Main listing | 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE | 2025-12-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Udenyca 6 mg/.6mLthis 69448-0025-63 | Accord | 1 syringe | — | — | FDA listed | — |
| Udenyca 6 mg/.6mL 70114-0101-01 | Coherus | 1 syringe | — | — | FDA listed | — |
| Udenyca 6 mg/.6mL 70114-0120-01 | Coherus | 1 syringe | — | — | FDA listed | — |
| Udenyca 6 mg/.6mL 69448-0026-63 | Accord | 1 syringe | — | — | FDA listed | — |
| Udenyca 6 mg/.6mL 69448-0027-63 | Accord | 1 syringe | — | — | FDA listed | — |
| Udenyca 6 mg/.6mL 70114-0130-01 | Coherus | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Sep 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
8 biosimilars are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Nov 2, 2030 |
Is there a biosimilar for UDENYCA 6 MG/0.6 ML SYRINGE?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Sep 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE UDENYCA is a leukocyte growth factor 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. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
1.1Patients with Cancer Receiving Myelosuppressive Chemotherapy 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 ( 14.1 )] . Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
1.2Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome UDENYCA is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Patients with cancer receiving myelosuppressive chemotherapy 6 mg administered subcutaneously once per chemotherapy cycle. ( 2.1 ) Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. ( 2.1 ) Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1 .
( 2.3 ) Patients acutely exposed to myelosuppressive doses of radiation Two doses, 6 mg each, administered 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 ) Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1 .
( 2.3 )
2.1Patients with Cancer Receiving Myelosuppressive Chemotherapy 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.
2.2Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome 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.
2.3Administration 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. Pediatric Patients Weighing Less than 45 kg 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 For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of UDENYCA 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 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.
2.4Advice to Give… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS UDENYCA 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 autoinjector. Injection: 6mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for UDENYCA (UDENYCA ONBODY).
Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only. ( 3 ) 6 mg/0.6 mL in a single-dose prefilled autoinjector. ( 3 ) 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector for UDENYCA.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 ( 5.3 )] . Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim products. ( 4 )
⚠️ Warnings and Cautions ▾
5 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 UDENYCA in patients with ARDS. ( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
( 5.3 ) The on-body injector for UDENYCA uses acrylic adhesives. 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 UDENYCA if sickle cell crisis occurs.
( 5.5 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely. ( 5.6 ) Thrombocytopenia: Monitor platelet count ( 5.8 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using UDENYCA 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 )
5.1Splenic Rupture 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.
5.2Acute Respiratory Distress Syndrome 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.
5.3Serious Allergic Reactions 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.
5.4Allergies to Acrylics 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.
5.5Use in Patients with Sickle Cell Disorders 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.
5.6Glomerulonephritis 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.
5.7Leukocytosis White blood cell (WBC) counts of 100 x 10 9 /L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
5.8Thrombocytopenia Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts.
5.9Capillary Leak Syndrome 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 closel… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 Allergic 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 )] Aortitis [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 Accord BioPharma at 1-866-941-7875 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch
6.1Clinical 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. 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/m 2 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 10 9 /L was observed in less than 1% of 932 patients with non-myeloid malignancies receiving pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.
6.2Immunogenicity 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 b… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary 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. 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).
8.2Lactation Risk Summary 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.
8.4Pediatric Use 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 ( 12.3 ) and… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary 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. 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).
🧒 Pediatric Use ▾
8.5Geriatric Use 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 ▾
10 OVERDOSAGE 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 ( 6 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics 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.
12.3Pharmacokinetics 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. Specific Populations 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 ( 8.5 )] .
Renal Impairment 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. Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies 14.1 ] . The mean (± standard deviation [SD]) systemic exposure (AUC 0-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. Patients Acutely Exposed to Myelosuppressive Doses of Radiation 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, Section 2.3 , Table 1 ] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING UDENYCA single-dose prefilled syringe for manual use 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, 1⁄2-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 69448-025-63).
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 single-dose prefilled autoinjector 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 69448-026-63). 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 UDENYCA ONBODY is provided in a carton containing one sterile prefilled syringe and one sterile on-body injector (OBI) for UDENYCA (NDC 69448-027-63).
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.
📋 Description ▾
11 DESCRIPTION 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 provided in three presentations: UDENYCA 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).
UDENYCA for subcutaneous injection is supplied in a 0.6 mL prefilled single-dose autoinjector. The prefilled autoinjector delivers the entire contents (6 mg in 0.6mL) in a single injection and is not adjustable. On-body injector (OBI) for UDENYCA is supplied with a prefilled syringe containing 0.67 mL of UDENYCA in solution that delivers 0.6 mL of UDENYCA in solution when used with the OBI for UDENYCA.
The syringe does not bear graduation marks and is only to be used with the OBI for UDENYCA. The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection, the prefilled autoinjector or the OBI for UDENYCA 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING 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 UDENYCA: Splenic rupture and splenomegaly Acute Respiratory Distress Syndrome Serious allergic reactions Sickle cell crisis Glomerulonephritis Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive UDENYCA in conjunction with chemotherapy and/or radiation therapy Capillary Leak Syndrome Aortitis 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 ( 14.2 )] .
