×

Indication and Limitations of Use

IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.1 IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).1 Close

IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin... Read more.

IMLYGIC® is for the treatment of unresectable melanoma recurrent after initial surgery located in the skin or lymph glands1

Indication and Limitations of Use

IMLYGIC® is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.1

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).1

IMLYGIC® (talimogene laherparepvec) Basics

Learn facts about IMLYGIC®—the only FDA-approved oncolytic viral therapy for unresectable melanoma recurrent after initial surgery—such as what it is, how it works, and how it is given.1,2

Start here by downloadingviewing the IMLYGIC® Patient Brochure.

Patient Brochure

The IMLYGIC® Patient Brochure is designed to help you understand what IMLYGIC® is and what you might expect during treatment.

Why IMLYGIC®?

Your doctor has prescribed IMLYGIC® for treating a type of skin cancer called melanoma when it is on your skin or in your lymph glands.1

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).1

Normally, the body’s immune system is able to fight illnesses by attacking foreign invaders like viruses and bacteria.3 Cancer cells are different—they can make themselves invisible to the immune system and avoid being recognized as an enemy.4 If the immune system cannot find the cancer cells, they may be able to grow and spread.4

How IMLYGIC® May Work

IMLYGIC® is made by modifying the virus that normally causes cold sores (herpes simplex virus type 1).1

IMLYGIC® is the first and only FDA-approved Oncolytic Viral Therapy designed to achieve local control and that may trigger a specific immune response against melanoma.1,2

Oncolytic Viral Therapy

IMLYGIC® is injected directly into melanoma tumors, where it multiplies inside the cancer cells and destroys them.1

Virally derived GM-CSF

The immune system can be activated and may cause a response against injected advanced melanoma tumors.1

An In-depth Look at IMLYGIC®

Exactly how IMLYGIC® works is unknown1; the descriptions here are meant for illustrative purposes only and are not meant to demonstrate how effectively IMLYGIC® may work.

HOW EFFECTIVE WAS IMLYGIC® (talimogene laherparepvec)?

Please speak with your healthcare provider about IMLYGIC® clinical trial results.

IMLYGIC® was studied in a clinical trial of 436 patients with stage IIIB/C and stage IV melanoma against a control group given another medication called GM-CSF.1*

How many patients responded to treatment with IMLYGIC® during the clinical trial?1

48 out of 295 patients (16.3%) had a durable response with IMLYGIC® compared to 3 out of 141 patients (2.1%) in the control group—meaning their tumors partially shrank or completely shrank for 6 months or longer.1,5

Patient responses were complete or partial.6

*IMLYGIC® was injected into tumors, and the control group was given GM-CSF subcutaneously (under the skin).

TREATMENT WITH IMLYGIC® (talimogene laherparepvec)

What Should I Tell My Healthcare Provider Before I Get IMLYGIC®?1

Before getting IMLYGIC®, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IMLYGIC® may affect the way other medicines work and other medicines may affect how IMLYGIC® works.

What Should I Avoid While Getting IMLYGIC®?1

IMLYGIC® virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed).

Do the following to avoid spreading IMLYGIC® to other areas of your body or to your close contacts:

How Do I Get Started With IMLYGIC®?

Once your doctor has prescribed IMLYGIC® here are a few things you may want to consider:

IMLYGIC® can be injected into 3 kinds of melanoma tumors:

What You Might Expect While You’re on IMLYGIC®

Therapy with IMLYGIC® will last at least 6 months, and possibly longer. In the clinical trial, IMLYGIC® treated patients typically saw a response by 4.1 months.1

If you have additional questions about IMLYGIC®, talk to your doctor and read the Medication Guide.

IMLYGIC® COST ASSISTANCE

Amgen believes in the importance of patient access to your prescribed IMLYGIC® (talimogene laherparepvec). If you have concerns about affording IMLYGIC®, Amgen may be able to help.

For eligible commercially insured patients:

IMLYGIC FIRST STEP Program


The IMLYGIC FIRST STEP Program can help eligible commercially insured patients meet their deductible, co-insurance, and co-payment.

Here’s what you need to qualify*:

*Other restrictions apply. Not valid where prohibited by law. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time.

Coverage limits:

For additional program details please visit www.AmgenFIRSTSTEP.com or call 1-888-65-STEP1 (1-888-657-8371)1-888-65-STEP1 (1-888-657-8371).


