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Prescription medicine

Eflapegrastim Brand names: Rolvedon

Eflapegrastim (Rolvedon) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the eflapegrastim FDA label on DailyMed (effective February 18, 2026); every eflapegrastim label on DailyMed.

Highlights of the record

FDA label of February 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

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.

Forms and strengths

  • 13.2 mg/.6ml

Injection (solution).

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
2 of which 0 under generic applications, 2 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
29 through July 30, 2026

What is eflapegrastim used for?

From the label: indications and usage

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 pharmacologic class: Leukocyte Growth Factor.

Source: FDA drug label (Rolvedon), Spectrum Pharmaceuticals, Inc., effective February 18, 2026 (SPL set 6e436115-62e7-4729-aeb0-ff78ea685206), via openFDA; the full label on DailyMed

Is there a generic for eflapegrastim (Rolvedon)?

No generic eflapegrastim is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the eflapegrastim label say about other medicines?

The eflapegrastim label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name eflapegrastim. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
FilgrastimcontraindicationsCONTRAINDICATIONS Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products.
PegfilgrastimcontraindicationsCONTRAINDICATIONS Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products.

Other labels that name eflapegrastim

Check eflapegrastim against other medicines

Source: FDA drug label (Rolvedon), Spectrum Pharmaceuticals, Inc., effective February 18, 2026 (SPL set 6e436115-62e7-4729-aeb0-ff78ea685206), via openFDA; the full label on DailyMed

What do FAERS reports show for eflapegrastim?

The FDA Adverse Event Reporting System holds 29 reports that list eflapegrastim among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 10 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.

The most reported reactions

  • White Blood Cell Count Increased4
  • Asthenia3
  • Diarrhoea (named in the label)3
  • Leukocytosis (named in the label)3
  • Abdominal Pain (named in the label)2
  • Accidental Exposure To Product2
  • Bone Pain (named in the label)2
  • Constipation2

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
Eflapegrastim side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other