Idecabtagene Vicleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 11, 2024.

Applies to idecabtagene vicleucel: intravenous suspension.

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.

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:

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:

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

• Very common (10% or more): Cytokine release syndrome (CRS) (85%), viral infections (27%), bacterial infections (15%), hypogammaglobulinemia (e.g., blood immunoglobulin G decreased, hypogammaglobulinemia, hypoglobulinemia, laboratory IgG levels below 500 mg/dL) (21%), febrile neutropenia (16%), unspecified pathogen infections (15%)
• Common (1% to 10%): Fungal infections, immunogenicity^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (e.g., arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, spinal pain) (45%), motor dysfunction (e.g., dysphonia, eyelid ptosis, hypotonia, motor dysfunction, muscle spasms, muscular weakness, restless legs syndrome) (11%)^[Ref]

Ocular

• Very common (10% or more): Dry eye (11%)^[Ref]

Metabolic

• Very common (10% or more): Hypophosphatemia (45%), anorexia (22%), weight decreased (13%), hyponatremia (10%), activated partial thromboplastin time (aPPT) increased (seconds) (10%)^[Ref]

Psychiatric

• Very common (10% or more): Insomnia/sleep deficit/sleep disorder (13%), nervousness/anxiety (12%)
• Common (1% to 10%): Delirium^[Ref]

Oncologic

• Frequency not reported: Secondary malignancies^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (e.g., laryngitis, nasopharyngitis, pharyngeal erythema, pharyngitis, respiratory tract congestion, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract infection, upper respiratory tract infection bacterial) (34%), cough (e.g., cough, productive cough, upper-airway cough syndrome) (23%), hypoxia (20%), pneumonia (e.g., bronchopulmonary aspergillosis, lung infection, pneumonia, pneumonia aspiration, pneumonia cytomegaloviral, pneumonia pneumococcal, pneumonia pseudomonal) (17%), dyspnea (e.g., respiratory failure, dyspnea, dyspnea exertional, respiratory failure) (13%)^[Ref]

Other

• Very common (10% or more): Pyrexia (98%), chills (31%), edema (e.g., edema, face edema, fluid overload, fluid retention, generalized edema, peripheral edema, peripheral swelling, scrotal swelling, swelling) (25%), fatigue/asthenia/malaise (12%), chills (11%), general physical health deterioration (11%)^[Ref]

Hematologic

• Very common (10% or more): Neutropenia (96%), leukopenia (96%), lymphopenia (92%). Thrombocytopenia (63%), anemia (63%)^[Ref]

Nervous system

• Very common (10% or more): CAR T cell-associated neurotoxicity (28%), encephalopathy (e.g., amnesia, bradyphrenia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dyscalculia, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes, metabolic encephalopathy, somnolence, toxic encephalopathy) (26%), headache (23%), dizziness/presyncope/syncope/vertigo (17%), neuropathy peripheral (e.g., carpal tunnel syndrome, hypoesthesia, hypoesthesia oral, neuralgia, neuropathy peripheral, paresthesia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, sciatica) (17%), asterixis/tremor (10%)^[Ref]

Renal

• Very common (10% or more): Renal failure (e.g., acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal impairment) (10%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (e.g., hypotension, orthostatic hypotension) (41%), tachycardia/sinus tachycardia (35%), hypertension (11%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (e.g., acne, dermatitis, dermatitis bullous, erythema, rash, rash macular, rash papular, urticaria) (14%), xerosis (e.g., dry eye, dry mouth, dry skin, lip dry, xerosis) (11%)^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (35%), nausea (29%), constipation (16%), vomiting (15%), oral pain (e.g., oral pain, oropharyngeal pain, toothache) (12%)^[Ref]

See also:

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.

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