Active Ingredient: Rituximab
Rituximab, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
Rituximab, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active GPA (Wegener’s) and MPA.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 375 milligrams rituximab per square meter of body surface, once weekly, 4 doses in total, over the duration of 20 weeks. Afterwards, intravenous, 500 milligrams rituximab, once every 2 weeks, 2 doses in total. Afterwards, intravenous, 500 milligrams rituximab, once every 6 months, over the duration of 2 to 5 years.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of rituximab.
In patients with GPA or MPA, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to each infusion of rituximab to decrease the incidence and severity of infusion related reactions (IRRs).
In adult patients with GPA or MPA, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of rituximab (the last dose of methylprednisolone may be given on the same day as the first infusion of rituximab). This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of rituximab treatment.
Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for adult patients with GPA/MPA during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Patients treated with rituximab must be given the patient alert card with each infusion.
The recommended dosage of rituximab for induction of remission therapy in adult patients with GPA and MPA is 375 mg/m² body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Following induction of remission with rituximab, maintenance treatment in adult patients with GPA and MPA should be initiated no sooner than 16 weeks after the last rituximab infusion.
Following induction of remission with other standard of care immunosuppressants, rituximab maintenance treatment should be initiated during the 4 week period that follows disease remission.
Rituximab should be administered as two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter. Patients should receive rituximab for at least 24 months after achievement of remission (absence of clinical signs and symptoms). For patients who may be at higher risk for relapse, physicians should consider a longer duration of rituximab maintenance therapy, up to 5 years.
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 cytokine release syndrome. 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, and normalisation of laboratory values and chest X-ray findings. 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 (IRRs) usually respond to a reduction in the rate of infusion. The infusion rate may be increased upon improvement of symptoms.
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 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.
For:
In case that patient age in years is ≥ 2, intravenous, 375 milligrams rituximab per square meter of body surface, once weekly, over the duration of 4 weeks.
In paediatric patients with GPA or MPA, prior to the first rituximab intravenous infusion, methylprednisolone should be given intravenous for three daily doses of 30 mg/kg/day (not to exceed 1 g/day) to treat severe vasculitis symptoms. Up to three additional daily doses of 30 mg/kg intravenous methylprednisolone can be given prior to the first rituximab infusion.
Following completion of intravenous methylprednisolone administration, patients should receive oral prednisone 1 mg/kg/day (not to exceed 60 mg/day) and tapered as rapidly as possible per clinical need.
Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for paediatric patients with GPA or MPA during and following rituximab treatment, as appropriate.
The recommended dosage of rituximab for induction of remission therapy in paediatric patients with severe, active GPA or MPA is 375 mg/m² BSA, administered as an intravenous infusion once weekly for 4 weeks.
The safety and efficacy of rituximab in paediatric patients (≥2 to <18 years of age) has not been established in indications other than severe, active GPA or MPA.
Rituximab should not be used in paediatric patients less than 2 years of age with severe, active GPA or MPA as there is a possibility of an inadequate immune response towards childhood vaccinations against common, vaccine preventable childhood diseases (e.g. measles, mumps, rubella, and poliomyelitis).
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 cytokine release syndrome. 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, and normalisation of laboratory values and chest X-ray findings. 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 (IRRs) usually respond to a reduction in the rate of infusion. The infusion rate may be increased upon improvement of symptoms.
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 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.
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