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

IMLYGIC® Has Special OPERATIONS AND HANDLING Requirements1

Interactive Operational Planning Checklist

Select each of the blue boxes below for more information.

1 Storage

Choose how you will store IMLYGIC®
Select each option (S1 or S2) below for more information.

S1 Store frozen in an ultra-low freezer (-90°C to -70°C).1

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

Additional Planning Question

  • Who is responsible for freezer monitoring at your institution?

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:

  • 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.
S2 Store frozen in the original IMLYGIC® shipping container for up to 96 hours after being sealed.2

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

Additional 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®.
Continue
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 after being sealed.2
2 Procurement

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

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

P1 Keep in stock.

You have selected Keep in stock.

Additional 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 Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®.
  • 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.3

Key Points to Consider:

  • For longer-term storage, IMLYGIC® 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
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) plaque-forming units (PFU)/mL
    • PDFSUBLEVELSubsequent Doses1 – 108 (100 million) PFU/mL
  • PDFBREAKPAGEThe 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 Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®. 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
P2 Use just-in-time ordering.

You have selected Use just-in-time ordering.

Additional 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 Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®.
  • 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.3

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
  • PDFBREAKPAGEThe 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 Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. Please see the Prescribing Information (section 2.1) for the recommended dosing schedule for IMLYGIC®. 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
Continue
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.

Order Set Considerations4
  • Build medication orders using the full generic name (talimogene laherparepvec) followed by the branded name (IMLYGIC®)4
  • Input the 2 concentrations with standard text, since the use of exponents may be easily confused4
    • 106 = 1 million plaque-forming units per mL (PFU/mL)1 
    • 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)4 
  • Create an order verification dose alert/message that warns against exceeding 4 mL (4 vials) per treatment visit4 
  • Please see full Prescribing Information. The Prescribing Information provides all of the requirements for handling IMLYGIC®
Preparation Considerations
  • When handling the product, all practitioners should be educated on injection safety and the safe use of single-use vials4
  • 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 ordered4
  • Practitioners should be educated on injection and the safe use of IMLYGIC®4
Creating Safeguard Rules
  • Prevent repeating the initial dose: Patients should not receive the initial dose concentration (106 PFU/mL) of IMLYGIC® twice.1 Create a rule that alerts users when a patient who has already received this concentration is prescribed it again4
  • Do not exceed the total dose volume: Create an IMLYGIC®-specific order entry that warns against exceeding a total of 4 mL per visit4 
  • 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)4
Continue
OS Order Set Considerations have been read.
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 below instructions 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 or 70% isopropyl alcohol 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) as biohazardous waste
    • 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 [20ºC to 25ºC (68ºF to 77ºF)] until IMLYGIC is liquid. The time to achieve complete vial thaw is expected to be 30 to 70 minutes, depending on the ambient temperature. 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, as follows:
    • Thawed IMLYGIC® is stable when stored at temperatures of 2ºC (36ºF) up to 25ºC (77ºF) protected from light in its original vial and carton for the storage times specified in the table below. Do not exceed the storage times specified in the table below.
    • IMLYGIC® must not be refrozen once it is thawed. Discard any thawed IMLYGIC® in the vial stored longer than the specified times in the table below.

Maximum Storage Time for Thawed IMLYGIC® in Vial

106 (1 million) PFU/mL 108 (100 million) PFU/mL
2ºC to 8ºC (36ºF to 46ºF) 24 hours 1 week (7 days)
up to 25ºC (77ºF) 12 hours 24 hours
 

Choose 1 of the 2 options below for how IMLYGIC® will be supplied to the health care professional administering treatment
Select each option (DH1 or DH2) below for more information.

DH1 Supplied in 1 mL vial(s)1

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

Additional Planning Questions

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

  • Where in the institution will IMLYGIC® be administered?

NOTES:
After thawing, administer IMLYGIC® immediately or store in its original vial and carton, as follows:

  • Thawed IMLYGIC® is stable when stored at temperatures of 2ºC (36ºF) up to 25ºC (77ºF) protected from light in its original vial and carton for the storage times specified in the table below. Do not exceed the storage times specified in the table below.
  • IMLYGIC® must not be refrozen once it is thawed. Discard any thawed IMLYGIC® in the vial stored longer than the specified times in the table below.

Maximum Storage Time for Thawed IMLYGIC® in Vial

106 (1 million) PFU/mL 108 (100 million) PFU/mL
2ºC to 8ºC (36ºF to 46ºF) 24 hours 1 week (7 days)
up to 25ºC (77ºF) 12 hours 24 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.

Maximum Storage Time for Thawed IMLYGIC® in Vial

106 (1 million) PFU/mL 108 (100 million) PFU/mL
2ºC to 8ºC (36ºF to 46ºF) 24 hours 1 week (7 days)
up to 25ºC (77ºF) 12 hours 24 hours

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


DH2 Supplied in syringe(s) drawn by healthcare practitioner

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

Additional 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?

