Carvykti Side Effects

Generic name: ciltacabtagene autoleucel

Medically reviewed by Drugs.com. Last updated on Dec 25, 2024.

Note: This document provides detailed information about Carvykti Side Effects associated with ciltacabtagene autoleucel. Some dosage forms listed on this page may not apply specifically to the brand name Carvykti.

Applies to ciltacabtagene autoleucel: intravenous suspension.

Serious side effects of Carvykti

Along with its needed effects, ciltacabtagene autoleucel (the active ingredient contained in Carvykti) 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:

Other side effects of Carvykti

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:

For healthcare professionals

Applies to ciltacabtagene autoleucel: intravenous suspension.

General adverse events

The most common adverse reactions were pyrexia, cytokine release syndrome (CRS), hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections of unspecified pathogen, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, vomiting, neutropenia, anemia, thrombocytopenia, leukopenia, lymphopenia, hypocalcemia, hypophosphatemia, hypokalemia, and increased transaminases. The most common grade 3 or 4 laboratory adverse reactions included lymphopenia, neutropenia, decreased WBC, thrombocytopenia, and anemia.^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (up to 51%), tachycardia (up to 27%), hypertension (up to 19%)
• Common (1% to 10%): Cardiac arrhythmias, chest pain, thrombosis, capillary leak syndrome

Hypotension included hypotension and orthostatic hypotension.

Tachycardia included sinus tachycardia and tachycardia.

Cardiac arrhythmias included atrial fibrillation, second degree atrioventricular block, atrial flutter, supraventricular tachycardia, ventricular extrasystoles, and ventricular tachycardia.

Chest pain included angina pectoris, chest discomfort, and chest pain.

Thrombosis included deep vein thrombosis, pulmonary embolism, limb venous thrombosis, cerebrovascular accident, embolism, jugular vein thrombosis, and device-related thrombosis.

Dermatologic

• Common (1% to 10%): Rash

Rash included psoriasiform dermatitis, drug eruption, erythema, pityriasis lichenoides et varioliformis acuta, rash, erythematous rash, maculopapular rash, papular rash, urticaria, generalized exfoliative dermatitis, pustular rash, and vesicular rash.

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 33%), nausea (up to 31%), constipation (up to 22%), vomiting (up to 20%), abdominal pain (up to 10%)
• Common (1% to 10%): Gastroenteritis, dysphagia

Diarrhea included colitis and diarrhea.

Gastroenteritis included viral enterocolitis, enterovirus infection, gastroenteritis, rotavirus gastroenteritis, Salmonella gastroenteritis, gastrointestinal infection, bacterial enterocolitis, infectious enterocolitis, cryptosporidial gastroenteritis, viral gastroenteritis, and large intestine infection.

Abdominal pain included abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and dyspepsia.

Genitourinary

• Common (1% to 10%): Urinary tract infection

Urinary tract infection included cystitis, Escherichia urinary tract infection, urinary tract infection, bacterial urinary tract infection, and viral urinary tract infection.

Hematologic

• Very common (10% or more): Decreased lymphocyte count (up to 99%), lymphopenia (up to 99%), neutropenia (up to 98%), decreased WBC (up to 98%), decreased neutrophil count (up to 95%), thrombocytopenia (up to 74%), anemia (up to 73%), leukopenia (up to 55%), decreased platelet count (up to 47%), decreased hemoglobin (up to 34%), coagulopathy (up to 22%), hemorrhage (up to 16%), febrile neutropenia (up to 13%), hypofibrinogenemia (up to 12%)
• Common (1% to 10%): Lymphocytosis
• Frequency not reported: Decreased fibrinogen

Anemia included anemia and iron deficiency anemia.

Coagulopathy included decreased blood fibrinogen, abnormal coagulation test, coagulopathy, disseminated intravascular coagulation, hypofibrinogenemia, prolonged activated partial thromboplastin time, increased INR, increased prothrombin level, increased fibrin D-dimer, and prolonged prothrombin time.

Hemorrhage included catheter site hemorrhage, conjunctival hemorrhage, contusion, epistaxis, hematemesis, hematoma, hematuria, ecchymosis, eye contusion, hematochezia, hemoptysis, infusion site hematoma, oral contusion, petechiae, postprocedural hemorrhage, pulmonary hemorrhage, retinal hemorrhage, lower gastrointestinal hemorrhage, retroperitoneal hemorrhage, subarachnoid hemorrhage, cerebral hemorrhage, and subdural hematoma.

