Talimogene Laherparepvec Injection

What is this medication?

TALIMOGENE LAHERPAREPVEC (tal IM oh jeen la HER pa REP vek) treats skin cancer. It works by helping your immune system slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): Imlygic

What should I tell my care team before I take this medication?

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

• History of blood conditions, such as sickle cell anemia or leukemia
• HIV or AIDS
• Immune system problems
• Infection especially a viral infection, such as chickenpox, cold sores, herpes
• Receiving steroid medications, such as dexamethasone or prednisone
• An unusual or allergic reaction to talimogene laherparepvec, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for injection into the tumor. It is given by your care team 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 care team about the use of this medication 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?

Keep appointment for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

• Antiviral medications, such as 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 medication?

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

This medication 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. A partner who is pregnant or trying to get pregnant should avoid contact with the treatment sites, dressings, or body fluids.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet
• New or worsening psoriasis—rash with itchy, scaly patches
• Pain, burning, tingling, or blistering around the mouth, genitals, or on any part of the body
• Skin infection—skin redness, swelling, warmth, or pain at the injection site
• Unusual weakness or fatigue, fever, headache, skin rash, muscle or joint pain, loss of appetite, pain, tingling, or numbness in the hands or feet

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Chills
• Diarrhea
• Fatigue
• Headache
• 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 medication?

This medication is given in a hospital or clinic. It 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.