NOTES:
After thawing, administer IMLYGIC® immediately or store in its original vial and carton, as follows:

  • Thawed IMLYGIC® is stable when stored at temperatures of 2ºC (36ºF) up to 25ºC (77ºF) protected from light in its original vial and carton for the storage times specified in the table below. Do not exceed the storage times specified in the table below.
  • IMLYGIC® must not be refrozen once it is thawed. Discard any thawed IMLYGIC® in the vial stored longer than the specified times in the table below.

Maximum Storage Time for Thawed IMLYGIC® in Vial

106 (1 million) PFU/mL 108 (100 million) PFU/mL
2ºC to 8ºC (36ºF to 46ºF) 24 hours 1 week (7 days)
up to 25ºC (77ºF) 12 hours 24 hours
  • Healthcare professionals who are handling IMLYGIC® should read the complete Prescribing Information, including the precautionary information within.

Key Points 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.1
  • 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.1
Continue
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.

References

1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc. 2. Data on file, Amgen; [1]; 2015. 3. Data on file, Amgen; [2]; 2015. 4. Data on file, Amgen; [3]; 2015.

This section offers information and resources related to the logistics of bringing IMLYGIC® (talimogene laherparepvec) to your practice or institution. Please be sure to fully review this information and the Prescribing Information to ensure you understand the special ordering, shipping, storage, and handling requirements of IMLYGIC®.

Storage and handling for IMLYGIC®

INSTRUCTIONAL VIDEO

This step-by-step video provides an example of what to do when you receive a shipment of IMLYGIC®, including instructions on storage and safe handling requirements. This video does not replace the Prescribing Information. Please review the Prescribing Information before handling IMLYGIC®.

Storage and handling video

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Implementing IMLYGIC® —customize your plan

INTERACTIVE OPERATIONAL PLANNING CHECKLIST

This tool walks you through questions about the operational and storage requirements of IMLYGIC® to help you make a plan for integrating IMLYGIC® into your practice. When you have completed the checklist, you can download a PDF that includes information related to your answers, as well as IMLYGIC® preparation and handling content.

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.

Complete a Customized Operational Planning Checklist

As an alternative, you can download a non-customized checklist here

Consider options for ordering and storing IMLYGIC®

PROCUREMENT

Keep in stock.

  • For longer-term storage, IMLYGIC® 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

OR

Use just-in-time ordering.

  • 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. Use 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. See the delivery schedule below for more information.

STORAGE

Store frozen in an ultra-low freezer.

  • 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

OR

Store frozen in the original IMLYGIC® shipping container for up to 96 hours after being sealed.2

  • 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

For additional storage and handling information, including developing order sets for your institution, creating safeguard rules, and thawing and dispensing IMLYGIC®, please use the downloadable checklists and guides located on this page or watch the step-by-step video above.

IMLYGIC® delivery schedule

Because of its special properties and storage requirements, IMLYGIC® is shipped on a fixed delivery schedule for coordination with patient scheduling. You can plan to receive your orders of IMLYGIC® based on the following calendar:

Order on Mon, Tue, Wed, Thu, and Fri, and receive on Wed, Thu, Fri, Tue, and Tue, respectively

Order on Mon, Tue, Wed, Thu, and Fri, and receive on Wed, Thu, Fri, Tue, and Tue, respectively

  • If your facility does not have access to a -80°C freezer, please schedule initial treatments from Tuesday afternoon through Friday, as deliveries do not take place on Monday.
  • Amgen does not process orders on the following holidays: New Year’s Day, Martin Luther King Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, the day after Thanksgiving, Christmas Eve, Christmas Day.
  • IMLYGIC® may only be ordered through an authorized distributor, who will then coordinate the shipment with AMGEN. To see a list of authorized distributors, please download the IMLYGIC® Product Ordering Guide.

Download the details

IMLYGIC® Clinical Overview and Handling Guide

Use this instructional guide to review efficacy, dosing, and administration details, and to get information about integrating IMLYGIC® into your practice.

Download Now

IMLYGIC® Product Ordering Guide

IMLYGIC® is shipped from select, authorized specialty distributors—use this guide to find a qualified distributor. Also find information on ordering options, the order and delivery schedule and product storage.

Download Now

IMLYGIC® Delivery Schedule

Because of its special properties and storage requirements, IMLYGIC® is shipped on a fixed delivery schedule for coordination with patient scheduling. Download and print a copy of the schedule here for convenience.

Download Now

IMLYGIC® Operational Planning Checklist

Get some key product information, including packaging details, information on ordering IMLYGIC®, and storage and handling requirements.

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.

Download Now

Before using IMLYGIC® it is important to review the Prescribing Information. IMLYGIC® requires special storage conditions. Please see the Prescribing Information (section 2) for details on preparation and handling, including guidance on thawing and storage of IMLYGIC® vials.

IMLYGIC® coding and billing information

To learn about billing and coding considerations for IMLYGIC®, please review the Hospital Outpatient Billing Information Sheet for IMLYGIC® and the Physician Office Billing Information Sheet for IMLYGIC®.

50OperationsStorageInjectionVideoIcon50OperationsStorageInjectionVideoIcon

Watch a video on how to inject IMLYGIC®

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REFERENCES

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

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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