Indication and Limitations of Use


IMLYGIC® (talimogene laherparepvec) 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.

Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases. Close Read More
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IMLYGIC® Dosing & Administration

For intralesional injection only. Do not administer intravenously.1

Administer IMLYGIC® (talimogene laherparepvec) by injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance.1

To minimize accidental exposure to IMLYGIC® by healthcare providers, patients, and their close contacts, it is very important that the instructions for storage and handling, preparation, dosing, and administration of IMLYGIC® in the full Prescribing Information are strictly followed.

Please see full Prescribing Information for dosing and administration details.

IMLYGIC® Injection Video

Watch the video below demonstrating intralesional injections of IMLYGIC®.

Lesion Tracking Sheet

The Lesion Tracking Sheet can help you document treatment of melanoma lesions.

Product Information

IMLYGIC® is provided in single-use vials of
1 mL each in two different dose strengths1:
  • 106 (1 million) plaque-forming units (PFU) per mL (light green cap)—for initial dose only
  • 108 (100 million) PFU per mL (royal blue cap)—for all subsequent doses
IMLYGIC® (talimogene laherparepvec) Product

Review the Clinical Overview and Handling Instructional Guide to learn about dosing and administration and to understand some of the requirements for safe handling and storage

. GET THE GUIDE >

Dosing Information

  • The initial recommended dose is up to a maximum of 4 mL of IMLYGIC® at a concentration of 106 (1 million) PFU/mL per treatment visit.1
  • The recommended dose for subsequent administrations is up to 4 mL of IMLYGIC® at a concentration of 108 (100 million) PFU/mL per treatment visit.1
  • It may not be possible to inject all lesions at each treatment visit or over the full course of treatment.
  • Previously injected and/or uninjected lesions may be injected at subsequent treatment visits.1

Dosing Schedule

INITIAL DOSE1

  • Inject lesion(s) largest to smallest in size until either the maximum injection volume of 4 mL is reached, or until all injectable lesions have been treated.
DOSE 2 and all subsequent doses1
  • First, inject any newly formed lesion(s).
  • Then inject lesion(s) largest to smallest in size until either the maximum injection volume of 4 mL is reached, or until all injectable lesions have been treated.
IMLYGIC® (talimogene laherparepvec) Dosing and Administration

Continue IMLYGIC® treatment for at least 6 months unless other treatment is required or until there are no injectable lesions to treat.1

Reinitiate IMLYGIC® treatment if new cutaneous, subcutaneous, or nodal lesions appear after a complete response.1­­

Injection Volume

Determination of IMLYGIC® Injection Volume Based on Lesion Size1

The number of vials and concentration needed are dependent on the number and size of injectable lesions. Total volume of IMLYGIC® injection for each lesion should be determined by the chart below.1

*Lesion sizes not to scale.

When lesions are clustered together, inject them as you would for a single lesion according to the above.1

There is no limit on the number of lesions that may be injected until the maximum cumulative dose of 4 mL per visit is reached. The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined.1

It may not be possible to inject all lesions at each treatment visit or over the full course of treatment. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits.1

During the course of therapy1:

  • IMLYGIC® treatment should be continued for at least 6 months unless other treatment is required or until no injectable lesions are remaining
  • Reinitiate IMLYGIC® treatment if new unresectable cutaneous, subcutaneous, or nodal lesions appear after a complete response

IMLYGIC® Starter Kits

IMLYGIC® Starter Kits can be obtained from your local sales representative.

Help for locating centers and clinics that may provide IMLYGIC® (talimogene laherparepvec) treatment to appropriate patients.

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Read on for practical information about ordering, handling, and shipping and storage requirements for IMLYGIC®.

OPERATIONS & STORAGE >
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IMLYGIC® (talimogene laherparepvec) Suspension for Injection

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IMPORTANT SAFETY INFORMATION

Contraindications
  • 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, due to the risk of life-threatening disseminated herpetic infection.
  • Do not administer IMLYGIC® to pregnant patients.
Warnings and Precautions
  • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
  • 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. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
  • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
  • Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC®-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
  • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care 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®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
  • 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.
  • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (eg, previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
  • 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.
  • Plasmacytoma at Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
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. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see full Prescribing Information and Medication Guide for IMLYGIC®.

INDICATION AND LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) 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.

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

IMPORTANT SAFETY INFORMATION

Contraindications
  • 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, due to the risk of life-threatening disseminated herpetic infection.
  • Do not administer IMLYGIC® to pregnant patients.
Warnings and Precautions
  • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
  • 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. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
  • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
  • Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC®-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
  • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care 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®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
  • 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.
  • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (eg, previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
  • 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.
  • Plasmacytoma at Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
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. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see full Prescribing Information and Medication Guide for IMLYGIC®.

INDICATION AND LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) 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.

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

Reference

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.