Rixathon

Rixathon

rituximab

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Rituximab
Indications/Uses
Treatment of previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy. Maintenance therapy for the treatment of follicular lymphoma patients responding to induction therapy. Monotherapy for treatment of patients w/ stage III-IV follicular lymphoma who are chemoresistant or are in their 2nd or subsequent relapse after chemotherapy. Treatment of patients w/ CD20 +ve diffuse large B cell non-Hodgkin's lymphoma in combination w/ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. In combination w/ chemotherapy for the treatment of patients w/ previously untreated & relapsed/refractory chronic lymphocytic leukaemia.
Dosage/Direction for Use
IV infusion 1st infusion: Initially 50 mg/hr. After the 1st 30 min, escalate in 50 mg/hr increments every 30 min to a max 400 mg/hr. Subsequent infusions: Initially 100 mg/hr, increased by 100 mg/hr increments at 30-min intervals to a max 400 mg/hr. Combination therapy for induction treatment of previously untreated or relapsed/refractory patients w/ follicular non-Hodgkin's lymphoma 375 mg/m2 per cycle, for up to 8 cycles. Administer on day 1 of each chemotherapy cycle, after IV administration of the glucocorticoid component of the chemotherapy if applicable. Maintenance therapy for previously untreated follicular lymphoma 375 mg/m2 once every 2 mth (starting 2 mth after the last dose of induction therapy) until disease progression or for a max period of 2 yr (12 infusions in total). Maintenance therapy for relapsed/refractory follicular lymphoma 375 mg/m2 once every 3 mth (starting 3 mth after the last dose of induction therapy) until disease progression or for a max period of 2 yr (8 infusions in total). Monotherapy as induction treatment for adults w/ stage III-IV follicular lymphoma who are chemoresistant or are in their 2nd or subsequent relapse after chemotherapy 375 mg/m2 IV infusion once wkly for 4 wk. Retreatment w/ Rixathon monotherapy in patients who have responded to previous treatment w/ rituximab monotherapy for relapsed/refractory follicular lymphoma 375 mg/m2 IV infusion once wkly for 4 wk. Diffuse large B cell non-Hodgkin's lymphoma 375 mg/m2, administered on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of the glucocorticoid component of CHOP. Chronic lymphocytic leukaemia 375 mg/m2 administered on day 0 of the 1st treatment cycle followed by 500 mg/m2 administered on day 1 of each subsequent cycle for 6 cycles in total. The chemotherapy should be given after Rixathon infusion.
Contraindications
Hypersensitivity to rituximab or to murine proteins. Active, severe infections. Patients in a severely immunocompromised state. Granulomatosis w/ polyangiitis & microscopic polyangiitis: Severe heart failure (NYHA class IV) or severe, uncontrolled cardiac disease.
Special Precautions
Should not be administered as IV push or bolus. Associated w/ infusion-related reactions including syndrome of cytokine release, tumour lysis syndrome & anaphylactic & hypersensitivity reactions. Monitor patients at regular intervals for any new or worsening neurological symptoms or signs suggestive of progressive multifocal leukoencephalopathy (PML). Permanently discontinue Rixathon if PML develops. Risk of angina pectoris, cardiac arrhythmias eg, atrial flutter & fibrillation, heart failure &/or MI; serious infections; hepatitis B reactivation. Caution in patients w/ neutrophils <1.5 x 109/L &/or platelet counts <75 x 109/L. Perform regular full blood counts during therapy. Permanently discontinue in case of severe skin reactions eg, TEN & SJS. Patients on a controlled Na diet. Vaccination w/ live virus vaccines is not recommended. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following treatment. Should not be administered to pregnant women unless the possible benefit outweighs the potential risk. Breast-feeding is not recommended while on treatment & for 12 mth following Rixathon treatment.
Adverse Reactions
Infusion related reactions, angioedema; bacterial infections, viral infections, bronchitis; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; nausea; pruritus, rash, alopecia; fever, chills, asthenia, headache; decreased IgG levels.
Drug Interactions
Patients w/ human anti-mouse Ab (HAMA) or anti-drug Ab (ADA) titres may have allergic or hypersensitivity reactions when treated w/ other diagnostic or therapeutic monoclonal Ab.
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
2 × 1's
Form
Rixathon conc for soln for infusion 500 mg/50 mL
Packing/Price
1's
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