Pronunciation:

lif-i-LOO-sel

Brand Names:

• Amtagvi

Dosage Forms:

• Suspension

Warnings:

Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage. Administer filgrastim or a biosimilar product to patients beginning Day 1 after lifileucel and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm(3) for 3 consecutive days, or per institutional standard. Treat severe infections. Monitor cardiopulmonary and renal functions throughout the treatment course. Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Lifileucel injection is used to treat melanoma (skin cancer) that has spread or cannot be removed by surgery. This medicine is given to patients who have received other cancer treatments (eg, PD-1 blocking medicine) that have not worked. It is used if the melanoma cells have the BRAF mutations and a BRAF inhibitor medicine with or without a MEK inhibitor medicine that has also stopped working.

Lifileucel injection is an antineoplastic (cancer) medicine that is made from your own cancer cells, which have been modified to recognize and attack your cancer cells. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of receiving it.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lifileucel injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lifileucel injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems or
• Heart rhythm problems (eg, arrhythmia, tachycardia) or
• Hypotension (low blood pressure) or
• Infection (eg, hepatitic B or C, HIV infection), active or recent or
• Kidney disease or
• Lung or breathing problems—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into a vein. The medicine must be given slowly, so the IV will have to remain in place for at least 1 ½ hours. It is given after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

This medicine usually comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor may also give you other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting this treatment.

You should plan to stay within 2 hours of the location where you received treatment for several weeks after your infusion.

This medicine is made specifically for each patient, using the patient's own cancer cells. Talk with your doctor if you have any concerns about this.

Tell your doctor if you have received a vaccine in the past 28 days or plan to have one.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

Tell your doctor if you are pregnant or plan to become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause bleeding problems. Check with your doctor right away if you have confusion, headaches, sudden, severe, nausea and vomiting, or weakness.

This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Avoid being near people who are sick or have infections. Wash your hands often.

Check with your doctor right away if you have chest pain or discomfort, dizziness, fainting, fast, pounding, or irregular heartbeat or pulse, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, swelling of the feet or lower legs, tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area, trouble breathing, unusual tiredness or weakness, or vomiting. These may be symptoms of heart problems.

This medicine may cause lung problems. Check with your doctor right away if you have blue lips, fingernails, or skin, or trouble breathing.

Check with your doctor right away if you have agitation, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, swelling of face, ankles, or hands, or unusual tiredness or weakness. These may be symptoms of serious kidney problems.

Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine. These may be symptoms of serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

back pain

being forgetful

black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blue lips and fingernails

blurred vision

burning, dry or, itching eyes

burning or stinging of skin

chest pain or tightness

chills

coma

confusion

cough

coughing that sometimes produces a pink frothy sputum

decreased awareness or responsiveness

decreased urine output

defects in intelligence, short-term memory, learning ability, and attention

delusions of persecution, mistrust, suspiciousness, and/or combativeness

depression

discharge, excessive tearing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

general feeling of illness

hallucinations

headache

hostility

increased blood pressure

increased sweating

irritability

loss of appetite

lower back or side pain

mood or mental changes

muscle aches and twitching

nausea

night sweats

not able to pass urine

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful or difficult urination

pale skin

palpitations

pinpoint red spots on the skin

problems with movement, walking, or speech

rapid weight gain

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

seizures

sneezing

sore throat

stiff neck or back

stomach pain

stuffy or runny nose

swelling in the legs and ankles

swollen glands

thirst

tingling of the hands or feet

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

unusual tiredness or weakness

unusual weight gain or loss

unusually deep sleep

unusually long duration of sleep

vomiting

white patches in the mouth or throat or on the tongue

Less common

Changes or decreased in vision

diarrhea

difficulty swallowing

eye pain

hives, itching, skin rash

muscle or joint pain

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the eye

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

sensitivity of the eye to light

swelling around the eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Lack or loss of strength

loss of thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.