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
- Agitation
- back pain
- black, tarry stools
- bladder pain
- bleeding gums
- blood in the eye
- bloody or cloudy urine
- blurred vision
- body aches or pain
- bone pain
- bruising
- chest pain or tightness
- chills
- confusion
- confusion as to time, place, or person
- cough or hoarseness
- coughing up blood
- decreased vision or other changes in vision
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- ear congestion
- eye pain
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- frequent urge to urinate
- hallucinations
- headache
- holding false beliefs that cannot be changed by fact
- increased menstrual flow or vaginal bleeding
- irritability
- large, flat, blue or purplish patches in the skin
- lightheadedness
- loss of voice
- lower back or side pain
- mood or mental changes
- muscle pain, spams, twitching, or jerking
- nervousness
- nosebleeds
- painful or difficult urination
- pale skin
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- red or dark brown urine
- redness in whites of the eyes
- rhythmic movement of the muscles
- seizures
- sneezing
- sore throat
- stiffness
- stuffy or runny nose
- sweating
- swelling
- trembling and shaking of the hands
- trouble breathing
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- vomiting
Less common
- Discouragement
- feeling sad or empty
- generalized slowing of mental and physical activity
- incremental or ratchet-like movement of the muscle
- lack of appetite
- loss of balance control
- loss of interest or pleasure
- muscle discomfort
- partial or slight paralysis
- rigid or stiff muscles
- seizures
- shuffling walk
- slowed movements
- slurred speech
- stiffness of the arms and legs
- tic-like (jerky) movements of the head, face, mouth, and neck
- trouble concentrating
- trouble sleeping
- uncontrolled eye movements
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
- Constipation
- diarrhea
- rash
Less common
- Abnormal posture
- double vision
- fall
- seeing double
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]
