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Yescarta
axicabtagene ciloleucel
Black Box Warnings .
Cytokine Release Syndrome
including fatal or life-threatening reaction, has occurred; do not administer if active infection or inflammatory disorders; confirm minimum 2 doses tocilizumab available prior to infusion; treat severe or life-threatening CRS with tocilizumab /- corticosteroids; monitor patients at least daily x7 days post-infusion, then monitor signs/symptoms x2wk after tx within proximity of healthcare facility; counsel patients on signs/symptoms and to seek immediate medical attention if they occur at any time
Neurological Toxicities
including fatal or life-threatening reaction, have occurred, including concurrently with CRS or after CRS resolution; provide supportive care and/or corticosteroids as needed; monitor patients at least daily x7 days post-infusion, then monitor signs/symptoms x2wk after tx within proximity of healthcare facility
Secondary Hematological Malignancies
including T-cell malignancies, have occurred; monitor life-long; contact Kite at 1-844-454-5483 to report malignancy occurrence and obtain instructions on patient sample collection
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing
follicular lymphoma, relapsed or refractory
- [2 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1]
- Start: 2 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Max: 2 x10^8 CAR-positive viable T-cells/total dose
large B-cell lymphoma, relapsed or refractory
- [2 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1]
- Start: 2 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Max: 2 x10^8 CAR-positive viable T-cells/total dose; Info: for patients who are potential autologous HSCT candidate as 2nd-line tx; for patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma as 3rd-line and subsequent tx
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- infection, active
- inflammatory disorder
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- caution: hypersensitivity to DMSO
- caution: hypersensitivity to gentamicin
- caution: patients of childbearing potential
- caution: HBV carriers
Drug Interactions .
Overview
axicabtagene ciloleucel
CAR T cell immunotherapy
- immunomodulatory effects
- lowers seizure threshold
- myelosuppressive oncologic agent
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- hypotension, severe
- fever
- hypoxia
- cardiac arrest
- cardiac failure
- respiratory failure
- pulmonary edema
- capillary leak syndrome
- HTN
- arrhythmia
- neurotoxicity, severe
- encephalopathy
- seizures
- aphasia
- cerebral edema
- hypersensitivity reaction, severe
- anaphylaxis
- infection, serious
- febrile neutropenia
- HBV reactivation
- neutropenia, including prolonged
- thrombocytopenia, including prolonged
- anemia, including prolonged
- hypogammaglobulinemia, including prolonged
- lymphopenia
- hemophagocytic lymphohistiocytosis
- macrophage activation syndrome
- thrombosis
- myelitis
- quadriplegia
- secondary malignancy
- T-cell malignancy
- chimeric antigen receptor (CAR)-positive lymphoma
Common Reactions
- cytokine release syndrome
- fever
- hypotension
- encephalopathy
- tachycardia
- fatigue
- infection
- headache
- febrile neutropenia
- nausea
- rigors
- appetite decr.
- diarrhea
- tremor
- cough
- hypoxia
- constipation
- vomiting
- musculoskeletal pain
- neutropenia, including prolonged
- arrhythmia
- dizziness
- motor dysfunction
- hypogammaglobulinemia
- delirium
- aphasia
- edema
- abdominal pain
- dyspnea
- rash
- HTN
- thrombocytopenia, including prolonged
- thrombosis
- renal insufficiency
- insomnia
- ataxia
- pneumonia
- extremity pain
- peripheral neuropathy
- weight decr.
- back pain
- affective disorder
- nasal congestion
- pleural effusion
- anemia, including prolonged
- xerostomia
- dehydration
- hemorrhage
- coagulopathy
- arthralgia
- pulmonary edema
- cardiac failure
- dysphagia
- visual impairment
- seizures
- lymphopenia
- hypophosphatemia
- hyponatremia
- infusion reaction
Safety/Monitoring .
Monitoring Parameters
screening for HBV, HCV, HIV before leukapheresis; pregnancy test at baseline; signs/symptoms of infection before and after infusion; CBC, IgG levels after infusion; signs/symptoms of cytokine release syndrome, neurological toxicities at least daily x7 days post-infusion, then x2wk after tx within proximity of healthcare facility; signs/symptoms of secondary hematologic malignancy life-long
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human or animal data available; possible risk of B-cell lymphocytopenia and hypogammaglobulinemia based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for axicabtagene ciloleucel: other; CYP450: unknown
Excretion: for axicabtagene ciloleucel: unknown; Half-life: unknown
Subclass: Immunotherapy, CAR T-Cells ; Immunotherapy, CD19 Inhibitors
Mechanism of Action
for axicabtagene ciloleucel: binds to CD19-expressing cells via chimeric antigen receptor (CAR)-positive autologous T-cells, inducing T-cell expansion, activation, and proliferation, and eliminating CD19-expressing cells
Formulary .
No Formulary Selected
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