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 • • • • • • • • 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
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