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® Operations & Storage

This section offers information and resources related to the logistics of bringing IMLYGIC® (talimogene laherparepvec) to your clinic or institution for appropriate patients.

IMLYGIC® has shipping and storage requirements.1 Please be sure to review the full instructions to ensure you understand how to order and store IMLYGIC®.

You can learn more about storage requirements as well as details on procurement, ordering, and safe handling of IMLYGIC® via the resources in this section, which include:

Interactive Operational Planning Checklist

An objective assessment of potential issues related to IMLYGIC® ordering and documentation was conducted. This tool will walk you through questions about operations and storage requirements of IMLYGIC® (talimogene laherparepvec) to help you make a plan for integrating IMLYGIC® into your practice.

The Checklist covers Storage, Procurement, Ordering, and Dispensing and Handling. When you have completed the 4 sections of the Checklist, you will have access to a PDF that includes information related to your answers and IMLYGIC® preparation and handling consistent with approved product labeling.

As an alternative, you can access a non-customized PDF version of the Operational Planning Checklist, which includes general directions for Storage, Procurement, Ordering, and Handling.

We also offer a Clinical Overview and Handling Instructional Guide to assist you in your preparations.

Before using IMLYGIC® it is important to review the Prescribing Information.

The Prescribing Information provides all of the requirements for handling IMLYGIC®. This Checklist is not intended to serve as a replacement for the Prescribing Information.

NOTE: IMLYGIC® requires storage conditions. Please see the Prescribing Information (section 2.2) for details on preparation and handling, including guidance on thawing and storage of IMLYGIC® vials.

Click each of the blue boxes below for more information.

1 Storage

How will you store IMLYGIC®? Click each option (S1 or S2) below for more information.

You have selected Store frozen in an ultra-low freezer (-90°C to -70°C).1

Please see the Important Planning Question below.

Important Planning Question

  • Who is responsible for freezer monitoring at your institution?

If an ultra-low freezer is not available to you, Amgen can provide access to an ultra-low freezer to your institution for storing IMLYGIC®. Get details

PDFBREAKLINEIMLYGIC® FREEZER PROGRAM

For institutions that need an ultra-low freezer for storing IMLYGIC®, Amgen can provide access to a Stirling Shuttle -86ºC Portable Ultra Low Temperature Freezer when you purchase IMLYGIC®. For more information, call 1-866-IMLYGIC (465-9442) 1-866-IMLYGIC (465-9442); choose Option 1 for Health Care Providers, then Option 2 for ordering.

Close ☒

Key Points to Consider:

  • IMLYGIC® should be protected from light and stored in the carton until use.1
  • Thaw IMLYGIC® immediately prior to administration.1
  • Do not draw IMLYGIC® into a syringe until immediately prior to administration.1

Key Points to Consider:

  • Amgen can place a -90°C to -70°C freezer at your institution for storage of IMLYGIC®. Contact 1-866-IMLYGIC for details.
  • IMLYGIC® should be protected from light and stored in the carton until use.1
  • The storage container that IMLYGIC® is shipped in includes specific handling instructions.

You have selected Store frozen in the original IMLYGIC® shipping container for up to 96 hours.

Please see the Important Planning Questions below.

Important Planning Questions

  • Who will be responsible for monitoring expiration time on the shipping container?

  • Where will the shipping container be stored?

Key Points to Consider:

  • The IMLYGIC® shipping container will hold the correct storage temperatures for up to 96 hours after being sealed for delivery. (This expiration time is printed on the container.)2
  • IMLYGIC® should be protected from light and stored in the carton until use.1
  • Thaw IMLYGIC® immediately prior to administration.1
  • Do not draw IMLYGIC® into a syringe until immediately prior to administration.1

Key Points to Consider:

  • The IMLYGIC® shipping container will hold the correct storage temperatures for up to 96 hours after being sealed for delivery. (This expiration time is printed on the container.)2
  • IMLYGIC® should be protected from light and stored in the carton until use.1
  • Printed on the outside of the storage container are instructions on how to properly store IMLYGIC®.
S1: Store frozen in an ultra-low freezer (-90°C to -70°C).1 S2: Store frozen in the original IMLYGIC® shipping container for up to 96 hours.2
2 Procurement

You have 2 options to choose from when planning your order for IMLYGIC®. Click each option (P1 or P2) below for more information.

Based on your selection of S2: Store frozen in the original IMLYGIC® shipping container for up to 96 hours above, your only option in this section is P2: Use just-in-time ordering.

