Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Carvykti

Descriptions


Ciltacabtagene autoleucel injection is used to treat multiple myeloma (bone marrow cancer) in patients whose cancer has come back and who have received at least 1 previous treatment (eg, a proteasome inhibitor, an immunomodulatory agent, and lenalidomide) that did not work well.

Ciltacabtagene autoleucel 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 Carvykti™ 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 ciltacabtagene autoleucel 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 ciltacabtagene autoleucel 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
  • Lung or breathing problems 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 an IV catheter that is placed into one of your veins using a pump. This medicine must be given slowly, so your IV will need to stay in place for at least 30 to 60 minutes. It is given 2 to 4 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 10 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 Carvykti™ REMS program, and become familiar with the Carvykti™ 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 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.

This medicine may cause serious nerve problems, which may be life-threatening and require immediate attention, including immune effector cell-associated neurotoxicity syndrome (ICANS), parkinsonism, Guillain-Barré syndrome, myelitis, peripheral neuropathy, and cranial nerve palsies. Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, agitation, back pain, blurred vision, changes in personality, coma, confusion, disorientation, difficulty with speaking, dizziness, drowsiness, facial numbness, fever, headache, irritability, mood or mental changes, slower movements, slurred speech, stiff neck, sudden numbness and weakness in the arms and legs, tremor, unusual tiredness or weakness, or vomiting.

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 risk for hypogammaglobulinemia (immune system problem). Talk to your doctor if you have questions about these risks.

This medicine may increase your risk of getting blood cancers (eg, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)). Tell your doctor if you have bone pain, blood in the urine or stools, fever or chills, cough, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

While you are being treated with ciltacabtagene autoleucel 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. bladder pain
  5. bleeding gums
  6. blood in the eye
  7. bloody or cloudy urine
  8. blurred vision
  9. body aches or pain
  10. bone pain
  11. bruising
  12. chest pain or tightness
  13. chills
  14. confusion
  15. confusion as to time, place, or person
  16. cough or hoarseness
  17. coughing up blood
  18. decreased vision or other changes in vision
  19. dizziness
  20. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  21. drowsiness
  22. ear congestion
  23. eye pain
  24. fainting
  25. fast, pounding, or irregular heartbeat or pulse
  26. fever
  27. frequent urge to urinate
  28. hallucinations
  29. headache
  30. holding false beliefs that cannot be changed by fact
  31. increased menstrual flow or vaginal bleeding
  32. irritability
  33. large, flat, blue or purplish patches in the skin
  34. lightheadedness
  35. loss of voice
  36. lower back or side pain
  37. mood or mental changes
  38. muscle pain, spams, twitching, or jerking
  39. nervousness
  40. nosebleeds
  41. painful or difficult urination
  42. pale skin
  43. paralysis
  44. pounding in the ears
  45. problems with speech or speaking
  46. prolonged bleeding from cuts
  47. red or dark brown urine
  48. redness in whites of the eyes
  49. rhythmic movement of the muscles
  50. seizures
  51. shakiness and unsteady walk
  52. sneezing
  53. sore throat
  54. stiffness
  55. stuffy or runny nose
  56. sweating
  57. swelling
  58. swollen glands
  59. trembling and shaking of the hands
  60. trouble breathing
  61. trouble sleeping
  62. ulcers, sores, or white spots in the mouth
  63. unsteadiness, trembling, or other problems with muscle control or coordination
  64. unusual bleeding or bruising
  65. unusual excitement, nervousness, or restlessness
  66. unusual tiredness or weakness
  67. vomiting

Less common

  1. Discouragement
  2. feeling sad or empty
  3. generalized slowing of mental and physical activity
  4. incremental or ratchet-like movement of the muscle
  5. lack of appetite
  6. loss of balance control
  7. loss of interest or pleasure
  8. muscle discomfort
  9. partial or slight paralysis
  10. rigid or stiff muscles
  11. seizures
  12. shuffling walk
  13. slowed movements
  14. slurred speech
  15. stiffness of the arms and legs
  16. tic-like (jerky) movements of the head, face, mouth, and neck
  17. trouble concentrating
  18. trouble sleeping
  19. uncontrolled eye movements

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. diarrhea
  3. rash

Less common

  1. Abnormal posture
  2. double vision
  3. fall
  4. seeing double

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: May 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/ciltacabtagene-autoleucel-intravenous-route/description/drg-20530907