Applies to lisocabtagene maraleucel: intravenous suspension.

Serious side effects

Along with its needed effects, lisocabtagene maraleucel 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 lisocabtagene maraleucel:

More common

• Agitation
• back pain
• bleeding gums
• bloody urine
• blurred vision
• body aches or pain
• burning, numbness, tingling, or painful sensations
• chest pain
• chills
• coma
• confusion
• cough
• coughing up blood
• decrease frequency or amount of urine
• diarrhea
• difficulty swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• ear congestion
• fast, pounding, or irregular heartbeat or pulse
• fever
• hallucinations
• headache
• hives, itching
• holding false beliefs that cannot be changed by fact
• increased menstrual flow or vaginal bleeding
• increased thirst
• irritability
• loss of appetite
• loss of voice
• lower back or side pain
• mood or mental changes
• muscle or bone pain
• muscle spasm, tenderness, twitching, jerking, wasting, or weakness
• nausea
• nosebleeds
• painful or difficult urination
• paralysis
• pounding in the ears
• problems with speech or speaking
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools
• red or dark brown urine
• runny or stuffy nose
• seizures
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• skin rash
• slow or fast heartbeat
• sneezing
• sore throat
• stiff neck
• stomach pain
• sweating
• trembling and shaking of the hands or feet
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting
• weight gain

Other side effects

Some side effects of lisocabtagene maraleucel 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

• Constipation
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site
• trouble sleeping

For Healthcare Professionals

Applies to lisocabtagene maraleucel: intravenous suspension.

Hematologic

Very common (10% or more): Lymphopenia (94%), neutropenia (81%), leukopenia (77%), anemia (58%), thrombocytopenia (54%), febrile neutropenia (37%), bleeding episodes (31%), international normalized ratio increased (13%)

Common (1% to 10%): Histiocytosis lymphocytic hemophagocytosis, coagulopathy, activated partial thromboplastin time prolonged^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity/anaphylaxis^[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (79%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%), hypogammaglobulinemia (e.g., hypogammaglobulinemia, immunoglobulins decreased, blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased) (43%), infections pathogen unspecified (41%), viral infections (26%), bacterial infections (19%), fungal infections (13%)

Common (1% to 10%): Graft versus host disease

Frequency not reported: Immunogenicity^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (15%), arthralgia (12%), back pain/pain in extremity (10%)

Common (1% to 10%): Muscle spasms^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (37%), hypophosphatemia (24%), edema (e.g., face edema, generalized edema, localized edema, edema peripheral) (21%), hypokalemia (12%), hyponatremia (11%), weight loss (11%), fluid overload (10%)

Common (1% to 10%): Tumor lysis syndrome^[Ref]

Psychiatric

Very common (10% or more): Delirium (21%), anxiety (13%), sleep disorders/insomnia/nightmare (10%)^[Ref]

Hepatic

Very common (10% or more): Acute kidney injury (e.g., acute kidney injury, anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, blood creatinine increased) (24%), increased alanine aminotransferase (21%), increased bilirubin (21%)

Oncologic

Frequency not reported: Secondary malignancies/cancer recurrence^[Ref]

Respiratory

Very common (10% or more): Hypoxia (24%), cough/productive cough (21%), dyspnea/respiratory distress/respiratory failure (16%), pulmonary edema (16%), tachypnea (12%), pleural effusion (10%), nasal congestion (10%)

Common (1% to 10%): Respiratory distress, respiratory failure, acute respiratory distress syndrome, oropharyngeal pain^[Ref]

Other

Very common (10% or more): Fatigue/malaise (48%), pyrexia (40%), increased aspartate aminotransferase (28%), hypokalemia (27%), hypophosphatemia pain (18%), fever (16%), chills (12%)

Common (1% to 10%): Multiple organ dysfunction syndrome^[Ref]

General

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (2% or greater) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.^[Ref]

Nervous system

Very common (10% or more): Headache/migraine (30%), encephalopathy (e.g., encephalopathy, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, lethargy, mental status changes, somnolence, automatism) (29%), delirium (e.g., delirium, agitation, hallucination, hallucination visual, irritability, restlessness) (21%), peripheral neuropathy (11%)

Common (1% to 10%): Tremor, dizziness, seizure, speech disorder/aphasia/dysarthria, motor dysfunction^[Ref]

Renal

Very common (10% or more): Acute kidney injury (24%)^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (26%), tachycardia/sinus tachycardia (25%)

Common (1% to 10%): Disseminated intravascular coagulation, cardiac arrest, cardiac failure, capillary leak syndrome, thrombosis^[Ref]

Dermatologic

Very common (10% or more): Rash/rash maculopapular/rash papular/rash pruritic (16%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (33%), diarrhea (26%), constipation (23%), vomiting (21%), abdominal pain (21%)^[Ref]

Ocular

Common (1% to 10%): Visual impairment^[Ref]