You have selected Keep in stock.

Please see the Important Planning Questions below.

Important Planning Questions

  • Who will be responsible for placing and tracking IMLYGIC® orders?

  • Where should IMLYGIC® orders be delivered?

  • Who should receive and unpack IMLYGIC® orders?

If an ultra-low freezer is not available to you, Amgen can provide access to an ultra-low freezer to your institution for storing IMLYGIC®. Get details

IMLYGIC® FREEZER PROGRAM

For institutions that need an ultra-low freezer for storing IMLYGIC®, Amgen can provide access to a Stirling Shuttle -86ºC Portable Ultra Low Temperature Freezer when you purchase IMLYGIC®. For more information, call 1-866-IMLYGIC (465-9442); choose Option 1 for Health Care Providers, then Option 2 for ordering.

Close ☒

NOTES:

IMLYGIC® is supplied in single-use 1 mL vials (1 vial per carton), containing a sterile frozen suspension, in two different concentrations noted by distinct vial cap colors (light green cap for initial dose, royal blue cap for subsequent doses)1:

One-Time Initial Dose1
106 (1 million) PFU/mL
Subsequent Doses1
108 (100 million) PFU/mL
  • The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined. It may not be possible to inject all lesions at each treatment visit or over the full course of treatment.1 Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits.
  • Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC® and should not come into direct contact with the IMLYGIC® injection sites, dressings, or body fluids of treated patients.1
  • IMPORTANT: If you are using the container to store IMLYGIC®, the product may only be inventoried once. Once the product container is removed, you will have 60 seconds to either place it back in the storage container or transfer it to a freezer.2

Key Points to Consider:

  • For longer-term storage, IMYGIC® must be stored in a freezer that is able to maintain temperature at -90°C to -70°C.1
  • Before placing the order it is important to determine the number of IMLYGIC® vials that will be kept on hand. (Up to 4 vials can be used per patient per treatment visit for all injectable lesions combined.)1
  • If an ultra-low freezer is not available to you, Amgen can provide access to a -90°C to -70°C freezer to your institution for storing IMLYGIC®. Get details
PDFBREAKPAGE

Additional Points to Consider:

  • IMLYGIC® is supplied in single-use 1 mL vials (1 vial per carton), containing a sterile frozen suspension, in two different concentrations noted by distinct vial cap colors (light green cap for initial dose, royal blue cap for subsequent doses)1:
    • PDFSUBLEVELOne-Time Initial Dose1 – 106 (1 million) PFU/mL
    • PDFSUBLEVELSubsequent Doses1 – 108 (100 million) PFU/mL
  • The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined. It may not be possible to inject all lesions at each treatment visit or over the full course of treatment.1 Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC® and should not come into direct contact with the IMLYGIC® injection sites, dressings, or body fluids of treated patients.1

You have selected Use just-in-time ordering.

Please see the Important Planning Questions below.

Important Planning Questions

  • Who will be responsible for placing and tracking IMLYGIC® orders?

  • Where should IMLYGIC® orders be delivered?

  • Who will be responsible for receiving and storing IMLYGIC®?

NOTES:

IMLYGIC® is supplied in single-use 1 mL vials (1 vial per carton), containing a sterile frozen suspension, in two different concentrations noted by distinct vial cap colors (light green cap for initial dose, royal blue cap for subsequent doses)1:

One-Time Initial Dose1
106 (1 million) PFU/mL
Subsequent Doses1
108 (100 million) PFU/mL
  • The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined. It may not be possible to inject all lesions at each treatment visit or over the full course of treatment.1 Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits.
  • Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC® and should not come into direct contact with the IMLYGIC® injection sites, dressings, or body fluids of treated patients.1
  • IMPORTANT: If you are using the container to store IMLYGIC®, the product may only be inventoried once. Once the product container is removed, you will have 60 seconds to either place it back in the storage container or transfer it to a freezer.2

Key Points to Consider:

  • IMLYGIC® can be stored in its shipping container as long as the ordered product is intended for use within 96 hours after the shipment has been sealed for delivery (per expiration time on the side of the container).2
  • Before placing the order for just-in-time delivery it is important to determine the number of IMLYGIC® vials that will be used (up to 4 vials per patient per treatment visit for all injectable lesions combined).1
  • To prevent treatment delays, timing of product delivery should be coordinated with scheduling of the patient visit for IMLYGIC® administration.

