Dose and Dosage

  • Dosage and Administration

    Administer only as an Intravenous Infusion.

    Do not administer as an intravenous push or bolus.

    Premedicate before each infusion with acetaminophen and an antihistamine.

    Premedicate before each infusion with acetaminophen and an antihistamine.

    Rituximab should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.

  • Recommended dose for RA

    Administer rituximab as two-1000 mg intravenous infusions separated by 2 weeks.

    Glucocorticoids administered as methylprednisolone 100 mg intravenous or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions.

    Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.

    Rituximab is given in combination with methotrexate.

  • Recommended dose for Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA):

    Administer rituximab as a 375 mg/m intravenous infusion once weekly for 4 weeks (four infusions in total)

    Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment

    Safety and efficacy of treatment with subsequent courses of rituximab have not been established

    Pneumocystis jiroveci pneumonia (PCP) prophylaxis is recommended for patients during and following the treatment, as appropriate

About Vortuxi

Method of Administration

The prepared rituximab solution should be administered as an intravenous infusion through a dedicated line. It should not be administered as an intravenous push or bolus. Patients should be closely monitored for the onset of IRRs. Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately. The infusion should not be restarted until complete resolution of all symptoms. At this time, the infusion can be initially resumed at not more than one-half the previous rate. If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis. Mild or moderate infusion-related reactions (IRR) usually respond to a reduction in the rate of infusion. The infusion rate may be increased upon improvement of symptoms.

First infusion: The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h. Subsequent infusions: Subsequent doses of rituximab can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.

Alternative subsequent, faster, infusion schedule for RA patients: If patients did not experience a serious infusion related reaction with their first or subsequent infusions of a dose of 1000 mg rituximab administered over the standard infusion schedule, a more rapid infusion can be administered for second and subsequent infusions using the same concentration as in previous infusions (4 mg/ml in a 250 ml volume). Initiate at a rate of 250 mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes. If the more rapid infusion is tolerated, this infusion schedule can be used when administering subsequent infusions.

Patients who have clinically significant cardiovascular disease, including arrhythmias, or previous serious infusion reactions to any prior biologic therapy or to rituximab, should not be administered the more rapid infusion Elderly patients: No dose adjustment is required in elderly patients (aged >65 years).