INDICATION AND LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) is a prescription medication injected on the skin, beneath the skin, or in your lymph glands to treat a type of skin cancer called melanoma when it can no longer be surgically removed. IMLYGIC® may not help you live longer and may not shrink canc…Read More

IMLYGIC® (talimogene laherparepvec) is a prescription …Read More

Indication Prescribing Information Medication Guide Healthcare Professionals Contact Us

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IMLYGIC® Is Different

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How IMLYGIC<sup>®</sup> is Different

How IMLYGIC® is Different

IMLYGIC® (pronounced “Im•LIE•jik”) is used to treat unresectable melanoma in the skin or lymph glands.
It's the first and only FDA-approved cancer treatment of its kind.1,2

  • IMLYGIC® is made by modifying—or changing—the herpes simplex virus type 1, the common virus known to
    cause cold sores1
  • IMLYGIC® treatment is targeted and precise*—it's injected directly into tumors and lesions by
    specially trained healthcare providers    1
  • IMLYGIC® attacks cancer cells differently because it is injected into tumor cells, which destroys them. This triggers an immune response.1 For an illustration of how IMLYGIC® is thought to work, scroll down this page
  • Most side effects with IMLYGIC® are mild to moderate and generally go away within 3 days1
  • Common side effects include tiredness, chills, fever, nausea, flu-like symptoms, and pain at treatment site1

*Exactly how IMLYGIC® works is not known.1

Understanding Metastatic Melanoma

Melanoma is a type of skin cancer. Compared to other types of skin cancer, it is more likely to
spread to other parts of the body.3

Normally, the immune system is able to fight illness and outside invaders such as viruses and bacteria.4 But cancer cells are able to grow without being recognized by your immune system.5

This means that cancer can spread to other parts of the body. When this happens, melanoma has
become metastatic melanoma.3

A Closer Look at How IMLYGIC® Works

IMLYGIC® is injected directly into the tumor. It's thought to work by destroying tumor cells
and triggering an immune response.1

IMLYGIC<sup>®</sup> is injected into melanoma tumors on your skin or lymph glands

IMLYGIC® is injected directly into melanoma tumors on your skin or lymph glands.1

IMLYGIC<sup>®</sup> multiplies inside the tumor cells and may trigger your immune system to fight the cancer

IMLYGIC® multiplies inside the tumor cells and may trigger your immune system to fight the cancer.1

IMLYGIC<sup>®</sup> continues to invade neighboring tumor cells

IMLYGIC® continues to invade neighboring tumor cells.1,6

Exactly how IMLYGIC® works is not known.1 The images above are only intended to help
describe how IMLYGIC® is thought to work.

GM-CSF=Granulocyte-Macrophage Colony-Stimulating Factor

IMLYGIC® Can Be Injected Into 3 Kinds of Melanoma Tumors

IMLYGIC<sup>®</sup> Can Be Injected into 3 Types of Melanoma Tumors: Tumors on the surface of the skin

Tumors on the surface of the skin. These are called cutaneous (pronounced kyoo-TANE-ee-us) lesions.1

IMLYGIC<sup>®</sup> Can Be Injected into 3 Types of Melanoma Tumors: Tumors just under the surface of the skin

Tumors just under the surface of the skin. These are called subcutaneous (pronounced SUB-kyoo-TANE-ee-us) lesions.1

IMLYGIC<sup>®</sup> Can Be Injected into 3 Types of Melanoma Tumors: Tumors that have spread to lymph nodes

Tumors that have spread to lymph nodes. These are called nodal lesions. The doctor sees or feels these tumors, or uses an ultrasound to find them.1

Next: IMLYGIC® Results

IMPORTANT SAFETY INFORMATION

What is IMLYGIC® used for?

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?

  • IMLYGIC® is a weakened form of Herpes Simplex Virus Type 1, which is commonly called the cold sore virus. Your doctor will inject IMLYGIC® directly into your tumor(s).
  • Your doctor will decide which tumor(s) to inject and may not inject every one. It is important to care for the treatment sites properly so that IMLYGIC® does not spread to other people. Your doctor will show you how to do this.

