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1. NICE approved as monotherapy for patients with relapsed or refractory Stage III or IV CD20 +ve follicular NHL
where there is resistance to or intolerance of chemotherapy
2. a) NICE approved for maintenance therapy for previously untreated, or relapsed, Stage III or IV CD20 +ve
follicular NHL which has responded to rituximab-containing induction chemotherapy
b) Maintenance therapy for mantle cell lymphoma in patients who respond to standard 1 st line chemotherapy
c) Maintenance therapy for marginal zone lymphoma in patients who respond to standard 1 st line chemotherapy
Drugs/Dosage:
Rituximab
375mg/m2
IV
Day 1
(dose banded according to dosing table below)
Frequency:
Premedication:
Paracetamol 1000mg po
Chlorphenamine 10mg IV
Dexamethasone 8mg IV
Other drugs:
Allopurinol 300mg po daily, starting at least 24 hours before first dose - review after 3 weeks
(not required for maintenance therapy)
Administration:
Rituximab diluted in 500ml 0.9% sodium chloride & administered according to the following
instructions:
start at 50mg/hr, according to infusion table below, or locally approved method of calculating
infusion rates;
escalate in 50mg/hr increments every 30 minutes to a maximum of 400mg/hr.
Monitor patients vital signs at baseline and then every 30 minutes (before each increase in
infusion rate) until end of infusion.
First infusion
for monotherapy:
Subsequent
infusions / first
infusion for
maintenance:
Rituximab
banded dose
at 375mg/m2
500mg
525mg
575mg
600mg
650mg
675mg
700mg
750mg
800mg
825mg
850mg
100
150
200
250
300
350
400
100
95
87
83
77
74
71
67
62
61
59
150
143
130
125
115
111
107
100
94
91
88
200
190
174
167
154
148
143
133
125
121
118
250
238
217
208
192
185
178
167
156
152
147
300
286
261
250
231
222
214
200
187
182
176
350
333
304
292
269
259
250
233
219
212
206
Main Toxicities:
severe cytokine release syndrome usually occurs within 12 hours of the first rituximab
infusion (see Comments) and consists of fever, headache, rigors, flushing, nausea, rash,
URTI symptoms;
transient hypotension and bronchospasm are usually infusion rate related;
tumour lysis syndrome (ensure pre-medicated with allopurinol and good hydration)
increased risk of infections
Anti- emetics:
Extravasation:
non-vesicant
Regular
Investigations:
Monotherapy:
FBC
LFTs
U&Es
LDH
Maintenance (first
line or relapsed):
FBC
LFTs & U&Es
LDH
Comments:
400
381
348
333
308
296
286
267
250
242
235
Use with caution if WBC > 25 x 109/l, as increased risk of severe cytokine release syndrome.
Consider giving with a reduced infusion rate and monitor very closely. If in doubt, check with
Consultant.
Full resuscitation equipment must be available, with immediate access to clinical staff trained
in resuscitation for the first hour of the first rituximab infusion. Blood pressure, pulse,
temperature and O2 saturation must be measured and recorded at regular intervals as
specified above.
Dose Modifications
Haematological
Toxicity:
If counts become low during treatment, this may be due to marrow infiltration and should be
discussed with Consultant before any further treatment is given.
Patient Information:
References: