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Ciltacabtagene autoleucel Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 18, 2024.

Applies to ciltacabtagene autoleucel: intravenous suspension.

Warning

Intravenous route (Suspension)

Warning: Cytokine release syndrome, neurological toxicities, HLH/MAS and prolonged and recurrent cytopenia Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ciltacabtagene autoleucel. Do not administer ciltacabtagene autoleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with ciltacabtagene autoleucel, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ciltacabtagene autoleucel. Provide supportive care and/or corticosteroids as needed.Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with ciltacabtagene autoleuce.Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with ciltacabtagene autoleucel. HLH/MAS can occur with CRS or neurologic toxicities.Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with ciltacabtagene autoleucel.Ciltacabtagene autoleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ciltacabtagene autoleucel REMS Program.

Serious side effects

Along with its needed effects, ciltacabtagene autoleucel 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 ciltacabtagene autoleucel:

More common

Less common

Other side effects

Some side effects of ciltacabtagene autoleucel 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

Less common

For Healthcare Professionals

Applies to ciltacabtagene autoleucel: intravenous suspension.

General

The most common adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common laboratory adverse reactions (incidence greater than or equal to 50%) include thrombocytopenia, neutropenia, anemia, aminotransferase elevation and hypoalbuminemia.[Ref]

Cardiovascular

Very common (10% or more): Tachycardia (any grade, 27%), hypotension (51%), hypertension (19%)

Common (1% to 10%): Thrombosis[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (33%), nausea (31%), constipation (22%), vomiting (20%)[Ref]

Hematologic

Very common (10% or more): Lymphopenia (99%), neutropenia (98%), white blood cell decrease (98%), anemia (72%), thrombocytopenia (63%), coagulopathy (22%), hemorrhage (15%) febrile neutropenia (10%)

Common (1% to 10%): Fibrinogen decreased[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (95%), hypogammaglobulinemia (94%)

Metabolic

Very common (10% or more): Decreased appetite (29%), AST decrease (21%)

Common (1% to 10%): Hypoalbuminemia, alanine aminotransferase increased, hyponatremia, hypocalcemia, gamma glutamyl transferase increased, alkaline phosphatase increased, hypokalemia, blood bilirubin increased

Common (1% to 10%): Tumor lysis syndrome

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (48%)

Common (1% to 10%): Abnormal posture[Ref]

Nervous system

Very common (10% or more): Encephalopathy (30%), headache (30%), dizziness (23%), motor dysfunction (16%)

Common (1% to 10%): Aphasia, ataxia, tremor, paresis, parkinsonism, peripheral neuropathy, micrographia, dysgraphia, reduced facial expression, bradykinesia, cogwheel rigidity, seizure, low speech, nystagmus[Ref]

Other

Very common (10% or more): Pyrexia (96%), fatigue (47%), chills (33%), edema (23%)[Ref]

Infectious:

Very common (10% or more): Infections-pathogen unspecified (41%), upper respiratory tract infections (28%), viral infections (23%), pneumonia (12%), sepsis (10%), bacterial infections (10%)

Common (1% to 10%): Urinary tract infections[Ref]

Psychiatric

Very common (10% or more): Insomnia (13%) Delirium, depression, psychomotor retardation

Common (1% to 10%):[Ref]

Respiratory

Very common (10% or more): Cough (39%), dyspnea (23%), nasal congestion (15%), hypoxia (12%)[Ref]

References

1. Product Information. Carvykti (ciltacabtagene autoleucel). Janssen Biotech, Inc. 2022;1.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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