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Prescription medicine

Talimogene laherparepvec Brand names: Imlygic

Talimogene laherparepvec (Imlygic) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the talimogene laherparepvec FDA label on DailyMed (effective April 4, 2025); every talimogene laherparepvec label on DailyMed.

Highlights of the record

FDA label of April 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Forms and strengths

Injection (suspension).

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
1,577 through July 30, 2026

What is talimogene laherparepvec used for?

From the label: indications and usage

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

Source: FDA drug label (Imlygic), Amgen Inc, effective April 4, 2025 (SPL set 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb), via openFDA; the full label on DailyMed

What does the patient leaflet for talimogene laherparepvec say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while getting IMLYGIC?

IMLYGIC virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed). Do the following to avoid spreading IMLYGIC to other areas of your body or to your close contacts: Avoid direct contact between your treatment sites, dressings, or body fluids and close contacts (for example, use condoms when engaging in sexual activity, avoid kissing close contacts if either has an open mouth sore). Wear gloves while putting on or changing your dressings. Keep treatment sites covered with airtight and watertight dressings for at least 1 week after each treatment (or longer if the treatment site is weeping or oozing). If the dressing comes loose or falls off, replace it right away with a clean dressing. Place all used dressings and cleaning materials in a sealed plastic bag and throw them away in the garbage. […]

Source: FDA drug label (Imlygic), Amgen Inc, effective April 4, 2025 (SPL set 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb), via openFDA; the full label on DailyMed

Is there a generic for talimogene laherparepvec (Imlygic)?

No generic talimogene laherparepvec 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 talimogene laherparepvec label say about other medicines?

The talimogene laherparepvec label names 1 other medicine 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
Acyclovirdrug interactionsAcyclovir or other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC.

Check talimogene laherparepvec against other medicines

Source: FDA drug label (Imlygic), Amgen Inc, effective April 4, 2025 (SPL set 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb), via openFDA; the full label on DailyMed

What do FAERS reports show for talimogene laherparepvec?

The FDA Adverse Event Reporting System holds 1,577 reports that list talimogene laherparepvec among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 189 are coded as a death and 301 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.

Reports received each year

The most reported reactions

  • Off Label Use (a use or a product term, not a reaction)222
  • Pyrexia (named in the label)144
  • Product Storage Error134
  • Metastatic Malignant Melanoma114
  • Death (an outcome recorded in the report)103
  • Circumstance Or Information Capable Of Leading To Medication Error (a use or a product term, not a reaction)89
  • Influenza Like Illness (named in the label)84
  • Fatigue (named in the label)78

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

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