STIMUFEND pegflilgrastim-fpgk 6 mg/.6mL Injection, Solution, 1 syringe — NDC 65219-371-10 (Billing 65219-0371-10)
This is a package of 1 syringe of STIMUFEND pegflilgrastim-fpgk 6 mg/.6mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Oct 2022 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 65219-371-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 65219 labeler · 371 product · 10 package
- Package marketed since
- Oct 6, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6521937110 6
- Medicaid fills, this package
- 701 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 083790
- GCN: 52848
- GPI-14 (Medi-Span): 8240157015E520
- HICL (First Databank): 048269
- AHFS class code: 20:16.00.00
- RxCUI (RxNorm): 2613763
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 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
Pegfilgrastim injection is used to increase white blood cells and decrease the risk of infection in patients receiving chemotherapy for certain types of cancer. Pegfilgrastim injection is also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to bone marrow. Pegfilgrastim is in a class of medications called colony stimulating factors. It works by helping the body make more neutrophils (a type of blood cell needed to fight infection).
Read the full MedlinePlus article ↗- 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 5, 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 | $4,714.62 | $2,828.77 / 0.6 ml |
| Medicare drug plans payPart D · Q2 2026 | $7,058.78 | $4,235.27 / 0.6 ml |
| Medicare Part B allowsASP · Q5127 | $143.673 / Q5127 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 |
|---|---|---|---|---|
| 65219-0371-10 You're viewing this Main listing | 1 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE | 2022-10-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Stimufend 6 mg/.6mLthis 65219-0371-10 | Fresenius | 1 syringe | — | — | FDA listed | — |
| Stimufend 6 mg/.6mL 72603-0402-01 | NORTHSTAR | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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 | Sep 1, 2034 |
Is there a biosimilar for STIMUFEND 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 Oct 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.
🧪 Avoiding an ingredient? See Pegfilgrastim Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 569DQM74SC
Acetate ion is a salt form derived from acetic acid. It's commonly used in medicines as a buffer to help maintain the correct pH level and stabilize the product.
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UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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UNII 9NEZ333N27
Sodium is a mineral element that helps regulate fluid balance and nerve function in the body. In medicines, sodium salts serve as buffers, preservatives, or carriers to stabilize the drug and control its pH.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Fresenius Kabi USA, LLC labeler code 65219
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- Multiple Electrolytes pH 5.5 sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium 526 mg/100mL; 502 mg/100mL; 368 mg/100mL; 37 mg/100mL; 30 mg/100mL Injection, Solution NDC 65219-387-05
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 Stimufend 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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
1.1Patients with Cancer Receiving Myelosuppressive Chemotherapy Stimufend 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 Stimufend 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 Stimufend 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 Stimufend 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 Stimufend 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 Stimufend 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 Stimufend 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 Stimufend is administered subcutaneously via a single-dose prefilled syringe for manual use. Prior to use, remove the carton from the refrigerator and allow the Stimufend prefilled syringe to reach room temperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 72 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Stimufend if discoloration or particulates are observed. The needle cap on the pre-filled syringes contains dry natural rubber (derived from latex); persons with latex allergies should not administer these products.
Pediatric Patients weighing less than 45 kg The Stimufend pre-filled 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 Stimufend 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 Stimufend for Pediatric Patients Weighing Less Than 45 kg *For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Stimufend.
Body Weight Stimufend 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
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Stimufend is a clear, colorless, preservative-free solution available as: Injection: 6 mg/0.6 mL in a single-dose pre-filled syringe for manual use only. Injection: 6 mg/0.6 mL solution in a single-dose pre-filled syringe for manual use only. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Stimufend 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 reactions 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 Stimufend in patients with ARDS.
( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue Stimufend in patients with serious allergic reactions. ( 5.3 ) Fatal sickle cell crises: Discontinue Stimufend if sickle cell crisis occurs. ( 5.4 ) Glomerulonephritis: Evaluate and consider dose- reduction or interruption of Stimufend if causality is likely.
( 5.5 ) Thrombocytopenia: Monitor platelet counts. ( 5.7 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using Stimufend in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. ( 5.10 )
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 Stimufend.
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 Stimufend for ARDS. Discontinue Stimufend 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 Stimufend in patients with serious allergic reactions. Do not administer Stimufend to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products.
5.4Use 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 Stimufend if sickle cell crisis occurs.
5.5Glomerulonephritis 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 Stimufend.
5.6Leukocytosis 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 Stimufend therapy is recommended.
5.7Thrombocytopenia Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts.
