Description and Brand Names

المعلومات عن الأدوية مقدَّمة من: IBM Micromedex

US Brand Name

  1. Breyanzi

Descriptions


Lisocabtagene maraleucel injection is used to treat large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B that has come back (relapsed) or did not respond to the treatment (refractory) in patients who have received at least 2 previous treatments that did not work well.

Lisocabtagene maraleucel 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 Breyanzi® 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 lisocabtagene maraleucel 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 lisocabtagene maraleucel 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
  • Infections (including hepatitis B), active or history of or
  • Kidney disease 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 medical facility. 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 at least 15 minutes. It is given 2 to 7 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

You may also receive other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.

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

It is very important that you understand the requirements of the Breyanzi® REMS program, and become familiar with the Breyanzi® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed Dose

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

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), which may be life-threatening and requires immediate attention. Tell your doctor right away if you have 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 lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. 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 increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

While you are being treated with lisocabtagene maraleucel 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.

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.

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. blurred vision
  6. body aches or pain
  7. burning, numbness, tingling, or painful sensations
  8. chest pain
  9. chills
  10. coma
  11. confusion
  12. cough
  13. coughing up blood
  14. decrease frequency or amount of urine
  15. diarrhea
  16. difficulty swallowing
  17. dizziness
  18. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  19. drowsiness
  20. ear congestion
  21. fast, pounding, or irregular heartbeat or pulse
  22. fever
  23. hallucinations
  24. headache
  25. hives, itching
  26. holding false beliefs that cannot be changed by fact
  27. increased menstrual flow or vaginal bleeding
  28. increased thirst
  29. irritability
  30. loss of appetite
  31. loss of voice
  32. lower back or side pain
  33. mood or mental changes
  34. muscle or bone pain
  35. muscle spasm, tenderness, twitching, jerking, wasting, or weakness
  36. nausea
  37. nosebleeds
  38. painful or difficult urination
  39. paralysis
  40. pounding in the ears
  41. problems with speech or speaking
  42. prolonged bleeding from cuts
  43. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  44. red or black, tarry stools
  45. red or dark brown urine
  46. runny or stuffy nose
  47. seizures
  48. shakiness and unsteady walk
  49. shakiness in the legs, arms, hands, or feet
  50. skin rash
  51. slow or fast heartbeat
  52. sneezing
  53. sore throat
  54. stiff neck
  55. stomach pain
  56. sweating
  57. trembling and shaking of the hands or feet
  58. trouble breathing
  59. ulcers, sores, or white spots in the mouth
  60. unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
  61. unusual bleeding or bruising
  62. unusual excitement, nervousness, or restlessness
  63. unusual tiredness or weakness
  64. vomiting
  65. weight gain

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. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site
  3. trouble sleeping

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.