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Indication and Limitations of Use

IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the ... Read more.

IMLYGIC® (talimogene laherparepvec) is a genetically modified ... Read more.

This site is intended for US healthcare professionals only.

In unresectable melanoma recurrent after initial surgery…

INJECT THE LESION.
TRIGGER AN IMMUNE RESPONSE.
THAT’S 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.1 The exact mechanism of action is unknown.1

Learn more about the clinical data

This site is intended for US healthcare professionals only.

New IMLYGIC® (talimogene laherparepvec) Suspension for Injection

In unresectable melanoma recurrent
after initial surgery…

INJECT THE LESION.
TRIGGER AN IMMUNE RESPONSE.
THAT’S 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.1 The exact mechanism of action is unknown.1

Learn more about the clinical data

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.

IMLYGIC® Essentials

Learn about IMLYGIC® (talimogene laherparepvec), the only FDA-approved Oncolytic Viral Therapy.1

Mechanism of Action

IMLYGIC® has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC® causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. However, the exact mechanism of action is unknown.1

Clinical Trials Experience

The safety of IMLYGIC® was evaluated in 419 patients who received at least 1 dose of either IMLYGIC® (n = 292) or subcutaneously administered granulocyte-macrophage colony-stimulating factor (GM-CSF) (n = 127) in a phase 3, multicenter, open-label, randomized clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable. The median duration of exposure to IMLYGIC® was 23 weeks (5.3 months). Twenty-six patients were exposed to IMLYGIC® for at least 1 year.1,2

Most adverse reactions reported were mild or moderate in severity and generally resolved within 72 hours. The most common grade 3 or higher adverse reaction was cellulitis.1

Pyrexia, chills, and influenza-like illness can occur any time during IMLYGIC® treatment but were more frequent during the first 3 months of treatment.1

