Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Rituximab

Generic name
Rituximab
Brand name
ATC Code
L01FA01

Pharmacokinetics in children

T1/2 median (range) 22 days ( 11-42 days)
Cl mean (range) 0,221 l/day (0,0996-0,381 l/day) 
Vd mean (range) 2,27 l (1,43-3,17 l).

n=25 (6-17 years) in GPA en MPA.375 mg/m2/week during 4 weeks (SmPC Mabthera)

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

EBV reactivation/PTLD in stem cell transplants
  • Intravenous
    • 1 month up to 18 years
      [2] [3] [4]
      • 375 mg/m²/dose once a week.
      • Duration of treatment:

        4-8 doses
Steroid-dependent nephrotic syndrome, ABO-incompatible kidney transplant (conditions that could lead to or preventing the rejection of the kidney), autoimmune cytopenia, primary vasculitis
Systemic lupus erythematodes (SLE) that does not respond to the conventional therapy
  • Intravenous
    • 1 month up to 18 years
      [31] [32] [35]
      • 375 mg/m²/dose once every 2 weeks.
      • Duration of treatment:

        2 doses
Granulomatosis with polyangiitis (GPA/Wegeners disease), microscopic polyangiitis (MPA)
  • Intravenous
    • 2 years up to 18 years
      [29]
      • Induction of remission: 375 mg/m²/dose once a week. during 4 weeks.

      • Premedication:

        • Methylprednisolone IV 30 mg / kg / day in 1 dose or 60 mg / / kg / day in 2 doses, max 1 g / day on 3 consecutive days prior to the first infusion of rituximab. The last dose methylprednisolone may be administerred shortly before the rituximab infusion. 
        • Prednisolone orally 1 mg / kg / day, max 60 mg/dag. Start at day of rituximab infusion. Taper prednisolone as soon as possible if clinically necessary
Non-Hodgkin Lymphoma
  • Intravenous
    • 6 months up to 18 years
      [29]
      • 375 mg/m²/dose as part of treatment protocol.

      • Dose and dose frequency of cytostatics depend on the condition and are strongly subject to new insights. Cytostatics are often used in combination in oncology / hematology. For these reasons, reference is made to the detailed treatment protocols.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Hypogammaglobulinaemia. Pneumocystis jirovecii pneumonia.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Recommended infusion duration: 3 hours. Fever, chills or rigor may occur during the first infusion. Premedication consisting of paracetamol and an antihistamine must therefore be given before each dose. Be aware of the possibility of blood pressure drops and bronchial spasms. The infusion rate of the first infusion should therefore be increased slowly.

