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Axicabtagene ciloleucel (Intravenous)

ax-i-KAB-ta-jeen sye-loe-LOO-sel

Intravenous route(Suspension)

Cytokine release syndrome and neurologic toxicitiesCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel. Do not administer axicabtagene ciloleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids .Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving axicabtagene ciloleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with axicabtagene ciloleucel. Provide supportive care and/or corticosteroids as needed .Axicabtagene ciloleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA(TM) REMS .

Medically reviewed on June 7, 2018

Commonly used brand name(s)

In the U.S.

  • Yescarta

Available Dosage Forms:

  • Suspension

Therapeutic Class: Immunological Agent

Uses For axicabtagene ciloleucel

Axicabtagene ciloleucel injection is used to treat large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL], primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, or DLBCL from follicular lymphoma) that has come back or after 2 or more lines of treatment did not work well.

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

Axicabtagene ciloleucel is available only under a restricted distribution program called Yescarta™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using axicabtagene ciloleucel

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 axicabtagene ciloleucel, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to axicabtagene ciloleucel 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 axicabtagene ciloleucel 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 axicabtagene ciloleucel 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.

Interactions with 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. When you are receiving axicabtagene ciloleucel, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using axicabtagene ciloleucel with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine, Live
  • Yellow Fever Vaccine
  • Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

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 axicabtagene ciloleucel. 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
  • Infections (including hepatitis B), active or history of or
  • Kidney disease or
  • Lung or breathing problems or
  • Seizures, history of—Use with caution. May cause side effects to become worse.

Proper Use of axicabtagene ciloleucel

A nurse or other trained health professional will give you axicabtagene ciloleucel in a hospital or cancer center. It is given through a needle placed into one of your veins using a pump. The medicine must be injected slowly, so your IV tube will need to stay in place for less than 30 minutes. It is given 3 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

Your doctor will check you for unwanted effects at least daily for 7 days. Your doctor may also want you to stay close to the hospital or center for at least 4 weeks after your infusion.

You may be given other medicines (eg, allergy medicine, fever medicine) 1 hour before starting treatment with axicabtagene ciloleucel.

It is very important that you understand the requirements of the Yescarta™ REMS program, and become familiar with the Yescarta™ 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.

Precautions While Using axicabtagene ciloleucel

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

Axicabtagene ciloleucel 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 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 have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech.

Axicabtagene ciloleucel 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 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.

Axicabtagene ciloleucel may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

Axicabtagene ciloleucel may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how axicabtagene ciloleucel affects you, for at least 8 weeks after treatment.

While you are being treated with axicabtagene ciloleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of axicabtagene ciloleucel.

Axicabtagene ciloleucel 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
  • bloody urine
  • blue lips and fingernails
  • blurred vision
  • chest pain or discomfort
  • chills
  • confusion as to time, place, or person
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • decreased frequency or amount of urine
  • diarrhea
  • difficult, fast, noisy breathing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • extreme tiredness or weakness
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • general feeling of discomfort or illness
  • headache
  • hoarseness
  • holding false beliefs that cannot be changed by fact
  • increase in heart rate
  • increased blood pressure
  • increased sweating
  • increased thirst
  • irregular breathing
  • irritability
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • mood or mental changes
  • muscle or joint pain
  • nausea
  • nervousness
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • problems with speech or speaking
  • rapid breathing
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness and unsteady walk
  • slow heartbeat
  • stiff neck
  • sunken eyes
  • swelling of the face, fingers, feet, or lower legs
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • thirst
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • troubled breathing
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual excitement, nervousness, or restlessness
  • unusual tiredness or weakness
  • vomiting
  • weight gain
  • wrinkled skin

Less common

  • Cloudy urine
  • muscle twitching or jerking
  • rhythmic movement of the muscles
  • stomach pain
  • unusual bleeding or bruising

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

  • Constipation
  • decreased appetite and weight
  • difficulty in moving
  • muscle stiffness
  • pain in the joints, arms or legs

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.

See also: Side effects (in more detail)

Further information

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

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