Medications
Eflapegrastim-xnst (Rolvedon)
Rolvedon is used to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How Medicare covers it
Part D (prefilled syringe listed in the Part D formulary data) and Part B where the clinician-administered path applies (HCPCS J1449 in the CMS Part B spending file). 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 eflapegrastim-xnst under HCPCS J1449 (Injection, eflapegrastim-xnst, 0.1 mg; brand Rolvedon) — a clinician-administered Part B path exists alongside the Part D formulary listing. |
| 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
Non-myeloid malignancies (cancers that are not cancers of the myeloid blood cells) in adults who are receiving myelosuppressive anti-cancer drugs (chemotherapy that lowers blood cell counts) linked with a clinically significant incidence of febrile neutropenia (fever with a low neutrophil count). It is used to decrease the incidence of infection, as shown by febrile neutropenia.
What it is for, in depth
ROLVEDON is a leukocyte growth factor for adult patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; it lowers the chance of infection showing up as febrile neutropenia. The label's limitation of use is that it is not indicated for mobilizing peripheral blood progenitor cells for hematopoietic stem cell transplantation. Its benefit was shown in two randomized, open-label, active-controlled non-inferiority studies (Study 1 and Study 2) in 643 patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy every 21 days for up to 4 cycles, where a fixed 13.2 mg dose given under the skin on Day 2 of each cycle was non-inferior to pegfilgrastim 6 mg on the duration of severe neutropenia in Cycle 1 (mean 0.20 and 0.31 days on Rolvedon versus 0.35 and 0.39 days on pegfilgrastim). The drug itself is made by joining a human G-CSF analog to an Fc fragment of human immunoglobulin G4 (IgG4) with a polyethylene glycol linker, and it has a molecular weight of about 72 kDa. It comes in one form only: an injection of 13.2 mg in 0.6 mL, a clear, colorless, preservative-free solution in a single-dose prefilled syringe with a 29-gauge, half-inch pre-attached needle and a needle guard, supplied in a dispensing pack of one syringe. It is stored refrigerated at 36 to 46 degrees F (2 to 8 degrees C) in the carton to protect it from light; it must not be shaken or frozen, and a syringe left at room temperature for more than 72 hours or that has been frozen is discarded.
How it works
It is a recombinant human granulocyte colony-stimulating factor (G-CSF), a leukocyte growth factor. It binds to G-CSF receptors on myeloid progenitor cells (early blood-forming cells) and neutrophils (a type of white blood cell), triggering signaling pathways that control how those cells grow, mature, move, and survive, which raises neutrophil counts.
How it is taken
It is given as a single injection under the skin (subcutaneously) of 13.2 mg, once per chemotherapy cycle, from a single-dose prefilled syringe. It is given approximately 24 hours after cytotoxic chemotherapy, and it must not be given during the period from 14 days before to 24 hours after cytotoxic chemotherapy. The entire contents of the syringe are given; the syringe has no graduation marks and is meant only to deliver its full contents (13.2 mg in 0.6 mL). Before use, the carton is taken out of the refrigerator and the sealed blister tray is left on a clean flat surface for a minimum of 30 minutes so the product reaches room temperature; it is not warmed any other way, it is not shaken, a syringe left at room temperature for more than 72 hours is discarded, and a syringe that was accidentally frozen is not used. For a missed dose, the label states: if the patient or caregiver misses a dose of Rolvedon, instruct them to contact their healthcare provider.
Common side effects
The most common side effects, each seen in at least 20 percent of patients in Studies 1 and 2, are fatigue (58 percent), nausea (52 percent), diarrhea (40 percent), bone pain (38 percent), headache (29 percent), fever (pyrexia, 28 percent), anemia (25 percent), rash (25 percent), muscle pain (myalgia, 22 percent), joint pain (arthralgia, 21 percent), and back pain (20 percent). Other side effects seen in at least 10 percent include decreased appetite, swelling of the arms or legs (peripheral edema), abdominal pain, dizziness, shortness of breath (dyspnea), cough, low platelet count (thrombocytopenia), pain, pain in an arm or leg, local administration reactions, and flushing. Permanent discontinuation because of a side effect occurred in 4 percent of patients; the reaction that led to discontinuation in 3 patients was rash.
