Imlygic

Imlygic is a prescription medication used to treat melanoma lesions on the skin and in the lymph nodes. 

It belongs to a group of drugs called oncolytic viruses. These work by replicating inside the cancer cells, causing the cancer cells to burst and die.

This medication is available as an injection and is directly injected into the melanoma lesions. 

Common side effects of Imlygic include fatigue, chills, and fever. 

Imlygic is a prescription medication used to treat melanoma lesions on the skin and in the lymph nodes that cannot be removed completely by surgery. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Amgen Inc

Serious side effects have been reported with Imlygic. See the “Imlygic Precautions” section.

Common side effects of Imlygic include the following:

• fatigue
• chills
• fever
• nausea
• flu-like symptoms
• pain at the injection site

This is not a complete list of Imlygic side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anti-herpes viral agents such as acyclovir, famciclovir, or valacyclovir
• steroids or other medications that suppress the immune system

This is not a complete list of Imlygic drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Imlygic including the following:

Accidental exposure to Imlygic. Being accidentally exposed to Imlygic can lead to transmission of Imlygic and herpes infections. Healthcare providers, pregnant women, newborns, and any close contacts should take precautions to avoid direct contact with injected lesions, dressings, or body fluids of treated patients. To help prevent transmission of Imlygic to other areas of the body, do not scratch or touch the injection site or dressing.

Herpes infection. Some patients on Imlygic have developed herpes infections such as cold sores or an infection in the eye called herpetic keratitis. Tell your doctor if you develop any blisters or sores that are painful, tingling, itching, or burning.

Injection site complications. Injections of Imlygic may damage the surrounding tissue or cause an infection that could spread into your bloodstream. Tell your doctor if you develop any signs or symptoms of an infection such as fever, chills, or redness or warmth around the injection site. 

Immune-mediated events. Your immune system can react to Imlygic and cause problems throughout your body. People whose immune systems do not work like they should are at an increased risk for these reactions.

Plasmacytoma at injection site. During a clinical study, a patient who was receiving Imlygic developed a new cancerous tumor in the soft tissue. Tell your doctor if you develop any new skin symptoms while being treated with Imlygic.

You should not receive Imlygic if you:

• are allergic to Imlygic or to any of its ingredients
• are pregnant
• have a weakened immune system (caused by conditions such as blood or bone marrow cancer, chronic steroid medication use, or HIV or AIDS)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Imlygic, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Imlygic, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Imlygic or to any of its ingredients
• are taking steroids or other medicines that weaken your immune system
• are taking antiviral medicines to treat or prevent herpes, such as acyclovir or valacyclovir (Valtrex)
• have or ever had medical conditions that weaken your immune system such as HIV infection or AIDS, blood or bone marrow cancer, or autoimmune disease
• have close contact with someone who has a weakened immune system
• have close contact with someone who is pregnant
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No well-controlled studies have been done in pregnant women with Imlygic. Due to the risk of potential harm to unborn babies, Imlygic should not be given to a pregnant woman. Women who are able to become pregnant should use an effective method of contraception to prevent pregnancy while being treated with Imlygic. Talk to your doctor about which method of contraception is right for you.

Women who are pregnant and in close contact with a person taking Imlygic should not change their dressing or clean the injection sites due to the potential risk for harm to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Imlygic crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Imlygic.

Imlygic comes in an injectable form that is injected directly into tumors with a needle and syringe by a healthcare professional. After it is injected, the specially trained virus destroys cancer cells without attacking normal healthy cells.

You will get a second treatment 3 weeks after the first treatment. After that, you will get treatments every 2 weeks for as long as you have tumor(s). You can get treated for 6 months or longer.

Your healthcare provider will decide which tumor(s) to inject. It is important to care for the treatment sites properly so that Imlygic does not spread to other people. Follow your healthcare provider's instructions on how to care for your injection sites after each treatment. It is important to keep the injection site(s) covered with airtight and waterproof dressings for at least the first week after each treatment or longer if the injection site is weeping or oozing. Wear gloves while putting on or changing your dressings. If the dressing comes loose or falls off, replace it right away with a clean dressing. Place all used dressings and cleaning materials in a sealed plastic bag and throw them away in the garbage. 

Avoid touching or scratching the injection sites to prevent spreading Imlygic to other people. Avoid direct contact between your treatment sites, dressings, or body fluids and people who are in close contact with you (such as using condoms during sexual intercourse, avoiding kissing if either person has an open mouth sore)

The dose of Imlygic your doctor recommends will be based on the number and size of your lesions. 

The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions (combined).

The recommended dosing schedule for Imlygic is an initial treatment, followed by a second treatment 3 weeks after the first treatment. All further treatments will be given 2 weeks after the previous treatment.

Your doctor will determine the length of your treatment with Imlygic. It is recommended to continue Imlygic for at least 6 months unless other treatment is needed or until there are no more injectable lesions to treat.

If Imlygic is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor during treatment with Imlygic.
• Follow your doctor's instructions on how to properly care for your injection sites after each treatment and prevent spreading of Imlygic to others.