Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Yescarta

Descriptions


Axicabtagene ciloleucel injection is used to treat follicular lymphoma and 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. It is also used to treat large B-cell lymphoma that has come back within a year of first treatment or after first line 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 this medicine as well as the possible risks of receiving it.

This medicine is available only under a restricted distribution program called Yescarta® and Tecartus™ REMS (Risk Evaluation and Mitigation Strategy) Program.

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 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.

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. When you are receiving this medicine, 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 this medicine 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
  • Dengue Tetravalent 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, Live
  • Varicella Virus Vaccine, Live
  • Yellow Fever Vaccine
  • Zoster Vaccine, Live

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
  • Infections (including hepatitis B), active or history of or
  • Kidney disease or
  • Lung or breathing problems or
  • Seizures, history of or
  • Stroke, history of—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 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, steroid medicine) 1 hour before starting treatment with this medicine.

It is very important that you understand the requirements of the Yescarta® and Tecartus™ 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

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

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 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 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. These could be symptoms of a serious nerve problem.

This medicine may cause serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention. 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.

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 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 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 this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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

  1. Agitation
  2. back pain
  3. bleeding gums
  4. bloody urine
  5. blue lips and fingernails
  6. blurred vision
  7. chest pain, discomfort, or tightness
  8. chills
  9. confusion as to time, place, or person
  10. cough
  11. coughing that sometimes produces a pink frothy sputum
  12. coughing up blood
  13. decreased frequency or amount of urine
  14. diarrhea
  15. difficult, fast, noisy breathing
  16. dilated neck veins
  17. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  18. drowsiness
  19. dry mouth
  20. fast, pounding, or irregular heartbeat or pulse
  21. fever
  22. general feeling of discomfort or illness
  23. headache
  24. hoarseness
  25. holding false beliefs that cannot be changed by fact
  26. increase in heart rate
  27. increased blood pressure
  28. increased menstrual flow or vaginal bleeding
  29. increased sweating
  30. increased thirst
  31. irregular breathing
  32. irritability
  33. lightheadedness
  34. loss of appetite
  35. loss of consciousness
  36. lower back or side pain
  37. mood or mental changes
  38. muscle, joint, or bone pain
  39. nausea
  40. nervousness
  41. nosebleeds
  42. painful or difficult urination
  43. pale skin
  44. paralysis
  45. pounding in the ears
  46. problems with speech or speaking
  47. prolonged bleeding from cuts
  48. rapid breathing
  49. red or black, tarry stools
  50. red or dark brown urine
  51. seeing, hearing, or feeling things that are not there
  52. seizures
  53. shakiness and unsteady walk
  54. slow heartbeat
  55. stiff neck
  56. sunken eyes
  57. swelling of the face, fingers, feet, or lower legs
  58. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  59. thirst
  60. trembling or shaking of the hands or feet
  61. trouble breathing
  62. unsteadiness, trembling, or other problems with muscle control or coordination
  63. unusual excitement, nervousness, or restlessness
  64. unusual tiredness or weakness
  65. vomiting
  66. weight gain
  67. wrinkled skin

Less common

  1. Cloudy urine
  2. muscle twitching or jerking
  3. rhythmic movement of the muscles
  4. stomach pain
  5. unusual bleeding or bruising

Incidence not known

  1. Difficulty in moving or walking
  2. difficulty swallowing
  3. muscle stiffness

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

  1. Constipation
  2. decreased appetite and weight
  3. pain in the 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.

Portions of this document last updated: Feb. 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/axicabtagene-ciloleucel-intravenous-route/description/drg-20406587