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Idecabtagene Vicleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 5, 2024.

Applies to idecabtagene vicleucel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

Intravenous route (suspension)

Warning: Cytokine Release Syndrome, Neurologic Toxicities, HLH/MAS, and Prolonged Cytopenia. Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with idecabtagene vicleucel.

Do not administer idecabtagene vicleucel to patients with active infection or inflammatory disorders.

Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with idecabtagene vicleucel, including concurrently with CRS, after CRS resolution, or in the absence of CRS.

Monitor for neurologic events after treatment with idecabtagene vicleucel.

Provide supportive care and/or corticosteroids as needed.Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with idecabtagene vicleucel.

HLH/MAS can occur with CRS or neurologic toxicities.Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with idecabtagene vicleucel.Idecabtagene vicleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Serious side effects

Along with its needed effects, idecabtagene vicleucel 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 while taking idecabtagene vicleucel:

More common side effects

  • agitation
  • back pain
  • black, tarry stools
  • being forgetful
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches and pain
  • bone pain
  • bleeding gums
  • blood in the urine or stools
  • blue lips, fingernails, or skin
  • blurred vision
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  • burning, numbness, pain, or tingling in all the fingers except the smallest finger
  • changes in patterns and rhythms of speech
  • chest discomfort, pain, or tightness
  • chills
  • cold flu-like symptoms
  • cold sweats
  • coma
  • confusion
  • confusion as to time, place, or person
  • cough or hoarseness
  • decreased frequency or amount of urine
  • depression
  • difficulty in breathing
  • difficulty in moving
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drooping upper eyelids
  • drowsiness
  • dryness or soreness of the throat
  • ear congestion
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • hallucinations
  • headache
  • holding false beliefs that cannot be changed by fact
  • hostility
  • increased blood pressure
  • increased thirst
  • infection from breathing foreign substance into the lungs
  • irregular, fast ,or slow, or shallow breathing
  • irritability
  • joint pain
  • loss of appetite
  • loss of memory
  • loss of strength or energy
  • loss of voice
  • lower back or side pain
  • mood or mental changes
  • muscle aches, cramps, pains, stiffness, spasms, or twitching
  • nausea
  • nerve pain
  • nervousness
  • pain in the lower back, bottom, hips, or upper leg
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • problems with memory
  • problems with speech
  • rapid weight gain
  • seizures
  • sleepiness
  • slow or fast heartbeat
  • slurred speech
  • sneezing
  • stiff neck
  • stuffy or runny nose
  • stupor
  • swollen joints
  • tender, swollen glands in the neck
  • tingling of the hands or feet
  • trembling and shaking of hands
  • trouble in swallowing
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
  • unusual excitement, nervousness, or restlessness
  • unusual weight gain or loss
  • voice changes
  • vomiting
  • weakness in the arms, hands, legs, or feet

Less common side effects

  • coughing that sometimes produces a pink frothy sputum
  • diarrhea
  • fainting
  • increased sweating
  • partial or slight paralysis
  • shakiness and unsteady walk
  • stomach pain
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • vomiting of blood or material that looks like coffee grounds

Other side effects

Some side effects of idecabtagene vicleucel 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 side effects

  • blemishes on the skin
  • blistering, crusting, irritation, itching, or reddening of the skin
  • constipation
  • cracked, dry, scaly skin
  • fear
  • feeling of constant movement of self or surroundings
  • pain in the mouth
  • pimples
  • sensation of spinning
  • skin rash or blisters
  • toothache
  • trouble sleeping
  • unusually warm skin

For healthcare professionals

Applies to idecabtagene vicleucel: intravenous suspension.

General adverse events

The most common nonlaboratory adverse reactions (20% or greater) included CRS, infections - pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.[Ref]

Immunologic

Musculoskeletal

Ocular

Metabolic

Psychiatric

Oncologic

Respiratory

Other

Hematologic

Nervous system

Renal

Cardiovascular

Dermatologic

Gastrointestinal

References

1. (2021) "Product Information. Abecma (idecabtagene vicleucel)." Celgene Corporation

Further information

Idecabtagene vicleucel side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.