Medications
Pegfilgrastim-cbqv (Udenyca)
A self-injected biosimilar of pegfilgrastim (a Neulasta biosimilar, Udenyca) — a long-acting white-blood-cell growth factor given once per chemotherapy cycle to lower the chance of infection from a low neutrophil count (febrile neutropenia).
How Medicare covers it
Part D (self-injected syringes used at home where a plan lists them). Part B covers the clinician-given injection where the CMS Part B spending file carries it (HCPCS Q5111 — see the Part B basis in this package). Part A during a covered inpatient stay.
| Coverage details | |
|---|---|
| Part B status | CMS Part B Spending by Drug HCPCS file (RY26, data through 2024) carries Q5111 (injection, pegfilgrastim-cbqv (udenyca), biosimilar, 0.5 mg): the clinician-given biosimilar path has a Part B basis; the self-injected home form is the Part D aggregation in this package. |
| Medicare Advantage | Most Medicare Advantage plans that include drug coverage (MAPD plans) use the same formulary-and-tier system; the plan's own drug list decides coverage and copay — check the plan's formulary. |
| Medicare Supplement (Medigap) | Medicare Supplement (Medigap) plans sold today do not include prescription drug coverage; drug coverage comes from Part D or an MAPD plan. |
What it treats
Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim), has two uses: (1) to decrease the incidence of infection, as shown by febrile neutropenia (fever with a low neutrophil count), in patients with non-myeloid cancers who are receiving myelosuppressive anti-cancer drugs that are associated with a clinically significant incidence of febrile neutropenia; and (2) to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome). It is not indicated for mobilizing peripheral blood progenitor cells for stem cell transplantation.
What it is for, in depth
Udenyca is a biosimilar of Neulasta (pegfilgrastim), which means it is highly similar to Neulasta with no clinically meaningful differences. Its main use is for people with cancers that are not myeloid cancers who are getting chemotherapy that strongly lowers the white blood cell count, putting them at risk of febrile neutropenia — fever when infection-fighting neutrophils are at their lowest, which can be life-threatening. It is a supportive care drug, not a cancer treatment: one shot per chemotherapy cycle shortens the low-count period and lowers the chance of infection. Udenyca also carries the second pegfilgrastim use, increasing survival in people acutely exposed to bone-marrow-damaging doses of radiation, given as two shots one week apart. It offers more delivery choices than most pegfilgrastim products: a 6 mg/0.6 mL prefilled syringe, a prefilled autoinjector, and an on-body injector version, all for injection under the skin.
How it works
It is a leukocyte growth factor, also called a colony-stimulating factor. It binds to receptors on blood-forming cells in the bone marrow and tells them to make more neutrophils, a type of white blood cell that fights infection. That shortens the time the white blood cell count stays dangerously low after chemotherapy.
How it is taken
For chemotherapy patients, the dose is a single 6 mg shot under the skin (subcutaneous injection) once per chemotherapy cycle, and it must not be given between 14 days before and 24 hours after cytotoxic chemotherapy. For patients acutely exposed to myelosuppressive doses of radiation, the dose is two 6 mg shots under the skin one week apart, with the first dose given as soon as possible after suspected or confirmed exposure. Children weighing less than 45 kg get weight-based doses per the label. Udenyca comes as a 6 mg/0.6 mL single-dose prefilled syringe for manual use, a 6 mg/0.6 mL single-dose prefilled autoinjector, and a 6 mg/0.6 mL prefilled syringe co-packaged with the on-body injector (Udenyca Onbody).
Common side effects
The most common side effects (at least 5% more often than with placebo in trials) are bone pain and pain in an arm or leg.
Serious warnings
Serious risks include splenic rupture, which can be fatal — report pain in the left upper belly or left shoulder tip; acute respiratory distress syndrome (ARDS), a serious lung problem; serious allergic reactions including anaphylaxis; severe and sometimes fatal sickle cell crises in people with sickle cell disorders; glomerulonephritis, a kidney problem; very high white blood cell counts (leukocytosis); low platelet counts (thrombocytopenia); capillary leak syndrome; a possible growth-stimulating effect on tumor cells; myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), which are monitored for in patients with breast and lung cancer who also get chemotherapy and/or radiation; and aortitis, inflammation of the aorta. With the on-body injector, allergic reactions to acrylics are also a labeled warning.
Who should be careful
Udenyca must not be used by anyone who has had a serious allergic reaction to a pegfilgrastim product or a filgrastim product. Tell your doctor if you have a sickle cell disorder, kidney problems, or breathing problems, and report left upper belly or shoulder pain, fever with breathing trouble, or signs of an allergic reaction right away. If you use the on-body injector and are allergic to acrylics, tell your doctor. Tell your doctor if you are pregnant or breastfeeding.
Major interactions
The label has no drug interactions section and lists no major drug interactions. The main timing rule is about chemotherapy itself: this drug must not be given in the period from 14 days before until 24 hours after a dose of cytotoxic chemotherapy.
