Talimogene Laherparepvec Injection

WHY is this medicine prescribed?

Talimogene laherparepvec injection is used to treat certain melanoma (a type of skin cancer) tumors that cannot be removed surgically or that came back after being treated with surgery. Talimogene laherparepvec is in a class of medications called oncolytic viruses. It is a weakened and changed form of Herpes Simplex Virus Type I (HSV-1 'cold sore virus') that works by helping to kill cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Talimogene laherparepvec injection comes as a suspension (liquid) to be injected by a doctor or nurse in a medical office. Your doctor will inject the medicine directly into tumors that are on your skin, just below your skin, or in your lymph nodes. You will receive a second treatment 3 weeks after the first treatment, and then every 2 weeks afterwards. The length of treatment depends on how well your tumors respond to treatment. Your doctor may not inject all of the tumors at each visit.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with talimogene laherparepvec and each time you receive the injections. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving talimogene laherparepvec injection,

• tell your doctor and pharmacist if you are allergic to talimogene laherparepvec, any other medications, or any of the ingredients in the talimogene laherparepvec injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking any medications that weaken your immune system such as antithymocyte globulin (Atgam, Thymoglobulin), azathioprine (Azasan, Imuran), basiliximab (Simulect), belatacept (Nulojix), belimumab (Benlysta), cortisone, cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone, fludrocortisone, methotrexate (Otrexup, Rasuvo, Trexall), methylprednisolone (Depo-medrol, Medrol, Solu-medrol), mycophenolate mofetil (Cellcept), prednisolone (Flopred, Orapred, Pediapred), prednisone (Rayos), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Prograf, Envarsus XR). Many other medications may also weaken your immune system, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor will probably tell you not to receive talimogene laherparepvec if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: any antiviral medications such as acyclovir (Sitavig, Zovirax), cidofovir, docosanol (Abreva), famciclovir (Famvir), foscarnet (Foscavir), ganciclovir (Cytovene), penciclovir (Denavir), trifluridine (Viroptic), valacyclovir (Valtrex), and valganciclovir (Valcyte). These medications may affect how well talimogene laherparepvec works for you.

• tell your doctor if you have or have ever had leukemia (cancer of the white blood cells), lymphoma (cancer of a part of the immune system), human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or any other condition that causes a weakened immune system. Your doctor will probably not want you not to receive talimogene laherparepvec injection.

• tell your doctor if you have or have ever had radiation treatment in the area of the melanoma tumors, multiple myeloma (cancer of the plasma cells in the bone marrow), any type of autoimmune disease (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage), or if you have close contact with someone who is pregnant or has a weakened immune system.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should not become pregnant during your treatment with talimogene laherparepvec injection. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while receiving talimogene laherparepvec injection, call your doctor immediately. Talimogene laherparepvec injection may harm the fetus.

• you should know that talimogene laherparepvec injection contains a virus that could spread and infect other people. You should be careful to cover all the injection sites with airtight and watertight bandages for at least 1 week after each treatment, or longer if the injection site is oozing. If the bandages become loose or fall off, be sure to replace them right away. You should use rubber or latex gloves when bandaging the injection sites. You should be sure to put all cleaning materials, gloves, and bandages that were used for the injection sites into a sealed plastic bag and throw them away into the garbage.

• you should not touch or scratch the injection sites or bandages. This can spread the virus in the talimogene laherparepvec medication to other parts of your body. The people around you should be careful not to come into direct contact with your injections sites, bandages, or bodily fluids. Call your doctor immediately if you, or anyone around you, develops signs of a herpes infection;: pain, burning, or tingling in a blister by your mouth, genitals, fingers, or ears; eye pain, redness, or tearing; blurry vision; sensitivity to light; weakness in arms or legs; extreme drowsiness; or mental confusion.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Talimogene laherparepvec injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• unusual tiredness
• nausea
• vomiting
• diarrhea
• constipation
• abdominal pain
• headache
• dizziness
• weight loss
• dry, cracked, itching, burning skin
• muscle or joint pain
• pain in arms or legs
• slowed healing of injection sites
• pain at the injection sites

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• shortness of breath or other breathing problems
• cough
• pink, cola colored, or foamy urine
• swelling of face, hands, feet, or stomach
• losing color in your skin, hair, or eyes
• warm, red, swollen, or painful skin around injection area
• fever, sore throat, chills, or other signs of infection
• dead tissue or open sores on the injected tumors

Talimogene laherparepvec injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about talimogene laherparepvec injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.