Instruct patients who self-administer UDENYCA using the single-dose prefilled syringe of the: Importance of following the Instructions for Use (see Instructions for Use ). Dangers of reusing syringes. Importance of following local requirements for proper disposal of used syringes.
For patients who will use the UDENYCA prefilled autoinjector, tell them that they: Will hear two "clicks" during the UDENYCA injection. The first 'click' means the start of injection and second 'click' means the end of injection. To start injection, push the prefilled autoinjector body down.
Continue holding down after hearing the first 'click'. In the viewing window, the orange indicator will advance to show the progress of the injection. 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: 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 UDENYCA will begin and when their dose delivery should be completed.
Advise the patient that serious allergic reactions can happen with UDENYCA. 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 UDENYCA during the approximately 5 minutes UDENYCA delivery and for an hour after the delivery.
Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the OBI for UDENYCA. If the OBI for UDENYCA is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the OBI for UDENYCA. If a patient calls the healthcare provider regarding any OBI for UDENYCA problems, the healthcare provider is advised to call Accord BioPharma at 1-866-941-7875.
Advise the patient: to call their healthcare provider immediately if the status light on the OBI for UDENYCA is flashing red ( see the Patient Instructions for Use ). to inform their healthcare provider if the adhesive on the OBI for UDENYCA 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 UDENYCA dry for approximately the last 3 hours prior to the dose delivery start to better enable potential leak detection. that the OBI for UDENYCA should only be exposed to temperatures between 41°F and 104°F (5°C to 40°C). to keep the OBI for UDENYCA 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 UDENYCA at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of UDENYCA. that if the nee… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary 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.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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. Specific Populations 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 ( 8.5 )] .
Renal Impairment 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. Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies 14.1 ] . The mean (± standard deviation [SD]) systemic exposure (AUC 0-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. Patients Acutely Exposed to Myelosuppressive Doses of Radiation 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, Section 2.3 , Table 1 ] provides exposures comparable to those in adults receiving two 6 mg doses one week apart.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics 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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Patients with Cancer Receiving Myelosuppressive Chemotherapy Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active- controlled studies that employed doxorubicin 60 mg/m 2 and docetaxel 75 mg/m 2 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 10 9 /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/m 2 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 ( 12.3 )] 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.
14.2Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons.… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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).
📄 Patient Package Insert ▾
Patient Information UDENYCA ® (yoo-den-i-kah) (pegfilgrastim-cbqv) Injection What is UDENYCA? UDENYCA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body.
It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. Acute Radiation Syndrome: The effectiveness of pegfilgrastim for this use was only studied in animals, because it could not be studied in people. 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: have a sickle cell disorder. have kidney problems. are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.
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? UDENYCA is given as an injection under your skin (subcutaneous injection) by a healthcare provider.
If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed " Instructions for Use " that comes with your UDENYCA for information on how to prepare and inject a dose of UDENYCA. You and your caregiver will be shown how to prepare and inject UDENYCA before you use it. UDENYCA comes in a prefilled syringe or a prefilled autoinjector.
Your healthcare provider will prescribe the type of UDENYCA that is right for you. Only adults can self-inject UDENYCA with the prefilled autoinjector. You should not inject a dose of UDENYCA to children weighing less than 45 kg from a UDENYCA prefilled syringe. or prefilled autoinjector.
A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled syringe or prefilled autoinjector. If you are receiving UDENYCA because you are also receiving chemotherapy, the last dose of UDENYCA should be injected at least 14 days before and 24 hours after your dose of chemotherapy. If you miss a dose of UDENYCA, talk to your healthcare provider about when you should give your next dose.
When using the UDENYCA prefilled autoinjector: You may miss your dose or may not receive your full dose if you lift the prefilled autoinjector before you hear the second "click" or if the orange indicator does not completely fill the viewing window. Call your healthcare provider right away if this happens, as you may need a replacement dose of UDENYCA. What are possible side effects of UDENYCA?
UDENYCA may cause serious side effects, including: Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death.
Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder. A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
Serious allergic reactions. UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating.
If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or get emergency medical help right away. Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive UDENYCA.
Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pai… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use UDENYCA ® (yoo-den-i-kah) (pegfilgrastim-cbqv) Injection Single-Dose Prefilled Syringe Guide to Parts Before Use Important: The needle is covered by a needle cap before use After Use Important Read the Patient Information for important information you need to know about UDENYCA before using these Instructions for Use. Storing the UDENYCA prefilled syringe Store UDENYCA prefilled syringes in the refrigerator between 36°F to 46° F (2°C to 8°C). Keep the UDENYCA prefilled syringe in the original carton to protect from light.
Do not freeze UDENYCA. If UDENYCA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting. Throw away (dispose of) any UDENYCA prefilled syringes that have been frozen more than 1 time.