Adverse Reactions Reported with at Least a 5% Greater Incidence in Patients Treated with IMLYGIC® Compared to GM-CSF
Adverse Reactions IMLYGIC®
(n=292)
GM-CSF
(n=127)
Any Grade
n (%)
Grade 3
n (%)
Any Grade
n (%)
Grade 3
n (%)
General disorders and administration site conditions
Fatigue 147 (50.3) 6 (2.1) 46 (36.2) 1 (<1)
Chills 142 (48.6) 11 (8.7)
Pyrexia 125 (42.8) 11 (8.7)
Influenza-like illness 89 (30.5) 2 (<1) 19 (15.0)
Injection site pain 81 (27.7) 2 (<1) 8 (6.3)
Gastrointestinal disorders
Nausea 104 (35.6) 1 (<1) 25 (19.7)
Vomiting 62 (21.2) 5 (1.7) 12 (9.5)
Diarrhea 55 (18.8) 1 (<1) 14 (11.0)
Constipation 34 (11.6) 8 (6.3) 1 (<1)
Abdominal pain 26 (8.9) 2 (<1) 3 (2.4)
Musculoskeletal and connective tissue disorders
Myalgia 51 (17.5) 1 (<1) 7 (5.5)
Arthralgia 50 (17.1) 2 (<1) 11 (8.7)
Pain in extremity 48 (16.4) 4 (1.4) 12 (9.5) 1 (<1)
Nervous system disorders
Headache 55 (18.8) 2 (<1) 12 (9.5)
Dizziness 28 (9.6) 4 (3.2)
Respiratory, thoracic, and mediastinal disorders
Oropharyngeal pain 17 (5.8) 1 (<1)
Investigations
Weight decreased 17 (5.8) 1 (<1) 1 (<1)
General disorders and administration site conditions
Fatigue
IMLYGIC® (n=292)
Any Grade n (%) 147 (50.3)
Grade 3 n (%) 6 (2.1)
GM-CSF (n=127)
Any Grade n (%) 46 (36.2)
Grade 3 n (%) 1 (<1)
Chills
IMLYGIC® (n=292)
Any Grade n (%) 142 (48.6)
Grade 3 n (%) -
GM-CSF (n=127)
Any Grade n (%) 11 (8.7)
Grade 3 n (%) -
Pyrexia
IMLYGIC® (n=292)
Any Grade n (%) 125 (42.8)
Grade 3 n (%) -
GM-CSF (n=127)
Any Grade n (%) 11 (8.7)
Grade 3 n (%) -
Influenza-like illness
IMLYGIC® (n=292)
Any Grade n (%) 89 (30.5)
Grade 3 n (%) 2 (<1)
GM-CSF (n=127)
Any Grade n (%) 19 (15.0)
Grade 3 n (%) -
Injection site pain
IMLYGIC® (n=292)
Any Grade n (%) 81 (27.7)
Grade 3 n (%) 2 (<1)
GM-CSF (n=127)
Any Grade n (%) 8 (6.3)
Grade 3 n (%) -
Gastrointestinal disorders
Nausea
IMLYGIC® (n=292)
Any Grade n (%) 104 (35.6)
Grade 3 n (%) 1 (<1)
GM-CSF (n=127)
Any Grade n (%) 25 (19.7)
Grade 3 n (%) -
Vomiting
IMLYGIC® (n=292)
Any Grade n (%) 62 (21.2)
Grade 3 n (%) 5 (1.7)
GM-CSF (n=127)
Any Grade n (%) 12 (9.5)
Grade 3 n (%) -
Diarrhea
IMLYGIC® (n=292)
Any Grade n (%) 55 (18.8)
Grade 3 n (%) 1 (<1)
GM-CSF (n=127)
Any Grade n (%) 14 (11.0)
Grade 3 n (%) -
Constipation
IMLYGIC® (n=292)
Any Grade n (%) 34 (11.6)
Grade 3 n (%) -
GM-CSF (n=127)
Any Grade n (%) 8 (6.3)
Grade 3 n (%) 1 (<1)
Abdominal pain
IMLYGIC® (n=292)
Any Grade n (%) 26 (8.9)
Grade 3 n (%) 2 (<1)
GM-CSF (n=127)
Any Grade n (%) 3 (2.4)
Grade 3 n (%) -
Musculoskeletal and connective tissue disorders
Myalgia
IMLYGIC® (n=292)
Any Grade n (%) 51 (17.5)
Grade 3 n (%) 1 (<1)
GM-CSF (n=127)
Any Grade n (%) 7 (5.5)
Grade 3 n (%) -
Arthralgia
IMLYGIC® (n=292)
Any Grade n (%) 50 (17.1)
Grade 3 n (%) 2 (<1)
GM-CSF (n=127)
Any Grade n (%) 11 (8.7)
Grade 3 n (%) -
Pain in extremity
IMLYGIC® (n=292)
Any Grade n (%) 48 (16.4)
Grade 3 n (%) 4 (1.4)
GM-CSF (n=127)
Any Grade n (%) 12 (9.5)
Grade 3 n (%) 1 (<1)
Nervous system disorders
Headache
IMLYGIC® (n=292)
Any Grade n (%) 55 (18.8)
Grade 3 n (%) 2 (<1)
GM-CSF (n=127)
Any Grade n (%) 12 (9.5)
Grade 3 n (%) -
Dizziness
IMLYGIC® (n=292)
Any Grade n (%) 28 (9.6)
Grade 3 n (%) -
GM-CSF (n=127)
Any Grade n (%) 4 (3.2)
Grade 3 n (%) -
Respiratory, thoracic, and mediastinal disorders
Oropharyngeal pain
IMLYGIC® (n=292)
Any Grade n (%) 17 (5.8)
Grade 3 n (%) -
GM-CSF (n=127)
Any Grade n (%) 1 (<1)
Grade 3 n (%) -
Investigations
Weight decreased
IMLYGIC® (n=292)
Any Grade n (%) 17 (5.8)
Grade 3 n (%) 1 (<1)
GM-CSF (n=127)
Any Grade n (%) 1 (<1)
Grade 3 n (%) -

Other adverse reactions associated with IMLYGIC® in the open-label, randomized study include glomerulonephritis, vitiligo, cellulitis, and oral herpes.1

Clinical Studies

The safety and efficacy of intralesional injections of IMLYGIC® compared with subcutaneously administered GM-CSF were evaluated in a phase 3, multicenter, open-label, randomized clinical study of patients with stage IIIB, IIIC, and IV melanoma that was considered to be not surgically resectable.1,2 IMLYGIC® was injected into cutaneous, subcutaneous, or nodal melanoma lesions and was not injected into visceral lesions.1 Previous systemic treatment for melanoma was allowed.1 Patients with active cerebral metastases, bony metastases, extensive visceral disease, primary ocular or mucosal melanoma, evidence of immunosuppression, or receiving treatment with a systemic antiherpetic agent were excluded from the study.1

  • The study included 250 (57%) men and 186 (43%) women.1

  • The mean age was 63 (range: 22 to 94) years.1

  • Most patients (98%) were white.1

  • Seventy percent (70%) of patients had baseline Eastern Cooperative Oncology Group (ECOG) performance status of zero.1

