Description
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.
This product is available in the following dosage forms:
- Suspension
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lifileucel injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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