Tisagenlecleucel (Intravenous route)
Warning: Cytokine release syndrome and neurological toxicitiesCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving tisagenlecleucel. Do not administer tisagenlecleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurological toxicities, which may be severe or life-threatening, can occur following treatment with tisagenlecleucel, including concurrently with CRS. Monitor for neurological events after treatment with tisagenlecleucel. Provide supportive care as needed.Tisagenlecleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS .
Uses of This Medicine:
Tisagenlecleucel injection is used to treat B-cell acute lymphoblastic leukemia (ALL) that has come back a second or later time or after other medicines did not work well in patients up to 25 years of age. Leukemia is a type of cancer where the body makes abnormal white blood cells.
Tisagenlecleucel injection is also used to treat diffuse large B-cell lymphoma (DLBCL) that has come back a second or later time or after at least 2 other medicines did not work well. Lymphoma is a type of cancer where the body makes abnormal white blood cells.
Tisagenlecleucel injection is an antineoplastic (cancer) medicine that is made from your own white blood cells. These cells are reprogrammed to contain a chimeric antigen receptor (CAR) to identify the cancer cells from the normal cells and kill them. 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 available only under a restricted distribution program called Kymriah® REMS (Risk Evaluation and Mitigation Strategy) Program.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tisagenlecleucel injection in children with ALL. Safety and efficacy have been established.
Appropriate studies have not been performed on the relationship of age to the effects of tisagenlecleucel injection in children with DLBCL. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of tisagenlecleucel injection in the elderly. Safety and efficacy have not been established.
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.
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.
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
- Hypotension (low blood pressure) or
- Infections (including hepatitis B), active or history of or
- Lung problems—Use with caution. May cause side effects to become worse.
- Neutropenia (low white blood cells) or
- Weak immune system—Use with caution. May increase risk for infection.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine in a hospital or cancer center. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for less than an hour. It is given 2 to 14 days (for ALL) or 2 to 11 days (for DLBCL) after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide, bendamustine).
You should stay within 2 hours of the office or center to check for unwanted effects for at least 4 weeks.
It is very important that you understand the requirements of the Kymriah® REMS program, and become familiar with the Kymriah® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
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 tests may be needed to check for unwanted effects.
This medicine may cause cytokine release syndrome (CRS) and infusion reactions. This may be life-threatening and requires immediate attention. Tell your doctor right away if you or your child have any of the following symptoms: a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.
Check with your doctor right away if you or your child have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These may be symptoms of serious nerve problems.
This medicine may cause serious allergic reactions, including anaphylaxis which can be life-threatening and requires immediate medical attention. Talk to your doctor right away if you have very fast or irregular breathing, a very fast or irregular heartbeat, a rash, fainting, hive-like swellings on the skin, or swelling of the eyelids or around the eyes, face, lips, or tongue.
This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.
This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.
While you are being treated with tisagenlecleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 2 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Side Effects of This Medicine:
- More common
- back pain
- blue lips, fingernails, or skin
- blurred vision
- chest pain or discomfort
- confusion as to time, place, or person
- coughing that sometimes produces a pink frothy sputum
- decreased urine output
- difficult, fast, noisy breathing
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extreme fatigue
- fast, pounding, or irregular heartbeat or pulse
- holding false beliefs that cannot be changed by fact
- increased sweating
- loss of consciousness
- lower back or side pain
- mood or mental changes
- muscle twitching
- painful or difficult urination
- pale skin
- pounding in the ears
- rapid shallow breathing
- rapid weight gain
- slow or fast heartbeat
- stiff neck
- swelling of the face, arms, fingers, feet, or lower legs
- trembling and shaking of hands
- troubled breathing at rest
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, or restlessness
- weight gain
- Less common
- Change in the amount of urine
- cloudy urine
- headache, sudden or severe
- stomach pain
- More common
- decreased appetite
- difficulty in moving
- joint pain
- muscle pain or stiffness
- nasal congestion
- pain in the arms or legs
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:
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:
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.
Last Updated: 8/2/2019