Talimogene laherparepvec Suspension for injection

What is this medicine?

TALIMOGENE LAHERPAREPVEC (tal IM oh jeen la HER pa REP vek) is a chemotherapy drug. It is used to treat melanoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• history of blood diseases, like sickle cell anemia or leukemia

• HIV or AIDS

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• receiving corticosteroids like dexamethasone or prednisone

• receiving antiviral medicines like acyclovir

• an unusual or allergic reaction to talimogene laherparepvec, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into the tumor. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medicines, like acyclovir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine can transfer to other areas of your body or from your body to other people. Avoid direct contact between treatment sites, dressings, or body fluids and other people. Do not touch or scratch the treated area. If accidental contact happens, the exposed area should be washed right away with soap and water and/or a disinfectant. Also, a female partner who is pregnant or trying to get pregnant should avoid contact with the treatment sites, dressings, or body fluids.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• confusion

• eye pain or discharge

• pain, burning, or tingling in a sore around the mouth or genitals, or on the fingers or ears

• sensitivity to light

• unusually weak or tired

• weakness in arms or legs

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• chills

• fever

• general ill feeling or flu-like symptoms

• pain at injection site

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.