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Imlygic Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Generic Availability
NO
Imlygic Indications
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
Adult
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
Not established.
Imlygic Contraindications
Contraindications
Immunocompromised or pregnant patients.
Imlygic Boxed Warnings
Not Applicable
Imlygic Warnings/Precautions
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
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
Notes
Report suspected herpetic lesions to Amgen at (855) 465-9442.
Imlygic Patient Counseling
See Literature
