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Abecma
idecabtagene vicleucel
Black Box Warnings .
Appropriate Use
restricted distribution program (ABECMA REMS) due to cytokine release syndrome (CRS) and neurological toxicity risk; admin. only at certified healthcare facility w/ on-site, immediate access to tocilizumab, and a minimum of 2 doses of tocilizumab for each pt w/in 2h after tx if needed; 1-866-340-7332 or www.AbecmaREMS.com for more information
Cytokine Release Syndrome
incl. fatal or life-threatening rxn, occurred; do not admin. if active infection or inflammatory disorders; treat severe or life-threatening CRS w/ tocilizumab +/- corticosteroids; monitor pts at least daily x7 days post-infusion at certified healthcare facility, then monitor s/sx for at least 4wk after tx w/in proximity of certified healthcare facility; counsel pts on s/sx and to seek immediate medical attention if they occur at any time
Neurological Toxicities
which may be severe or life-threatening, occurred, incl. concurrently w/ CRS, after CRS resolution, or in the absence of CRS; provide supportive care, levetiracetam, and/or corticosteroids as needed; monitor pts at least daily x7 days post-infusion at certified healthcare facility, then monitor s/sx for at least 4wk after tx w/in proximity of certified healthcare facility; counsel pts on s/sx and to seek immediate medical attention if they occur at any time
Hemophagocytic Lymphohistiocytosis/Macrophage activation syndrome
incl. fatal or life-threatening rxn, occurred; can occur w/ CRS or neurologic toxicities
Prolonged Cytopenias
w/ bleeding and infection, incl. fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred
Secondary Hematological Malignancies
incl. myelodysplastic syndrome, AML, T-cell malignancies, have occurred; monitor life-long; contact Bristol-Myers Squibb at 1-888-805-4555 to report malignancy occurrence and obtain instructions on pt sample collection
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-866-340-7332 or www.AbecmaREMS.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing
multiple myeloma, relapsed or refractory
- [300-510 x10^6 chimeric antigen receptor (CAR)-positive viable T-cells IV x1]
- Start: 2-7 days after completing lymphodepleting combo chemo regimen cyclophosphamide + fludarabine; Info: for pts refractory to at least 2 prior tx, incl. an anti-CD38 agent, a proteasome inhibitor, and an immunomodulatory agent
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.