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 doctor before getting IMLYGIC®?

  • Because certain medications can affect your immune system, or affect how IMLYGIC® works, tell your doctor if you are taking steroids or other medicines that suppress your immune system, or are taking antiviral medications to treat or prevent herpes, like acyclovir.
  • Tell your doctor if you have or ever had certain medical conditions like: HIV infection or AIDS, blood or bone marrow cancer, autoimmune disease, or other medical conditions that can weaken your immune system.
  • Tell your doctor if you have close contact with someone who has a weakened immune system or is pregnant.
  • IMLYGIC® may harm your unborn baby. Tell your doctor if you are pregnant or planning to become pregnant, nursing, or planning to breastfeed. You should not become pregnant during treatment with IMLYGIC®. Your doctor will determine whether you should receive IMLYGIC®. Talk to your doctor about effective birth control methods.
  • Tell your doctor about all the medications 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.

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:

  • Avoid direct contact between your treatment sites, dressings, or body fluids and close contacts (for example, use condoms when engaging in sexual activity, avoid kissing close contacts if either of you has an open mouth sore).
  • Don’t touch or scratch the parts of your body that have been injected with IMLYGIC®.
  • Wear gloves while putting on or changing your dressings.
  • Keep treatment sites covered with airtight and watertight dressings for at least 1 week after each treatment (or longer if the treatment site is weeping or oozing).
  • Replace dressings right away with a clean dressing if they become loose or come off.
  • Place all used dressings and cleaning materials in a sealed plastic bag, and throw them away in the garbage.

What are the possible side effects of IMLYGIC®?

  • Common side effects of IMLYGIC® include tiredness, chills, fever, nausea, flu-like symptoms, and pain at treatment site.
  • Tell your doctor right away if you get any of the signs and symptoms of herpes infection, including but not limited to:
  • Pain, burning, tingling, or blister formation around the mouth, genitals, or any part of the body, near or far from the injection site
  • Eye pain, light sensitivity, discharge from the eyes, or blurry vision
  • Weakness in arms or legs
  • Extreme drowsiness (feeling sleepy)
  • Mental confusion
  • If you think you have a herpes infection, inform your health care provider. Life-threatening herpes infection and herpes infection spreading to any part of the body far from the injection site (disseminated herpetic infection) may occur in patients treated with IMLYGIC. If you have any new or worsening symptoms, call your health care provider right away. You or your healthcare provider should call Amgen at 1-855-IMLYGIC (1-855-465-9442) for follow-up testing, if needed.
  • Tell your doctor if you have any side effect that bothers you or does not go away.
  • These are not all the possible side effects of IMLYGIC®.

If you would like more information, talk with your doctor.

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.

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

Indication and Limitations of Use

IMLYGIC® (talimogene laherparepvec) is a prescription medication injected on the skin, beneath the skin, or in your lymph glands, to treat a type of skin cancer called melanoma when it can no longer be surgically removed.

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

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

What is IMLYGIC® used for? 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).

References:

1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen, Inc.
2. FDA approves first oncolytic virus therapy: Imlygic for melanoma. Oncology Times. Accessed at: https://journals.lww.com/oncology-times/Fulltext/2015/12100/FDA_Approves_First_Oncolytic_Virus_Therapy_.27.aspx. Accessed March 15, 2018.
3. PubMed Health. U.S. National Library of Medicine. Melanoma treatment. https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0032763/. Accessed on March 15, 2018.
4. National Institute of Allergy and Infectious Diseases. Overview of the immune system. https://www.niaid.nih.gov/research/immune-system-overview. Accessed on March 15, 2018.
5. Motz GT, Coukos G. Deciphering and reversing tumor immune suppression. Immunity. 2013;39(1):61-73.
6. Liu BL, Robinson M, Han ZQ, et al. ICP34.5 deleted herpes simplex virus with enhanced oncolytic, immune stimulating, and anti-tumour properties. Gene Ther. 2003;10:292-303.