Hypofibrinogenemia included decreased blood fibrinogen and hypofibrinogenemia.

Lymphocytosis included increased lymphocyte count and lymphocytosis.

Among patients receiving this drug in 2 studies, grade 3 or higher cytopenias not resolved by day 30 after infusion occurred in 62% of patients and included thrombocytopenia (33%), neutropenia (27%), lymphopenia (24%), and anemia (2%). After day 60 after infusion 22%, 20%, 5%, and 6% of patients had a recurrence of grade 3/4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their grade 3/4 cytopenia; 77% of patients had at least 1 recurrence of grade 3/4 cytopenias after initial recovery of grade 3/4 cytopenia. Grade 3/4 neutropenia and thrombocytopenia were present in 16 and 25 patients, respectively, at time of death.

Hepatic

• Very common (10% or more): Increased transaminases (up to 37%), increased AST (up to 21%), increased GGT (up to 14%)
• Common (1% to 10%): Hyperbilirubinemia
• Frequency not reported: Increased ALT, increased blood bilirubin

Increased transaminases included increased ALT and increased AST.

Hypersensitivity

• Common (1% to 10%): Hypersensitivity reaction

Among patients receiving this drug in 2 studies, hypersensitivity reactions occurred in 5%, all of which were grade 2 or lower. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, noncardiac chest pain, and pyrexia.

Immunologic

• Very common (10% or more): CRS (up to 95%), hypogammaglobulinemia (up to 94%), positive for anti-chimeric antigen receptor antibodies (up to 23%), positive for anti-product antibodies (up to 19.6%)
• Common (1% to 10%): Hemophagocytic lymphohistiocytosis (HLH), HLH/macrophage activation syndrome (MAS)

CRS included CRS and systemic inflammatory response syndrome.

Hypogammaglobulinemia included decreased blood immunoglobulin G (IgG), hypogammaglobulinemia, and laboratory IgG levels that decreased to less than 500 mg/dL after infusion.

CRS (including fatal or life-threatening reactions) occurred after treatment with this drug; CRS occurred in 78% of patients in 1 study (3% grade 3 to 4) and in 95% of patients in another study (4% grade 3 to 4). Among patients receiving this drug for relapsed/refractory multiple myeloma in 2 studies, CRS occurred in 84% (including grade 3 or higher in 4%) of patients. The median time to onset of CRS (any grade) was 7 days (range: 1 to 23 days); CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (at least 10%) included fever (84%), hypotension (29%), and increased AST (11%).

Among patients receiving this drug in 2 studies, hypogammaglobulinemia adverse event was reported in 36% of patients; laboratory IgG levels decreased to less than 500 mg/dL after infusion in 93% of patients. Hypogammaglobulinemia (either as an adverse reaction or laboratory IgG level below 500 mg/dL) after infusion occurred in 94% of patients treated; 56% of patients received IV immunoglobulin after this drug for either an adverse reaction or prophylaxis.

Among patients receiving this drug in 2 studies, HLH/MAS occurred in 1% of patients. Onset occurred within 99 days of receiving this drug in all cases, with a median onset of 10 days (range: 8 to 99 days); all cases occurred in the setting of ongoing/worsening CRS. Manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multiorgan dysfunction (including renal dysfunction and respiratory failure).

Metabolic

• Very common (10% or more): Decreased appetite (up to 29%), hypocalcemia (up to 27%), hypophosphatemia (up to 25%), hypokalemia (up to 20%), hyponatremia (up to 19%), hypoalbuminemia (up to 18%), hypomagnesemia (up to 16%), hyperferritinemia (up to 10%)
• Common (1% to 10%): Tumor lysis syndrome
• Frequency not reported: Hypertriglyceridemia

Hyperferritinemia included hyperferritinemia and increased serum ferritin.

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 48%)
• Common (1% to 10%): Abnormal posture

Musculoskeletal pain included arthralgia, back pain, bone pain, bursitis, musculoskeletal chest pain, musculoskeletal pain, myalgia, myositis, neck pain, noncardiac chest pain, osteoarthritis, pain in extremity, plantar fasciitis, rotator cuff syndrome, spinal pain, tendonitis, joint stiffness, muscle strain, musculoskeletal discomfort, and musculoskeletal stiffness.

