Sign Out
It is important to check the product labels to ensure that the appropriate strength is being given to the patients, as prescribed.
Truxima should be administered as an IV infusion through a dedicated line, in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced physician.
Do not administer the prepared infusion solutions as an IV push or bolus.
Premedication and Prophylactic Medications: Premedication consisting of an analgesic/anti-pyretic (e.g. paracetamol/acetaminophen) and an anti-histaminic drug (e.g. diphenhydramine) should always be administered before each infusion of Truxima. Premedication with glucocorticoids should be administered in order to reduce the frequency and severity of infusion-related reactions.
In adult patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Truxima is not given in combination with glucocorticoid-containing chemotherapy. In pediatric patients with non-Hodgkin's lymphoma, premedication with paracetamol and H1 antihistamine (= diphenhydramine or equivalent) should be administered 30 to 60 minutes before the start of the infusion of Truxima. In addition, prednisone should be given as indicated in Table 23.
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 intravenously shortly before administration with Truxima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
In patients with rheumatoid arthritis, GPA or MPA or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to each infusion of Truxima 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 Truxima (the last dose of methylprednisolone may be given on the same day as the first infusion of Truxima). 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 Truxima treatment.
Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for adult patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Pediatric population: In pediatric patients with GPA or MPA, prior to the first Truxima 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 Truxima 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 (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for paediatric patients with GPA or MPA during and following rituximab treatment, as appropriate.
Dosage adjustments during treatment: No dose reductions of Truxima are recommended. When Truxima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic drugs should be applied.
Standard dosage: Low-grade or follicular non-Hodgkin's lymphoma: Initial treatment: The recommended dosage of Truxima used as monotherapy for adult patients is 375 mg/m2 body surface area (BSA), administered as an IV infusion (see "First infusion" and "Subsequent infusions" as follows) once weekly for 4 weeks.
The recommended dosage of Truxima in combination with any chemotherapy is 375 mg/m2 body surface area per cycle for a total of: 8 cycles with R-CVP (21 days/cycle); 8 cycles with R-MCP (28 days/cycle); 8 cycles with R-CHOP (21 days/cycle); 6 cycles if a complete remission is achieved after 4 cycles; 6 cycles with R-CHVP-Interferon (21 days/cycle).
Truxima should be administered on day 1 of each chemotherapy cycle after IV administration of the glucocorticoid component of the chemotherapy, if applicable.
Re-treatment following relapse: Patients who have responded to Truxima initially may receive Truxima at a dose of 375 mg/m2 body surface area, administered as an IV infusion once weekly for 4 weeks (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies: Low-grade or follicular non-Hodgkin's lymphoma: Monotherapy: Re-treatment, weekly for 4 doses under Actions).
Maintenance treatment: Previously untreated patients after response to induction treatment may receive maintenance therapy with Truxima given at 375 mg/m2 body surface area once every 2 months until disease progression or for a maximum period of two years (12 infusions).
Relapsed/refractory patients after response to induction treatment may receive maintenance therapy with Truxima given at 375 mg/m2 body surface area once every 3 months until disease progression or for a maximum period of two years (8 infusions in total).
Adult Diffuse large B-cell non-Hodgkin's lymphoma: In patients with diffuse large B cell non-Hodgkin's lymphoma. Truxima should be used in combination with CHOP (cyclophosphamide, doxorubicin, prednisone and vincristine) chemotherapy. The recommended dosage of Truxima is 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after IV administration of the glucocorticoid component of CHOP. The other components of CHOP should be given after the administration of Truxima (see "First infusion" and "Subsequent infusions" as follows).
First infusion: The recommended initial infusion rate is 50 mg/h; subsequently, the rate can be escalated in 50 mg/h increments every 30 minutes to a maximum of 400 mg/h.
Subsequent infusions: Subsequent infusions of Truxima can be started at a rate of 100 mg/h and increased by 100 mg/h increments every 30 minutes to a maximum of 400 mg/h.
Pediatric non-Hodgkin's lymphoma: In pediatric patients from ≥ 6 months to < 18 years of age with previously untreated, advanced stage CD20 positive DLBCL/BL/BAL/BLL, Truxima should be used in combination with systemic Lymphome Malin B (LMB) chemotherapy (see Tables 23 and 24). The recommended dosage of Truxima is 375 mg/m2 BSA, administered as an intravenous infusion. No Truxima dose adjustments, other than by BSA, are required. (See Tables 23 and 24.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageFirst infusion: The recommended initial rate for infusion is 0.5 mg/kg/h (maximum 50 mg/h); it can be escalated by 0.5 mg/kg/h every 30 minutes if there is no hypersensitivity or infusion-related reactions, to a maximum of 400 mg/h.
