Lifileucel

Generic name: lifileucel [ LIF-i-LOO-sel ]
Brand name: Amtagvi
Dosage form: intravenous suspension (-)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com on Apr 9, 2024. Written by Cerner Multum.

What is lifileucel?

Lifileucel is used in adults to treat melanoma (skin cancer) that has spread to other parts of the body or cannot be removed by surgery.

Lifileucel may also be used for purposes not listed in this medication guide.

Lifileucel side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Lifileucel may cause serious side effects. Call your doctor at once if you have:

• severe infections such as sepsis, pneumonia, encephalitis;

• breathing problems;

• easy bruising or bleeding, unusual weakness;

• sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• kidney problems--swelling, urinating less, feeling tired or short of breath; or

• heart problems--irregular heartbeats, swelling, rapid weight gain, feeling short of breath.

Common side effects of lifileucel may include:

• fever, chills;

• mouth sores, rash, skin sores, sore throat, cough;

• pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;

• hair loss;

• swelling;

• fast or irregular heartbeats;

• low blood pressure; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Tell your doctor if you use other medicines or have other medical conditions or allergies.

You may be given another medication during treatment to help your body make white blood cells.

Call your doctor right away if you have signs of infection such as: fever, chills, sore throat, mouth sores, red or swollen gums, pale skin, easy bruising, unusual bleeding, or chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Before taking this medicine

Tell your doctor if you have or have ever had:

• a recent or an active infection;

• an inflammatory condition including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection;

• if your cancer symptoms are getting worse;

• if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests;

• if you received a vaccine in the past 28 days;

• if you are scheduled to receive a vaccine in the next few months;

• heart problems;

• lung disease;

• low blood pressure; or

• liver or kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

It is not known if lifileucel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using lifileucel.

How is lifileucel given?

Lifileucel is available only at an authorized hospital or clinic, and must be given by specially trained healthcare professionals. This medicine is injected into a vein by a healthcare provider.

You may be given other medications to help prevent serious side effects or allergic reaction.

Lifileucel dosing information

Usual Adult Dose for Melanoma -- Metastatic:

7.5 x 10(9) to 72 x 10(9) viable cells IV once as a single dose
-Infuse an initial rate of 1 mL/min for the first 5 minutes, then at a rate of 5 to 10 mL/min thereafter.

Comments:
-A single dose of this drug is provided in 1 to 4 patient-specific IV infusion bag(s) containing a suspension of tumor-derived T cells; multiple infusions may be required to deliver a single dose.
-Administer under the supervision of a physician experienced in the use of anticancer agents in the inpatient hospital setting with access to an intensive care facility and skilled cardiopulmonary/intensive care specialists.

Use: As a tumor-derived autologous T cell immunotherapy for the treatment of unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

What happens if I miss a dose?

In a medical setting you are not likely to miss a dose.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving lifileucel?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect lifileucel?

Tell your doctor about all your current medicines. Many drugs can affect lifileucel, especially an oral, nasal, inhaled, or injectable steroid medicine.

Other drugs may affect lifileucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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