Nervous system

• Very common (10% or more): Encephalopathy (up to 30%), headache (up to 27%), neurologic toxicities (up to 23%), dizziness (up to 23%), immune effector cell-associated neurotoxicity syndrome (ICANS; up to 23%), motor dysfunction (up to 17%), peripheral neuropathy (up to 13%)
• Common (1% to 10%): Cranial nerve palsies, tremor, aphasia, ataxia, parkinsonism, micrographia, dysgraphia, reduced facial expression, bradykinesia, paresis, cogwheel rigidity, cerebrovascular accident, seizure, slow speech, nystagmus, cranial nerve palsy, neurotoxicity, Guillain-Barre syndrome (GBS)
• Uncommon (0.1% to 1%): Immune mediated myelitis

Encephalopathy included amnesia, bradyphrenia, confusional state, depressed level of consciousness, disturbance in attention, ICANS, lethargy, psychomotor retardation, encephalopathy, memory impairment, mental impairment, mental status changes, noninfective encephalitis, slow response to stimuli, cognitive disorder, sleep disorder, and somnolence.

Headache included headache and tension headache.

Dizziness included dizziness, postural dizziness, presyncope, syncope, exertional dizziness, and vertigo.

Motor dysfunction included bradykinesia, abnormal coordination, dysgraphia, extrapyramidal disorder, micrographia, muscle spasms, muscular weakness, parkinsonism, motor dysfunction, muscle tightness, agraphia, eyelid ptosis, muscle rigidity, cogwheel rigidity, abnormal posture, stereotypy, and myoclonus.

Peripheral neuropathy included peripheral neuropathy, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, hypoesthesia, neuralgia, paresthesia, ear paresthesia, sensory loss, and polyneuropathy.

Cranial nerve palsies included facial paralysis, facial paresis, 3rd nerve paralysis, trigeminal palsy, Bell's palsy, cranial nerve paralysis, facial nerve disorder, and 6th nerve paralysis.

Tremor included resting tremor and tremor.

Aphasia included aphasia, dysarthria, slow speech, and speech disorder.

Ataxia included ataxia, balance disorder, dysmetria, and gait disturbance.

Paresis included facial paralysis, hemiparesis, paresis, and peroneal nerve palsy.

Neurologic toxicities (including severe, life-threatening, or fatal cases) occurred after treatment with this drug; neurologic toxicities included ICANS, neurologic (movement and neurocognitive) toxicity with signs/symptoms of parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Among patients receiving this drug in 2 studies for relapsed/refractory multiple myeloma, at least 1 neurologic toxicity occurred in 24% (including grade 3 or higher in 7%) of patients. The median time to onset was 10 days (range: 1 to 101) with 91% of cases developing by 30 days; neurologic toxicities resolved in 72% of patients with a median resolution duration of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% also developed CRS. Subtypes of neurologic toxicities included ICANS (13%), peripheral neuropathy (7%), cranial nerve palsy (7%), parkinsonism (3%), and immune mediated myelitis (0.4%).

ICANS occurred in 7% of patients in 1 study (0.5% grade 3) and in 23% of patients in another study (3% grade 3). Among patients receiving this drug in 2 studies, ICANS occurred in 13% (including grade 3 or higher in 2%) of patients. The median time to onset was 8 days (range: 1 to 28 days). ICANS resolved in 83% of patients with a median resolution time of 3 days (range: 1 to 143 days); the median duration was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at time of death/data cut off. Of patients with ICANS, 97% had CRS; the onset of ICANS occurred during CRS in 69% of patients, and before and after the onset of CRS in 14% of patients, respectively. The most frequent manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%).

Parkinsonism occurred in 1% of patients in 1 study (no grade 3 to 4) and in 6% of patients in another study (4% grade 3 to 4). Among patients receiving this drug in 2 studies, parkinsonism occurred in 8 (including grade 3 or higher in 5) of 285 patients. The median time to onset was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 patients with a median resolution time of 523 days; the median duration was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at time of death/data cut off. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients. The manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes.

A fatal outcome after GBS occurred after treatment with this drug despite treatment with IV immunoglobulins; reported symptoms included those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.

