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Overview: Amtagvi is used to treat melanoma, which is a type of skin cancer. It is a one-time treatment made from your own immune cells. You will need to stay in the hospital and receive certain medicines before and after Amtagvi treatment while your health care team monitors you closely for side effects. Get help right away if you have a fever, chills, trouble breathing, chest pain, a fast or irregular heartbeat, unusual bleeding, or blood in your urine or stool. 

Uses

What is Amtagvi used for?

Amtagvi is commonly used to treat a type of skin cancer called melanoma.

What to Know About Amtagvi for Advanced Melanoma

Amtagvi may also be used for other conditions as determined by your health care provider.

How does Amtagvi work (mechanism of action)?

Amtagvi is a tumor-infiltrating lymphocyte (TIL) therapy. It is a one-time treatment that uses your own immune cells to help fight cancer. Amtagvi is made from certain immune cells, called T cells, that are taken from your tumor. The cells are tested in a lab to find the ones that are best able to detect your cancer cells. These cells are then grown into billions of cells and infused back into your body to treat your cancer.

How is Amtagvi supplied (dosage forms)?

Amtagvi is available in an injectable form that is given by a health care provider.

How should I store Amtagvi?

Amtagvi is given by a health care provider in a hospital or treatment center. You will not store it at home.

Side Effects

What are the most common side effects of Amtagvi?

The most common side effects of Amtagvi are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Chills and fever
  • Tiredness
  • Fast heartbeat
  • Diarrhea
  • Low white blood cells (see Low Blood Cell Levels below)
  • Fluid retention
  • Rash
  • Low blood pressure
  • Hair loss
  • Infections (see below)
  • Shortness of breath

There may be other side effects of Amtagvi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Amtagvi?

While less common, the most serious side effects of Amtagvi are described below, along with what to do if they happen.

Severe Allergic Reactions. Amtagvi may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Low Blood Cell Levels. Amtagvi can cause your blood cell levels to stay very low for several weeks or longer. This may include low platelets (thrombocytopenia), low neutrophils (neutropenia), or other low white blood cells (lymphopenia or leukopenia). Low blood cell levels can be serious and may increase your risk of infections and bleeding. Your health care provider will do blood tests to monitor your blood cell levels after treatment. Be sure to attend all medical and blood work appointments after you leave the hospital.

Infections. Amtagvi can increase your risk of infections, including serious infections that can be life-threatening. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Fever of 100.4 F (38 C) or higher
  • Burning or pain when you pee
  • Cough or coughing up blood 
  • Chills, sweating, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Serious Bleeding. Amtagvi can cause serious bleeding inside your body, including bleeding in the brain or gut, which can be life-threatening. Get medical help right away if you have any of the following symptoms.

  • Severe or unusual headache
  • Confusion or trouble speaking
  • Severe stomach pain
  • Vomiting blood
  • Blood in your stool or black, tarry stools
  • Unusual bruising or bleeding that does not stop

Heart Problems. Amtagvi can cause serious heart problems, including changes in your heart rhythm and heart attack, which can be life-threatening. Get medical help right away if you have any of the following symptoms.

  • Chest pain or pressure
  • Fast, pounding, or irregular heartbeat
  • Shortness of breath
  • Dizziness or fainting
  • Swelling in your legs or feet

Breathing Problems. Amtagvi can cause serious breathing problems that may become life-threatening, including sudden respiratory failure. Get medical help right away if you have any of the following symptoms.

  • Trouble breathing or shortness of breath
  • Rapid breathing
  • Chest pain
  • Severe cough

Kidney Problems. Amtagvi can cause serious kidney problems, including kidney failure. Call your health care provider right away if you have any of the following symptoms.

  • Peeing much less than usual
  • Blood in your urine
  • Swelling in your feet, ankles, or legs
  • Severe tiredness
  • Shortness of breath

Infusion Reactions. Amtagvi can cause a reaction during or within a day after the infusion. These reactions usually improve the same day, but some can be serious. Tell your health care provider right away if you have any of the following symptoms.

  • Fever, chills, or shaking
  • Fast heartbeat
  • Rash
  • Dizziness or lightheadedness
  • Cough, wheezing, or shortness of breath
  • Chest tightness

Warnings & Precautions

Who should not use Amtagvi?

Allergies to Ingredients. People who are allergic to any of the following should not use Amtagvi.

  • Amtagvi
  • Lifileucel
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Amtagvi.

What should I know about Amtagvi before using it?

Amtagvi is made using your own immune cells, so it will take a few weeks for the medicine to be ready. Talk with your health care provider about what to expect during the process.

Amtagvi is given as a single dose by a health care provider in a hospital or treatment center. You will usually need to stay in the hospital before and after receiving Amtagvi. You will also be given certain medicines before and after receiving Amtagvi. These medicines help get your body ready for treatment and may lower the chance of side effects. You will likely stay in the hospital until after you have completed treatment and you have recovered from any side effects.

Plan on staying within 2 hours of the location where you received Amtagvi for several weeks after your treatment. Your health care provider will check how well the treatment is working and help manage any side effects.

What should I tell my health care provider before using Amtagvi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Amtagvi is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Tell your health care provider if you have recently received a vaccine or plan to get one in the next few months. Amtagvi and the medicines given before and after Amtagvi treatment can affect your immune system, which may affect when it is safest or most effective to receive vaccines. Your health care provider can help you decide the best timing for any vaccines you may need.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Amtagvi may interact with other medicines and supplements. Before receiving Amtagvi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known whether Amtagvi can harm a fetus, and it is not recommended during pregnancy. If you can become pregnant, your health care provider will likely do a pregnancy test before treatment with Amtagvi. Tell your health care provider if you are pregnant, think you might be pregnant, or plan to become pregnant. Discuss any plans for pregnancy after treatment with your health care provider. If you become pregnant after receiving Amtagvi, tell your health care provider and report the pregnancy to the drugmaker at 833-400-4682.

Breastfeeding. It is not known if Amtagvi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should breastfeed around the time of your treatment.

How can I get more information about Amtagvi?

For more information about Amtagvi, you can visit the drugmaker’s website at www.amtagvi.com or call them at 833-400-4682.

Interactions

Does Amtagvi interact with foods or drinks?

There are no known interactions between Amtagvi and foods or drinks.

It is unknown if drinking alcohol will affect Amtagvi, but heavy drinking can slow your immune response and make it harder for your body to fight cancer and infections.

Does Amtagvi interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Amtagvi.

  • A blood thinner, such as warfarin, apixaban (Eliquis), or rivaroxaban (Xarelto), which is a medicine used to treat or prevent blood clots
  • A corticosteroid, which is a medicine for certain inflammatory conditions

This may not be a complete list of medicines that can interact with Amtagvi. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Amtagvi?

If you or someone else has used too much Amtagvi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Amtagvi?

Amtagvi is usually given by a health care provider in a hospital. Your health care provider will make sure you receive Amtagvi as scheduled.