Talimogene Laherparepvec Injection

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

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

In the U.S.

• Imlygic

Available Dosage Forms:

• Suspension

Therapeutic Class: Antineoplastic Agent

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For talimogene laherparepvec, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to talimogene laherparepvec or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of talimogene laherparepvec injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of talimogene laherparepvec injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of talimogene laherparepvec. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune disease or
• Glomerulonephritis (kidney problem) or
• Pneumonitis (inflammation of the lung tissue) or
• Psoriasis (skin problem) or
• Vasculitis (inflammation of the blood vessels) or
• Vitiligo (skin problem)—Use with caution. May make these conditions worse.

• Leukemia, history of or
• Lymphoma, history of or
• Weak immune system (including AIDS or HIV infection), history of—Should not be used in patients with these conditions.

• Multiple myeloma—May increase risk for more serious side effects.

Your doctor will check your progress closely while you are receiving talimogene laherparepvec. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using talimogene laherparepvec while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

talimogene laherparepvec can spread to other areas of the body or to other people (eg, household members, caregiver, or persons sharing the same bed). To avoid spreading the medicine:

• Avoid direct contact between your treatment sites, dressings, body fluids or close contacts. Do not touch or scratch the treatment sites.
• Wear gloves when putting on or changing your dressings.
• Cover the treatment sites with airtight and watertight dressings for at least 1 week after each treatment.
• If the dressing comes loose or falls off, use a new, clean dressing to replace it.
• Place all used dressings and cleaning materials in a sealed plastic bag and throw them in the trash can.

talimogene laherparepvec may cause herpes infections (including cold sores). Tell your doctor right away if you have pain, burning, or tingling in a blister around the mouth or genitals or on the fingers or ears, confusion, extreme drowsiness, blurred vision, eye pain, sensitivity to light, or weakness in your arms or legs.

talimogene laherparepvec may cause delayed healing at the injection site. It is more likely to occur if you had previous radiation treatment at the injection site or lesions. Tell your doctor right away if you have infection or delayed healing of the injection sites.

Immune-mediated events may occur while receiving talimogene laherparepvec. These include glomerulonephritis, pneumonitis, psoriasis, vasculitis, or vitiligo. Tell your doctor if you have bloody or cloudy urine, swelling of the feet or lower legs, weight gain, fever, sores, welting, or blisters, or red, scaling, or crusted skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Before using talimogene laherparepvec, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection, autoimmune disease), certain types of cancer (such as leukemia, lymphoma, multiple myeloma), psoriasis.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. Men and women should use condoms to prevent spreading the cold sore virus to their sexual partner. If you become pregnant or think you may be pregnant, tell your doctor right away. See also How to Use section.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, prednisone).