0.4–2 x 10 8 cells infusion fluid, dispersion
axikabtagencilloleucel (CAR+ viable T-cells )
What Yescarta is and what it is used for
Yescarta is a gene therapy medicine for the treatment of adults with aggressive diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma (FL) that affect your lymph tissue (part of the immune system), which in turn affects a type of white blood cell called B-lymphocyte er, as well as other organs in the body. Too many of these abnormal white blood cells accumulate in your tissues and cause the symptoms you may have.
The medicine is specially prepared for you as a one-time treatment with your own modified white blood cells.
What you need to know before you receive Yescarta
You should not receive Yescarta
- if you are allergic to axicabtagenciloleucel or any of the other ingredients of this medicine (listed in section 6).
- if you cannot receive treatment with so-called lymphocyte-depleting chemotherapy, which reduces the number of white blood cells in the blood (see also section 3, “How Yescarta is given”).
Warnings and precautions
Yescarta is made from your white blood cells and must only be given to you
( autologous use).
Before you are treated with Yescarta, you must tell your doctor if you:
- have problems with the nervous system (eg seizures, stroke, or memory loss).
- have kidney problems.
- have a low number of blood cells (blood cell count).
- have had a stem cell transplant in the last 4 months.
- have any problems with the lungs, heart, or blood pressure (low or high).
- have signs or symptoms of graft-versus-host disease. This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhea, and bloody stools.
- notice that the symptoms of your cancer are getting worse. If you have lymphoma, this may include fever, feeling weak, night sweats, and sudden weight loss.
- have an infection. The infection will be treated before you receive the Yescarta infusion.
- have had an infection with hepatitis B, hepatitis C or human immunodeficiency virus ( HIV ).
If any of the above apply to you (or if you are not sure), talk to your doctor before being treated with Yescarta.
Tests and checks
Before you are given Yescarta, your doctor will:
- check lungs, heart, and blood pressure.
- look for signs of infection; any infection will be treated before you are treated with Yescarta.
- check your cancer to see if it has worsened.
- look for signs of graft-versus-host disease, which can occur after a transplant.
- check your blood for uric acid and how many cancer cells are in your blood. This shows whether you are likely to develop a condition called tumor lysis syndrome. You may be given medication to help prevent this condition.
- check if you have hepatitis B, hepatitis C or HIV infection.
- check if you have received a vaccination in the previous 6 weeks or if you are scheduled to receive one in the coming months.
After you have been treated with Yescarta
Tell your doctor or nurse immediately if you have any of the following:
- Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, or palpitations, may be symptoms of a condition known as cytokine release syndrome. Measure your temperature twice a day for 3-4 weeks after treatment with Yescarta. If your temperature is elevated, see your doctor immediately.
- Seizures, tremors or difficulty speaking or slurred speech, unconsciousness or reduced level of consciousness, confusion and disorientation, impaired balance or coordination
- Fever, can be a symptom of an infection.
- Extreme tiredness, weakness, and shortness of breath, can be symptoms of a lack of red blood cells.
- Bleeding or bruising easily, which can be symptoms of low levels of blood cells called platelets.
Your doctor will regularly check your blood cell count as the number of blood cells and other blood components may decrease.
You must not donate blood, organs, tissues, or cells for transplantation.
If any of the above applies to you (or if you are not sure), talk to your doctor or nurse before being treated with Yescarta. Your doctor may need to give you special care during your treatment with Yescarta.
In some cases, it may not be possible to proceed with the planned treatment with Yescarta. For example:
- If the infusion of Yescarta is delayed more than 2 weeks after you have received preparatory chemotherapy, you may need to receive more preparatory chemotherapy.
Children and young people
Other medicines and Yescarta
Tell the doctor or nurse if you are taking, have recently taken, or might take other medicines.
Before receiving Yescarta, tell your doctor or nurse if you are taking any medicines that weaken the immune system, such as cortisone, as these medicines may interfere with the effect of Yescarta.