Subsequent infusions: Subsequent doses of Truxima can be infused at an initial rate of 1 mg/kg/h (maximum 50 mg/h); it can be increased by 1 mg/kg/h every 30 minutes to a maximum of 400 mg/h.
Chronic Lymphocytic Leukaemia: The recommended dosage of Truxima in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 1 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 (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions). The chemotherapy should be given after Truxima infusion.
First infusion: The recommended initial infusion rate is 50 mg/h; subsequently, the rate can be escalated in 50 mg/h increments every 30 minutes to a maximum of 400 mg/h.
Subsequent infusions: Subsequent infusions of Truxima can be started at a rate of 100 mg/h and increased by 100 mg/h increments every 30 minutes to a maximum of 400 mg/h.
Dosage adjustments during treatment: No dose reductions of Truxima are recommended. When Truxima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic drugs should be applied.
Rheumatoid arthritis (RA): A course of Truxima consists of two 1000 mg IV infusions. The recommended dosage of Truxima is 1000 mg by IV infusion followed two weeks later by the second 1000 mg IV infusion.
The need for further courses should be evaluated 24 weeks following the previous course with retreatment given based on residual or disease activity returning to a level above a DAS28-ESR of 2.6 (treatment to remission) (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions). Patients may receive further courses no sooner than 16 weeks following the previous course.
Patients should receive 100 mg IV methylprednisolone to be completed 30 minutes prior to both Truxima infusions to decrease the incidence and severity of infusion-related reactions (see Precautions).
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 Truxima 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.
Alternative subsequent, faster, infusion schedule: If patients did not experience a serious infusion-related reaction with their first or subsequent infusions of a dose of 1000 mg Truxima 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.
Adult Patients with Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangiitis (MPA): Induction of Remission: The recommended dosage of Truxima for induction of remission therapy in adult patients with GPA and MPA is 375 mg/m2 BSA, administered as an IV infusion once weekly for 4 weeks (four infusions in total).
Methylprednisolone given IV for 1 to 3 days and a dose of 1000 mg per day is recommended in combination with Truxima to treat severe vasculitis symptoms, followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible per clinical need) during and after the 4 week induction course of Truxima treatment.
Maintenance Treatment: Following induction of remission with Truxima, maintenance treatment in adult patients with GPA and MPA, should be initiated no sooner than 16 weeks after the last Truxima infusion.
Following induction of remission with other standard of care immunosuppressants, Truxima maintenance treatment should be initiated during the 4 week period that follows disease remission.
Administer Truxima as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion at month 6, 12 and 18 and then every 6 months thereafter based on clinical evaluation. Patients should receive Truxima 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 Truxima maintenance therapy, up to 5 years.
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 Truxima 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.
Pediatric Patients with Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangiitis (MPA): Induction of remission: The recommended dosage of Truxima for induction of remission therapy in pediatric patients with severe, active GPA/MPA is 375 mg/m2 BSA, administered as an IV infusion once weekly for 4 weeks.
Prior to the first Truxima infusion, methylprednisolone should be given IV 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 IV methylprednisolone can be given prior to the first Truxima infusion.
Following completion of IV methylprednisolone, patients should receive oral prednisone 1 mg/kg/day (not to exceed 60 mg/day) and tapered as rapidly as possible per clinical need (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Pemphigus Vulgaris: The recommended dosage of Truxima 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 (see General as previously mentioned).
Maintenance Treatment: Maintenance infusions of 500 mg IV should be administered at month 12 and then every 6 months thereafter based on clinical evaluation.
Treatment of Relapse: In the event of relapse during the course of Truxima therapy, 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 Dosage Instructions: Children and adolescents: No dose adjustments are recommended in pediatric patients (≥2 to <18 years of age) with active GPA/MPA. Currently available data are described in Use in Children under Precautions, PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies and Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
The safety and efficacy of Truxima in pediatric patients ≥ 6 months to < 18 years of age have not been established in indications other than previously untreated advanced stage CD20 positive DLBCL/BL/BAL/BLL. Only limited data are available for patients under 3 years of age (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Truxima should not be used in pediatric patients from birth to < 6 months of age with CD20 positive diffuse large B-cell lymphoma (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
The safety and efficacy of Truxima in children and adolescents (≥2 to <18 years) have not been established in indications other than severe, active GPA or MPA.
Truxima should not be used in pediatric patients with severe, active GPA/MPA <2 years of age (see Use in Children under Precautions) 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) (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Elderly: No dose adjustment is required in elderly patients (aged > 65 years).
Route of Administration: Intravenous (IV) infusion.
Continue with Google