When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to talimogene laherparepvec, or if you are pregnant.

How to Use This Medicine:
Injectable

• A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is injected directly into your tumor.
• This medicine can spread to other parts of your body or to other people that you come in close contact with. Follow these instruction to help avoid spreading the medicine.
  
  • Do not touch or scratch the treatment sites or dressings. Do not let other people touch the treatment site or dressings. Do not let your bodily fluids come in contact with other people.
  • Cover the treatment sites with airtight and watertight dressings for at least 1 week after each treatment.
  • Wear gloves when you put on or change your dressings.
  • If the dressing comes loose or falls off, replace it with a new, clean dressing.
  • Place all used dressings and cleaning materials in a sealed plastic bag, and throw them in the trash can.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how talimogene laherparepvec works. Tell your doctor if you are using any of the following:
  
  • Medicine to treat herpes (including acyclovir, valacyclovir)
  • Medicine that weakens the immune system (including a steroid)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• This medicine contains a virus. Be careful that you do not infect other people. Be extra careful if you are around a pregnant woman, a baby, or a person who has a weak immune system (such as a person who has cancer, AIDS, or HIV).
• Tell your doctor if you are breastfeeding, or if you have kidney problems or have ever had any other kind of cancer. Tell your doctor if you have a weak immune system or disease related to the immune system (including autoimmune disease, psoriasis, or vitiligo).
• This medicine may cause the following problems:
  
  • Herpes infection (including cold sores)
  • Delayed healing at the injection site
  • Diseases related to immune system problems, such as kidney problems, swelling of the blood vessels, breathing problems, skin damage
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, eye pain, sensitivity to light
• Confusion, extreme drowsiness, or weakness in your arms or legs
• Delayed healing at the injection site
• Fever, chills, cough, sore throat, and body aches
• Pain, burning, or tingling in a blister around your mouth or genitals or on your fingers or ears
• Pain, itching, burning, or swelling at the injection site

If you notice these less serious side effects, talk with your doctor:

• Nausea
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088