Quick answers
- What is Eflapegrastim-xnst used for?
- The FDA-approved label (Rolvedon, Spectrum Pharmaceuticals, Inc., February 18, 2026) says: “Rolvedon is indicated 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 clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eflapegrastim-xnst have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Eflapegrastim-xnst?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eflapegrastim-xnst been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Eflapegrastim-xnst?
- 2 companies list prescription products of Eflapegrastim-xnst in the FDA NDC Directory, including Spectrum Pharmaceuticals, Inc. and Assertio Specialty Pharmaceuticals LLC.
What Eflapegrastim-xnst is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Rolvedon is indicated 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 clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. …
— FDA label: Rolvedon, Spectrum Pharmaceuticals, Inc., effective February 18, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Rolvedon |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Spectrum Pharmaceuticals, Inc.1 product
- Assertio Specialty Pharmaceuticals LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761148 ROLVEDON | Spectrum Pharms | September 9, 2022 | 2, latest December 12, 2025 2025: Labeling · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2612541, 2612547 |
|---|---|
| SPL set ID of the quoted label | 6e436115-62e7-4729-aeb0-ff78ea685206 |
| FDA labels (SPL) | 2 |
| FDA applications | BLA761148 |
| Active ingredients (FDA) | EFLAPEGRASTIM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rolvedon, Spectrum Pharmaceuticals, Inc., effective February 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →