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See related MabThera inj information |
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Manufacturer |
Roche |
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Distributor |
Hong Kong: DKSH |
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Contents |
Rituximab |
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Indications |
Treatment of patients w/ stage III-IV follicular lymphoma who are chemoresistant or are in the 2nd or subsequent relapse after chemotherapy; previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy. Treatment of patients w/ CD20 positive diffuse large B-cell non-Hodgkin's lymphoma (NHL) in combination w/ cyclophosphamide, doxorubicin, vincristine & prednisolone (CHOP) chemotherapy. In combination w/ chemotherapy for the treatment of patients w/ previously untreated & relapsed/refractory chronic lymphocytic leukaemia (CLL). In combination w/ methotrexate (MTX) for the treatment of adult patients w/ moderate to severe active RA after failing ≥1 treatments w/ tumour necrosis factor (TNF) inhibitors. Maintenance therapy in patients w/ relapsed/refractory follicular lymphoma responding to induction therapy w/ chemotherapy w/ or w/o rituximab. |
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Dosage |
IV infusion only. Follicular NHL Monotherapy: 375 mg/m2 BSA once wkly for 4 wk. Maintenance: Previously untreated follicular lymphoma 375 mg/m2 BSA once every 2 mth until disease progression or max of 2 yr. Relapsed/refractory follicular lymphoma 375 mg/m2 BSA once every 3 mth until disease progression or max of 2 yr. Combination therapy: 375 mg/m2 BSA on day 1 of each chemotherapy cycle for 8 cycles administered after IV infusion of glucocorticoid component of chemotherapy. Diffuse large B-cell NHL in combination w/ CHOP chemotherapy 375 mg/m2 BSA on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of the glucocorticoid component of CHOP. CLL in combination w/ chemotherapy 375 mg/m2 BSA on day 0 of the 1st treatment cycle followed by 500 mg/m2 BSA on day 1 of each subsequent cycle for 6 cycles. RA 2 courses of 1,000 mg given 2 wk apart. |
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Contraindications |
Hypersensitivity to murine proteins. Patient w/ severe active infection or severely immunocompromised. Lactation. |
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Special Precautions |
Patients w/ high number (>25 x 109/L) of circulating malignant cells or high tumour burden. Pulmonary insufficiency, pulmonary tumour infiltration or other severe infusion-related symptoms; cardiac disease. Laboratory monitoring for patients w/ rapid tumour lysis. Neutrophil count <1.5 x 109/L &/or platelet count <75 x 109/L. HBV infection. Progressive multifocal leukoencephalopathy. Use of live vaccines. MTX-naive patients. Pregnancy. Childn. |
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Adverse Drug Reactions |
Bacterial or viral infections, neutropenia (including febrile neutropenia), leucopenia, angioedema, nausea, pruritus, rash, fever, chills, asthenia, headache, decreased IgG levels. Bronchitis, thrombocytopenia, alopecia. Upper resp tract infection, UTI, infusion related reactions.
View ADR Monitoring Form |
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Pregnancy Category (US FDA) |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
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ATC Classification |
L01XC02 - rituximab ; Belongs to the class of monoclonal antibodies antineoplastic agents. Used in the treatment of cancer. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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MabThera injection |
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MabThera 100 mg/10 mL x 2's |
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MabThera 500 mg/50 mL x 1's |
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Manufacturer: |
Roche |
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Distributor: |
Hong Kong: DKSH |
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