MabThera IV

MabThera IV

rituximab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Rituximab
Indications/Uses
Relapsed or chemoresistant low-grade or follicular, CD20 +ve, B-cell non-Hodgkin's lymphoma (NHL); previously untreated patients w/ stage III-IV follicular lymphoma (FL) in combination w/ chemotherapy; maintenance treatment in FL after response to induction therapy; CD20 +ve diffused large B-cell (DLBCL) NHL in combination w/ CHOP chemotherapy. In combination w/ chemotherapy for previously untreated & relapsed/refractory CD20 +ve chronic lymphocytic leukemia (CLL). In combination w/ methotrexate (MTX) for adult patients w/ active RA & inadequate response or intolerance to ≥1 tumor necrosis factor (TNF) inhibitor therapies. In combination w/ glucocorticoids for adult patients w/ severe active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA).
Dosage/Direction for Use
FL Monotherapy: Initially 375 mg/m2 once wkly for 4 wk. FL in combination w/ chemotherapy 375 mg/m2 on day 1 of each cycle after IV administration of glucocorticoid component of chemotherapy. FL retreatment after relapse Patient who have responded to MabThera IV, 375 mg/m2 once wkly for 4 wk. FL maintenance treatment Previously untreated patient 375 mg/m2 once every 2 mth until disease progression or max period: 2 yr. Relapse/refractory patient 375 mg/m2 once every 3 mth until disease progression or max period: 2 yr (8 infusions). DLBCL 375 mg/m2 on day 1 of each CHOP cycle for 8 cycles in total after IV administration of CHOP glucocorticoid component. CLL 375 mg/m2 on day 1 of 1st chemotherapy cycle followed by 500 mg/m2 on day 1 of each subsequent cycle for total: 6 cycles. Chemotherapy should be given after MabThera IV. RA Two 1,000 mg IV infusion given 2 wk apart. GPA & MPA 375 mg/m2 once wkly for 4 wk. Severe vasculitis Methylprednisolone 1,000 mg IV daily in combination w/ MabThera IV followed by oral prednisone 1 mg/kg daily (not to exceed 80 mg daily) during & after MabThera IV.
Contraindications
Hypersensitivity to rituximab or murine proteins.
Special Precautions
Infusion-related reactions, pulmonary events, rapid tumour lysis, CV events, neutrophil counts of <1.5 x 109/L &/or platelet counts of <75 x 109/L, increased infection risk, hepatitis B reactivation, progressive multifocal leukoencephalopathy, severe skin reactions eg, toxic epidermal necrolysis & Stevens-Johnson syndrome. Not recommended w/ concomitant use of live vaccines. Not recommended for use in methotrexate-naive populations. Renal & hepatic impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy &  lactation. Childn & adolescents <18 yr.
Adverse Reactions
Haemato-oncology Bacterial or viral infections, neutropenia (including febrile neutropenia), leucopenia, angioedema, nausea, pruritus, rash, fever, chills, asthenia, headache, decreased IgG levels, bronchitis, thrombocytopenia, alopecia. RA Upper resp tract infection, UTI, infusion-related reactions. GPA & MPA Infections, nausea, diarrhea, headache, muscle spasm, arthralgia, anaemia, leukopaenia, peripheral edema, fatigue, insomnia, increased ALT, cough, epistaxis, dypsnea, HTN, infusion-related reactions, rash.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC02 - rituximab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
MabThera IV infusion 100 mg/10 mL
Packing/Price
2 × 1's
Form
MabThera IV infusion 500 mg/50 mL
Packing/Price
1's
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