- 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
- In children:
-
- 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
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL;
-
- 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
- In combination with first line chemotherapy: IV 375mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses
- Previously untreated follicular, CD20-positive, B-cell NHL:
-
-
- 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
- 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
- Administer ibritumomab within 4 hours following completion of rituximab infusion
- In combination with ibritumomab: IV 250mg/m2/dose *1 on day 1, then on days 7, 8 or 9 of regimen
-
-
- 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
- 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
- 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
- Adults and children >2 years: IV 375mg/m2 once weekly *4/52
- Induction:
-
- 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
- Follow up treatment:
- Microscopic polyangiitis (MPA) in combination with glucocorticoids:
- Induction:
- Adults & children >2 years: IV 375mg/m2 once weekly *4/52
- Induction:
-
- 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
- Follow up treatment:
- 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
- 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
- Treatment relapse: IV 1000mg
- 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 |