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Tecvayli (teclistamab-cqyv)
teclistamab
Black Box Warnings .
Appropriate Use
restricted distribution program (TECVAYLI and TALVEY REMS) due to cytokine release syndrome (CRS) and neurological toxicity risk; admin. only at certified healthcare facility w/ trained healthcare providers to manage CRS and neurological toxicities; 1-855-810-8064 or www.TEC-TALREMS.com for more information
Cytokine Release Syndrome
incl. fatal or life-threatening rxns occurred in 72% of pts; initiate tx according to step-up dosing schedule and admin. premeds to decr. CRS risk; monitor pts x48h in hospital after each dose of step-up dosing schedule for CRS s/sx, incl. fever, hypoxia, chills, hypotension, sinus tachycardia, headache, elevated transaminases; provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Neurological Toxicities
incl. immune effector cell-assoc. neurotoxicity syndrome (ICANS) and serious and life-threatening rxns occurred in 57% of pts; may occur concurrently w/ CRS, after CRS resolution, or in the absence of CRS; monitor pts x48h in hospital after each dose of step-up dosing schedule; provide supportive care as needed; withhold tx until s/sx resolve or permanently D/C, based on severity
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-855-810-8064 or www.TEC-TALREMS.com for more information]
Special Note
- [formulation clarification]
- Info: nonproprietary name = teclistamab-cqyv
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing incl. toxicity-related dose adjustments
multiple myeloma, relapsed or refractory
- [Dose: 0.06 mg/kg/dose SC x1 on day 1 (1st step-up dose), then 0.3 mg/kg/dose SC x1 on day 4 (2nd step-up dose), then 1.5 mg/kg/dose SC x1 on day 7 (1st tx dose) as part of step-up dosing schedule, then 1.5 mg/kg/dose SC qwk starting 1wk after 1st tx dose]
- Info: for pts refractory to at least 4 prior tx, incl. an anti-CD38 agent, a proteasome inhibitor, and an immunomodulatory agent; may give 2nd step-up dose 2-4 days or up to 7 days after 1st step-up dose; may give 1st tx dose 2-4 days or up to 7 days after 2nd step-up dose; may decr. frequency of tx dose to q2wk if complete response or better achieved and maintained for at least 6mo
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.