Imlygic

What is Imlygic?

Imlygic is a cancer medication that works by affecting the immune system of the body and helping it produce an "antitumor" response.Imlygic (a weak genetically modified form of the type 1 herpes virus, which causes cold sores) is a weakened version of this virus.Imlygic can be used to treat a cancerous condition called melanoma that occurs on the skin or in the glands of the lymphatic system.

Warnings

Please read all the instructions on the label or package of your medication. Inform your healthcare provider about your medical conditions, your allergies, and the medicines you are using.

Before you take this drug

The herpes virus can be contracted by accident. Not treating melanoma may allow it to spread and progress to other areas of the body. This type of cancer is fatal and difficult to treat once it has progressed. Imlygic is not without risks. Discuss with your doctor the benefits and risks.

Imlygic should not be used if you have an allergy to talimogene or laherparepvec.

• You have a weakened immune system, either because of a disease or certain medicines.
• You are pregnant.

Tell your doctor about any of the following to ensure Imlygic will be safe for you:

• Cold sores, or genital herpes
• Blood cancer (leukemia)
• Bone marrow cancer, also known as myeloma
• HIV or AIDS
• An autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis.

Inform your doctor if you suspect that anyone in your family is pregnant or suffers from a weakened immune system.Talimogene can cause birth defects or harm to an unborn child. Imlygic should not be used if pregnant. Tell your doctor immediately if you get pregnant.

Imlygic can cause pregnancy, so use effective birth control while using it. After your treatment, follow your doctor's advice on how long you should continue to use birth control.Imlygic can cause problems with breastfeeding. Consult your doctor if you are concerned about any risks.

Similar/related drugs

Keytruda, pembrolizumab, nivolumab, Opdivo, atezolizumab, Yervoy, and dabrafenib

How to take Imlygic?

Imlygic can be injected into a skin tumor or a lymphatic node beneath the skin. This injection will be given by a healthcare provider.

Imlygic can be given every two weeks, or until the tumor has disappeared. Imlygic's first two injections are typically given three weeks apart.

You will be advised to take special precautions by your healthcare provider to ensure that this medication does not get into any other parts of your body. If you accidentally get this medicine on your skin, thoroughly wash it with warm, soapy water.

Imlygic contains a weak version of the herpes virus, which can spread to different parts of your body. Follow your doctor's instructions on how to care for the areas of your body where Imlygic has been injected.

• Keep the treated area covered for at least one week after your injection with a waterproof and airtight bandage. If the area is oozing or draining, you may have to cover it for more than one week.
• Keep the area clean by changing your dressings frequently.
• Wear latex gloves when cleaning the area to be treated or applying a bandage. Put used gloves and bandages into a sealed plastic bag and toss them in the garbage.

You can spread the virus to others who are in close contact with you. Avoid being around people who are ill or infected. Kissing someone with a cold sore or a sore on the mouth (also called a fever blister) is not recommended. Avoid being around pregnant women.

If you notice any new lesions on your skin or signs of a lymph gland tumor after stopping Imlygic, call your doctor.

Details on dosage

Adult dose of imlygic for metastatic melanoma:

Initial Dose
Intralesional injection of up to 4 ml with a plaque-forming unit (PFU), concentration 10 (6) [1,000,000] per ml
Inject the largest lesion(s).
Prioritize the remaining lesions for injection according to their size.
Second Dose
Intralesional injection of up to 4 ml with a 10(8) [100,000,000] PFU/ml concentration 3 weeks after the initial treatment
Injecting new lesions that have developed since the initial treatment is recommended.
Prioritize the remaining lesions for injection according to their size.
All Subsequent Treatments, including Reinitiation:
Intralesional injection of up to 4 ml with a 10(8) [100,000,000] PFU/ml concentration 2 weeks after the previous treatment
Injecting new lesions that have developed since the previous treatment is recommended.
Prioritize the remaining lesions for injection according to their size.
Maximum Dose: Total injection volume per treatment session should not exceed 4 ml, including all lesions injected together.

Duration of treatment:
At each treatment, lesions should be treated until the maximum volume of injection is reached or all injectable lesions have been treated.
Full treatment course: 6 months minimum, unless another treatment is needed or there are no injectable lesions to treat.
Comments:
The volume of injection should be determined by the size of the lesion (clustered lesions should be treated as one lesion).
Greater than 5 cm: up to 4 ml
From 2.5 cm up to 5 cm: 2 ml or less
More than 1.5 cm up to 2.5 cm: 1 ml
More than 1.5 cm up to 0.5 ml
-0.5 cm: up to 0.1 ml
Use: local treatment for unresectable lesions of the skin, subcutaneous tissue, and nodal tissues in patients with melanoma that has recurred after initial surgery.

What happens if I miss the dose?

If you are unable to attend your scheduled injection, call your doctor.

What happens if I overdose?

Imlygic will be administered by a healthcare professional within a medical environment, so an overdose should not occur.

What should be avoided?

Avoid scratching or touching the area where this medicine has been injected.Imlygic contains a virus that can be passed into bodily fluids such as urine, feces, and vomit. Avoid letting your body fluids come into contact with surfaces such as your hands and other surfaces that cannot be cleaned. Use a latex-based condom whenever you are having sex. Rubber gloves should be worn by carers when cleaning up body fluids from patients, changing diapers, or handling contaminated laundry or trash. Hands should be washed before and after gloves are removed. Separately, wash soiled linens and clothing.

After your Imlygic treatment has ended, follow your doctor's instructions on how long to continue using these precautions.

Side effects of Imlygic

If you experience any of the following symptoms of an allergy to Imlygic, seek immediate medical attention: hives, difficulty breathing, swelling of the face, lips, or throat.

If you notice any symptoms that indicate you might be infected with the herpes virus, call your doctor immediately.

• The sensation of tingling or burning (especially in the mouth or genital area);
• Sometimes there is burning pain or weakness in the arm or leg.
• Eye pain, crusting, drainage, or blurred vision (Your eyes may be more sensitive to the light.)
• Confusion, severe drowsiness,
• Blisters on the fingers, ears, or mouth.

Call your doctor immediately if you:

• Any skin lesion that does not heal
• Redness, swelling, or warmth at the site of injection

Imlygic side-effects include:

• Fever, chills, flu-like symptoms;
• Feeling tired
• Nausea;
• Pain where the medication was injected.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Tell your doctor if you are taking any other medications, including Imlygic.

• Medicine to treat herpes, such as acyclovir or valacyclovir;
• Drugs that suppress the immune system, such as steroids, cancer medicines, and drugs to prevent rejection of organ transplants,

This list is incomplete. This includes prescription and non-prescription drugs, vitamins, and herbal products. This medication guide does not list all drug interactions.