Amtagvi (lifileucel) is a one-time treatment for certain people with melanoma that cannot be removed with surgery or has spread. It is made from immune cells called T cells that are taken from your tumor, grown into billions of cells in a lab, and then given back to you through an intravenous (IV) infusion.
To prepare your body for Amtagvi, you will be treated with chemotherapy. After the infusion, you will usually be treated with an immunotherapy medicine called interleukin-2 (IL-2) to help activate the T cells.
Because the treatment process includes chemotherapy, Amtagvi, and IL-2, its side effects can be serious and sometimes life-threatening. So you will usually need to stay in the hospital and be closely monitored before, during, and after Amtagvi treatment.
Your health care provider can help weigh the possible risks and benefits of Amtagvi. Keep reading to learn about Amtagvi side effects, follow-up monitoring, and what to expect before and after treatment.
What Are the Most Common Side Effects of Amtagvi?
The most common side effects reported with the Amtagvi treatment regimen include:
- Fever and chills
- Tiredness (fatigue)
- Fast heartbeat
- Diarrhea
- Fluid retention
- Rash
- Low blood pressure
- Hair loss
- Infections
- Shortness of breath
- Low blood cell counts
Other side effects are possible. Tell your health care provider right away about any new or worsening symptoms.
The sections below offer more information about some potentially serious side effects of Amtagvi.
Low Blood Cell Counts
Amtagvi treatment can cause severe drops in blood cell counts, also called cytopenias. This is partly due to the chemotherapy given before Amtagvi, which lowers certain immune cells to prepare your body for treatment.
Low blood cell counts can affect different types of cells:
- Low white blood cells can raise your risk of infection.
- Low platelets can raise your risk of bleeding.
- Low red blood cells can cause tiredness, weakness, or shortness of breath.
For some people, severe low blood cell counts can continue for weeks or longer. In clinical studies, about 46% of people had severely low blood cell counts that lasted beyond 30 days or had not improved to a milder level by then.
Your health care team will check your blood counts after treatment. You will likely receive filgrastim or a similar medicine starting the day after Amtagvi to help your body make more infection-fighting white blood cells.
Serious Infections
Amtagvi treatment can raise your risk of serious infections because your immune system is weakened during treatment.
In studies, infections related to the Amtagvi treatment regimen occurred in about 27% of people, while severe infections occurred in nearly 14%. Fever along with a very low white blood cell count, called febrile neutropenia, affected about 47% of people.
Amtagvi should not be given if you have a serious infection that is not under control. Your health care team will watch for infection before and after treatment. They may also give medicines to help prevent infections.
Contact your health care team if you have possible signs of infection, such as fever, chills, cough, or other new symptoms.
Bleeding
Low platelet counts after Amtagvi treatment can increase the risk of bleeding. Although rare, serious bleeding may occur inside the body, including in the gut or brain.
Make sure to tell your health care provider if you take a blood thinner. If you continue to have low platelet counts after treatment, blood thinners may need to be avoided or used with close monitoring if they cannot be avoided. Do not stop a prescribed blood thinner on your own. Your health care provider can tell you whether you need to make any changes.
Your health care team will monitor your blood counts and watch for signs of bleeding. Contact your health care provider if you have unusual or severe bleeding, blood in your urine or stool, severe headache, dizziness, or other symptoms that concern you.
Heart, Lung, and Kidney Problems
Amtagvi treatment can cause serious problems involving the heart, lungs, or kidneys. These problems may sometimes be life-threatening.
Heart problems reported during treatment have included fast or irregular heartbeat and other serious heart conditions. Breathing problems and kidney failure have also been reported. Your health care team will monitor your heart, lung, and kidney function throughout treatment.
Contact your health care provider if you have symptoms such as chest pain, trouble breathing, a fast or irregular heartbeat, severe dizziness, or a major change in how much you urinate (pee).
Infusion or Allergic Reactions
Amtagvi can cause reactions during or shortly after the infusion. Symptoms may include:
- Fever or chills
- Fast heartbeat
- Rash
- Low blood pressure
- Shortness of breath
- Cough
- Chest tightness
- Wheezing
Serious allergic reactions are also possible. During and after the infusion, health care professionals will monitor you. Let them know right away if you feel unwell or have unusual symptoms.
Shortly before your Amtagvi infusion, you may be given medicines to help prevent these side effects, such as acetaminophen to prevent fever and an antihistamine to reduce the risk of a rash or allergic reaction.
Frequently Asked Questions About Amtagvi
Amtagvi requires careful preparation and monitoring because treatment affects your immune system and blood cells. The answers below explain what to expect before and after treatment.
Will I need to stay in the hospital after Amtagvi?
Yes. Amtagvi is given in a hospital setting. After receiving Amtagvi, you will receive IL-2 starting 3-24 hours later. You may receive up to six doses of IL-2, generally given every 8-12 hours. You will need to stay in the hospital until you have finished IL-2 treatment and recovered from any serious side effects.
After leaving the hospital, you should plan to stay within about two hours of the treatment center for several weeks. Your health care team will continue checking how you are recovering, how well treatment is working, and whether you are having any side effects.
Will I need blood tests after Amtagvi?
Yes, blood tests are an important part of follow-up after Amtagvi.
Chemotherapy and the Amtagvi treatment regimen can cause significant drops in white blood cells, red blood cells, and platelets. Your health care team will check your blood counts after the infusion and continue monitoring them as you recover. Severe low blood counts can sometimes last longer than a month. Your health care team will also monitor your heart, lung, and kidney function during the treatment.
Can I get vaccines around the time of Amtagvi treatment?
Tell your health care provider if you received a vaccine within the past 28 days or plan to receive one in the next few months. Your health care team can tell you which vaccines are safe and when you can get them based on your treatment and recovery.
How Can I Reduce My Risk of Problems?
Because Amtagvi treatment can cause serious and sometimes life-threatening problems, close monitoring is an important part of the treatment.
Follow all instructions from your health care provider before and after Amtagvi. Keep your scheduled blood tests and follow-up visits, and stay near the treatment center for the recommended period after leaving the hospital.
Make sure your health care team knows about your health conditions, medicines, supplements, vaccines, and any signs of infection or bleeding. Contact them about new or worsening symptoms so problems can be caught and treated as early as possible.
