Description and Brand Names

المعلومات عن الأدوية مقدَّمة من: IBM Micromedex

US Brand Name

  1. Abecma

Descriptions


Idecabtagene vicleucel injection is used treat multiple myeloma (bone marrow cancer) in patients whose cancer has come back and who have received at least 4 previous treatments (eg, an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent) that did not work well.

Idecabtagene vicleucel 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 Abecma® 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 idecabtagene vicleucel 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 idecabtagene vicleucel 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, 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 hospital or cancer center. It is given through a needle placed into one of your veins using a pump. This medicine must be given slowly, so your IV tube will need to stay in place for at least 30 minutes. It is given 2 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 Abecma® REMS program, and become familiar with the Abecma® Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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 a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), which is caused by an overactive immune system. Check with your doctor right away if you have a fever, cough that does not go away, right upper abdominal or stomach pain and fullness, rash, redness in one part of your body, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, seizures, or warm feeling or swelling of your skin.

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. These may be symptoms of serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention.

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 idecabtagene vicleucel 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. black, tarry stools
  4. being forgetful
  5. bloating or swelling of the face, arms, hands, lower legs, or feet
  6. body aches and pain
  7. bone pain
  8. bleeding gums
  9. blood in the urine or stools
  10. blue lips, fingernails, or skin
  11. blurred vision
  12. burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  13. burning, numbness, pain, or tingling in all the fingers except the smallest finger
  14. changes in patterns and rhythms of speech
  15. chest discomfort, pain, or tightness
  16. chills
  17. cold flu-like symptoms
  18. cold sweats
  19. coma
  20. confusion
  21. confusion as to time, place, or person
  22. cough or hoarseness
  23. decreased frequency or amount of urine
  24. depression
  25. difficulty in breathing
  26. difficulty in moving
  27. dizziness
  28. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  29. drooping upper eyelids
  30. drowsiness
  31. dryness or soreness of the throat
  32. ear congestion
  33. fast, pounding, or irregular heartbeat or pulse
  34. fever
  35. hallucinations
  36. headache
  37. holding false beliefs that cannot be changed by fact
  38. hostility
  39. increased blood pressure
  40. increased thirst
  41. infection from breathing foreign substance into the lungs
  42. irregular, fast ,or slow, or shallow breathing
  43. irritability
  44. joint pain
  45. loss of appetite
  46. loss of memory
  47. loss of strength or energy
  48. loss of voice
  49. lower back or side pain
  50. mood or mental changes
  51. muscle aches, cramps, pains, stiffness, spasms, or twitching
  52. nausea
  53. nerve pain
  54. nervousness
  55. pain in the lower back, bottom, hips, or upper leg
  56. painful or difficult urination
  57. pale skin
  58. pinpoint red spots on the skin
  59. pounding in the ears
  60. problems with memory
  61. problems with speech
  62. rapid weight gain
  63. seizures
  64. sleepiness
  65. slow or fast heartbeat
  66. slurred speech
  67. sneezing
  68. stiff neck
  69. stuffy or runny nose
  70. stupor
  71. swollen joints
  72. tender, swollen glands in the neck
  73. tingling of the hands or feet
  74. trembling and shaking of hands
  75. trouble in swallowing
  76. ulcers, sores, or white spots in the mouth
  77. unsteadiness or awkwardness
  78. unusual bleeding or bruising
  79. unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
  80. unusual excitement, nervousness, or restlessness
  81. unusual weight gain or loss
  82. voice changes
  83. vomiting
  84. weakness in the arms, hands, legs, or feet

Less common

  1. Coughing that sometimes produces a pink frothy sputum
  2. diarrhea
  3. fainting
  4. increased sweating
  5. partial or slight paralysis
  6. shakiness and unsteady walk
  7. stomach pain
  8. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins
  9. unsteadiness, trembling, or other problems with muscle control or coordination
  10. vomiting of blood or material that looks like coffee grounds

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. Blemishes on the skin
  2. blistering, crusting, irritation, itching, or reddening of the skin
  3. constipation
  4. cracked, dry, scaly skin
  5. fear
  6. feeling of constant movement of self or surroundings
  7. pain in the mouth
  8. pimples
  9. sensation of spinning
  10. skin rash or blisters
  11. toothache
  12. trouble sleeping
  13. unusually warm skin

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.