In particular, you must not be given certain vaccines called live vaccines:
- in the 6 weeks before you are given a short course of chemotherapy (called lymphocyte-depleting chemotherapy ) to prepare your body for the Yescarta cells.
- during Yescarta treatment.
- after treatment while the immune system recovers.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine. This is because the effects of Yescarta on pregnant or breastfeeding women are unknown, and it may harm your unborn baby or your breastfed baby.
- If you are pregnant or think you may be pregnant after treatment with Yescarta, talk to your doctor immediately.
- You will be given a pregnancy test before the treatment starts. Yescarta can only be given if the result shows that you are not pregnant.
Driving ability and use of machinery
Some people may feel tired, dizzy, or shaky after receiving Yescarta. If this happens to you, you should not drive or use heavy machinery for at least 8 weeks after infusion one, or until your doctor says you are fully recovered.
Yescarta contains sodium, dimethyl sulfoxide (DMSO), and traces of gentamicin
This medicine contains 300 mg of sodium (the main component of table salt) in each infusion. This corresponds to 15% of the recommended maximum daily intake of sodium for an adult.
How Yescarta is given
Yescarta is always given by healthcare professionals. It is given as a drip ( infusion ) into a vein ( intravenously ).
- Because Yescarta is made from your white blood cells, your blood cells will be collected from you to make your medicine. Your doctor will collect some of your blood via a catheter placed in a vein (a procedure called leukapheresis). Some of your white blood cells are separated from your blood and the rest of the blood is returned to your vein. This may take 3 to 6 hours and may need to be repeated. Your white blood cells are sent off to make Yescarta. It usually takes around 3 to 4 weeks to receive your Yescarta treatment but the time can vary.
Medicines are given before Yescarta treatment
In the 30 to 60 minutes before you are given Yescarta, you may be given other medicines. This is done to prevent infusion reactions and fever. These other medicines may include:
- an antihistamine such as diphenhydramine.
Before you receive Yescarta, you will receive other medicines such as preparatory chemotherapy, which causes your modified white blood cells in Yescarta to multiply in your body while you receive the medicine.
How you are given Yescarta
Yescarta is always given by a doctor in a qualified treatment unit.
- Yescarta is given as a single dose.
- Your doctor or nurse will give you a single infusion of Yescarta through a catheter inserted into a vein ( intravenous infusion ) over about 30 minutes.
You must receive the Yescarta infusion at a qualified clinic, and will only be prescribed when your doctor thinks it is safe for you to go home.
Your doctor may take blood tests to check if you have any side effects.
After you have received Yescarta
- Plan to stay near the hospital where you were treated for at least 4 weeks after you are treated with Yescarta. Your doctor will recommend that you return to the hospital every day for at least 10 days and will consider whether you need to remain in the hospital as an inpatient for the first 10 days after the infusion. This is done so that the doctor can check whether your treatment is working and help you if you experience side effects.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Yescarta can cause side effects on the immune system, which can be serious or life-threatening and can lead to death.
The following side effects have been reported with Yescarta.
Very common (may affect more than 1 in 10 patients)
- Fever, chills, and low blood pressure, can cause symptoms such as dizziness, vertigo, and fluid in the lungs, which can be serious and fatal (all of these are symptoms of a condition called cytokine release syndrome).
- Abnormally low white blood cell count, can increase your risk of infection.
- Unconsciousness or reduced level of consciousness, confusion, or memory loss due to disturbances in brain function, involuntary shaking ( tremor ), sudden confusion with agitation, disorientation, hallucinations, or irritability ( delirium ).
- Decreased number of red blood cells (cells that carry oxygen): symptoms may include extreme tiredness with loss of energy.
- Extreme fatigue.
- A low number of cells that help the blood clot ( thrombocytopenia ): symptoms may include excessive or prolonged bleeding or bruising.
