Imlygic

What is Imlygic used for?

Imlygic is a prescription medicine that is used to treat a type of skin cancer (melanoma).

Description

IMLYGIC (talimogene laherparepvec) is a sterile suspension for intralesional injection. IMLYGIC is a live, attenuated HSV-1 that has been genetically modified to express huGM-CSF. The parental virus for IMLYGIC was a primary isolate, which was subsequently altered using recombinant methods to result in gene deletions and insertions.

Each vial contains 1 mL deliverable volume of IMLYGIC at either 1 × 106 (1 million) PFU per mL or 1 × 108 (100 million) PFU per mL concentrations and the following excipients: di-sodium hydrogen phosphate dihydrate (15.4 mg), sodium dihydrogen phosphate dihydrate (2.44 mg), sodium chloride (8.5 mg), myo-inositol (40 mg), sorbitol (20 mg), and water for injection.

The 106 (1 million) PFU per mL vial of IMLYGIC contains a clear to semi-translucent liquid following thaw from its frozen state. The 108 (100 million) PFU per mL vial of IMLYGIC contains a semi-translucent to opaque liquid following thaw from its frozen state. The liquid in each vial may contain white, visible, variously shaped, virus-containing particles.

Each vial of IMLYGIC may also contain residual components of VERO cells including DNA and protein and trace quantities of fetal bovine serum.

The product contains no preservative.

Mechanism of Action

IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. However, the exact mechanism of action is unknown.

Before taking Imlygic, tell your doctor:

• If you are allergic to Imlygic; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have or have ever had any of these health problems: A weak immune system or a disease that may cause a weak immune system like leukemia, lymphoma, HIV, or AIDS.
• If you are taking any drugs that suppress your immune system. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are pregnant or may be pregnant. Do not use Imlygic if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Imlygic with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Imlygic?

• Tell all of your health care providers that you take Imlygic. This includes your doctors, nurses, pharmacists, and dentists.
• Keep the treated area covered with an airtight and watertight dressing for at least 1 week after each treatment. Leave covered for longer if the area is weeping or oozing. If the dressing falls off, put on a clean dressing right away.
• You will need to take special care when handling and throwing away used dressings, gloves, and cleaning supplies. Throw them away in household waste in a sealed plastic bag. Check with the doctor or pharmacist if you have questions about how to handle them.
• Do not allow pregnant women, newborns, or close contacts like household members, caregivers, sex partners, or someone who shares the same bed to have direct contact with the treated area or dressings. Do not let them come into contact with body fluids. Use a condom if having sex. Avoid kissing if either person has an open mouth sore.
• Wear gloves while putting on or changing dressings.
• Pregnant women or someone who has a weak immune system must not change dressings or clean where Imlygic was given.
• If anyone else comes into contact with Imlygic, the treated area, dressings, or body fluids, have them wash well with soap and water or a disinfectant. If signs of an infection occur, talk with the doctor.
• Do not touch or scratch the treated area. You may spread Imlygic to other parts of the body.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Imlygic, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy while taking Imlygic.

How is Imlygic best taken?

Use Imlygic as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will give Imlygic.
• It is given as a shot.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Imlygic that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Shortness of breath.
• Chest pain.
• White patches on the skin.
• Irritation where the shot is given.
• Small bump where the shot is given.
• Change in skin color where the shot was given.
• Herpes infections have happened with Imlygic. This includes cold sores. Call your doctor if you or a close contact have signs of a herpes infection like arm or leg weakness, blurred eyesight, eye pain or discharge, confusion, feeling sleepy, or if light bothers your eyes. Call the doctor if you or a close contact have pain, burning, or tingling in a blister around the mouth or genitals, on the fingers, or in the ears.

What are some other side effects of Imlygic?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Fever or chills.
• Flu-like signs.
• Headache.
• Dizziness.
• Upset stomach or throwing up.
• Diarrhea.
• Constipation.
• Belly pain.
• Pain in arms or legs.
• Muscle or joint pain.
• Pain where the shot was given.
• Mouth or throat pain or irritation.
• Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Imlygic?

• If you need to store Imlygic at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

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