5.8Capillary 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 closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
5.9Potential for Tumor Growth Stimulatory Effects on Malignant Cells 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… [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 )] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] Glomerulonephritis [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Thrombocytopenia [see Warnings and Precautions ( 5.7 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.8 )] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions ( 5.9 )] Myelodysplastic syndrome [see Warnings and Precautions ( 5.10 )] Acute myeloid leukemia [see Warnings and Precautions ( 5.10 )] Aortitis [see Warnings and Precautions ( 5.11 )] 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 Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-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 As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other pegfilgrastim products may be misleading. Binding antibodies to pegfilgrastim were detec… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Although available data with Stimufend 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 embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis.
At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).
8.2Lactation 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 Stimufend and any potential adverse effects on the breastfed child from Stimufend or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Stimufend 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 Stimufend in pediatric patients for chemotherapy-induced neutropenia is based on Stimufend'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 (… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Although available data with Stimufend 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 embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis.
At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Stimufend 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 Stimufend in pediatric patients for chemotherapy-induced neutropenia is based on Stimufend'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 Clinical Studies ( 14.1 )] .
The use of Stimufend to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on Stimufend's approval as a biosimilar to pegfilgrastim, 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 weight-based doses of pegfilgrastim ( Table 1 ) administered one week apart provide pediatric patients weighing less than 45 kg with exposures comparable to that of adults receiving two 6 mg doses one week apart [see Dosage and Administration ( 2.3 ), Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.2 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.
🆘 Overdosage ▾
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 Stimufend is based on reducing the duration of severe neutropenia.
12.3Pharmacokinetics The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils.
In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed.
The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection. Specific Populations No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (³ 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 products 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 Stimufend single-dose prefilled syringe for manual use Stimufend (pegfilgrastim-fpgk) injection is a clear, colorless, preservative-free solution supplied in a pre-filled single-dose syringe for manual use containing 6 mg pegfilgrastim-fpgk, supplied with a 27-gauge, 1/2-inch needle with a Safe'n'Sound ® passive Needle Guard. The needle cap of the pre-filled syringe contains natural rubber (a derivative of latex). Stimufend is provided in a dispensing pack containing one sterile 6 mg/0.6 mL pre-filled syringe (NDC 65219-371-10).
Stimufend pre-filled 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 pre-filled 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 36°F to 46°F (2°C to 8°C) in the carton to protect from light.
Do not shake. Discard syringes stored at room temperature for more than 72 hours. Do not freeze.
Discard syringe if frozen.
📋 Description ▾
11 DESCRIPTION Pegfilgrastim-fpgk 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 (kD). 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.
To produce pegfilgrastim-fpgk, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-fpgk is approximately 39 kD. Stimufend (pegfilgrastim-fpgk) injection is supplied in 0.6 mL pre-filled syringes for manual subcutaneous injection.
The pre-filled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-fpgk (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 Stimufend: 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 Stimufend 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 Stimufend using the single-dose pre-filled 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.
Manufactured by: Fresenius Kabi USA, LLC Lake Zurich, Illinois 60047 U.S. License No. 2146 Product of Italy
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils.
In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed.
The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection. Specific Populations No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (³ 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 products 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 Stimufend 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 x 10 9 /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 re… [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 ▾
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: September 2022 Patient Information Stimufend ® (stim-yu-fend) (pegfilgrastim-fpgk) injection Single-Dose Prefilled Syringe What is Stimufend?
Stimufend 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.
Do not take Stimufend if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products. Before you receive Stimufend, tell your healthcare provider about all of your medical conditions, including if you: have a sickle cell disorder. have kidney problems. are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex).
You should not give Stimufend using the prefilled syringe if you have latex allergies. are pregnant or plan to become pregnant. It is not known if Stimufend will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Stimufend 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 Stimufend? Stimufend 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 Stimufend for information on how to prepare and inject a dose of Stimufend. You and your caregiver will be shown how to prepare and inject Stimufend before you use it. You should not inject a dose of Stimufend to children weighing less than 45 kg from a Stimufend prefilled syringe.
A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Stimufend prefilled syringe. If you are receiving Stimufend because you are also receiving chemotherapy, the last dose of Stimufend should be injected at least 14 days before and 24 hours after your dose of chemotherapy. If you miss a dose of Stimufend, talk to your healthcare provider about when you should give your next dose.
What are possible side effects of Stimufend? Stimufend 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. Stimufend 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 Stimufend 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 Stimufend. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. Kidney injury (glomerulonephritis).
