Rituximab

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Contents 1 More Specific Terms 2 Indications 3 Contraindications 4 Dosage 5 Monitor 6 Adverse-effects 7 Mechanism-of-action 8 More General Terms 9 References

More Specific Terms

• cyclophosphamide/pentostatin/rituximab (PCR regimen)
• N-PEP-12 (MemoProve)
• rituximab/cyclophosphamide/doxorubicin/vincristine (Oncocin)/prednisone (R-CHOP)

Indications

• treatment of patients with relapsed or refractory, low-grade or CD20-positive, B-cell non- Hodgkin's follicular lymphoma, large cell lymphoma, mantle cell lymphoma
• treatment of chronic lymphocytic leukemia [4]
• treatment of autoimmune disorders:

• rheumatoid arthritis unresonsive to TNF-alpha inhibitor
• lupus ??

Contraindications

• concurrent use of other biologic agent ( TNF inhibitor, anakinra, abatacept)

Dosage

• administer by slow IV infusion (50 mg/hour 1st infusion); maximum infusion rate 400 mg/hour
• 375 mg/m2 weekly for 4 doses (days 1, 8, 15 & 22)

• Injection: 100 mg ( preservative free) (10 mL) 500 mg (10 mL)

Monitor

• complete blood count ( CBC)
• CD20 cells

Adverse-effects

• infusion-related effects

• 80% 1st infusion; 40% therafter
• fever/ chills/ rigors, hypotension, bronchospasm, angioedema
• interrupt infusion; resume at 1/2 rate after resolution of symptoms
• medications for treatment of hypersensitivity reactions ( epinephrine, antihistamines, corticosteroids) should be available for immediate use

• common (> 10%)

• headache (14%)
• nausea (18%)
• leukopenia (11%)
• fever (49%)
• chills (32%)
• asthenia (16%)
• angioedema (13%)
• hypotension (10%)
• pruritis (10%)
• rash (10%)

• less common

• myalgia, dizziness, urticaria, vomiting, abdominal pain, thrombocytopenia (8%), bronchospasm (8%), throat irritation, rhinitis

• uncommon (< 1%)

• arrhythmias, angina, myocardial infarction, aplastic anemia, hemolytic anemia
• progressive multifocal leukoencephalopathy ( PML) [5,6]
• reactivation of viral infection ( hepatitis B)

Mechanism-of-action

• binds specifically to CD20, a B-cell restricted differentiation antigen
• the monoclonal antibody contains murine light & heavy chain variable regions & human constant region (Fc)
• complement or antibody-dependent cell mediated cytotoxicity
• in cultured cells, rituximab induces apoptosis

More General Terms

• immunoglobulin-G (IgG)
• monoclonal antibody
• antineoplastic agent (chemotherapeutic agent)
• disease-modifying antirheumatic agent (DMARD)

References

1. Kaiser Permanente Northern California Pharmacy update, 11/2000
2. PDR 2000
3. Rituximab Plus Chemo More Effective in Elderly Lymphoma Patients [1]
4. Van Oers MHJ et al, Rituximab maintenance improves clinical outcome of relapsed/ resistance follicular non-Hodgkin lymphoma in patients with and without rituximab during induction: Results of a prospective randomized phase 3 intergroup trial. Blood 2006, 108:3295 PMID: [2]
5. FDA Medwatch [3]
6. FDA MedWatch [4]
7. Medical Knowledge Self Assessment Program (MKSAP) 15, American College of Physicians, Philadelphia 2009
8. National Guideline Clearinghouse Rituximab in lymphoma and chronic lymphocytic leukemia: a clinical guideline (Program in Evidence-based Care) ngc-guideline: [5]
   - Rituximab for the first-line treatment of chronic lymphocytic leukaemia. National Institute for Health and Clinical Excellence (NICE) ngc-guideline: [6]
   - Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor. National Institute for Health and Clinical Excellence ngc-guideline: [7]
   - Rituximab in chronic lymphocytic leukemia Program in Evidence-based Care ngc-guideline: [8]
   - Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia. National Institute for Health and Clinical Excellence (NICE) ngc-guideline: [9]

rituximab (Rituxin, Mabthera)