Prescription medicine
Pegfilgrastim Brand names: Udenyca, Neulasta, Stimufend, Ziextenzo, Nyvepria
Pegfilgrastim (Neulasta) is a prescription medicine with an FDA approval on record since 2002. No generic is listed; pharmacies paid $3,369.51 per mL (Fulphila 6 mg/0.6 mL syringe) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the pegfilgrastim FDA label on DailyMed (effective August 10, 2026, Amgen, Inc); the BLA 125031 record on Drugs@FDA; every pegfilgrastim label on DailyMed.
Highlights of the record
FDA label of August 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNeulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Forms and strengths
- 4 mg/.4ml
- 6 mg/.6ml
Injection (solution); injection; solution; kit.
On the market
- Earliest approval on file
- January 31, 2002 Neulasta, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 10 of which 0 under generic applications, 10 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $3,369.51 per mL Fulphila 6 mg/0.6 mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 1 Class I among all firms' recalls; latest January 16, 2026
- FAERS reports
- 100,402 through July 30, 2026
What is pegfilgrastim used for?
From the label: indications and usageNeulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). […]
FDA pharmacologic class: Leukocyte Growth Factor.
Source: FDA drug label (Neulasta), Amgen, Inc, effective August 10, 2026 (SPL set fdfe5d72-6b80-435a-afa4-c5d74dd852ce), via openFDA; the full label on DailyMed
What does the patient leaflet for pegfilgrastim say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I need to know about receiving Neulasta with the on-body injector for Neulasta?See the Instructions for Use for the on-body injector for Neulasta for detailed information about the on-body injector for Neulasta and important information about your dose delivery that has been written by your healthcare provider. Know the time that delivery of your dose of Neulasta is expected to start. Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta is applied. Avoid activities and places that may interfere with monitoring during the 45-minute period that Neulasta is expected to be delivered by the on-body injector for Neulasta, and for 1 hour after delivery. A caregiver should be with you the first time that you receive Neulasta with the on-body injector for Neulasta. Before your next scheduled Neulasta dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen) to help keep the device on your skin. If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector. If you have an allergic reaction during the delivery of Neulasta, remove the on-body injector for Neulasta by grabbing the edge of the adhesive pad and peeling off the on-body injector for Neulasta. Get emergency medical help right away. You should only receive a dose of Neulasta on the day your healthcare provider tells you. You should not receive your dose of Neulasta any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector for Neulasta is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for Neulasta on your skin. […]
From the patient leaflet: How should I store Neulasta?Store Neulasta in the refrigerator between 36°F and 46°F (2°C to 8°C). Avoid freezing Neulasta prefilled syringes. If Neulasta prefilled syringe is frozen 1 time, thaw in the refrigerator before using it. If it is frozen more than 1 time, throw it away and use a new Neulasta prefilled syringe. Do not freeze Neulasta vials. Keep Neulasta in the original carton to protect from light or physical damage. Do not shake Neulasta. Take Neulasta out of the refrigerator 30 minutes before use and allow it to reach room temperature, 68°F to 77°F (20°C to 25°C), before preparing an injection. Throw away (dispose of) any Neulasta that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours. Keep Neulasta and all medicines out of the reach of children.
Source: FDA drug label (Neulasta), Amgen, Inc, effective August 10, 2026 (SPL set fdfe5d72-6b80-435a-afa4-c5d74dd852ce), via openFDA; the full label on DailyMed
Is there a generic for pegfilgrastim (Neulasta)?
No generic pegfilgrastim is approved (Drugs@FDA, October 8, 2026).
- 2002 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pegfilgrastim (Neulasta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3,369.51 per mL (Fulphila 6 mg/0.6 mL syringe), up 6% from $3,182.35 on November 19, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fulphila 6 mg/0.6 mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fulphila 6 mg/0.6 mL syringe | Brand | $3,369.51 per mL | $2,021.71 per single-dose syringe | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pegfilgrastim been recalled?
The FDA's Enforcement Report lists 1 recall naming pegfilgrastim since 2026: 1 Class I (the most serious), 0 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 16, 2026 | Class I | McKesson | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pegfilgrastim label say about other medicines?
The pegfilgrastim label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name pegfilgrastim. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Filgrastim | contraindications | CONTRAINDICATIONS Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim. |
Other labels that name pegfilgrastim
Source: FDA drug label (Neulasta), Amgen, Inc, effective August 10, 2026 (SPL set fdfe5d72-6b80-435a-afa4-c5d74dd852ce), via openFDA; the full label on DailyMed
What do FAERS reports show for pegfilgrastim?
The FDA Adverse Event Reporting System holds 100,402 reports that list pegfilgrastim among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,662 are coded as a death and 15,826 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other leukocyte growth factors
- the pharmacologic class, with prices and generics
- Pegfilgrastim side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other