Grade 3 myelitis occurred 25 days after treatment with this drug in 1 study in a patient who received this drug as subsequent therapy. Reported symptoms included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control; symptoms improved with corticosteroids and IV immune globulin. Myelitis was ongoing at time of death from other cause.

Peripheral neuropathies occurred in 7% of patients in 1 study (0.5% grade 3 to 4) and in 7% of patients in another study (2% grade 3 to 4). Among patients receiving this drug in 2 studies, peripheral neuropathy occurred in 7% (including grade 3 or higher in 1%) of patients. The median time to onset was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 52% of patients with a median resolution time of 58 days (range: 1 to 215 days); the median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at time of death/data cut off.

Cranial nerve palsies occurred in 9% of patients in 1 study (1% grade 3 to 4) and in 3% of patients in another study (1% grade 3 to 4). Among patients receiving this drug in 2 studies, cranial nerve palsies occurred in 7% (including grade 3 or higher in 1%) of patients. The median time to onset was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 89% of patients with a median resolution time of 66 days (range: 1 to 209 days); the median duration was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at time of death/data cut off. The most frequent cranial nerve affected was cranial nerve VII; cranial nerves III, V, and VI were also reported to be affected.

Ocular

• Common (1% to 10%): Diplopia

Oncologic

• Very common (10% or more): Hematologic malignancy (up to 10%)
• Uncommon (0.1% to 1%): Secondary malignancy of T-cell origin
• Postmarketing reports: T-cell malignancies

Hematologic malignancy included myelodysplastic syndrome, acute myeloid leukemia, myelodysplastic syndrome with multilineage dysplasia, T-cell lymphoma, and unspecified peripheral T-cell lymphoma.

Among patients receiving this drug in 2 studies, myeloid neoplasms occurred in 13 of 285 patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with this drug. Of the 13 patients, 10 died after developing myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after starting subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported during postmarketing experience. T-cell malignancies have occurred after treatment of hematologic malignancies with B-cell maturation antigen-directed and CD19-directed genetically modified autologous T-cell immunotherapies, including this drug.

Other

• Very common (10% or more): Pyrexia (up to 96%), fatigue (up to 47%), infections of unspecified pathogen (up to 41%), chills (up to 33%), viral infection (up to 23%), edema (up to 23%), bacterial infection (up to 15%), pain (up to 13%), increased serum ferritin (up to 12%), increased blood alkaline phosphatase (up to 11%), increased LDH (up to 11%), sepsis (up to 10%)
• Common (1% to 10%): Increased C-reactive protein, fungal infection, CMV infection, fall, death

Fatigue included asthenia, fatigue, decreased exercise tolerance, and malaise.

Infections of unspecified pathogen included limb abscess, atypical pneumonia, bacteremia, bronchitis, conjunctivitis, infectious enterocolitis, folliculitis, gastroenteritis, lung abscess, lung opacity, osteomyelitis, otitis media, parotitis, perirectal abscess, pneumonia, pustular rash, rhinitis, sepsis, septic shock, sinusitis, skin infection, soft tissue infection, upper respiratory tract infection, and urinary tract infection.

Viral infection included adenovirus infection, asymptomatic COVID-19, COVID-19, CMV infection, CMV infection reactivation, CMV viremia, hepatitis B reactivation, herpes simplex reactivation, herpes virus infection, herpes zoster, human herpesvirus 6 infection, influenza, viral lymphadenitis, metapneumovirus infection, parainfluenza virus infection, parvovirus B19 infection, parvovirus infection, respiratory syncytial virus infection, viral respiratory tract infection, rotavirus infection, positive adenovirus test, coronavirus infection, CMV syndrome, enterovirus infection, viral gastroenteritis, disseminated herpes zoster, influenza like illness, oral herpes, rhinovirus infection, viral urinary tract infection, and viral upper respiratory tract infection.

Edema included face edema, generalized edema, localized edema, peripheral edema, periorbital edema, peripheral swelling, pulmonary edema, fluid retention, hypervolemia, edema, palatal edema, pulmonary congestion, joint swelling, and scrotal edema.

