Pronunciation:

tal-IM-oh-jeen la-her-pa-REP-vek

Brand Names:

• Imlygic

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Talimogene laherparepvec injection is used to treat melanoma (skin cancer) when it is on your skin or in your lymph glands. This medicine is a weakened form of Herpes Simplex Virus Type 1 (cold sore virus).

This medicine is given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

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.

Other 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

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 this medicine. 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.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is injected directly into your tumor(s).

You will receive this medicine again 3 weeks after your first treatment. After that, you will receive this medicine every 2 weeks for as long as you have tumor(s).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. 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 this medicine 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.

This medicine 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.

This medicine 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.

This medicine 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 this medicine. 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

pain at the injection site

runny nose

shivering

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid

burning or stinging of the skin

painful cold sores or blisters on the lips, nose, eyes, or genitals

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

difficulty having a bowel movement (stool)

difficulty with moving

dizziness

muscle pain or stiffness

pain in the arms or legs

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.