Amtagvi: Uses, Side Effects and Dosage

Serious warnings and precautions box

What AMTAGVI is used for:

For the following indication(s) AMTAGVI has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.

• AMTAGVI is used to treat adult patients with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma. AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that also has stopped working, and who have no satisfactory alternative treatment options.

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Severe and fatal adverse reactions have occurred in patients treated with the AMTAGVI treatment:

• Low blood counts that last longer than expected and may cause bleeding; increased risk of infection with symptoms like fever, chills or shivering, cough, shortness of breath, rapid breathing, sore throat, mouth sores, and rapid pulse; tiredness, or weakness.
• Heart problems like heart attack, which can cause chest pain, pressure or discomfort, shortness of breath, and pain in the arm, jaw, or back; or an abnormal, slow, or rapid heartbeat, which can lead to dizziness, shortness of breath, or feeling faint.
• Difficulty breathing or shortness of breath that may require extra medical support.
• The kidneys may suddenly stop working, which may cause decreased urine output, swelling in your legs or other parts of your body, nausea, confusion, or shortness of breath.

AMTAGVI should only be administered in an inpatient hospital setting at a qualified treatment center by a physician experienced in the use of anti-cancer agents.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How AMTAGVI works:

AMTAGVI is a type of medicine called a ‘Tumour infiltrating lymphocyte immunotherapy.’ The active substance in the medicine is lifileucel, which is comprised of T cells derived from tissue excised from your tumour. Tumour infiltrating lymphocytes are cells produced by the body’s immune system that may recognize and kill cancer (tumour) cells.

The ingredients in AMTAGVI are:

Medicinal ingredients: lifileucel

Non-medicinal ingredients:

AMTAGVI is cryopreserved in 5% DMSO, 0.5% albumin (human), and 300 IU/mL IL-2 (aldesleukin).

AMTAGVI may contain trace amounts of gentamicin, streptomycin, and amphotericin B.

AMTAGVI comes in the following dosage form:

AMTAGVI is a cell suspension for intravenous infusion.

A single dose of AMTAGVI contains 7.5 x 10⁹ to 72 x 10⁹ viable cells suspended in a cryopreservation medium. A single dose is split into 1 to 4 patient-specific infusion bag(s) (100 mL per bag) in individual protective metal cassettes.

Do not use AMTAGVI if:

• you are allergic or hypersensitive to lifileucel or to any ingredient in the formulation, including dimethyl sulfoxide (DMSO).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMTAGVI. Talk about any health conditions or problems you may have, including if you:

• Have any lung, heart, liver or kidney problems
• Have low blood pressure
• Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
• Have history of nervous system disease, such as delirium and encephalopathy.

• Are pregnant, think you may be pregnant, or plan to become pregnant

• Are breastfeeding
• Notice the symptoms of your cancer are getting worse
• Have had a vaccination in the past 28 days or plan to have one in the next few months
• Have been taking blood thinner

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Educational material for healthcare professionals and patients related to the risks of capillary leak syndrome, cytokine release syndrome, and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome are available via the Learning Management System.

How you will receive AMTAGVI:

• AMTAGVI is made from your surgically removed tumour.
• Your tumour tissue is sent to a manufacturing center to make AMTAGVI. It takes a little more than a month from the time your tumour tissue is received at the manufacturing center until AMTAGVI is available to be shipped back to your healthcare provider, but the time may vary.
• After your AMTAGVI arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.

• Approximately 30 to 60 minutes before you are given AMTAGVI, you may be given other medicines. These may include:

  • Medicines for an allergic reaction (anti-histamines)
  • Medicines for fever (such as acetaminophen)
• Your AMTAGVI will be provided in 1 to 4 infusion bag(s) containing 100 mL of viable cells per bag. When your body is ready for AMTAGVI infusion, your healthcare provider will give AMTAGVI to you by intravenous infusion. This usually takes less than one and a half hours.

After getting AMTAGVI:

Beginning 3 to 24 hours after AMTAGVI is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you present severe side effects.

You will have to stay in the treatment centre until you have completed the IL-2 (aldesleukin) treatment, and you have recovered from any serious side effects associated with the AMTAGVI treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting AMTAGVI. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

Usual dose:

AMTAGVI is provided as a single dose for infusion containing a suspension of tumour-derived T cells. The dose is supplied in 1 to 4 patient-specific IV infusion bag(s) in individual protective metal cassettes. Each dose contains 7.5 x 10⁹ to 72 x 10⁹ viable cells.

Possible side effects from using AMTAGVI

These are not all the possible side effects you may have when taking AMTAGVI. If you experience any side effects not listed here, tell your healthcare professional.

Very common:

• Nausea, vomiting
• Diarrhoea
• Tired or lack of energy
• Change in appetite
• Muscle pain
• Headache
• A change in the minerals in blood and body fluids
• Hair loss
• Laboratory test results showing increased levels of liver enzymes
• Itching
• High blood pressure
• Low protein in the blood
• Rash
• Patches of skin turning lighter than the surrounding skin (vitiligo)
• Buildup of fluid in the body causing swelling or weight gain

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

If you want more information about AMTAGVI:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (Drug Product Database: Access the database); the manufacturer’s website Iovance.com, or by calling 1-833-215-7566.

Distributed by: Bioscript Logistics Inc.

Date of Authorisation August 15, 2025

Lifileucel is a trademark of Iovance Biotherapeutics, Inc. All rights reserved.