Rituximab Sub Cutaneous - Northern England Clinical Networks

Rituximab Sub Cutaneous
Cumbria, Northumberland,
Tyne & Wear Area Team
DRUG ADMINISTRATION SCHEDULE
Day
Drug
Dose
Route
Diluent
Paracetamol
1gram
Oral
Once Only
Chlorphenamine
4mg
Oral
Once Only
Prednisolone
40mg
Oral
Once Only
1400mg
Subcutaneous
1
Rituximab
Rate
5 mins
Since 21st July 2014, Sub-cutaneous rituximab has been approved for use in certain
cases by NHS England. The dose, and formulation of sub-cutaneous rituximab are
different from the intra-venous product. This protocol only covers subcutaneous
rituximab.
CYCLE LENGTH AND NUMBER OF DAYS
Depends on indication
● First Line Maintenance therapy 8 weekly for 2 years
● Second Line Maintenance therapy 12 weekly for 2 years
APPROVED INDICATIONS
• Patients with:
• Follicular Lymphoma,
• Mantle cell lymphoma (off-label),
• Marginal zone lymphoma (off-label),
• Lymphoplasmacytic lymphoma (off-label)
• who have responded to induction chemotherapy
Sub-cutaneous rituximab is not approved for use by NHS England in combination with intravenous
chemotherapy.
INVESTIGATIONS / MONITORING REQUIRED
Prior to each cycle: FBC
REVIEW BY CLINICIAN
Prior to each cycle, unless being reviewed by a Nurse Specialist or Pharmacist under
a locally agreed framework. Minimum consultant review annually.
Copy of Rituximab NECN protocol CRP08 H035 (updated)
Page 1 of 3
Date Issued: Feb 2013
Expiry Date: Feb 2015
Rituximab Sub Cutaneous
NURSE / PHARMACIST LED REVIEW
As per locally agreed framework, or under share care with GP. 3 monthly review
when stable.
ADMINISTRATION NOTES
•
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•
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Patients receiving rituximab must be screened for Hepatitis B prior to starting
treatment.
Patients receiving maintenance treatment with SC rituximab must have
previously received intravenous rituximab.
Risk of hypersensitivity and anaphylaxis – patients must be observed for at least
15 minutes and full resuscitation facilities must be available. Longer
observation should be used for patients with increased risk of reactions.
Use the abdomen for injection and ensure the injection site is disinfected
thoroughly according to local practice.
Draw up 11.7ml of rituximab, ensuring the correct formulation has been
selected.
Attach a sub-cutaneous needle to the syringe, immediately prior to
administration to avoid needle clogging.
Hold the syringe at no more than 30°C for 5 minutes to reduce the viscosity of
the solution.
Pinch the skin with one hand to create a skin fold and then insert the needle
into the skin fold using the other hand, using good aseptic technique. Then
release the skin fold. Apply pressure to the syringe plunger using the palm of
the hand. Inject the full content of the syringe over approximately 5 minutes.
TOXICITIES
Common: Hypersensitivity Reactions, Lethargy
DOSE MODIFICATION / TREATMENT DELAYS
Haematological Toxicity:
(Note: where haematological disease is affecting bone marrow function, lower
treatment parameters may be acceptable. This should be clearly documented for the
specific patient.)
Delay treatment on Day 1 if ANC < 1.5 x 109cells/l or PLT < 100 x 109cells/l
Page 3 of 3
Expiry Date: July 2016
Rituximab Sub Cutaneous
Renal Function:
No dose modification normally required
Hepatic Function:
No dose modification normally required
TREATMENT LOCATION
Suitable for administration in chemotherapy day units, under the supervision of
haematology teams from Level 1 – 4 Haematology Services.
REFERENCES:
• Roche. Summary of product Characteristics – Mabthera. October 2006
• National Institute for Clinical Excellence. Rituximab for follicular lymphoma
TAG 110. February 2008.
Document Control
Document Title:
Rituximab Sub Cutaneous NECN protocol CRP08 H035
Document No:
CRP08-H0035
Author:
Current
Version:
Calum Polwart, Network Pharmacist
NECN
1.0
Reviewed
by:
Date
Reviewed:
Approved by:
Due for Review:
July 2016
Summary of
Changes
1.0a
‘Final version’ approved
Page 3 of 3
Expiry Date: July 2016