Additional Points to Consider:

  • IMLYGIC® is supplied in single-use 1 mL vials (1 vial per carton), containing a sterile frozen suspension, in two different concentrations noted by distinct vial cap colors (light green cap for initial dose, royal blue cap for subsequent doses)1:
    • PDFSUBLEVELOne-Time Initial Dose1 – 106 (1 million) PFU/mL
    • PDFSUBLEVELSubsequent Doses1 – 108 (100 million) PFU/mL
  • PDFBREAKPAGE The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined. It may not be possible to inject all lesions at each treatment visit or over the full course of treatment.1 Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC® and should not come into direct contact with the IMLYGIC® injection sites, dressings, or body fluids of treated patients.1
P1: Keep in stock. P2: Use just-in-time ordering.
3 Order Sets

Considerations for Developing IMLYGIC® Order Sets

An objective assessment of potential issues related to IMLYGIC® ordering and documentation was conducted. Below are some considerations that may help as you determine the plan for your institution.

  • Build medication orders using the full generic name (talimogene laherparepvec) followed by the branded name (IMLYGIC®)2
  • Input the 2 concentrations with standard text, since the use of exponents may be confusing2
    • 106 = 1 million PFU/mL1 
    • 108 = 100 million PFU/mL1  
  • Develop a standard order set (electronic or printed) for the patient’s first dose (1 million PFU/mL) and a separate order set for subsequent doses (100 million PFU/mL)1,2 
  • Create an order verification dose alert/message that indicates a patient can receive a maximum of 4 mL (4 vials) per treatment visit1,2 
  • Please see full Prescribing Information. The Prescribing Information provides all of the requirements for handling IMLYGIC®.
  • When handling the product, all practitioners should be educated on injection safety and the safe use of single-use vials2
  • If drug is prepared with pharmacy services, consider preparing patient-specific 1 mL-sized pharmacy-labeled syringes. The number of syringes dispensed should be based on the total volume of drug ordered2
  • Practitioners should be educated on injection and the safe use of IMLYGIC®2
  • Prevent repeating the initial dose: Patients should not receive the initial dose concentration (106 PFU/mL) of IMLYGIC® twice.1,2 Create a rule that alerts users when a patient who has already received this concentration is prescribed it again
  • Do not exceed the total dose volume: Create an IMLYGIC®-specific order entry that warns against exceeding a total of 4 mL per visit1,2 
  • Adhere to the dosing schedule: Create an alert that warns users when a patient has been prescribed an IMLYGIC® treatment less than 14 days since Cycle 1 (initial and second treatment)1,2
There are no options to choose for Order Sets.
4 Dispensing and Handling

IMLYGIC® Handling1

Please review the handling information below and then answer the question related to how IMLYGIC® will be handled in your institution.

Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC® and should not come into direct contact with the IMLYGIC® injection sites, dressings, or body fluids of treated patients.

  • Avoid accidental exposure to IMLYGIC® and follow universal biohazard precautions for preparation, administration, and handling of IMLYGIC®:
    • Wear personal protective equipment (protective gown or laboratory coat, safety glasses or face shield, and gloves) while preparing or administering IMLYGIC®
    • Avoid accidental exposure to IMLYGIC®, especially contact with skin, eyes, and mucous membranes
      • Cover any exposed wounds before handling
      • In the event of an accidental occupational exposure (eg, through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes
      • In the event of exposure to broken skin or needle stick, clean the affected area thoroughly with soap and water and/or a disinfectant
    • Treat all IMLYGIC® spills with a virucidal agent such as 1% sodium hypochlorite and blot using absorbent materials
    • Dispose of all materials that may have come in contact with IMLYGIC® (eg, vial, syringe, needle, cotton gauze, gloves, masks, or dressings) in accordance with universal biohazard precautions
    • Advise patients to place used dressings and cleaning materials into a sealed plastic bag and dispose in household waste

Thawing IMLYGIC® Vials

  • IMLYGIC® is supplied in single-use 1 mL vials (1 vial per carton)
  • Thaw frozen IMLYGIC® vials at room temperature [20º to 25ºC (68º to 77ºF)] until IMLYGIC® is liquid (approximately 30 minutes). Do not expose the vial to higher temperatures. Keep the vial in original carton during thawing
  • After thawing, administer IMLYGIC® immediately or store in its original vial and carton, protected from light in a refrigerator [2° to 8°C (36° to 46°F)] for no longer than the specified duration in the table below. Do not refreeze IMLYGIC® after thawing. Discard any IMLYGIC® vial left in the refrigerator longer than the specified times in the table below
One-Time Initial Dose1
106 (1 million) PFU/mL
Subsequent Doses1
108 (100 million) PFU/mL
Up to 12 hours Up to 48 hours

How will IMLYGIC® be provided to the health care professional administering treatment? Click each option (DH1 or DH2) below for more information.

