Applies to idecabtagene vicleucel: intravenous suspension.

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

• 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

• 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

• 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.

Hematologic

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

General

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]

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]