rituximab (Rituxan, Mabthera, Truxima, Ruxience, Riabni)
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Indications
- treatment of patients with relapsed or refractory, low-grade or CD20-positive
- treatment of Waldenstrom's macroglobulinemia[14]
- treatment of chronic lymphocytic leukemia[4]
- treatment of autoimmune disorders:
- rheumatoid arthritis unresponsive to TNF-alpha inhibitor
- adjunct to methotrexate[17]
- as effective as TNF-alpha inhibitor[17]
- ANCA-associated vasculitis[7][10]
- systemic lupus erythematosus (off label)
- in conjunction with dexamethasone for treatment of immune thrombocytopenic purpura (ITP), but high risk of adverse effects[9]
- microscopic polyangitis[14]
- IgG4-related disease[7]
- myasthenia gravis
- rheumatoid arthritis unresponsive to TNF-alpha inhibitor
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
- serum IgG, CBC, basic metabolic panel, LFTs at baseline, at 2 weeks, & every 3-6 months thereafter
- CD20 cells[7]
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%)
- pruritus (10%)
- rash (10%)
- less common
- myalgia, dizziness, urticaria, vomiting, abdominal pain, thrombocytopenia (8%), bronchospasm (8%), throat irritation, rhinitis
- uncommon (< 1%)
- reactivation of viral infection (hepatitis B)
- serum sickness-like reaction to murine light & heavy chain variable regions
- hypogammaglobulinemia
- opportunistic infection
- poor humoral response to influenza vaccine[11]
- associated with severe COVID-19 infection[19]
- Boxed warning:
- risk of reactivation of hepatitis B infection[2]
- hepatitis B core IgG in serum positive
- risk of reactivation of hepatitis B infection[2]
- drug adverse effects of immunosuppressive agents
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of pharmaceutical monoclonal antibodies
Mechanism of action
- binds specifically to CD20, a B-cell restricted differentiation antigen
- chimeric mouse + human monoclonal Ab[7]
- the monoclonal Ab contains murine light & heavy chain variable regions & human constant region (Fc)
- complement or antibody-dependent cell mediated cytotoxicity
- in cultured cells, rituximab induces apoptosis
- vitamin D may enhance antibody-dependent cellular cytotoxicity by rituximab[18]
Management
- whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent[7]
More general terms
Component of
- rituximab/cyclophosphamide/doxorubicin/vincristine (Oncocin)/prednisone (R-CHOP)
- rituximab/cyclophosphamide/doxorubicin/vincristine (Oncocin)/dexamethasone (R-CVAD)
- rituximab/cyclophosphamide/vincristine (Oncocin)/prednisone (R-CVP)
- N-PEP-12 (MemoProve)
- hylenex/rituximab
- cyclophosphamide/pentostatin/rituximab (PCR regimen)
References
- ↑ Kaiser Permanente Northern California Pharmacy update, 11/2000
- ↑ 2.0 2.1 PDR 2000
- ↑ Rituximab Plus Chemo More Effective in Elderly Lymphoma Patients http://www.nci.nih.gov/clinicaltrials/results/rituximab-plus-chemo0202
- ↑ 4.0 4.1 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: https://www.ncbi.nlm.nih.gov/pubmed/16873669
- ↑ 5.0 5.1 FDA Medwatch http://www.fda.gov/medwatch/safety/2006/safety06.htm#Rituxan
- ↑ 6.0 6.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rituxan
- ↑ 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 Medical Knowledge Self Assessment Program (MKSAP) 15, 16, 17, 18, 19. American College of Physicians, Philadelphia 2009, 2012, 2015, 2018, 2022.
- ↑ 8.0 8.1 Martin-Garrido I et al. Pneumocystis pneumonia in patients treated with rituximab. Chest 2012 Dec 20 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23258406 <Internet> http://journal.publications.chestnet.org/article.aspx?articleid=1486940
- ↑ 9.0 9.1 Gudbrandsdottir S et al. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood 2013 Mar 14; 121:1976. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23293082
- ↑ 10.0 10.1 Specks U et al. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med 2013 Aug 1; 369:417 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23902481 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1213277
- ↑ 11.0 11.1 van Assen S, Holvast A, Benne CA et al Humoral responses after influenza vaccination are severely reduced in patients with rheumatoid arthritis treated with rituximab. Arthritis Rheum. 2010 Jan;62(1):75-81 PMID: https://www.ncbi.nlm.nih.gov/pubmed/20039396
- ↑ Bingham CO 3rd, Looney RJ, Deodhar A et al Immunization responses in rheumatoid arthritis patients treated with rituximab: results from a controlled clinical trial. Arthritis Rheum. 2010 Jan;62(1):64-74 PMID: https://www.ncbi.nlm.nih.gov/pubmed/20039397
- ↑ FDA Drug Safety Communication: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab). September 25, 2013 http://www.fda.gov/Drugs/DrugSafety/ucm366406.htm
- ↑ 14.0 14.1 14.2 14.3 Deprecated Reference
- ↑ Jones RB, Tervaert JW, Hauser T et al Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20 PMID: https://www.ncbi.nlm.nih.gov/pubmed/20647198
- ↑ Oddis CV, Reed AM, Aggarwal R et al Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: a randomized, placebo- phase trial. Arthritis Rheum. 2013 Feb;65(2):314-24. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23124935
- ↑ 17.0 17.1 17.2 Coblyn JS Head-to-Head Comparison of Rituximab vs. TNF Inhibitors for Rheumatoid Arthritis. NEJM Journal Watch. June 21, 2016 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
Porter D, van Melckebeke J, Dale J et al. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): An open-label, randomised controlled, non-inferiority, trial. Lancet. 2016 May 16. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27197690 - ↑ 18.0 18.1 Minerd J. Expert critique by Taylor J Hodgkin Lymphoma Risk: 'Intriguing' Early Links Suggestive of Season Patterns, Role for Vitamin D Relates to biological evidence that vitamin D enhances antibody-dependent cellular cytotoxicity by rituximab. MedPage Today. ASCO Reading Room 06.06.2018 https://www.medpagetoday.com/reading-room/asco/hematologic-malignancies/73311
Hohaus S, Tisi MC, Bellesi S et al. Vitamin D deficiency and supplementation in patients with aggressive B-cell lymphomas treated with immunochemotherapy. Cancer Medicine 2018; 7: 270-281. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29271084 Free PMC Article - ↑ 19.0 19.1 Ingram I Anti-CD20 Drugs Tied to Severe COVID in Cancer Patients - Plus: Active chemo treatment may not be a COVID risk factor. MedPage Today February 5, 2021 https://www.medpagetoday.com/hematologyoncology/lymphoma/91092
- ↑ Medscape: rituximab (Rx) https://reference.medscape.com/drug/rituxan-truxima-rituximab-342243