Serious warnings
Rolvedon can cause splenic rupture, including fatal cases, as can other recombinant human G-CSF products; patients who report left upper abdominal or shoulder pain are evaluated for an enlarged spleen or splenic rupture. It can cause acute respiratory distress syndrome (ARDS); patients who develop fever, lung infiltrates, or breathing distress are evaluated, and Rolvedon is stopped in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur, and Rolvedon is permanently stopped in patients with serious allergic reactions. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders, and Rolvedon is stopped if a crisis occurs. Other warnings are glomerulonephritis (kidney inflammation; dose reduction or interruption is considered if Rolvedon is the likely cause), very high white blood cell counts (leukocytosis; complete blood counts are monitored and treatment is stopped if the white count reaches 100 x 10^9/L or more), low platelet counts (thrombocytopenia; platelet counts are monitored), capillary leak syndrome (which may be life-threatening if treatment is delayed), a possible growth-stimulating effect on tumor cells (the G-CSF receptor has been found on tumor cell lines, so an effect on myeloid cancers and myelodysplasia, for which Rolvedon is not approved, cannot be excluded), myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving it with chemotherapy and/or radiotherapy (patients are monitored for signs), aortitis (inflammation of the aorta, which may occur as early as the first week), and increased bone marrow activity that can change bone imaging results.
Who should be careful
Rolvedon must not be used by patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as eflapegrastim, pegfilgrastim, or filgrastim products; that is its contraindication. People with sickle cell disorders are at risk of severe and sometimes fatal sickle cell crises. For pregnancy, there are no available data on Rolvedon use in pregnant women, although published studies of other rhG-CSF products in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; in rabbits, the drug caused embryofetal death and reduced fetal weight at about 6 times the clinical exposure, while rats showed no harm at up to 7 times the clinical exposure. For breastfeeding, there are no data on whether the drug is in human milk or its effects on the breastfed child or milk production; natural G-CSF is present in human milk, and other rhG-CSF products are present in human milk at low levels and are not absorbed by mouth by infants. Safety and effectiveness have not been established in children. Of the 314 patients in the clinical studies, 39 percent were 65 and over and 6 percent were 75 and over, with no overall differences in safety or effectiveness compared with younger patients.
Major interactions
The label states that no studies evaluating the drug interaction potential of eflapegrastim-xnst have been conducted, so it lists no specific drug interactions. The one timing rule in the label is about chemotherapy itself: Rolvedon is given approximately 24 hours after cytotoxic chemotherapy and must not be administered within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy.
Why it is in its tier
The most common Part D tier for this drug in the CMS data is Tier 5, the specialty tier — the highest cost share, usually a percentage of the drug's cost. This is a brand-name drug (Rolvedon) with no generic version in the CMS-matched products. It is listed by 42 of 5,495 Part D plans (0.76%), and 100.0% of listing plans place it on Tier 5. In the CMS Part D Drug Spending Dashboard data through 2024, the Rolvedon row averaged $16,237.17 in total spending per beneficiary (a small group — 100 beneficiaries in 2024) — a program average across Part D (before rebates), not a reader's copay. The tier shown is the most common one across plans. Individual plans vary, so check your own plan's drug list for your exact cost.
Part D formulary coverage
| Formulary summary | |
|---|---|
| Most common tier | 5 |
| Plans listing this drug | 42 |
| Total Part D plans | 5495 |
| Share of plans listing it | 0.76 |
| Formularies listing it | 3 |
| Tier | Plans |
|---|---|
| Tier 5 | 42 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 for the expansion queue resolved from the CMS file itself and name-verified via the NLM RxNav (RxNorm) API (ops/medications/data/expansion_uncovered_names.json).
What you pay
| With Medicare Part D | |
|---|---|
| Most common tier | Tier 5 |
| Typical coinsurance | 30.5% of the price |
| Based on | 42 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 2026-11-07
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 |
|---|---|---|---|---|---|
| Rolvedon | Eflapegrastim-Xnst | 345 | 1.62372e+06 | 100 | 2726 |
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
42 plans from 5 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.
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