Talimogene Laherparepvec, Injection

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KEY POINTS

• This medicine is given by injection to treat skin cancer.
• This medicine can cause serious side effects in your eyes, lungs, kidneys, nerves, or skin which can lead to death. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); genetically modified HSV-1

Generic and brand names: talimogene laherparepvec, injection; Imlygic

What is this medicine used for?

This medicine is given by injection (shot) to treat skin cancer (melanoma) that has spread or cannot be removed by surgery.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A condition that affects your immune system, such as HIV/AIDS Crohn’s disease, lupus, or sarcoidosis
• An organ transplant
• Blood or bone marrow cancer

Also tell your provider if you have recently had any kind of infection or if you are taking chemotherapy, radiation therapy, or steroid medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use effective birth control during treatment. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while receiving this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start this medicine and each time you get a treatment.

These injections are given directly into tumors by your healthcare provider. Injections are usually given every 2 weeks (depending on your response to the medicine). Keep all appointments.

What should I watch out for?

This medicine is a weakened form of the herpes simplex virus (which causes cold sores and genital herpes). The virus from the medicine can spread to other areas of your body or to people in close contact with you. To avoid spreading the virus:

• Avoid close contact with pregnant women and anyone with a weakened immune system while you are receiving this medicine.
• Do not touch or scratch the treatment sites. Wash your hands well if you touch the treatment sites, especially if you have oozing or draining.
• Avoid direct contact between your treatment sites, dressings, or body fluids and other people:
  • Use latex or polyurethane condoms during foreplay and every time you have vaginal, oral, or anal sex.
  • Avoid kissing close contacts if either of you has a mouth sore.
  • Avoid sharing soaps, washcloths, and utensils for eating or drinking.
• 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 oozing or draining). If the dressing comes loose or falls off, replace it right away with a clean dressing. Don’t touch your eyes or genitals after changing your dressing.
• Place all used dressings and cleaning materials in a sealed plastic bag and dispose of them.

You need check ups regularly to find out how this medicine is affecting you. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (Report these to your healthcare provider right away.): Fever, unusual tiredness or weakness; severe stomach pain, nausea or vomiting; severe drowsiness; confusion; skin rash with or without itching; pain, burning, or tingling in blisters or sores around your mouth, ears, fingers, or genitals; eye pain, light sensitivity, or blurry vision; severe muscle or joint pain.

Other: Redness, bruising, warmth, burning, or tenderness at the spot where the injection is given; headache; dizziness; diarrhea; constipation; runny or stuffy nose; sore throat; nausea; mild tiredness; chills; weight loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiviral medicines such as acyclovir (Zovirax), famciclovir (Famvir), and valacyclovir (Valtrex)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.