• CD20-positive Non-Hodgkin’s Lymphoma:
    • In children:
      • Previously untreated, 6 months and older: IV 375mg/m2/dose on days 1 and 2 during induction treatment *2 cycles, then 375mg/m2/dose on day 1 during consolidation treatment *2 cycles (total of 6 doses)
      • For patients with advanced stage, diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma or mature B-cell acute leukemia
      • Part of multi-drug chemo regimen
    • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL;
      • As a single agent: IV 375mg/m2 once weekly *4-8 doses
      • Retreatment: IV 375 mg/m2 once weekly *4 doses
      • In combination with ibritumomab: IV 250mg/m2/dose *1 on day 1, then on days 7, 8 or 9 of regimen
    • Previously untreated follicular, CD20-positive, B-cell NHL:
      • In combination with first line chemotherapy: IV 375mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses
      • If complete or partial response achieved, may give maintenance monotherapy: IV 375mg/m2/dose *1 on day 1 of 56-day cycle *12 cycles starting 56 days after completion of 1st-line combo chemo
      • In combination with ibritumomab: IV 250mg/m2/dose *1 on day 1, then on days 7, 8 or 9 of regimen
        • Administer ibritumomab within 4 hours following completion of rituximab infusion
    • Nonprogressing, low-grade, CD20-positive, B-cell NHL as a single agent after first-line chemotherapy: IV 375mg/m2/dose *1 on days 1, 8, 15, 22 of 6 month cycle
    • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with other chemotherapy agents: IV 375 mg/m2 on day 1 of each cycle of chemotherapy for up to 8 infusions
  • CD20-positive Chronic Lymphocytic Leukemia:
    • 375 mg/m2 IV infusion on day 1 of 1st cycle (for 1st cycle, administer 1 day before chemotherapy with FC),then 500 mg/m2 on day 1 of cycles 2-6 (administer on same day as chemotherapy with FC)
    • Combined therapy with fludarabine and cyclophosphamide (FC)
  • Moderately-to severely-active rheumatoid arthritis:
    • IV 1000mg every 2 weeks *2 doses
    • May repeat course every 16-24 weeks
    • Use with methotrexate
    • For patients with inadequate response to TNF antagonist
  • Granulomatosis with polyangiitis (GPA; Wegener granulomatosis) with glucocorticoids:
    • Induction:
      • Adults and children >2 years: IV 375mg/m2 once weekly *4/52
    • Follow up treatment:
      • Adults: IV 500mg every 2 weeks *2 doses, then 500mg every 6 months
      • Children >2 years: IV 250mg every 2 weeks *2 doses, then 250mg every 6 months
      • Started 16-24 weeks after last induction treatment with rituximab, or within 4 weeks of disease control achieved with other standard of care immunosuppressants
  • Microscopic polyangiitis (MPA) in combination with glucocorticoids:
    • Induction:
      • Adults & children >2 years: IV 375mg/m2 once weekly *4/52
    • Follow up treatment:
      • Adults: IV 500mg every 2 weeks *2 doses, then 500mg every 6 months
      • Children >2 years: IV 250mg every 2 weeks *2 doses, then 250mg every 6 months
  • Moderate-to-severe pemphigus vulgaris (PV):
    • Induction: IV 1000mg *1, then repeat dose in 2 weeks then starting at month 12, give 500mg 6 months
    • Treatment relapse: IV 1000mg
      • Maintenance and relapse doses should be dosed at least 16 weeks apart
  • Myasthenia gravis (Off-label):
    • IV 375mg/m2/dose weekly *4/52

Injection: 10mg/mL

  • Give HBV prophylaxis before treatment start, during treatment and for up to 12 months after discontinuation in anti-HBc positive patients
  • Do not mix with other drugs when preparing IV
  • Before each infusion premedicate with acetaminophen and an antihistamine
  • For a rapid 90-min infusion, administer glucocorticoid component of the chemotherapy regimen before infusion
  • Should ONLY be given as an IV infusion
  • Vials should be refrigerated

Anti-CD20 Monoclonal Antibodies

It binds to B-lymphocyte CD20 surface antigens, inducing cell lysis of CD20-expressing cells via antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)

  • Fever
  • Lymphopenia
  • Febrile neutropenia
  • Nausea
  • Rigors
  • Stomatitis
  • Asthenia
  • Infection
  • Headache
  • Arthralgia
  • Hypertension
  • Rash
  • Abdominal pain
  • Leukopenia
  • Cough
  • Rhinitis
  • Night sweats
  • Diarrhea
  • Pruritus
  • Neutropenia
  • URI
  • Anemia
  • Peripheral edema
  • Increased ALT/AST
  • Pain
  • Thrombocytopenia
  • Dizziness
  • Urticaria
  • Angioedema
  • Enteritis
  • Infusion reaction
  • Hypotension
  • Myalgia
  • Vomiting
  • Dyspnea
  • Hyperglycemia
  • Sepsis
  • Anxiety
  • Bronchospasm
  • Hypokalemia
  • Hypersensitivity to class/components
  • Hypersensitivity to murine protein
  • Active severe infection
  • Breastfeeding during treatment and for 6 months after discontinuation

WARNING

  • Serious, including fatal infusion reactions can occur; deaths have been reported within 24 hours of infusion
  • Severe mucocutaneous reactions can occur
  • Reactivation of hepatitis B virus (HBV) infection reported, including deaths
  • John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy and death has been reported
  • Live vaccines
  • Tamoligene
  • Cidofovir

                          Drug Status

Availability Prescription only
Pregnancy Category C
Breastfeeding Contraindicated
Schedule Not controlled
BRAND NAME STRENGTH FORMULATION PACK SIZE MANUFACTURER DISTRIBUTOR
Mabthera 100mg/10mL Injection 1’s F. Hoffman-La Roche Roche Kenya
Mabthera 500mg/50mL Injection 1’s F. Hoffman-La Roche Roche Kenya
Rilast 100mg/10mL Injection 1’s Hetero Biopharma Unisel Ltd
Rilast 500mg/50mL Injection 1’s Hetero Biopharma Unisel Ltd
Rituximab Amring 100mg/10mL Injection 2’s Amring Pharma Surgipharm Ltd
Rituximab Amring 500mg/50mL Injection 1’s Amring Pharma Surgipharm Ltd
Rituxirel 100mg/10mL Injection 1’s Galaxy Pharma Galaxy Pharma
Rituxirel 500mg/50mL Injection 1’s Galaxy Pharma Galaxy Pharma