INTERACTIONS IMLYGIC is sensitive to acyclovir. Acyclovir or other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC. No drug interaction studies have been conducted with IMLYGIC.
Immunocompromised Patients ( 4.1 )
Pregnant
Patients ( 4.2 )
4.1 Immunocompromised Patients IMLYGIC is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy <span class="opacity-50 text-xs">[see Nonclinical Toxicology ( 13.2 )]</span> .
4.2 Pregnant Patients Do not administer IMLYGIC to pregnant patients.
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.
Accidental
Exposure to IMLYGIC continued: 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 the Injection Site: Consider the risks and benefits in patients with multiple myeloma or in whom plasmacytoma develops during treatment. ( 5.5 )
Obstructive Airway
Disorder: Use caution when injecting lesions close to major airways. ( 5.6 )
Hepatic
Hemorrhage from Transcutaneous Intrahepatic Route of Administration: IMLYGIC is not indicated for treatment via transcutaneous intrahepatic route of administration. ( 5.7 )
5.1 Accidental Exposure to IMLYGIC Accidental exposure may lead to transmission of IMLYGIC and herpetic infection. Accidental needle stick and splashback to the eyes have been reported in healthcare providers during preparation and administration of IMLYGIC. Healthcare providers, close contacts (household members, caregivers, sex partners, or persons sharing the same bed), pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients [ see Dosage and Administration ( 2.2 )] . Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC. Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials [ see Dosage and Administration ( 2.2 ) ] . In the event of an accidental exposure to IMLYGIC, exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant. If signs or symptoms of herpetic infection develop, the exposed individuals should contact their healthcare provider for appropriate treatment [ see Warnings and Precautions ( 5.2 )] . Patients should avoid touching or scratching injection sites or their occlusive dressings, as doing so could lead to inadvertent transfer of IMLYGIC to other areas of the body.
5.2 Herpetic Infection Herpetic infections (including but not limited to cold sores and herpetic keratitis) and serious cases of disseminated herpetic infections have been reported in patients treated with IMLYGIC, including fatal disseminated herpetic infection in the immunocompromised patient population <span class="opacity-50 text-xs">[see Clinical Trials Experience (6.1) and Postmarketing Experience (6.2) ]</span> . Immunocompromised patients may be at increased risk of life-threatening disseminated herpetic infection <span class="opacity-50 text-xs">[see Contraindications (4.1) ]</span> . Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission. Patients or close contacts with suspected herpetic infections should also contact their healthcare provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442); patients or close contacts have the option of follow-up testing for further characterization of the infection. IMLYGIC is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC. Therefore, consider the risks and benefits of IMLYGIC treatment before administering antiviral agents to manage herpetic infection.
5.3 Injection Site Complications Necrosis or ulceration of tumor tissue may occur during IMLYGIC treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds. In clinical studies, impaired healing at the injection site has been reported. IMLYGIC may increase the risk of impaired healing in patients with underlying risk factors (e.g., previous radiation at the injection site or lesions in poorly vascularized areas). One patient had an amputation of a lower extremity 6 months after IMLYGIC injection due to an infected non-healing wound. This wound area had been treated with surgery and radiation prior to IMLYGIC treatment and had previous wound complications. If there is persistent infection or delayed healing of the injection site(s), consider the risks and benefits of IMLYGIC before continuing treatment with IMLYGIC.
5.4 Immune-Mediated Events IMLYGIC may result in immune-mediated events. In clinical studies, immune-mediated events, including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC. 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.
5.5 Plasmacytoma at the Injection Site In a clinical study, a plasmacytoma has been reported in proximity to the injection site after administration of IMLYGIC in a patient with smoldering multiple myeloma. Consider the risks and benefits of IMLYGIC in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
5.6 Obstructive Airway Disorder Obstructive airway disorder has been reported following IMLYGIC treatment. Use caution when injecting lesions close to major airways.
5.7 Hepatic Hemorrhage from Transcutaneous Intrahepatic Route of Administration IMLYGIC is not indicated for transcutaneous intrahepatic route of administration. In clinical studies, cases of hepatic hemorrhage resulting in hospitalization and death have been reported in patients receiving transcutaneous intrahepatic IMLYGIC injections.