Independent Co-pay Foundations

If you need assistance with your medication out-of-pocket costs, you may be eligible for assistance from an Independent Nonprofit Co-pay Foundation.* For a referral to an independent co-pay foundation, visit www.amgenassistonline.com, or call 1-888-4ASSIST (1-888-427-7478)1-888-4ASSIST (1-888-427-7478).

*Amgen provides donations to various nonprofit independent entities but has no influence over the distribution of the funds.


For eligible uninsured patients:

The Safety Net Foundation

The Safety Net Foundation may be able to provide IMLYGIC® at no cost to qualifying uninsured patients. For more information, visit www.safetynetfoundation.com, or call 1-888-SN-AMGEN (1-888-762-6436)1-888-SN-AMGEN (1-888-762-6436).

SUPPORT THROUGHOUT YOUR EXPERIENCE

Fighting melanoma can be a challenge. It is important to have a support network to rely on during this difficult time. There are many options—here are a few that may help.

The AIM at Melanoma Foundation is an organization that provides information, support, educational symposia, and more—for melanoma patients and their caregivers.8 Go to www.aimatmelanoma.org for more.
Melanoma International Foundation offers guidance to melanoma patients and their loved ones with services that include patient outreach/support via email, a helpline, and an online forum.9 See www.melanomainternational.org to learn more.
The Melanoma Research Alliance (MRA) funds research projects with the goal of making advances in the prevention, diagnosis, and treatment of melanoma. MRA partners with individuals, private foundations, and corporations on various initiatives, including public awareness campaigns.10 Visit www.curemelanoma.org for more information.
Visitors to the Melanoma Research Foundation website will find resources and tools for melanoma patients, including a treatment center finder, a Phone Buddy Program, an Ask a Nurse email program, and an online patient community.11 To find out more visit www.melanoma.org.

These resources are provided for your information. Amgen does not endorse or control the content of the third-party patient support sites listed.


IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).

What is IMLYGIC® made from and how is it given?

Who should not take IMLYGIC®?

You should not get IMLYGIC® if you are pregnant or have a weakened immune system (for example, an immune deficiency, blood or bone marrow cancer, steroid use, or HIV/AIDS).

What should you tell your healthcare provider before getting IMLYGIC®?

The IMLYGIC® virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed). Do the following to avoid spreading IMLYGIC® to other areas of your body or to your close contacts. You should share this information with them:

What are the possible side effects of IMLYGIC®?

If you would like more information, talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 1-800-FDA-1088.

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

Indication and Limitations of Use

IMLYGIC® is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).


References

  1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen Inc.
  2. FDA News release. FDA approves first-of-its-kind product for the treatment of melanoma. October 27, 2015. Accessed at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm
  3. Goldsby RA, Kindt TJ, Osborne BA, Kuby J. Overview of the immune system. In: Immunology. 5th ed. New York, NY: WH Freeman and Company; 2003.
  4. Motz GT, Coukos G. Deciphering and reversing tumor immune suppression. Immunity. 2013;39(1):61-73.
  5. 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).
  6. Data on file, Amgen.
  7. 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.
  8. AIM at Melanoma. AIM mission. http://www.aimatmelanoma.org/aim-mission. Accessed May 26, 2015.
  9. Melanoma International Foundation. Programs & services. http://melanomainternational.org/who-we-are/programs/#.Veo55f9Lhdg. Accessed September 4, 2015.
  10. Melanoma Research Alliance. http://www.curemelanoma.org. Accessed September 22, 2015.
  11. Melanoma Research Foundation. http://www.melanoma.org. Accessed September 21, 2015.

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).

What is IMLYGIC® made from and how is it given?

Who should not take IMLYGIC®?

You should not get IMLYGIC® if you are pregnant or have a weakened immune system (for example, an immune deficiency, blood or bone marrow cancer, steroid use, or HIV/AIDS).

What should you tell your healthcare provider before getting IMLYGIC®?

The IMLYGIC® virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed). Do the following to avoid spreading IMLYGIC® to other areas of your body or to your close contacts. You should share this information with them:

What are the possible side effects of IMLYGIC®?

If you would like more information, talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

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

Indication and Limitations of Use

IMLYGIC® is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).