Prophylaxis for Pneumocystis jiroveci pneumonia (PJP) is recommended in children with GPA or MPA during and after treatment with rituximab, as appropriate.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Anthracyclines and related substances
L01DB02
L01DB01
Other cytotoxic antibiotics
L01DC01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Gallego S, et al, Post-transplant lymphoproliferative disorders in children: the role of chemotherapy in the era of rituximab. , Pediatr Transplant, 2010, Feb;14(1), 61-6
  3. Svoboda J et al, Management of patients with post-transplant lymphoproliferative disorder: the role of rituximab, Transpl Int, 2006, Apr;19(4):, 259-69
  4. Worth A et al, Pre-emptive rituximab based on viraemia and T cell reconstitution: a highly effective strategy for the prevention of Epstein-Barr virus-associated lymphoproliferative disease following stem cell transplantation, Br J Haematol, 2011, Nov;155(3), 377-85
  5. Bader-Meunier B et al. , Rituximab therapy for childhood Evans syndrome. , Haematologica. , 2007, Dec;92(12):, 1691-4
  6. Basu B et al. , Favourable renal survival in paediatric microscopic polyangiitis: efficacy of a novel treatment algorithm. , Nephrol Dial Transplant., 2015, Apr;30 Suppl 1:i, 113-8
  7. Billing H et al. , IVIG and rituximab for treatment of chronic antibody-mediated rejection: a prospective study in paediatric renal transplantation with a 2-year follow-up., Transpl Int., 2012, Nov;25(11):, 1165-73
  8. Comoli P et al., Treatment of EBV-related post-renal transplant lymphoproliferative disease with a tailored regimen including EBV-specific T cells., Am J Transplant, 2005 , Jun;5(6):, 1415-22
  9. Donnithorne KJ et al. , Rituximab therapy for severe refractory chronic Henoch-Schönlein purpura. , J Pediatr., 2009, Jul;155(1):, 136-9
  10. Eleftheriou D et al. , Biologic therapy in primary systemic vasculitis of the young., Rheumatology (Oxford)., 2009, Aug;48(8), 978-86
  11. Fornoni A et al. , Rituximab targets podocytes in recurrent focal segmental glomerulosclerosis. , Sci Transl Med., 2011, Jun 1;3(85):, 85ra46
  12. Genberg H et al. , ABO-incompatible kidney transplantation using antigen-specific immunoadsorption and rituximab: a 3-year follow-up., Transplantation, 2008, Jun 27;85(12):, 1745-54
  13. Giulino LB et al. 2007 , Treatment with rituximab in benign and malignant hematologic disorders in children., J Pediatr. , 2007, Apr;150(4):, 338-44, 344.e1
  14. Harambat J et al. , Successful treatment with rituximab for acute refractory thrombotic thrombocytopenic purpura related to acquired ADAMTS13 deficiency: a pediatric report and literature review., Pediatr Crit Care Med., 2011, Mar;12(2), e90-3
  15. Hugle B et al. , Pneumocystis jiroveci pneumonia following rituximab treatment in Wegener's granulomatosis. , Arthritis Care Res (Hoboken)., 2010, Nov;62(11):, 1661-4
  16. Iijima K et al. , Rituximab for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial., Lancet., 2014, Oct 4;384(9950):, 1273-81
  17. Kemper MJ et al. , Is rituximab effective in childhood nephrotic syndrome? Yes and no., Pediatr Nephrol., 2014, Aug;29(8):, 1305-11
  18. Khandelwal P et al. , Outcomes of renal transplant in patients with anti-complement factor H antibody-associated hemolytic uremic syndrome., Pediatr Transplant. , 2014, Aug;18(5):, E134-9
  19. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerulonephritis Work Group. , KDIGO Clinical Practice Guideline for Glomerulonephritis., Kidney int Suppl., 2012, 2, 139–274
  20. Kimata T et al. , Novel use of rituximab for steroid-dependent nephrotic syndrome in children. , Am J Nephrol., 2013, 38(6):, 483-8
  21. Kumar J et al. , Rituximab in post-transplant pediatric recurrent focal segmental glomerulosclerosis., Pediatr Nephrol. , 2013 , Feb;28(2):, 333-8
  22. Liang Y et al. , Rituximab for children with immune thrombocytopenia: a systematic review., PLoS One, 2012, 7(5), :e36698
  23. Losa Frías V et al. , Role of rituximab in the management of refractory autoimmune cytopenia., An Pediatr (Barc). , 2013 , Jun;78(6):, 398-404
  24. Neunert C et al. , The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia., Blood. , 2011 , Apr 21;117(16):, 4190-207
  25. Pescovitz MD et al. , Use of antibody induction in pediatric renal transplantation. , Curr Opin Organ Transplant., 2008 , Oct;13(5):, 495-9
  26. Provan D et al. , International consensus report on the investigation and management of primary immune thrombocytopenia., Blood. , 2010 , Jan 14;115(2):, 168-86
  27. Ravani P et al. , Rituximab is a safe and effective long-term treatment for children with steroid and calcineurin inhibitor-dependent idiopathic nephrotic syndrome., Kidney Int. , 2013 , Nov;84(5):, 1025-33
  28. Reese JA et al. , Children and adults with thrombotic thrombocytopenic purpura associated with severe, acquired Adamts13 deficiency: comparison of incidence, demographic and clinical features., Pediatr Blood Cancer. , 2013 , Oct;60(10):, 1676-82
  29. Roche registration limited. , SPC Mabthera (EU/1/98/067) 25-03-2020, www.ema.europa.eu
  30. Steele M et al. , Thrombotic thrombocytopenic purpura in pediatric patients., Zhongguo Dang Dai Er Ke Za Zhi. , 2012 , Nov;14(11):, 803-10
  31. Su GX et al. , Rituximab therapy for severe pediatric systemic lupus erythematosus., Zhonghua Er Ke Za Zhi., 2012 , Sep;50(9):, 697-704
  32. Tullus K et al. , New developments in the treatment of systemic lupus erythematosus., Pediatr Nephrol., 2012 , May;27(5):, 727-32
  33. Tydén H et al. , ABO-incompatible kidney transplantation in children., Pediatr Transplant. , 2011, Aug;15(5):, 502-4
  34. Vinai M et al. , Recurrence of focal segmental glomerulosclerosis in renal allograft: an in-depth review., Pediatr Transplant. , 2010 , May;14(3):, 314-25
  35. Watson L et al. , The indications, efficacy and adverse events of rituximab in a large cohort of patients with juvenile-onset SLE., Lupus. , 2015 , Jan;24(1), 10-7
  36. Zarkhin V et al. , A randomized, prospective trial of rituximab for acute rejection in pediatric renal transplantation., Am J Transplant., 2008 , Dec;8(12):, 2607-17
  37. Stojanovic J et al. , Immune Desensitization Allows Pediatric Blood Group Incompatible Kidney Transplantation, Transplantation. , 2017 , Jun;101(6), 1242-1246

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Changes

Changes