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Aucatzyl
obecabtagene autoleucel
Black Box Warnings .
Cytokine Release Syndrome
do not administer if active infection or inflammatory disorders; ensure providers have immediate access to meds, resuscitative equipment to manage CRS before administration; monitor patients daily for at least 7 days 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
immune effector cell-associated neurotoxicity syndrome, including fatal or life-threatening, occurred, including concurrently with CRS or after CRS resolution; ensure providers have immediate access to meds, resuscitative equipment to manage neurologic toxicities before administration; provide supportive care and/or corticosteroids as needed; monitor patients daily for at least 7 days 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
Secondary Hematological Malignancies
including T-cell malignancies, have occurred; monitor life-long; contact Autolus Therapeutics at 1-855-288-5227 to report malignancy occurrence and obtain instructions on patients 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
- [bone marrow blast <20%]
- Dose: 100 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 1, then 310 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 10; Start: 3 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
- [bone marrow blast >20% or biopsy results inconclusive]
- Dose: 10 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 1, then 400 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg/dose IV x1 on day 10; Start: 3 days after completing lymphodepleting combo chemo cyclophosphamide + fludarabine
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.