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Kymriah
tisagenlecleucel
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 daily during 1st wk post-infusion, then monitor signs/symptoms for at least 2wk 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
which may be severe or life-threatening, can occur after tx, including concurrently with CRS; provide supportive care as needed; monitor patients daily during 1st wk post-infusion, then monitor signs/symptoms for at least 2wk after tx within proximity of healthcare facility
Secondary Hematological Malignancies
including T-cell malignancies, have occurred; monitor life-long; contact Novartis at 1-844-459-6742 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
B-cell precursor ALL, relapsed or refractory
- [25 yo and younger, <50 kg]
- Dose: 0.2-5 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
- [25 yo and younger, >50 kg]
- Dose: 0.1-2.5 x10^8 CAR-positive viable T-cells IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
large B-cell lymphoma, relapsed or refractory
- [0.6-6 x10^8 CAR-positive viable T-cells IV x1]
- Start: 2-11 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: for patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma; may omit lymphodepleting regimen if WBC <1000 within 1wk before tisagenlecleucel tx; see pkg insert for alternative lymphodepleting regimen
follicular lymphoma, relapsed or refractory
- [0.6-6 x10^8 CAR-positive viable T-cells IV x1]
- Start: 2-6 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: use as 3rd-line and subsequent tx; may omit lymphodepleting regimen if WBC <1000 within 1wk before tisagenlecleucel tx; see pkg insert for alternative lymphodepleting regimen
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds 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 including toxicity-related dose adjustments
B-cell precursor ALL, relapsed or refractory
- [3 yo and older, <50 kg]
- Dose: 0.2-5 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
- [3 yo and older, >50 kg]
- Dose: 0.1-2.5 x10^8 CAR-positive viable T-cells IV x1; Start: 2-14 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- infection, active
- inflammatory disorder
- GVHD, active
- chemotherapy-associated serious reaction, unresolved
- baseline bone marrow blasts >50%
- tumor burden refractory to lymphodepleting chemotherapy
- avoid: blood donation indefinitely
- avoid: organ donation indefinitely
- avoid: tissue donation indefinitely
- avoid: cell donation indefinitely
- caution: hypersensitivity to DMSO
- caution: patients of childbearing potential
- caution: HBV carriers
Drug Interactions .
Overview
tisagenlecleucel
CAR T cell immunotherapy
- immunomodulatory effects
- lowers seizure threshold
- myelosuppressive oncologic agent
- peripheral neuropathy
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
- hypersensitivity reaction, severe
- anaphylaxis
- infection, serious
- febrile neutropenia
- HBV reactivation
- neutropenia, including prolonged
- thrombocytopenia, including prolonged
- anemia
- hypogammaglobulinemia, including prolonged
- lymphopenia
- histiocytosis lymphocytic hemophagocytosis
- thrombosis
- hypofibrinogenemia
- intracranial hemorrhage
- DIC
- tumor lysis syndrome
- renal failure
- abdominal compartment syndrome
- graft vs. host disease
- multi-organ dysfunction syndrome
- secondary malignancy
- T-cell malignancy
- chimeric antigen receptor (CAR)-positive lymphoma
Common Reactions
- cytokine release syndrome
- neutropenia, including prolonged
- infection
- fever
- diarrhea
- hypotension
- headache
- nausea
- thrombocytopenia, including prolonged
- fatigue
- hypogammaglobulinemia
- febrile neutropenia
- encephalopathy
- edema
- appetite decr.
- cough
- acute kidney injury
- tachycardia
- dyspnea
- constipation
- pain
- vomiting
- hypoxia
- delirium
- rigors
- abdominal pain
- rash
- arthralgia
- anxiety
- myalgia
- sleep disorder
- dizziness
- HTN
- pulmonary edema
- tremor
- back pain
- oropharyngeal pain
- pleural effusion
- weight decr.
- hypofibrinogenemia
- thrombosis
- visual impairment
- DIC
- INR incr.
- peripheral neuropathy
- tachypnea
- motor dysfunction
- nasal congestion
- arrhythmia
- histiocytosis lymphocytic hemophagocytosis
- multi-organ dysfunction syndrome
- seizures
- speech disorder
- tumor lysis syndrome
- cardiac failure
- dermatitis
- prolonged aPTT
- coagulopathy
- respiratory failure
- lymphopenia
- anemia
- hypophosphatemia
- hypokalemia
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 daily during 1st wk post-infusion, then for at least 2wk 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
Pregnancy Reporting
report pregnancy to Novartis Pharmaceuticals Corp. at 1-888-669-6682
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 tisagenlecleucel: other; CYP450: unknown
Excretion: for tisagenlecleucel: unknown; Half-life: 2.5 days (non-responding peds patients), 13.6 days (non-responding adult patients), 16.8 days (responding peds patients), 45.3 days (responding adult patients)
Subclass: Immunotherapy, CAR T-Cells ; Immunotherapy, CD19 Inhibitors
Mechanism of Action
for tisagenlecleucel: 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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