Throw away (dispose of) any UDENYCA prefilled syringes that have been left out at room temperature for more than 48 hours. Keep the UDENYCA prefilled syringe out of the reach of children. Using the prefilled syringe It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
Make sure that the name UDENYCA appears on the carton and prefilled syringe label. Check the carton and prefilled syringe label to make sure the dose strength is 6 mg/0.6 mL. You should not inject a dose of UDENYCA to children weighing less than 45 kg from a UDENYCA prefilled syringe.
A dose less than 0.6 mL (6 mg) cannot be accurately measured using the UDENYCA prefilled syringe. Do not use a prefilled syringe after the expiration date on the label. Do not shake the prefilled syringe Do not remove the needle cap from the prefilled syringe until you are ready to inject.
Do not use the prefilled syringe if the carton is open or damaged. Do not use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break.
Use a new prefilled syringe. Do not attempt to activate the needle safety guard prior to injection Call your healthcare provider if you have any questions. Prepare the injection 1 - Remove carton from refrigerator and check expiration date 1A: Remove the carton from the refrigerator and check the expiration date printed on the carton.
(See Figure 3 ) Do not use if the expiration date has passed. 1B: Open the carton and remove the sealed syringe tray. (See Figure 4 ) 2 - Allow UDENYCA to reach room temperature and gather supplies 2A: Place the sealed syringe tray on a flat, clean work surface and allow it to sit at room temperature for at least 30 minutes.
(See Figure 5 ) Do not attempt to warm up the syringe in any other way, such as a microwave, hot water, or direct sunlight. 2B: Gather the following supplies: (See Figure 6 ) Alcohol wipe Cotton ball or gauze 1 adhesive bandage Sharps disposal container 3 - Wash your hands and remove syringe from tray 3A: Wash your hands well with soap and warm water. (See Figure 7 ) 3B: Open the tray by peeling away the cover.
Remove the prefilled syringe from the tray by grasping the middle of the syringe body and carefully pulling it out of the tray. (See Figure 8 ) For Safety reasons: Do not grab the plunger or the plunger head. Do not grab the needle cap.
4 - Inspect the syringe and medicine Check the medicine through the Inspection Window. The medicine should be clear and colorless. It is normal to see 1 or more air bubbles in the syringe.
Removal of the air is not needed. (See Figure 9 ) Do not use the prefilled syringe if: the medicine appears discolored or cloudy. the medicine contains lumps, flakes, or particles. it appears used or damaged. the needle cap is missing or not securely attached. the expiration date printed on the label has passed. In all cases, use a new prefilled syringe and call your healthcare provider.
Select and clean injection site 5 - Select and clean the injection site 5A: Select the injection site. The recommended injection sites for a subcutaneous injection are the: (See Figure… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration ( 2.2 ) and ( 2.3 ) MM/YYYY
📄 Package Label / Principal Display Panel ▾
Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled Syringe - UDENYCA PRINCIPAL DISPLAY PANEL 6 mg/ 0.6 mL 69448-025-63 UDENYCA ® pegfilgrastim-cbqv Injection Rx Only 6 mg in 0.6 mL Single-Dose Prefilled Syringe For Subcutaneous Use Sterile Solution - No Preservative Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. coli One 6 mg/0.6 mL single-dose Prefilled Syringe image of carton label - principal panel
Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled AUTOINJECTOR - UDENYCA PRINCIPAL DISPLAY PANEL 69448-026-63 UDENYCA ® pegfilgrastim-cbqv Injection Rx Only 6 mg in 0.6 mL Single-Dose Prefilled AUTOINJECTOR For Subcutaneous Use Sterile Solution - No Preservative One 6 mg/0.6 mL Single-Dose Prefilled Autoinjector Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. coli 6 mg/0.6 mL image of AI carton label - principal panel
Carton Label - One 6 mg/0.6 mL Single-Dose Prefilled On-body Injector (OBI) - UDENYCA PRINCIPAL DISPLAY PANEL 6 mg/ 0.6 mL* See package insert for full Prescribing Information and Instructions for Use. Rx Only 1 - Single-Dose UDENYCA Prefilled Syringe 1 - Sterile On-body Injector for UDENYCA 69448-027-63 UDENYCA ® ONBODY™ (pegfilgrastim-cbqv) Injection Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from E. Coli *Prefilled syringe contains 0.67 mL to deliver 6 mg/0.6 mL when used with On-bodv Injector.
For Subcutaneous Use Only Carton Contents (intended to be dispensed as a unit): 1 Sterile On-body Injector for UDENYCA 1 UDENYCA Prefilled Syringe Labeled for Use With On-body Injector Only 1 Prescribing Information and 1 Patient information 1 Patient Instructions for Use 1 Healthcare Provider Instructions for Use Store refrigerated at 2°C to 8°C (36°F to 46°F) Keep in carton to protect from light Do not freeze. Do not shake image of OBI carton label - principal panel
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| NDC identity (package / product / labeler codes) | ✓ Available |
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