To see all protocols that comply with the WHO Essential Medicine List 
This rapid infusion regimen is ONLY to be used in patients who are receiving their second or subsequent cycle of rituximab and who received their previous dose/s without grade 3 or 4 infusion-related toxicities.

For first dose with rapid infusion regimen, patients are to be under constant visual observation during all dose increases and for 30 minutes after infusion is completed.

Administration:

  • it is recommended that patients omit their antihypertensive medication on the day of rituximab treatment and that they take their premedication orally before they arrive at the clinic
  • give premedication 30 to 60 minutes prior to administration of rituximab:
    • paracetamol 1000 mg PO AND
    • loratadine 10 mg PO (or similar antihistamine)
    • patients who are receiving prednisolone or dexamethasone as part of their chemotherapy regimen may receive this as part of their rituximab premedication (the rituximab product information recommends that a glucocorticoid premedication should be considered if not given as part of the chemotherapy regimen)
  • measure and document baseline observations and repeat every 30 minutes

The following rates are based on loading the rituximab into a 500 mL volume. The total infusion time is 90 minutes. Use a controlled rate infusion pump set:

  • first 100 mL over 30 minutes (i.e. 200 mL/hr)
  • the remaining 400 mL over 60 minutes (i.e. 400 mL/hr)
  • if cytokine-release syndrome or acute infusion reaction occurs, temporarily discontinue infusion and notify medical officer
  • when symptoms have resolved recommence infusion at half the rate prior to the reaction
  • if applicable, administer accompanying cytotoxic regimen either prior to, or after the rituximab according to institutional policy
  • upon completion of the entire regimen, flush the line and remove IV cannula or deaccess central venous access device (CVAD) as per protocol

Dakhil et al (2014) reported on a phase III study of 363 patients which evaluated the safety and feasibility of a 90 minute infusion of rituximab 375 mg/m2 in cycle 2 and onward in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) receiving R-CHOP or R-CVP chemotherapy, who tolerated their first infusion at the standard rate without grade 3/4 infusion-related reactions (IRRs). Only four patients (1.1%) experienced grade 3 IRRs with the 90 min infusion during cycle 2, and only 10 patients (2.8%) experienced grade 3/4 IRRs with the 90 min infusion during cycles 2 – 8. No fatal IRRs or other adverse effects (AEs) occurred on days 1 or 2 of any cycle, and no unexpected AEs were associated with the faster infusion schedule. In conclusion this study demonstrated the safety of a 90 minute infusion of rituximab.r

Sehn et al (2007) reported on 150 patients included in their initial safety analysis who safely received rapid infusion rituximab in combination with corticosteroid-containing chemotherapy, with no grade 3 or 4 infusion reactions observed. A further 56 patients received rapid infusion rituximab in the setting of single agent rituximab maintenance without concurrent corticosteroids. There were two reports of transient grade 1 toxicities in this group. At the time the report was written, more than 1200 patients had received rapid infusion rituximab in combination with corticosteroid-containing chemotherapy in British Columbia, with only one patient reported to have experienced a significant grade 3 reaction. They conclude that this protocol can be safely delivered and is well tolerated.r 

Salar et al (2006) studied 70 patients with NHL having 319 rapid infusions of rituximab with (n= 126) and without (n = 193) steroids. The rapid infusions were well tolerated with no grade 3 or 4 adverse events and only 3 patients developing grade 1 symptoms. There was no difference between those patients who had steroids and those who did not. r

Provencio et al (2006) treated 40 patients with Hodgkin and non-Hodgkin disease with 233 infusions, including the first course administered according to the standard infusion protocol recommended by the manufacturer. All subsequent infusions were administered over 60 minutes. The rapid-infusion rituximab was given either as monotherapy or in combination with regimens such as CHOP or CVP. r

A number of other similar studies have concluded that the rapid infusions of rituximab are well tolerated by patients with minimal adverse events. Middleton et al (2005) showed similar results in a similar patient population.r Aurran-Schleinitz et al (2005) administered 115 rapid infusions of rituximab over 60 minutes to 69 patients with NHL, CLL and ITP, the majority having combination therapy.r A literature search conducted by Firth (2012) further supports the safety of rapid rituximab infusions over 90 and 60 minutes. r

Toxicity

In all of the above studies rapid infusions were well tolerated with no grade 3 or 4 adverse events reported. Sehn et al reported on two patients in their initial safety analysis that developed transient grade 1 toxicity.r Sehn et al have reported only one grade 3 reaction since the rituximab rapid infusion protocol was recommended by the BC Cancer Agency and adopted throughout British Columbia. Salar et al reported on 3 patients who developed grade 1 symptoms, two of these patients then went on to successfully receive rapid rituximab in subsequent infusions.r

While every effort has been made to ensure the accuracy of the content at the time of publication, the Cancer Institute NSW does not accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omission in the contents of this work. Any reference to specific pharmaceuticals and/or medical products as examples does not imply endorsement of any of these products. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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22 Sep 2019