  • Seventy percent (70%) of patients had stage IV disease (27% M1a; 21% M1b; and 22% M1c), and 30% had stage III disease.1

  • Fifty-three percent (53%) of patients had received prior therapy for melanoma (other than or in addition to surgery, adjuvant therapy, or radiation), and 58% were seropositive for wild-type HSV-1 at baseline.1


A total of 436 patients were randomized to receive either IMLYGIC® (n = 295) or GM-CSF (n = 141). IMLYGIC® was administered by intralesional injection at an initial concentration of 106 (1 million) PFU per mL on Day 1, followed by a concentration of 108 (100 million) PFU per mL on Day 21 and every 2 weeks thereafter, at a dose of up to 4 mL per visit. GM-CSF was administered subcutaneously in 28-day cycles, i.e., 125 µg/m2 daily for 14 days followed by 14 days without GM-CSF administration.1

Patients were to be treated for a minimum of 6 months or until no injectable lesions were remaining. During this period, treatment could continue despite an increase in size in existing lesion(s) and/or development of new lesion(s), unless the patient’s clinical condition required discontinuation/initiation of a new therapy for melanoma.1

After 6 months of treatment, patients were to continue treatment until clinically relevant disease progression up to 12 months. Patients experiencing a response 12 months from initiation of treatment could continue for up to an additional 6 months, unless there were no remaining injectable lesions or disease progression.1

Primary Endpoint: Durable Response Rate
  • The major efficacy outcome was durable response rate defined as:

    • The percent of patients with complete response or partial response maintained continuously for a minimum of 6 months.1

      • Complete response was defined as disappearance of all evidence of tumor.3

      • Partial response was defined as a ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment, as compared with baseline.3

Response Rate and Median Time to Response
  • The durable response rate was 16.3% in the IMLYGIC® arm (n = 48) and 2.1% in the GM-CSF arm (n = 3) in the overall study population.1,2

  • The unadjusted relative risk was 7.6 (95% CI: 2.4, 24.1), with a p-value < 0.0001.1

    • 29.1% of durable responders had a durable complete response (n = 14).4

  • The median time to response was 4.1 months (range: 1.2 to 16.7 months) in the IMLYGIC® arm.1

Clinical Resources

Familiarize yourself with the prescribing information and medication guide for important details about IMLYGIC®.

Pharmacy Support

Take advantage of pharmacy resources to help bring IMLYGIC® (talimogene laherparepvec) to your clinic or institution.

  • Get key product information, including packaging details, instructions for ordering IMLYGIC®, and storage and handling requirements.

  • Get information for ordering IMLYGIC®, including details on authorized distributors, the order and delivery schedule, product storage, and the IMLYGIC® freezer program.

  • Please complete a Customer Registration Profile at the IMLYGIC® Customer Registration Page to ensure that Amgen has the information needed for your IMLYGIC® orders.

  • 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 instructions for product handling and storage requirements, as well as resources for integrating IMLYGIC® into your practice.

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

  • Get the information needed to develop a process for the safe and effective handling of IMLYGIC®, including guidance on storing vials and product procurement and order set considerations.

If you have any questions, please contact 1-866-IMLYGIC (1-866-465-9442)1-866-IMLYGIC (1-866-465-9442).

Dosing & Administration

For intralesional injection only. Do not administer intravenously.1
  • Administer IMLYGIC® by injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance.1

  • 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

  • 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.

Watch the video below to learn about intralesional injections of IMLYGIC®.

The Lesion Tracking Sheet can be used to document treatment of melanoma lesions.

Billing and Coding Information for IMLYGIC®

See the links below for IMLYGIC® (talimogene laherparepvec) coding and billing instructions.

Visit amgenassistonline.com for information on reimbursement and billing and coding.

If you have any questions, please contact 1-866-IMLYGIC (1-866-465-9442)1-866-IMLYGIC (1-866-465-9442).

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)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. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33(25):2780-2788. Published online: May 26, 2015 (doi: 10.1200/JCO.2014.58.3377).
  3. Wolchok JD, Hoos A, O’Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009;15(23):7412-7420.
  4. Data on file, Amgen.

IMPORTANT SAFETY INFORMATION

Contraindications
Warnings and Precautions
Adverse Reactions

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® Prescribing Information, Amgen.
  2. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015; 33(25):2780-2788. Published online: May 26, 2015 (doi: 10.1200/JCO.2014.58.3377).
  3. Wolchok JD, Hoos A, O’Day S, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009;15(23):7412-7420.
  4. 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 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.