Restarting Subcutaneous MabThera after Treatment Interruption
This letter responds to your request for information on MabThera SC® (rituximab and hyaluronidase human) and restarting MabThera subcutaneous administration after a treatment interruption.
Last updated August 10, 2023
Mabthera SC treatment interruptions allowed in Roche pivotal trials
Roche has no recommendations on when to restart MabThera SC after a treatment interruption. We cannot provide therapeutic recommendations for individual patients.
However, treatment interruptions were allowed in pivotal studies to allow patients to recover from hematological toxicities, infections, or other clinical conditions that precluded treatment according to institutional practice.
Table 1 provides a summary of the pivotal trial study designs.
Abbreviations: CHOP=chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone; CLL=chronic lymphocytic leukemia; CR=complete response; CRu=unconfirmed complete response; CVP=chemotherapy regimen consisting of cyclophosphamide, vincristine sulfate, and prednisone; DLBCL=diffuse large b-cell lymphoma; FC=chemo regimen consisting of fludarabine and cyclophosphamide; FL=follicular lymphoma; IV=intravenous; N/A=not available; ORR=objective response rate (CR,CRu, & PR); PR=Partial Response; PK=Pharmacokinetics, SC=subcutaneous; 1L=1st line/previously untreated
Safety considerations for restarting MabThera SC
Clinicians should consider individual patient factors such as previous IRRs or ARRs, tumor burden and peripheral B-cell counts when deciding how to restart Mabthera SC after a dose interruption.
Previous infusion-related reactions (IRRs) and administration-related reactions (ARRs)
Patients are at the highest risk of experiencing an IRR from MabThera IV at Cycle 1. Patients with a high tumor burden may be at higher risk of developing severe IRRs.[6]
Restarting MabThera treatment with an IV-first dose after an extended delay or interruption of MabThera SC may help to manage ARRs because of the ability to control slowing or stopping the IV infusion.[6]
The rate of IRRs after varying intervals of treatment interruptions were not evaluated in pivotal studies.[6]
References
- Davies A, Merli F, Mihaljević B, et al. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol 2017;4:e272-e282. https://www.ncbi.nlm.nih.gov/pubmed/28476440
- Roche Internal Clinical Study Report. (Accessed on 29 Jun 2023).
- Assouline S, Buccheri V, Delmer A, et al. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol 2016;3:e128-38. https://www.ncbi.nlm.nih.gov/pubmed/26947201
- Roche Internal Clinical Study Report. (Accessed on 26 Jun 2023).
- Lugtenburg P, Avivi I, Berenschot H, et al. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica 2017;102:1913-1922. https://www.ncbi.nlm.nih.gov/pubmed/28935843
- Roche Internal Regulatory Document. (Accessed on 26 Jun 2023).
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