What is Tisagenlecleucel
Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell therapy and the first gene therapy approved by the FDA. It is CD19-directed immunotherapy that works by using a patient’s own genetically altered immune cells to kill B-cell cancer cells in the blood.
Tisagenlecleucel is indicated for use in patients up to 25 years of age with relapsed or refractory B-cell precursor acute lymphoblastic leukemia and in adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.
It is not indicated for use in patients with primary central nervous system lymphoma.
Cytokine release syndrome and severe neurotoxicity have been reported.
Tisagenlecleucel is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.
Brand Name
KYMRIAH
Indications
- acute lymphocytic leukemia (ALL)
- non-Hodgkin’s lymphoma (NHL)
Side Effects
- abdominal pain
- acute respiratory distress syndrome (ARDS)
- agitation
- anemia
- anorexia
- antibody formation
- anuria
- anxiety
- aphasia
- arthralgia
- asthenia
- ataxia
- atrial fibrillation
- azotemia
- back pain
- blurred vision
- capillary leak syndrome
- cardiac arrest
- chills
- coagulopathy
- confusion
- constipation
- contact dermatitis
- cough
- cytokine release syndrome
- delirium
- diarrhea
- disseminated intravascular coagulation (DIC)
- dizziness
- drowsiness
- dysarthria
- dyspnea
- edema
- elevated hepatic enzymes
- encephalopathy
- fatigue
- fecal incontinence
- fever
- graft-versus-host disease (GVHD)
- hallucinations
- headache
- heart failure
- hyperbilirubinemia
- hyperesthesia
- hypertension
- hypoesthesia
- hypokalemia
- hyponatremia
- hypophosphatemia
- hypotension
- hypoxia
- impaired cognition
- infection
- insomnia
- intracranial bleeding
- irritability
- lethargy
- leukopenia
- lymphopenia
- maculopapular rash
- malaise
- memory impairment
- migraine
- muscle cramps
- myalgia
- myopathy
- nasal congestion
- nausea
- nephrotoxicity
- neurotoxicity
- neutropenia
- nightmares
- pancytopenia
- paresthesias
- peripheral edema
- peripheral neuropathy
- pleural effusion
- prolonged bleeding time
- pulmonary edema
- pulmonary embolism
- rash
- renal failure (unspecified)
- renal tubular necrosis
- respiratory depression
- restlessness
- seizures
- sinus tachycardia
- stroke
- supraventricular tachycardia (SVT)
- syncope
- tachypnea
- thrombocytopenia
- thrombosis
- tremor
- tumor lysis syndrome (TLS)
- visual impairment
- vomiting
- weight loss
Monitoring Parameters
- CBC with differential
- hepatitis B serology
- neurologic function
- plasma hepatitis C RNA
- plasma HIV RNA
- pregnancy testing
- serum creatinine/BUN
- serum electrolytes
- serum IgG concentations
- serum uric acid
Contraindications
- blood donation
- breast-feeding
- contraception requirements
- cytokine release syndrome
- driving or operating machinery
- encephalopathy
- fungal infection
- hepatitis
- hepatitis B exacerbation
- hypogammaglobulinemia
- infection
- infusion-related reactions
- laboratory test interference
- neonates
- neurotoxicity
- neutropenia
- new primary malignancy
- pregnancy
- pregnancy testing
- reproductive risk
- requires a specialized care setting
- requires an experienced clinician
- seizures
- thrombocytopenia
- tumor lysis syndrome (TLS)
- vaccination
- viral infection
Interactions
- Live Vaccines
