MabThera SC

MabThera SC

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) non-Hodgkin's lymphoma in combination w/ CHOP chemotherapy.
Dosage/Direction for Use
All NHL patient must receive 1st dose of MabThera by IV administration at 375 mg/m2. Low-grade or FL initial treatment Monotherapy: 1,400 mg once wkly for 4 wk. Combination therapy: 1,400 mg on day 0 or 1 of each cycle after administration of glucocorticoid component of chemotherapy. Low-grade or FL re-treatment after relapse 1,400 mg once wkly for 4 wk. Low-grade or FL maintenance treatment in previously untreated patient 1,400 mg once every 2 mth until disease progression or max 2 yr. Low-grade or FL maintenance treatment in relapsed/refractory patient 1,400 mg once every 3 mth until disease progression or max 2 yr. DLBCL 1,400 mg on day 1 of each cycle for 8 cycles, after IV administration of the glucocorticoid component of CHOP.
Contraindications
Hypersensitivity to rituximab or murine proteins.
Special Precautions
Inj site reactions, pulmonary events, rapid tumour lysis, CV events. Patients w/ neutrophil counts of <1.5 x109/L &/or platelet counts of <75 x 109/L, increased infection risk, hepatitis B reactivation, progressive multifocal leukoencephalopathy (PML), severe skin reactions eg, toxic epidermal necrolysis & Stevens-Johnson syndrome. Not recommended w/ concomitant use of live vaccines. Not to be used during pregnancy & lactation, paed population.
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.
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 SC inj 1,400 mg/11.7 mL
Packing/Price
(single-dose) 1's
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