- Muscle and joint pain, back pain.
- Fever or chills may be signs of an infection.
- High uric acid or sugar ( glucose ) levels show up in blood tests. Low levels of sodium or phosphate, show up in blood tests.
- Nausea, constipation, diarrhea, abdominal pain, vomiting.
- Decreased appetite.
- Low blood pressure, dizziness.
- Shortness of breath, cough.
- Rapid heartbeat.
- Irregular heart rhythm ( arrhythmia ).
- Low levels of immunoglobulins, which show up in blood tests, can lead to infection.
- Accumulation of fluids in tissue ( edema ) can lead to swelling, weight gain, difficulty breathing, and reduced urine output.
- Lack of energy or strength, muscle weakness, difficulty moving, muscle spasms.
- Skin rash or skin problems.
- Difficulty sleeping.
- High blood pressure.
- Elevated levels of liver enzymes, show up in blood tests.
Common side effects (may affect up to 1 in 10 people)
- Dry mouth, dehydration, difficulty swallowing.
- Pain in hands or feet.
- High levels of bilirubin, which shows up in blood tests. Low levels of albumin, potassium, or calcium, show up in blood tests.
- Low oxygen level in the blood.
- Kidney failure causes fluid to build up in the body, which can be serious or life-threatening.
- Swelling in the extremities, fluid around the lungs (pleural effusion).
- Alteration of the blood’s ability to form blood clots ( coagulopathy ): symptoms may include excessive or prolonged bleeding or bruising.
- Vision changes make it difficult to see things (vision impairment).
- Sudden unexpected cardiac arrest (cardiac arrest): this is serious and life-threatening.
- Heart failure.
- Blood clots: symptoms may include pain in the chest or upper back, difficulty breathing, coughing up blood or cramping pain, swelling in a single leg, and warm and dark skin around the painful area.
- Convulsions (seizures, including seizures that can be prolonged and life-threatening).
- Inability to move one side of the body.
- Hypersensitivity: symptoms such as skin rash, itching, swelling, and anaphylaxis.
- Mood disorders.
- Nasal inflammation.
- Weakness or inability to move one side of the body, making it difficult to carry out daily activities such as eating or dressing.
- Loss of control over body movements.
- Loss of movement of facial muscles.
- Inability to breathe on your own (respiratory failure).
- Weight loss.
Uncommon (may affect up to 1 in 100 people)
- Difficulty understanding numbers.
- Breakdown of muscle tissue leads to the release of muscle fibers into the blood.
- At least two organs that are not functioning properly (eg, liver, lungs, and kidneys), require medical treatment and/or procedures that restore normal organ function.
- Swelling of the spinal cord, can cause partial or total paralysis of the limbs and trunk.
- Paralysis of all four limbs.
- State of severe systemic inflammation.
Tell your doctor immediately if you get any of the side effects listed above. Do not try to treat your symptoms yourself with other medicines.
How to store Yescarta
The following information is intended for medical use only.
Use before the expiry date stated on the container label and the infusion bag.
Contents of the packaging and other information
What Yescarta contains
- The active substance is axicabtagencilloleucel. Each patient-specific single-use infusion bag contains a dispersion of anti-CD19 CAR T-cells in approximately 68 mL for a target dose of 2 x 10 6 anti-CD19 CAR-positive viable T cells/kg.
- Other ingredients are Cryostor CS10 (contains DMSO), sodium chloride, and human albumin. See section 2 “Yescarta contains sodium, dimethyl sulfoxide (DMSO), and traces of gentamicin”.
This medicine contains genetically modified human blood cells.
Appearance and packaging of the medicine
Yescarta is a clear to opaque, white-to-red dispersion for infusion, supplied in an infusion bag individually wrapped in a metal cassette. A single-use infusion bag contains approximately 68 ml of cell dispersion.
Kite Pharma EU BV
2132 NT Hoofddorp