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Txagorrapid: Ultrarapid infusion in 30 minutes of the biosimilar of rituximab truxima- A cohort study
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005689
ABSTRACT

Background:

Rituximab (anti-CD20 Ab) is the cornerstone of the treatment of non-Hodgkin B lymphomas. Infusion-related reactions (IRR) are the most common adverse effects. To reduce them, intravenous premedication with antihistamine and acetaminophen is administered prior to rituximab. If no IRR after first infusion, subsequent infusions time takes 3-6 hours. Many centers use the rapid 90-minute infusion (off-label). Since 2017 subcutaneous rituximab formulation is available, that takes 5 minutes of administration. Nevertheless, in order to reduce cost, due to approval of biosimilars, some health providers continue using intravenous rituximab. On the other hand, with COVID pandemic, an effort to reduce visits and day-care hospitals stays has been made. In the current situation, it would be convenient to reduce day-care stay and the nursing care burden. We wanted to evaluate the safety of an ultrarapid infusion of biosimilar rituximab in a total time of 30 minutes by analyzing IRR and adverse events (AE).

Methods:

Since November 2021, 3 cohorts of ultrafast infusion have been studied as follows One cohort (Cohort 1) with intravenous premedication with dexchlorpheniramine and acetaminophen, followed by rituximab infusion over 1 hour, and 2 cohorts with rituximab infusion over 30 minutes Cohort 2 with intravenous premedication, and cohort 3 with oral premedication. IRR and adverse events have been independently reviewed and graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (November 27, 2017).

Results:

34 patients have been included receiving 48 rituximab infusions (16 infusions in each cohort). Median age was 64 years old (range 51-91). Diagnostic of NHL were as follows large b cell 10;follicular 13;marginal 7;mantle cell 1, Waldeström 1;Ritcher transformation 2. Rituximab infusion was in monotherapy (21), and in combination (27) with bendamustine 9, CHOP 17, GEMOX 1. Considering safety, no IRR has been observed in cohort 1 (1 hour infusion), and 1 IRR grade II in cohort 3 (30 minutes, oral premedication). Other AE were hypertension grade I and hypotension grade I, both in cohort 2.

Conclusions:

Ultrarapid rituximab infusion is safe. Oral premedication is feasibly allowing a total infusion time of 30 minutes. This infusion rate alleviates day-care burden saving between 75-90% of time in each rituximab infusion, reduce day-care stay and is comfortable for the patients.
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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Language: English Journal: Journal of Clinical Oncology Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Language: English Journal: Journal of Clinical Oncology Year: 2022 Document Type: Article