Talimogene laherparepvec

Talimogene laherparepvec is a cancer medicine that works by affecting how the body's immune system functions, helping the body create an "antitumor" response. Talimogene laherparepvec is a specially changed weak version of the type 1 herpes simplex virus (the virus that causes common cold sores).

Talimogene laherparepvec is used to treat a type of cancer known as melanoma when it is located on the skin or in the lymph glands.

Talimogene laherparepvec may also be used for reasons not mentioned in this medication guide.

Talimogene laherparepvec is injected directly into a tumor on your skin or into a lymph node under your skin. A healthcare provider will give you this injection.

This medicine is usually given every 2 weeks or until your tumor is gone. The first two injections of talimogene laherparepvec are usually given 3 weeks apart.

Your care providers will take special precautions to prevent this medicine from getting on other parts of your body. If this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water.

The virus in talimogene laherparepvec is a weak form of the herpes simplex virus that can spread to other parts of your body. Carefully follow your doctor's instructions about caring for the areas where this medicine is injected.

• For at least 1 week after your injection, keep the treatment area covered with an airtight and waterproof bandage. You may need to keep the treated area covered for longer than 1 week if it is draining or oozing.
• Change your dressing often to keep the treated area clean.
• Wear latex gloves while you are cleaning the treatment area or putting on a new bandage. Place used gloves and bandages in a sealed plastic bag and throw it away in the trash.

The virus in this medicine can also spread to other people you have close contact with. Avoid being near people who are sick or have infections. Avoid kissing anyone who has a mouth sore or cold sore (sometimes called a fever blister). Also avoid being near pregnant women.

Call your doctor if you have any new skin lesions or signs of lymph gland tumors after you have stopped using talimogene laherparepvec.

Follow all instructions on your medicine label and package. Inform all of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

Accidental exposure to the virus in talimogene laherparepvec may lead to symptoms of herpes virus infection. However, not treating melanoma can allow the cancer to worsen and spread to other areas of the body. Melanoma is hard to treat once it has progressed, and this type of cancer can be life-threatening. Discuss with your doctor the risks and benefits of using talimogene laherparepvec.

You should not receive talimogene laherparepvec if you are allergic to it, or if:

• you have a weak immune system (due to a disease or certain medicines); or
• you are pregnant.

Inform your doctor if you have ever had:

• cold sores or genital herpes;
• blood cancer (leukemia);
• bone marrow cancer (myeloma);
• HIV or AIDS; or
• an autoimmune disorder like rheumatoid arthritis, lupus, or psoriasis.

Let your doctor know if anyone in your household is pregnant or has a weak immune system.

Use effective birth control to avoid pregnancy, and inform your doctor if you become pregnant. If you show symptoms of herpes virus infection while using talimogene laherparepvec, the virus could be transmitted to your baby during childbirth.

It may not be safe to breastfeed while using talimogene laherparepvec. Consult your doctor about any potential risks.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you notice any signs that you might be developing herpes simplex virus, such as:

• tingling, burning, or pain (especially around your mouth or genitals);
• weakness or cramps in an arm or leg, sometimes with burning pain;
• eye pain, crusting or drainage, blurred vision (your eyes may be more sensitive to light);
• confusion, severe drowsiness; or
• blisters forming on your fingers or ears, or around your mouth or genitals.

Also call your doctor if you have:

• any skin lesion that does not heal; or
• redness, swelling, warmth, oozing, or skin changes where the injection was given.

Common side effects of talimogene laherparepvec may include:

• fever, chills, flu-like symptoms;
• feeling tired;
• nausea; or
• pain at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Melanoma -- Metastatic:

Initial Dose: -Up to 4 mL at a concentration of 10(6) [1 million] plaque-forming units (PFU) per mL by intralesional injection.-Largest lesion(s) should be injected first.-Remaining lesion(s) should be prioritized for injection based on lesion size.Second Dose: -Up to 4 mL at a concentration of 10(8) [100 million] PFU per mL by intralesional injection 3 weeks after initial treatment.-New lesions that developed since initial treatment should be injected first.-Remaining lesion(s) should be prioritized for injection based on lesion size.All Subsequent Treatments (including Reinitiation):-Up to 4 mL at a concentration of 10(8) [100 million] PFU per mL by intralesional injection 2 weeks after previous treatment.-New lesions that developed since previous treatment should be injected first.-Remaining lesion(s) should be prioritized for injection based on lesion size.Maximum Dose: The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined.Duration of Therapy: -At each treatment visit: Lesions should be injected until maximum injection volume is reached or until all injectable lesion(s) have been treated. -Full treatment course: At least 6 months unless other treatment is required or until there are no injectable lesions to treat.Comments:The injection volume should be based on lesion size (lesions clustered together should be treated as a single lesion):-Greater than 5 cm: Up to 4 mL-Greater than 2.5 cm to 5 cm: Up to 2 mL-Greater than 1.5 cm to 2.5 cm: Up to 1 mL-Greater than 0.5 cm to 1.5 cm: Up to 0.5 mL-0.5 cm or less: Up to 0.1 mLUse: Local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Call your doctor for instructions if you miss an appointment for your injection.

Since talimogene laherparepvec is administered by a healthcare professional in a medical setting, the chance of an overdose is very low.

Do not touch or scratch the areas where this medicine was injected.

The virus in talimogene laherparepvec can be present in body fluids (urine, feces, vomit, semen). Do not let your body fluids touch your hands or surfaces that cannot be cleaned. Always use a latex condom during sex. Caregivers must wear rubber gloves when cleaning up a patient's body fluids, handling contaminated trash or laundry, or changing diapers. Wash hands before and after taking off gloves. Wash soiled clothing and linens separately from other laundry.

Follow your doctor's instructions about how long you should continue these precautions after your treatment is finished.

Tell your doctor about all your other medicines, especially:

• medicine to treat herpes (acyclovir, valacyclovir, or others); or
• drugs that weaken the immune system (such as cancer medicine, steroids, and medicines to prevent organ transplant rejection).

This list is not complete. Other drugs may affect talimogene laherparepvec, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.