Class: Viral Therapy

Generic Name: talimogene laherparepvec

Trade Name: Imlygic™

For which conditions is this drug approved? Imlygic can be used to treat melanomas in the skin or lymph nodes that can’t be removed with surgery.

What is the mechanism of action?  Imlygic is a herpes germ that has been altered to infect and kill cancer cells. These altered viruses are known as oncolytic viruses. Along with killing the cells directly, the viruses can also alert the immune system to attack the cancer cells.

How is Imlygic typically given (administered)?  Imlygic is injected directly into melanoma tumors.

What are the most common side effects of treatment with Imlygic?

• Fatigue
• Chills
• Fever
• Nausea
• Flu-like illness
• Pain at injection site

What are some of the more serious but less common side effects of Imlygic?

• Herpes infection
• Injection site complications

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What should patients be aware of after treatment with Imlygic?

• Pregnant women should not change dressings or clean injection sites.
• In case of accidental exposure to Imlygic, clean the affected area with soap and water and/or a disinfectant. Contact a healthcare provider.
• Follow instructions to prevent viral transmission:

• Avoid direct contact with injection sites, dressings, or body fluids of patients.
• Wear gloves when changing dressing.
• Avoid touching or scratching injection sites.
• Keep injection sites covered and well bandaged.
• Dispose used dressings and cleaning material in sealed plastic bag.

Are there any special precautions patients should be aware of before starting treatment?

• Close contacts (family, friends, etc.) should avoid direct contact with injected lesions, dressings, or body fluids of treated patients.
• It is possible patients may be infected with the herpes virus.
• There could be complications at the injection site.
• Patients with autoimmune issues (or who develop them during treatment) should consider risks and benefits of Imlygic.
• Patients with multiple myeloma should consider risks and benefits of Imlygic.
• Imlygic is not administered to immunocompromised patients.
• Imlygic is not administered to pregnant patients.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition, or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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