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Prescription medicine

Efbemalenograstim alfa Brand names: Ryzneuta

Efbemalenograstim alfa (Ryzneuta) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the efbemalenograstim alfa FDA label on DailyMed (effective May 19, 2026); every efbemalenograstim alfa label on DailyMed.

Highlights of the record

FDA label of May 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

INDICATIONS AND USAGE RYZNEUTA 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 a clinically significant incidence of febrile neutropenia.

Forms and strengths

  • 20 mg/ml

Injection.

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 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
37 through July 30, 2026

What is efbemalenograstim alfa used for?

From the label: indications and usage

INDICATIONS AND USAGE RYZNEUTA 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 a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA 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 (RYZNEUTA), Acrotech Biopharma Inc, effective May 19, 2026 (SPL set 290ed754-758c-9cae-e063-6294a90ae68b), via openFDA; the full label on DailyMed

Is there a generic for efbemalenograstim alfa (Ryzneuta)?

No generic efbemalenograstim alfa 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 efbemalenograstim alfa label say about other medicines?

The efbemalenograstim alfa label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
EflapegrastimwarningsRYZNEUTA is contraindicated in patients with a history of serious allergic reactions to RYZNEUTA or other rhG-CSF products such as pegfilgrastim, eflapegrastim or filgrastim products.
FilgrastimcontraindicationsCONTRAINDICATIONS RYZNEUTA is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products [see Warnings and Precautions ( 5.3 )].
PegfilgrastimcontraindicationsCONTRAINDICATIONS RYZNEUTA is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products [see Warnings and Precautions ( 5.3 )].

Check efbemalenograstim alfa against other medicines

Source: FDA drug label (RYZNEUTA), Acrotech Biopharma Inc, effective May 19, 2026 (SPL set 290ed754-758c-9cae-e063-6294a90ae68b), via openFDA; the full label on DailyMed

What do FAERS reports show for efbemalenograstim alfa?

The FDA Adverse Event Reporting System holds 37 reports that list efbemalenograstim alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 18 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

  • Anaphylactic Shock9
  • Asthenia7
  • Dizziness (named in the label)6
  • Dyspnoea5
  • Hyperhidrosis4
  • Nausea (named in the label)4
  • Pyrexia4
  • Blood Pressure Decreased3

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