Imlygic

Generic name: Talimogene Laherparepvec
Drug class: Miscellaneous antineoplastics

Usage of Imlygic

Imlygic is a cancer medicine that affects the actions of the body's immune system, helping the body produce an "antitumor" response.

Imlygic is a genetically modified weak form of type 1 herpes simplex virus (the virus that causes common cold sores).

Imlygic is used to treat a type of cancer called melanoma when it is on the skin or in the lymph glands.

Imlygic side effects

Get emergency medical help if you have signs of an allergic reaction to Imlygic: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any signs that you may be developing herpes simplex virus, such as:

tingling, burning, or pain (especially around your mouth or genitals);

weakness or cramps in an arm or leg, sometimes with burning pain;

eye pain, crusting or drainage, blurred vision (your eyes may be more sensitive to light);

confusion, severe drowsiness; or

blisters forming on your fingers or ears, or around your mouth or genitals.

Also call your doctor if you have:

any skin lesion that will not heal; or

redness, swelling, warmth, oozing, or skin changes where the injection was given.

Common Imlygic side effects may include:

fever, chills, flu-like symptoms;

feeling tired;

nausea; or

pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Imlygic

Accidental exposure to the virus in Imlygic may cause you to develop symptoms of herpes virus infection. However, not treating melanoma can allow the cancer to progress and spread to other parts of the body. Melanoma is difficult to treat after it progresses, and this type of cancer can be fatal. Talk to your doctor about the risks and benefits of using Imlygic.

You should not be treated with Imlygic if you are allergic to talImogene laherparepvec, or if:

you have a weak immune system (caused by disease or by using certain medicine); or

you are pregnant.

To make sure Imlygic is safe for you, tell your doctor if you have:

cold sores or genital herpes;

blood cancer (leukemia);

bone marrow cancer (myeloma);

HIV or AIDS; or

an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis.

Tell your doctor if anyone in your household is pregnant or has a weak immune system.

Talimogene laherparepvec can harm an unborn baby or cause birth defects. Do not use Imlygic if you are pregnant, and tell your doctor right away if you become pregnant. If you develop symptoms of herpes virus infection while using Imlygic, the virus could be passed to your baby during childbirth.

Use effective birth control to prevent pregnancy while you are using Imlygic. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It may not be safe to breastfeed while using Imlygic. Ask your doctor about any risk.

Relate drugs

How to use Imlygic

Usual Adult Dose of Imlygic for Melanoma - Metastatic:

Initial Dose: -Up to 4 mL at a concentration of 10(6) [1 million] plaque-forming units (PFU) per mL by intralesional injection. -Largest lesion(s) should be injected first. -Remaining lesion(s) should be prioritized for injection based on lesion size. Second Dose: -Up to 4 mL at a concentration of 10(8) [100 million] PFU per mL by intralesional injection 3 weeks after initial treatment. -New lesions that developed since initial treatment should be injected first. -Remaining lesion(s) should be prioritized for injection based on lesion size. All Subsequent Treatments (including Reinitiation): -Up to 4 mL at a concentration of 10(8) [100 million] PFU per mL by intralesional injection 2 weeks after previous treatment. -New lesions that developed since previous treatment should be injected first. -Remaining lesion(s) should be prioritized for injection based on lesion size. Maximum Dose: The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined. Duration of Therapy: -At each treatment visit: Lesions should be injected until maximum injection volume is reached or until all injectable lesion(s) have been treated. -Full treatment course: At least 6 months unless other treatment is required or until there are no injectable lesions to treat. Comments: The injection volume should be based on lesion size (lesions clustered together should be treated as a single lesion): -Greater than 5 cm: Up to 4 mL -Greater than 2.5 cm to 5 cm: Up to 2 mL -Greater than 1.5 cm to 2.5 cm: Up to 1 mL -Greater than 0.5 cm to 1.5 cm: Up to 0.5 mL -0.5 cm or less: Up to 0.1 mL Use: Local treatment of unresectable cUTAneous, suBCutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What other drugs will affect Imlygic

Tell your doctor about all your current medicines and any you start or stop using while being treated with Imlygic, especially:

medicine to treat herpes (acyclovir, valacyclovir, or others); or

drugs that weaken the immune system (such as cancer medicine, steroids, and medicines to prevent organ transplant rejection).

This list is not complete. Other drugs may interact with talimogene laherparepvec, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed in this medication guide.

Disclaimer

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