• Melanoma and other skin cancers

Imlygic Generic Name & Formulations

General Description

Talimogene laherparepvec 106 (1 million) PFU/mL, 108 (100 million) PFU/mL; susp for intralesional inj; preservative-free.

Pharmacological Class

Genetically modified oncolytic viral therapy.

How Supplied

Single-use vial (1mL)—1


Generic Availability


Imlygic Indications


Treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of Use

Not shown to improve overall survival or have an effect on visceral metastases.

Imlygic Dosage and Administration


See full labeling. Inject intralesionally into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance. Total inj volume per treatment visit: max 4mL for all injected lesions combined. Initial dose: up to 4mL of 106 (1 million) PFU/mL. 2nd dose: up to 4mL of 108 (100 million) PFU/mL given 3 weeks later. All subsequent doses (including reinitiation): up to 4mL of 108 (100 million) PFU/mL given 2 weeks apart. Continue for ≥6 months unless other treatment required or until no injectable lesions to treat; reinitiate if new lesions appear after a complete response.


Not established.

Imlygic Contraindications


Immunocompromised or pregnant patients.

Imlygic Boxed Warnings

Not Applicable

Imlygic Warnings/Precautions


For intralesional inj only. Avoid accidental exposure (esp. skin, eyes, mucous membranes) and direct contact with patient's injected lesions, dressings, or body fluids. Advise patients to avoid inadvertent transfer of drug to other areas of the body (eg, touching/scratching inj sites or occlusive dressings). Evaluate lesions if suspected herpetic infection occurs. Inj site complications (eg, necrosis or ulceration of tumor tissue, cellulitis, systemic bacterial infection). Persistent infection or delayed healing of inj site. Underlying autoimmune disease. Multiple myeloma or plasmacytoma. Pregnancy. Women of childbearing potential should use effective method of contraception. Nursing mothers: not recommended.

Imlygic Pharmacokinetics

See Literature

Imlygic Interactions


Acyclovir or other antiherpetic viral agents may interfere with efficacy.

Imlygic Adverse Reactions

Adverse Reactions

Fatigue, chills, pyrexia, nausea, influenza-like illness, inj site pain; immune-mediated events.

Imlygic Clinical Trials

See Literature

Imlygic Note


Report suspected herpetic lesions to Amgen at (855) 465-9442.

Imlygic Patient Counseling

See Literature