Data from FDA - Curated by Toby Galbraith - Last updated 28 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)


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.

of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. (1)

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Advisory information

• Immunocompromised Patients (4.1)
• Pregnant Patients (4.2)
Special warnings and precautions

• Accidental Exposure to IMLYGIC: Accidental exposure may lead to transmission of IMLYGIC and herpetic infection. Healthcare providers
and close contacts should avoid direct contact with injected lesions,
dressings, or body fluids of treated patients. Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC. If accidental exposure occurs, exposed individuals should clean the affected area. (5.1)
• Herpetic Infection: Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission. (5.2)
• Injection Site Complications: Consider the risks and benefits before continuing IMLYGIC treatment if persistent infection or delayed healing develops. (5.3)
• Immune-Mediated Events: Consider the risks and benefits of IMLYGIC before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop
immune-mediated events. (5.4)
• Plasmacytoma at Injection Site: Consider the risks and benefits in patients with multiple myeloma or in whom plasmacytoma develops during treatment. (5.5)

Adverse reactions

The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. (6)

Usage information

Dosing and administration
• Administer IMLYGIC by injection into cutaneous, subcutaneous, and/or nodal lesions. (2)
• Recommended starting dose is up to a maximum of 4 mL of IMLYGIC at a concentration of 106 (1 million) plaque-forming units (PFU) per mL. Subsequent doses should be administered up to 4 mL of IMLYGIC at a concentration of 108 (100 million) PFU per mL. (2)
Use in special populations
• Pregnancy: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment
with IMLYGIC. (8.1)
• Lactation: Discontinue drug or nursing. (8.2)

More information

Category Value
Authorisation number BLA125518
Orphan designation No
Product NDC 55513-078,55513-079
Date First Approved 02-11-2015
Date Last Revised 29-10-2015
RXCUI 1721289
Marketing authorisation holder Amgen Inc