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Rixathon

Rixathon

rituximab

Manufacturer:

Lek Pharma
Concise Prescribing Info
Contents
Rituximab

Information is sourced from publicly available references. The information is for educational purpose of healthcare professionals and we are not liable for any loss or damage.
Indications/Uses
Relapsed or chemoresistant indolent B-cell non-Hodgkin's lymphoma (NHL). CD20 +ve diffuse large B-cell NHL (DLCL) in combination w/ cyclophosphamide, doxorubicin, vincristine & prednisone (CHOP). Stage III-IV follicular lymphoma in combination w/ cyclophosphamide, vincristine & prednisone (CVP) chemotherapy in previously untreated patient. Maintenance therapy for follicular lymphoma in patients responding to induction therapy. Chronic lymphocytic leukaemia (CLL) in combination w/ fludarabine & cyclophosphamide (FC) in previously untreated patient & previously treated CD20 +ve CLL. In combination w/ MTX for adult patients w/ severe active RA who have had inadequate response or intolerance to ≥1 tumour necrosis factor (TNF) inhibitor therapies.
Dosage/Direction for Use
Premed w/ analgesic/antipyretic (eg, paracetamol) & antihistamine (eg, diphenhydramine) before each infusion; may consider premed w/ corticosteroids if not given in combination w/ glucocorticoid-containing chemotherapy for NHL. IV infusion Low-grade or follicular NHL Adult Monotherapy: Initially 375 mg/m2 once wkly for 4 wk. In combination w/ CVP chemotherapy: 375 mg/m2 for 8 cycles (21 days/cycle) administered on day 1 of each cycle after corticosteroid IV. Re-treatment following relapse: 375 mg/m2 once wkly for 4 wk. Patient w/ previously untreated follicular lymphoma Maintenance: 375 mg/m2 once every 2 mth (starting 2 mth after last dose of induction therapy) until disease progression. Max: 2 yr. Relapsed/refractory follicular lymphoma Maintenance: 375 mg/m2 once every 3 mth until disease progression. Max: 2 yr. DLCL In combination w/ CHOP chemotherapy: 375 mg/m2 on day 1 of each cycle after corticosteroid IV. CLL 1st infusion: 375 mg/m2 in the 1st cycle. Initial infusion rate: 50 mg/hr, may increase by 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent infusions: 500 mg/m2 in cycles 2-6, in combination w/ FC, administered every 28 days. Infusion rate: 100 mg/hr may increase by 100 mg/hr increments every 30 min. Max: 400 mg/hr. Prophylaxis w/ adequate hydration & administer uricostatics 48 hr prior to start of therapy. Patient w/ lymphocyte count >25 x 109/L Administer prednisone/prednisolone 100 mg IV shortly before Rixathon infusion. RA 1,000 mg followed 2 wk later by 2nd 1,000 mg. Premed w/ methylprednisolone 100 mg IV 30 min prior to therapy. Alternative subsequent, faster, infusions schedule: 4 hr 15 min for the 1st infusion & 3 hr 15 min for the 2nd infusion. If patients did not experience serious infusion-related adverse event, initiate at a rate of 250 mg/hr for the 1st 30 min & then 600 mg/hr for the next 90 min.
Contraindications
Hypersensitivity to rituximab or murine proteins. Active, severe infections. Severely immunocompromised patients.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FA01 - rituximab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Rixathon conc for soln for infusion 100 mg/10 mL
Packing/Price
1's
Form
Rixathon conc for soln for infusion 500 mg/50 mL
Packing/Price
1's
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