Bacterial infection included Bordetella infection, bacterial bronchitis, Campylobacter infection, catheter site infection, cellulitis, chalazion, Citrobacter infection, Clostridioides difficile colitis, device-related infection, gingivitis, perichondritis, acute pyelonephritis, salmonellosis, skin infection, staphylococcal infection, bacterial superinfection, vascular access site infection, vascular device infection, limb abscess, cholecystitis, acute cholecystitis, C difficile infection, bacterial enterocolitis, osteomyelitis, perirectal abscess, breast cellulitis, ecthyma, enterococcal infection, folliculitis, hordeolum, Klebsiella infection, lung abscess, bacterial sinusitis, tooth infection, and soft tissue infection.

Pain included anorectal discomfort, catheter site pain, flank pain, inflammatory pain, pain, pain in jaw, pain of skin, pelvic pain, rhinalgia, ear pain, eye pain, fracture pain, noncardiac chest pain, odynophagia, proctalgia, sacral pain, sinus pain, testicular pain, and toothache.

Sepsis included bacteremia, Candida sepsis, device-related bacteremia, enterococcal bacteremia, Haemophilus sepsis, neutropenic sepsis, pseudomonal sepsis, sepsis, septic shock, staphylococcal bacteremia, systemic Candida, urosepsis, bacterial sepsis, streptococcal sepsis, and pseudomonal bacteremia.

Fungal infection included Candida infection, oral candidiasis, tongue fungal infection, Aspergillus infection, cerebral aspergillosis, Aspergillus sinusitis, and vulvovaginal candidiasis.

CMV infection included CMV syndrome and CMV viremia.

Among patients receiving this drug in 2 studies, infections occurred in 57% (including grade 3 or higher in 24%) of patients. Grade 3/4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% of patients had grade 5 infections, with 2.5% due to COVID-19; patients treated with this drug had an increased rate of fatal COVID-19 infections compared to the standard therapy arm. Fatal infections have included COVID-19 pneumonia, pneumonia, sepsis, C difficile colitis, septic shock, bronchopulmonary aspergillosis, pseudomonal sepsis, neutropenic sepsis, and lung abscess.

In 1 study, early deaths occurred more often in patients randomized to this drug compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208) occurred in the arm with this drug compared to (25/211) in the control arm. Of the 29 deaths in the arm with this drug, 10 deaths occurred before infusion (all due to disease progression), and 19 deaths occurred after infusion. Of the 19 deaths that occurred after infusion of this drug, 3 occurred due to disease progression, and 16 occurred due to adverse events (12 due to infection).

Psychiatric

• Very common (10% or more): Insomnia (up to 13%), sleep disorder (up to 10%)
• Common (1% to 10%): Delirium, personality changes, depression, psychomotor retardation

Sleep disorder included insomnia, sleep disorder, hypersomnia, and somnolence.

Delirium included agitation, disorientation, hallucination, irritability, personality change, delirium, euphoric mood, and restlessness.

Personality changes included flat affect, indifference, personality change, apathy, and reduced facial expression.

Depression included depression and flat affect.

Renal

• Common (1% to 10%): Renal failure

Renal failure included acute kidney injury, increased blood creatinine, chronic kidney disease, renal failure, and renal impairment.

Respiratory

• Very common (10% or more): Cough (up to 39%), upper respiratory tract infection (up to 35%), dyspnea (up to 23%), nasal congestion (up to 15%), pneumonia (up to 14%), hypoxia (up to 13%)

Cough included cough, productive cough, and upper-airway cough syndrome.

Upper respiratory tract infection included bronchitis, nasal congestion, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, rhinorrhea, rhinovirus infection, sinusitis, upper respiratory tract infection, viral pharyngitis, positive human rhinovirus test, paranasal sinus discomfort, pharyngeal inflammation, respiratory tract congestion, sinus congestion, and viral upper respiratory tract infection.

Dyspnea included dyspnea, exertional dyspnea, respiratory failure, tachypnea, wheezing, and acute respiratory failure.

Pneumonia included COVID-19 pneumonia, lower respiratory tract infection, metapneumovirus pneumonia, pneumonia, Moraxella pneumonia, pseudomonal pneumonia, streptococcal pneumonia, atypical pneumonia, lung abscess, lung opacity, Pneumocystis jirovecii pneumonia, and aspiration pneumonia.

Hypoxia included hypoxia, decreased oxygen consumption, and decreased oxygen saturation.

Frequently asked questions

• What is the success rate for Carvykti for Multiple Myeloma?
• What’s the mechanism of action of Carvykti?

Further information

Carvykti 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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