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).

Treatment with IMLYGIC®

Treatment with IMLYGIC®
Getting Started with IMLYGIC®

Getting Started With IMLYGIC®1

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

The first 2 treatments of IMLYGIC® are given 3 weeks apart.
After that, IMLYGIC® will be administered every 2 weeks* for as long as there
are injectable tumors. You can get treated 6 months or longer.

IMLYGIC® Dosing ScheduleIMLYGIC® Dosing Schedule

*According to your physician’s instruction.

On the day of injection, know what to expect.

IMLYGIC® is injected by a healthcare professional at the doctor's office

The healthcare professional will inject IMLYGIC® directly into 1 or more tumors using a needle and syringe. If lesions are clustered together, they will be injected as if they are one lesion

The amount of IMLYGIC® injected is based on the number and size of the tumors and will be determined by your doctor before the injection of IMLYGIC®

Your healthcare provider will decide which tumor(s) to inject and may not inject each one

Managing your care during and after treatment

Care After Treatment with IMLYGIC®

Important things to know while being treated with IMLYGIC®:

IMLYGIC® virus can spread to other areas of your body or to people close to you (household members, caregivers, sex partners, or people you share a bed with).

To avoid spreading IMLYGIC® to other areas of your body or to others:

Avoid direct contact between your treatment sites, dressings, or body fluids and people close to you (for example, use condoms when engaging in sexual activity, and avoid kissing close contacts if either 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

This section is for informational purposes only. Please talk with your doctor to find out if IMLYGIC® is the right treatment option for you.

Other Considerations with IMLYGIC®

Before getting IMLYGIC® treatment, tell your healthcare provider:

About any other medicines you're taking

If you're taking steroids or medicines that suppress your immune system, or anti-viral medications, like acyclovir, to treat or prevent herpes

If you have or ever had medical conditions such as:

  • HIV infection or AIDS
  • Blood or bone marrow cancer
  • Autoimmune disease
  • Other medical conditions that can weaken your immune system

If you have contact with people close to you who have a weakened
immune system or are pregnant

IMLYGIC® may harm your unborn baby. Tell your doctor if you are pregnant
or plan 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 healthcare provider about effective birth control methods

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.

Next: Resources and Support

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).

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 following:
  • Pain, burning, or tingling in a blister around the mouth or genitals or on the fingers or ears
  • 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 doctor. You or your doctor 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).

Reference:

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