Cost and saving notes
If this drug is covered under your Medicare Part D plan and the cost is high, you can ask your plan for a tier exception to pay a lower cost share. If you have limited income, Extra Help (the Part D Low-Income Subsidy) can lower your Part D premiums and drug costs. In 2027, your total yearly out-of-pocket spending on covered Part D drugs is capped at $2,400, and you can spread those costs out in monthly payments through the Medicare Prescription Payment Plan.
Why it is in its tier
Pegfilgrastim-cbqv (Udenyca) sits on Tier 5 in 97.43% of the plans that list it (2202 of 2260 listing plans). Tier 5 is the specialty tier — instead of a flat copay, patients usually pay a percentage of the drug's cost (coinsurance), which is why specialty drugs feel expensive even with coverage. The data-visible drivers: It is a brand-only product with no generic version in the formulary data, and the CMS dashboard puts its average Part D spending at about $13,959 per beneficiary for 2024 — a high-cost drug, which matches where plans place it. Only 41.13% of Part D plans list it at all, so many readers will find their plan does not list it and covers a similar drug instead. The tier shown is the most common one; individual plans vary.
Sources
- UDENYCA (PEGFILGRASTIM-CBQV) INJECTION, SOLUTION [ACCORD BIOPHARMA, INC.] — DailyMed
- MedlinePlus — National Library of Medicine
- MedlinePlus — Pegfilgrastim Injection
What official patient guides say
Pegfilgrastim-cbqv (Udenyca) is an injection under the skin, not a pill, so you can keep your normal diet. Your doctor sets the exact timing around your chemotherapy — for chemo patients the label dose is a single shot once per chemotherapy cycle. A nurse may give the shot, you may be trained to give it yourself at home with the prefilled syringe or autoinjector, or a nurse may fit the on-body injector, which delivers the dose on its own about a day later. Do not shake the syringe or autoinjector, check that the liquid is clear and colorless before use, and use each syringe or device only once, putting used needles in a puncture-resistant container. MedlinePlus gives no catch-up rule — if you miss a scheduled home dose, ask your doctor what to do. Store it in the refrigerator in its carton, away from direct sunlight, and do not freeze it; the Udenyca syringe and autoinjector may sit at room temperature for up to 48 hours. Bone pain and pain in the arms or legs are common.
Part D formulary coverage
| Formulary summary | |
|---|---|
| Most common tier | 5 |
| Plans listing this drug | 2260 |
| Total Part D plans | 5495 |
| Share of plans listing it | 41.13 |
| Formularies listing it | 61 |
| Tier | Plans |
|---|---|
| Tier 1 | 21 plans |
| Tier 4 | 37 plans |
| Tier 5 | 2202 plans |
Source: CMS Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files — Monthly file 2026-10-15 (plan year 2027), file 2027_20261008.zip (data.cms.gov dataset ed1496ea-23e7-41f1-9292-172fa842ccfb): basic drugs formulary file + plan information file, both dated 20261031 inside the zip; downloaded and aggregated 2026-10-30. Medication RxCUI sets resolved through the NLM RxNav (RxNorm) API.
What you pay
| With Medicare Part D | |
|---|---|
| Most common tier | Tier 5 |
| Typical copay | $0 — half of plans charge between $0 and $0 |
| Typical coinsurance | 26.0% of the price |
| Based on | 2153 plans that cover this drug · 2027 plan year |
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Sources: CMS Plan Benefit Package + formulary data; CMS NADAC · Checked 2026-11-08
Similar medications
Other medications in the same FDA pharmacologic class (Leukocyte Growth Factor):
Read next
Part D spending averages (2024)
| Brand name | Generic name | Total claims 2024 | Total spending 2024 | Total beneficiaries 2024 | Rank by beneficiaries 2024 |
|---|---|---|---|---|---|
| Udenyca | PEGfilgrastim-Cbqv | 2873 | 1.34282e+07 | 962 | 1837 |
| Udenyca Autoinjector | PEGfilgrastim-Cbqv | 1604 | 6.71347e+06 | 493 | 2099 |
| Udenyca Onbody | PEGfilgrastim-Cbqv | 250 | 1.08033e+06 | 98 | 2733 |
Source: CMS Medicare Part D Spending by Drug (Drug Spending Dashboard), release RY26 P04 V10, data through 2024 (DSD_PTD_RY26_P04_V10_DY24_BGM.csv), downloaded 2026-10-30
Companies covering this drug
2,260 plans from 139 companies list this drug on a formulary for 2027. Search by company or plan name, or filter by tier. Cost sharing is the plan's published amount for this drug's tier in the initial coverage stage (1-month retail supply), where the plan publishes it; a blank means the plan does not publish it.
| Company | Plan | Tier | Copay | Coinsurance |
|---|
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Coverage and costs change. Drug lists (formularies), tiers, and copays can change during the year and differ by plan. Always check with your insurance company or plan directly to confirm what is covered and what you will pay.
Care and Living Guide is not connected with or endorsed by the U.S. government or the federal Medicare program. For official information visit Medicare.gov or call 1-800-MEDICARE.