Stimufend can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: swelling of your face or ankles blood in your urine or dark colored urine you urinate less than usual Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Stimufend.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatmen… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use STIMUFEND® (STIM-yu-fend) (pegfilgrastim-fpgk) Injection, for subcutaneous use Single-Dose Prefilled Syringe Guide to parts After Use (Clear needle guard locked in place) Important: The needle is covered by a gray needle cap before use. Important: Read the Patient Information for important information you need to know about STIMUFEND before using these Instructions for Use. Before you use a STIMUFEND prefilled syringe, read this important information.
Storing the prefilled syringe Store STIMUFEND in the refrigerator between 36°F and 46°F (2°C to 8°C). Do not freeze. Throw away (dispose of) STIMUFEND that has been frozen.
Keep the prefilled syringe in the original carton to protect from light or physical damage. Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. Throw away (dispose of) any STIMUFEND that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.
Keep the STIMUFEND 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 the name STIMUFEND 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 STIMUFEND to children weighing less than 45 kg from a STIMUFEND prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the STIMUFEND 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 gray 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. The gray needle cap on the prefilled syringe contains dry natural rubber (made from latex). Tell your healthcare provider if you are allergic to latex.
You should not give STIMUFEND using the prefilled syringe if you have latex allergies. The prefilled syringe has a clear needle guard that automatically activates to cover the needle after the injection is given. Do not use a prefilled syringe if the clear needle guard has been activated.
Use another prefilled syringe that has not been activated and is ready to use. Call your healthcare provider if you have any questions. Step 1: Prepare
1.1Remove the prefilled syringe carton from the refrigerator. Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection.
Do not use the prefilled syringe if the carton is damaged. Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave. Do not leave the prefilled syringe in direct sunlight.
Do not shake the prefilled syringe. Open the tray by peeling away the cover. Grab the clear needle guard to remove the prefilled syringe from the tray (see Figure C ).
For safety reasons: Do not grab the plunger rod. Do not grab the gray needle cap.
1.2Inspect the medicine and prefilled syringe. Make sure the medicine in the prefilled syringe is clear and colorless. Do not use the prefilled syringe if: The needle safety guard is activated (see Figure D ).
The medicine is cloudy or discolored, or contains flakes or particles (see Figure E ). Any part appears cracked or broken. The prefilled syringe has been dropped.
The gray needle cap is missing or not securely attached (see Figure E ). The expiration date printed on the label has passed (see Figure E ). In all cases use a new syringe and call your healthcare provider.
1.3Gather all materials needed for the injection (see Figure F ).… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage, Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome ( 1.2 ) 9/2023 Dosage and Administration, Patients with Hematopoietic Subsyndrome of Acute radiation Syndrome ( 2.2 ) 9/2023
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY – STIMUFEND –One 0.6 mL Single-Dose Prefilled Syringe CARTON PANEL Stimufend pegfilgrastim-fpgk Injection 6 mg/0.6 mL NDC 65219-371-10 Rx Only Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-methHuG-CSF) derived from E Coli For Subcutaneous Use Only 1 single-dose pre-filled syringe This product contains Dry Natural Rubber Sterile Solution-No Preservative PACKAGE LABEL – PRINCIPAL DISPLAY – STIMUFEND –One 0.6 mL Single-Dose Prefilled Syringe CARTON PANEL
PACKAGE LABEL – PRINCIPAL DISPLAY – STIMUFEND – 0.6 mL Single-Dose Prefilled Syringe BLISTER PACK LABEL Stimufend (pegfilgrastim-fpgk) Injection 6 mg/0.6 mL Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-methHuG-CSF) derived from E Coli For Subcutaneous Use Only Store refrigerated between 36 o F to 46 o F (2 o C to 8 o C). Do not freeze or shake. Protect from light.
This product contains dry natural rubber. Sterile Solution-No Preservative PACKAGE LABEL – PRINCIPAL DISPLAY – STIMUFEND – 0.6 mL Single-Dose Prefilled Syringe BLISTER PACK LABEL
PACKAGE LABEL – PRINCIPAL DISPLAY – STIMUFEND – 0.6 mL Single-Dose Prefilled SYRINGE LABEL Stimufend (pegfilgrastim-fpgk) Injection 6 mg/0.6 mL U.S. License No. 2146 Fresenius Kabi USA LLC PACKAGE LABEL – PRINCIPAL DISPLAY – STIMUFEND – 0.6 mL Single-Dose Prefilled SYRINGE LABEL
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