Redditux Dosage/Direction for Use

Rituximab (Redditux) should only be administered under close supervision by an experienced medical person in a facility where immediate resuscitation measures are available.
Premedication and Prophylactic medications: Premedication with glucocorticoids should be considered if rituximab is not given in combination with glucocorticoid-containing chemotherapy for treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukaemia.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be administered before each infusion of Rituximab (Redditux).
In patients with non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, premedication with glucocorticoids should be considered if Rituximab (Redditux) is not given in combination with glucocorticoid containing chemotherapy.
Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome. For CLL patients whose lymphocyte counts are > 25 x 10⁹/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with rituximab to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Redditux infusions to decrease the incidence and severity of infusion related reactions (IRRs).
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, 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 (Redditux) (the last dose of methylprednisolone may be given on the same day as the first infusion of Rituximab (Redditux)). 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 (Redditux) treatment.
Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following Rituximab (Redditux) treatment, as appropriate according to local clinical practice guidelines.
Posology: Follicular non-Hodgkin's lymphoma: Combination therapy: The recommended dose of Rituximab (Redditux) in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular NHL is: 375 mg/m² body surface area per cycle, for up to 8 cycles.
Rituximab (Redditux) should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Maintenance therapy: Previously untreated follicular lymphoma: The recommended dose of Rituximab (Redditux) used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m² body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years.
Relapsed/refractory follicular lymphoma: The recommended dose of Rituximab (Redditux) used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m² body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years.
Monotherapy: Relapsed/refractory follicular lymphoma: The recommended dose of Rituximab (Redditux) monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m² body surface area, administered as an intravenous infusion once weekly for four weeks.
For retreatment with Rituximab (Redditux) monotherapy for patients who have responded to previous treatment with Redditux monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m² body surface area, administered as an intravenous infusion once weekly for four weeks.
Diffuse large B cell non-Hodgkin's lymphoma: Rituximab (Redditux) should be used in combination with CHOP chemotherapy. The recommended dosage is 375 mg/m² body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP. Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Dosage adjustments during treatment: No dose reductions of Rituximab (Redditux) are recommended. When Rituximab (Redditux) is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Chronic lymphocytic leukaemia: The recommended dosage of Rituximab (Redditux) in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m² body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m² body surface area administered on day 1 of each subsequent cycle for 6 cycles in total. The chemotherapy should be given after rituximab infusion.
Granulomatosis with polyangiitis and microscopic polyangiitis: Induction of remission: The recommended dosage of Rituximab (Redditux) for induction of remission therapy of granulomatosis with polyangiitis and microscopic polyangiitis is 375 mg/m² body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Maintenance treatment: Following induction of remission with Rituximab (Redditux), maintenance treatment should be initiated no sooner than 16 weeks after the last Rituximab (Redditux) infusion.
Following induction of remission with other standard of care immunosuppressants, Rituximab (Redditux) maintenance treatment should be initiated during the 4 week period that follows disease remission.
Rituximab (Redditux) should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter. Patients should receive Rituximab (Redditux) 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 (Redditux) maintenance therapy, up to 5 years.
Pemphigus vulgaris: The recommended dosage of Rituximab (Redditux) for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Maintenance treatment: A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Treatment of relapse: In the event of relapse, patients may receive 1000 mg IV. The healthcare provider should also consider resuming or increasing the patient's glucocorticoid dose based on clinical evaluation.
Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion.
Special populations: Paediatric use: Safety and efficacy of rituximab is not established below the age of 18 yrs.
Elderly: No dose adjustment is required in elderly patients (aged >65 years).
Method of Administration: The prepared Rituximab (Redditux) 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 (see Precautions). Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately. Patients with non-Hodgkin's lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest x-ray. In all patients, 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 (see Adverse Reactions) 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/hr; after the first 30 minutes, it can be escalated in 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
Subsequent infusions: Subsequent doses of Redditux can be infused at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30 minutes intervals, to a maximum of 400 mg/hr.