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Mabarex (Rituximab) Oncology

Rituximab is a Chimeric Monoclonal Antibody

Composition: 
Active ingredient: Rituximab. Vials contain 100mg/10ml and 500mg/50 ml.

Indication:
Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL, Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL, Previously Untreated, Follicular, CD20-Positive, B-Cell NHL Non-progressing, Low-Grade, CD20-Positive, B-cell NHL, after first-line CVP chemotherapy, Diffuse Large B-Cell NHL, CLL

Dosage and Administration:

Dose:
375 mg/m2 (duration and Frequency of administration depends on the ongoing chemotherapy

Administer only as an Intravenous Infusion. Do not administer as an intravenous push or bolus. Premedicate before each infusion.

First Infusion of each course: Recommended initial infusion rate is 50mg/hr; after the first 30 minutes, can be escalation in 50mg/hr, increments every 30 minutes to a maximum of 400mg/hr.

Subsequent infusions in each course: Subsequent doses of Rituximab can be infused at an initial rate of 100mg/hr, increase by 100mg/hr increments at 30minutes intervals, to a maximum of 400mg/hr.

Special Dosage Instructions:
No dose adjustment is required in elderly patients. Safety and efficacy is not established in children.

Storage:
Store vials at 2°C – 8°C (in a refrigerator).

Mabarex – RITUXIMAB in RA

Composition:
Active ingredient: Rituximab. Vials contain 100mg/10ml and 500mg/50 ml.

Indication:
For the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF inhibitor therapies.

In combination with glucocorticoids is indicated for the treatment of adult patients with Wegener’s Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

Dosage and Administration:

Premedicate the patient: 
A course of Rituximab consists of two infusions: the recommended dosage is 1000mg by i.v. infusion followed by a second 1000mg i.v. infusion two weeks later. The need for further courses should be evaluated 24 weeks following the previous course. Retreatment should be given at that time if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns. Patients should receive treatment with 100 mg intravenous methylprednisolone to be completed 30 minutes prior to Rituximab infusions to decrease the incidence and severity of infusion related reactions.

Storage: 
Store vials at 2°C – 8°C

Presentation:
Rituximab is supplied as vials of l0ml (10mg/ml) [each pack contains 1 vial] and vials of 50ml (10mg/ml) [each pack contains 1 vial].