Imlygic 10exp6 (1 million) PFU/mL suspension for injection

Generic name:
Talimogene laherparepvec - injection

Pronunciation
(tal-IM-oh-jeen la-HER-pa-REP-vek)

Brand name(s)
Imlygic

This medication is used to treat a certain type of skin cancer (melanoma). It contains a live virus (cold sore virus) that has been weakened. Talimogene laherparepvec infects the cancer cells and works by slowing or stopping their growth.

Read the Medication Guide provided by your pharmacist before you start using talimogene laherparepvec and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into your tumor(s) by a health care professional. It is given as directed by your doctor, usually every 2 weeks. However, your second treatment should be 3 weeks after your first treatment.

The dosage is based on your medical condition and response to treatment.

After getting this medication, you may be able to make others sick with the cold sore virus. To prevent the spread of infection, do not touch or scratch the injection site(s). Keep the injection site(s) covered with airtight and watertight dressing(s) for at least 1 week after each treatment. If the injection site is still oozing or weeping after 1 week, you will need to keep it covered for longer. Ask your doctor for more details. If the dressing comes loose or falls off, replace it right away with a clean dressing. Always wear gloves when changing the dressing. Throw away all used dressings and medical supplies in a sealed plastic bag.

Since you may be able to make others sick with the cold sore virus, people close to you (such as household members, caregivers, sexual partners) should not touch your injection site(s), dressing(s), and body fluids. Caregivers should wear gloves when changing the dressing. Women who are pregnant or who may become pregnant and people with weakened immune systems should not change your dressing or clean your injection site. If someone touches your injection site(s), dressing(s), or body fluids, they should clean the skin that touched you with a disinfectant or soap and water right away. If they have any signs of infection (such as cold sores), they should tell their doctor right away.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Diarrhea, constipation, abdominal pain, dizziness, pain at injection site, white patches on the skin, or flu-like symptoms (such as body aches, cough, sneezing, chills, fever, unusual tiredness, headache, nausea, vomiting) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• cold sores/blisters
• eye infection (such as vision changes, eye redness/pain, light sensitivity, eye discharge)
• open sore/wound at the injection site
• slow wound healing at the injection site
• signs of kidney problems (such as change in the amount of urine, pink/bloody urine)
• joint pain
• muscle pain

Get medical help right away if you have any very serious side effects, including:

• trouble breathing

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using talimogene laherparepvec, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• immune system problems (such as HIV infection, autoimmune disease)
• certain types of cancer (such as leukemia, lymphoma, multiple myeloma)
• psoriasis

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. Men and women should use condoms to prevent spreading the cold sore virus to their sexual partner. If you become pregnant or think you may be pregnant, tell your doctor right away. See also How to Use section.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, prednisone)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Not applicable. This medication is given in a clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.