INDICATION & 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...READ MORE

Prescribing Information Medication Guide Indication Important Safety Information References FAQ Downloads Visit Patient Site

For intralesional injection only. Do not administer intravenously.1

TREAT ADVANCED MELANOMA WITH THE PRECISION OF IMLYGIC®*,1

*IMLYGIC® is the first and only FDA-approved oncolytic viral therapy designed to replicate in cancer cells leading to oncolysis, whereby the release of tumor-derived antigens, virally derived GM-CSF, and replicated IMLYGIC® may promote an antitumor immune response. The exact mechanism of action is unknown.

IMLYGIC® dosing and administration videos

Videos are not intended to replace the Prescribing Information. Please review the Prescribing Information prior to administering IMLYGIC®.

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Dose determination video

This video outlines how to determine the correct dose of IMLYGIC® to administer into each lesion.

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This video outlines how to determine the correct dose of IMLYGIC® to administer into each lesion.

Watch Now

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Dose preparation video

This video explains how to prepare an appropriate dose of IMLYGIC®.

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This video explains how to prepare an appropriate dose of IMLYGIC®.

Watch Now

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Injection video

This video demonstrates how to administer an intralesional injection of IMLYGIC®.

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This video demonstrates how to administer an intralesional injection of IMLYGIC®.

Watch Now

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These videos are intended to provide you with an overview of some basic information about preparation of IMLYGIC®. These videos are not comprehensive reviews and do not replace the IMLYGIC® Prescribing Information. Prior to using IMLYGIC®, please review the Prescribing Information.

IMLYGIC® administration precautions

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.

IMLYGIC® exposure 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. If signs or symptoms of herpetic infection develop, the exposed individuals should contact their healthcare provider for appropriate treatment.

To minimize accidental exposure to IMLYGIC® by health care 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.

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 (including but not limited to cold sores and herpetic keratitis) and serious cases of disseminated herpetic infections have been reported in IMLYGIC®- treated patients, including fatal disseminated herpetic infection in the immunocompromised patient population. Immunocompromised patients may be at increased risk of life-threatening disseminated herpetic infection. 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.

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.

Injection site precautions

Injection site complications1

Necrosis or ulceration of tumor tissue may occur during IMLYGIC® (talimogene laherparepvec) 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 injection site healing1

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.

Plasmacytoma at injection site1

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.

Obstructive Airway Disorder1

Obstructive airway disorder has been reported following IMLYGIC® treatment. Use caution when injecting lesions close to major airways.

Dosing details

IMLYGIC® is provided in single-use vials of 1 mL each, in two different concentrations1:

  • 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

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.

Inject IMLYGIC® directly into lesions—
Follow steps 1-2-3 to reach up to 4 mL per treatment visit1

Please see full Prescribing Information for details about dosing and administration.

Image showing the dosing schedule

Image showing the dosing schedule

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

Reinitiate IMLYGIC® treatment at 108 concentration if new unresectable cutaneous, subcutaneous, or nodal lesions appear after a complete response.1

Determine injection volume of IMLYGIC® based on lesion size1

Please see full Prescribing Information for details on dosing and administration.

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

Maximum cumulative dose is 4 mL across multiple lesions

Image showing injection volume by lesion size

Image showing injection volume by lesion size

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

Remember, 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

*Lesion sizes not to scale.

Lesion Tracking Sheet

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

Download Now

Inject IMLYGIC® for local treatment of unresectable lesions1

Injectable lesions

Images are for illustrative purposes only.

Images showing cutaneous, subcutaneous, and nodal lesions

Images showing cutaneous, subcutaneous, and nodal lesions

Injectable lesions may vary in appearance.

Steps to take before, during, and after an injection of IMLYGIC®

Please see full Prescribing Information for details on dosing and administration.

Illustrations demonstrating injections into cutaneous, subcutaneous, and nodal lesions

Illustrations demonstrating injections into cutaneous, subcutaneous, and nodal lesions

Pre-injection1

  1. Clean the lesion and surrounding areas with an alcohol swab and let dry.
  2. Treat the injection site with a topical or local anesthetic agent, if necessary. Do not inject anesthetic agent directly into the lesion. Inject anesthetic agent around the periphery of the lesion.

Injection1

  1. Inject IMLYGIC® intralesionally into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance. Using a single insertion point, inject IMLYGIC® along multiple tracks as far as the radial reach of the needle allows within the lesion to achieve even and complete dispersion. Multiple insertion points may be used if a lesion is larger than the radial reach of the needle.
  2. Inject IMLYGIC® evenly and completely within the lesion by pulling the needle back without exiting the lesion. Redirect the needle as many times as necessary while injecting the remainder of the dose of IMLYGIC®. Continue until the full dose is evenly and completely dispersed.
  3. When removing the needle, withdraw it from the lesion slowly to avoid leakage of IMLYGIC® at the insertion point.
  4. Repeat steps 1-2 under pre-injection and steps 1-3 under injection for other lesions to be injected.
  5. Use a new needle any time the needle is completely removed from a lesion and each time a different lesion is injected.

Post-injection1

  1. Apply pressure to the injection site(s) with sterile gauze for at least 30 seconds.
  2. Swab the injection site(s) and surrounding area with alcohol.
  3. Change gloves and cover the injected lesion(s) with an absorbent pad and dry occlusive dressing.
  4. Wipe the exterior of occlusive dressing with alcohol.
  5. Advise patients to:
    • Keep the injection site(s) covered for at least the first week after each treatment visit or longer if the injection site is weeping or oozing.
    • Replace the dressing if it falls off.
30DosingAdministrationSafelyStoreIcon30DosingAdministrationSafelyStoreIcon

UNDERSTAND HOW TO SAFELY STORE AND HANDLE IMLYGIC®

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REFERENCE

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

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 but not limited to cold sores and herpetic keratitis) and serious cases of disseminated herpetic infections have been reported in IMLYGIC-® treated patients, including fatal disseminated herpetic infection in the immunocompromised patient population. Immunocompromised patients may be at increased risk of life-threatening disseminated herpetic infection. 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 the 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.
  • Obstructive Airway Disorder: Obstructive airway disorder has been reported following IMLYGIC® treatment. Use caution when injecting lesions close to major airways.
  • 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
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

IMLYGIC® 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

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