axicabtagene ciloleucel

Action and Spectrum

Actions and Spectrum 

axicabtagene ciloleucel is designed to harness a patient’s own immune system to fight cancer cells.  

It is specifically classified as a chimeric antigen receptor (CAR) T-cell therapy.

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% 

Any Grade 

Pulmonary edema (9%) 

Capillary leak syndrome (3%) 

Myoclonus (2%) 

Hypersensitivity (1%) 

Coagulopathy (2%) 

Rash (9%) 

Cardiac failure (6%) 

Seizure (4%) 

Dyscalculia (2%) 

Cardiac arrest (4%) 

Arthralgia (10%) 

Thrombosis (10%) 

Ataxia (6%) 

Fungal infections (5%) 

Grades 3-4 

Bacterial infections (9%) 

Dyspnea (3%) 

Pain in extremity (2%) 

Vomiting (1%) 

Dizziness (1%) 

Thrombosis (1%) 

Abdominal pain (1%) 

Aphasia (6%) 

Tremor (2%) 

Pleural effusion (2%) 

Motor dysfunction (1%) 

Back pain (1%) 

Diarrhea, grades 3-4 (4%) 

Dehydration (3%) 

Tachycardia (2%) 

Headache (1%) 

Decreased appetite (2%) 

Renal insufficiency, grades 3-4 (5%) 

Arrhythmia (7%) 

Edema (1%) 

Muscle pain (1%) 

Viral infections (3%) 

Fatigue (3%) 

Delirium (6%) 

Hypertension (6%) 

Hypokalemia (10%) 

Increased ALT (10%) 

>10% 

Any grade 

Fever (86%) 

Hypertension (15%) 

Pleural effusion (13%) 

Dehydration (11%) 

Abdominal pain (14%) 

Muscle pain (14%) 

Chills (40%) 

Delirium (17%) 

Back pain (15%) 

Hypoxia (32%) 

Dyspnea (19%) 

Aphasia (18%) 

Fatigue (46%) 

Arrhythmia (23%) 

Dizziness (21%) 

Headache (45%) 

Tachycardia (57%) 

Renal insufficiency (12%) 

Dry mouth (11%) 

Diarrhea (38%) 

Weight decreased (16%) 

Hypogammaglobulinemia (15%) 

Constipation (23%) 

Edema (19%) 

Motor dysfunction (19%) 

Pain in extremity (17%) 

Nausea (34%) 

Hypotension (57%) 

Tremor (31%) 

Cough (30%) 

Vomiting (26%) 

Decreased appetite (44%) 

Cytokine release syndrome (94%) 

Encephalopathy (57%) 

Grades 3-4 

Neutropenia (93%) 

Hyperuricemia (13%) 

Direct bilirubin increased (13%) 

Encephalopathy (29%) 

Hypotension (15%) 

Anemia (66%) 

Infections, pathogen unspecified (16%) 

Hypoxia (11%) 

Cytokine release syndrome (13%) 

Lymphopenia (100%) 

Thrombocytopenia (58%) 

Hyponatremia (19%) 

Fever (16%) 

Leukopenia (96%) 

Hypophosphatemia (50%) 

Post marketing Reports 

Nervous system disorders: Spinal cord edema, myelitis, status epilepticus, quadriplegia and dysphagia 

Black Box Warning

Black Box Warning 

Most patients reported experiencing cytokine release syndrome (CRS), which can include deadly or life-threatening events.  

Cardiovascular arrhythmias, cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, and hypotension are serious conditions that may be linked to CRS.  

Encephalopathy, headache, tremor, dizziness, aphasia, delirium, sleeplessness, and anxiety were the most frequent neurological toxicities. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

None  

Caution: 

• Following lymphodepleting chemotherapy and axicabtagene ciloleucel infusion, prolonged cytopenias may arise and linger for several weeks; keep track of blood cell counts. 
• Reactivation of a viral infection is possible; reactivation of the hepatitis B virus (HBV) can cause fulminant hepatitis, hepatic failure, and fatalities. 
• Secondary cancers may occur; patient should be continuously monitored for them. 

Pregnancy / Lactation

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology  

Genetically modifying a patient’s own T cells to express a chimeric antigen receptor (CAR) that can recognize and attach to both benign and malignant B cells that express CD19 is known as CD19-directed autologous T cell immunotherapy. 

The CAR consists of an extracellular antigen-recognition domain, a transmembrane domain, and intracellular signaling domains. 

Pharmacodynamics 

Limited information available  

Pharmacokinetics 

Absorption   

The absorption of modified T cells is directly infused into the patient’s bloodstream via intravenous infusion. 

Distribution 

axicabtagene ciloleucel CAR T cells distribute throughout the body. 

Metabolism 

axicabtagene ciloleucel metabolism mostly affects the functionality and cell growth of the transformed T cells. 

Elimination and excretion 

Excretion process is not understood yet. 

Adminstartion

Administration 

axicabtagene ciloleucel is administered via intravenous infusion. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: axicabtagene ciloleucel 

Why do we use axicabtagene ciloleucel? 

axicabtagene ciloleucel is a type of immunotherapy drug used in the treatment of certain types of cancer like large B-cell lymphoma and high-grade B-cell lymphoma. axicabtagene ciloleucel is indicated for adult patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL).