Melanoma and other skin cancers:

Indications for IMLYGIC:

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.

Adult Dosage:

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.

Children Dosage:

Not established.

IMLYGIC Contraindications:

Immunocompromised or pregnant patients.

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 Classification:

Genetically modified oncolytic viral therapy.

IMLYGIC Interactions:

Acyclovir or other antiherpetic viral agents may interfere with efficacy.

Adverse Reactions:

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

Note:

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

Generic Drug Availability:

NO

How Supplied:

Single-use vial (1mL)—1