(teclistamab-cqyv)
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TECVAYLI® (teclistamab-cqyv)
Medical Information
Restarting TECVAYLI After Dosage Delay
Last Updated: 03/20/2025
Abbreviations: CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity.
a
accordingly. c
reaction.
PRODUCT LABELING
Restarting TECVAYLI after Dosage Delay
- If a dose of TECVAYLI is delayed, restart therapy based on: Recommendations for Restarting Therapy With TECVAYLI After Dose Delay and resume the treatment schedule accordingly.1
- Administer pretreatment medications as indicated in Recommendations for Restarting Therapy With TECVAYLI After Dose Delay.1
- Due to the risk of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS), patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule.1
| Last Dose Administered | Time Since the Last Dose Administered | Action |
|---|---|---|
| Step-up dose 1 | More than 7 days | Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).a |
| Step-up dose 2 | 8 days to 28 days | Repeat step-up dose 2 (0.3 mg/kg)a and continue TECVAYLI step-up dosing schedule. |
| More than 28 daysb | Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).a | |
| Any weekly treatment dose | 28 days or less | Continue TECVAYLI at last treatment dose in weekly schedule (1.5 mg/kg once weekly). |
| 29 days to 56 daysb | Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg).a | |
| More than 56 daysb | Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).a | |
| Any biweekly (every 2 weeks) treatment dose | 63 days or lessb | Continue TECVAYLI at last treatment dose in biweekly schedule (1.5 mg/kg every 2 weeks). |
| 64 days to 112 daysb | Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg).a | |
| More than 112 daysb | Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).a | |
| aAdminister pretreatment medications prior to TECVAYLI dose and monitor patients accordingly. bConsider the benefit-risk of restarting TECVAYLI in patients who require a dose delay of more than 28 days due to an adverse reaction. | ||
Additional data
Other relevant data have been identified in addition to the data summarized above:
- van de Donk et al (2024)2
applied population pharmacokinetic modeling to a retrospective clinical analysis of MajesTEC-1 (at a data cut-off of August 22, 2023) to evaluate repeat step-up doses (SUD) and CRS events in the setting of prolonged dosing intervals (>28-62 days, ≥63–111 days, and ≥112 days). - Tan et al (2025)3
examined the impact of omitting repeat SUD on the incidence of CRS and/or ICANS in TECVAYLI or talquetamab patients restarting therapy after a prolonged dose delay (>28 days) outside of a clinical trial at Memorial Sloan Kettering.
Literature Search
A literature search of MEDLINE®
References
| 1 | TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf. |
| 2 | van de Donk NWCJ, Chari A, Karlin L, et al. Analysis of repeat step-up dosing and cytokine release syndrome events following prolonged dosing intervals of teclistamab in the phase 1/2 MajesTEC-1 study. Poster presented at: 66th American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, CA. |
| 3 | Tan CR, Wang A, Nemirovsky D, et al. Restarting teclistamab and talquetamab after prolonged dose delay may not require re-step-up dosing. Blood Advances. 2025. doi:10.1182/bloodadvances.2024015344. |