You have selected Supplied in 1 mL vial(s).

Please see the Important Planning Questions below.

Important Planning Questions

  • Who will be responsible for transporting IMLYGIC® to the healthcare professional administering treatment?

  • Where in the institution will IMLYGIC® be administered?

NOTE:
After thawing, administer IMLYGIC® immediately or store in its original vial and carton, protected from light in a refrigerator [2° to 8°C (36°C to 46°F)] for no longer than the specified duration in the table below. Do not refreeze IMLYGIC® after thawing. Discard any IMLYGIC® vial left in the refrigerator longer than the specified times in the table.

One-Time Initial Dose1
106 (1 million) PFU/mL
Subsequent Doses1
108 (100 million) PFU/mL
Up to 12 hours Up to 48 hours

Key Points to Consider:

  • After thawing, administer IMLYGIC® immediately or store in its original vial and carton, protected from light in a refrigerator [2° to 8°C (36° to 46°F)] for no longer than the specified duration in the table below. Do not refreeze IMLYGIC® after thawing. Discard any IMLYGIC® vial left in the refrigerator longer than the specified times in the table.
One-Time Initial Dose1
106 (1 million) PFU/mL
Subsequent Doses1
108 (100 million) PFU/mL
Up to 12 hours Up to 48 hours

  • IMLYGIC® should not be drawn into a syringe until immediately prior to administration.1


You have selected Supplied in syringe(s) drawn by healthcare practitioner.

Please see the Important Planning Questions below.

Important Planning Questions

  • Where will IMLYGIC® be transferred from the 1 mL vial(s) into the syringe(s)?

  • How will syringes be labeled?

  • Who will be responsible for transporting IMLYGIC® to the healthcare professional administering treatment?

  • Where in the institution will IMLYGIC® be administered?

NOTE:
After thawing, administer IMLYGIC® immediately or store in its original vial and carton, protected from light in a refrigerator [2° to 8°C (36°C to 46°F)] for no longer than the specified duration in the table below. Do not refreeze IMLYGIC® after thawing. Discard any IMLYGIC® vial left in the refrigerator longer than the specified times in the table.

One-Time Initial Dose1
106 (1 million) PFU/mL
Subsequent Doses1
108 (100 million) PFU/mL
Up to 12 hours Up to 48 hours
  • Healthcare professionals who are handling IMLYGIC® should read the complete Prescribing Information, including the precautionary information within.

Key Point to Consider:

  • IMLYGIC® should not be drawn into a syringe until immediately prior to administration.1
  • Prepare sterile syringes and needles. A detachable needle of 18–26G may be used for IMLYGIC® withdrawal and a detachable needle of 22–26G may be used for injection. Small unit syringes (e.g., 0.5 mL insulin syringes) are recommended for better injection control.
  • Using aseptic technique, remove the vial cap and withdraw the product from the vial into the syringe(s), noting the total volume. Avoid generating aerosols when loading syringes with product, and use a biologic safety cabinet if available.
DH1: Supplied in 1 mL vial(s)1 DH2: Supplied in syringe(s) drawn by healthcare practitioner

You must complete all 4 sections in order to print your interactive Checklist.

Review the IMLYGIC® Clinical Overview and Handling Instructional Guide for efficacy data, information on dosing and administration, and details on planning for receipt of IMLYGIC®, including how it is supplied and product handling and storage requirements, as well as resources for integrating IMLYGIC® into your practice.

Customer Info for Your IMLYGIC® Orders

IMLYGIC® orders are managed directly by Amgen. Please complete a Customer Registration Profile at the IMLYGIC® Customer Registration Page to ensure that Amgen has the information needed for processing your orders.

IMLYGIC® Product Ordering Sheet

IMLYGIC® is shipped from select authorized specialty distributors. Refer to the Product Ordering Sheet to identify a qualified distributor for IMLYGIC®. The sheet also includes information on ordering options, the order and delivery schedule, product storage, and the IMLYGIC® freezer program.

Checking and Storing Your IMLYGIC® Shipment

Watch the video below to learn about the process for receiving an IMLYGIC® shipment, including instructions on the special storage requirements for the product.

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

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Get information on billing and coding and learn about access programs in the next section.

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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.

References

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