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RUXIENCE is a brand name for Rituximab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Non-Hodgkin’s Lymphoma (NHL) RUXIENCE (rituximab for injection) is indicated for: • the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B cell non- Hodgkin’s lymphoma. • the treatment of patients with CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL) in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Hypersensitivity reactions and severe infusion-related reaction may occur with administration of RUXIENCE (see 7 WARNINGS AND PRECAUTIONS). Since transient hypotension may occur during RUXIENCE (rituximab for injection) Page 7 of 126 infusion with RUXIENCE, consideration should be given to withholding anti-hypertensive medications 12 hours prior to and throughout infusion with RUXIENCE.
• Patients who develop clinically significant arrhythmias should undergo cardiac monitoring during and after subsequent infusions of RUXIENCE. Patients with pre-existing cardiac conditions such as angina and arrhythmias should be monitored during and after the infusion of RUXIENCE.
g. g. diphenhydramine) should always be administered before each infusion of RUXIENCE. Premedication with glucocorticoids should also be considered, particularly if RUXIENCE is not given in combination with steroid-containing chemotherapy (See 7 WARNINGS AND PRECAUTIONS: Non- Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia-Infusion- Related Events).
Initial treatment The recommended dosage of RUXIENCE as a single agent is 375 mg/m2 given as an IV infusion once weekly for four doses (on days 1, 8, 15, and 22). The recommended dosage of RUXIENCE in combination with CVP chemotherapy is 375 mg/m2 for 8 cycles (21 days/cycle), administered as an IV infusion on day 1 of each chemotherapy cycle after IV administration of the corticosteroid component of CVP.
Maintenance treatment In previously untreated patients with advanced high-tumour burden follicular lymphoma, after complete or partial response to induction treatment the recommended dose of RUXIENCE maintenance therapy is 375 mg/m2 body surface area.
RUXIENCE maintenance therapy should be initiated eight weeks following completion of RUXIENCE in combination with chemotherapy. RUXIENCE as a single agent should be administered every 8 weeks for a maximum of 12 doses (two years). The recommended dose of RUXIENCE for relapsed or refractory patients after response to induction treatment is 375 mg/m2 every 3 months until disease progression or for a maximum period of two years.
g. g. diphenhydramine) should always be administered before each infusion of RUXIENCE. Premedication with glucocorticoids should also be considered, particularly if RUXIENCE is not given in combination with steroid-containing chemotherapy (See 7 WARNINGS AND PRECAUTIONS/ Non- Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia/Infusion- Related Events).
for details. 2 CONTRAINDICATIONS • RUXIENCE (rituximab for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORM, STRENGTHS, COMPOSITION AND PACKAGING. • RUXIENCE is contraindicated in patients with known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or to any component of this product (See 7 WARNINGS AND PRECAUTIONS).
• RUXIENCE is also contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). • RUXIENCE is not recommended for use in patients with severe, active infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • General RUXIENCE (rituximab for injection) is a potent drug.
Several adverse reactions are associated with RUXIENCE, some of which are severe and life-threatening (see 7 WARNINGS AND PRECAUTIONS). This drug should only be used by health professionals experienced in treating Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
, epinephrine, antihistamines, glucocorticoids) are immediately available in the event of an allergic reaction during administration (see 4 DOSAGE RUXIENCE (rituximab for injection) Page 6 of 126 AND ADMINISTRATION). • Infusion Reactions Deaths within 24 hours of RUXIENCE infusion have occurred.
Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RUXIENCE infusion and provide medical treatment for Grade 3 or 4 infusion reactions (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
). • RUXIENCE is also contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). • RUXIENCE is not recommended for use in patients with severe, active infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • General RUXIENCE (rituximab for injection) is a potent drug.
Several adverse reactions are associated with RUXIENCE, some of which are severe and life-threatening (see 7 WARNINGS AND PRECAUTIONS). This drug should only be used by health professionals experienced in treating Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
, epinephrine, antihistamines, glucocorticoids) are immediately available in the event of an allergic reaction during administration (see 4 DOSAGE RUXIENCE (rituximab for injection) Page 6 of 126 AND ADMINISTRATION). • Infusion Reactions Deaths within 24 hours of RUXIENCE infusion have occurred.
Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RUXIENCE infusion and provide medical treatment for Grade 3 or 4 infusion reactions (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
• Progressive Multifocal Leukoencephalopathy (PML) Patients with RA, NHL and CLL who received treatment with RUXIENCE may have an increased risk of PML. PML can cause disability or death. Healthcare professionals should monitor patients on RUXIENCE for any new sign or symptom that may be suggestive of PML.
Further treatment with RUXIENCE should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy). • Tumour Lysis Syndrome (TLS) Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment of NHL patients with RUXIENCE (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
• RUXIENCE (rituximab for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORM, STRENGTHS, COMPOSITION AND PACKAGING.
• RUXIENCE is contraindicated in patients with known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or to any component of this product (See 7 WARNINGS AND PRECAUTIONS).
• RUXIENCE is also contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). • RUXIENCE is not recommended for use in patients with severe, active infections.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rituximab in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
RUXIENCE should be used in combination with CHOP chemotherapy. The recommended dosage of RUXIENCE is 375 mg/m2 administered on day 1 of each chemotherapy cycle after IV administration of RUXIENCE (rituximab for injection) Page 8 of 126 the glucocorticoid component of CHOP.
The other components of CHOP (cyclophosphamide, doxorubicin, vincristine) should be given after the administration of RUXIENCE. g. g. diphenhydramine) should always be administered before each infusion of RUXIENCE. Premedication with glucocorticoids should also be considered, particularly if RUXIENCE is not given in combination with steroid-containing chemotherapy (See 7 WARNINGS AND PRECAUTIONS: Non- Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia-Infusion-Related Events).
The recommended dosage of RUXIENCE in combination with chemotherapy for previously untreated and previously treated patients is 375 mg/m2 body surface area administered on day 1 of the first treatment cycle followed by 500mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
The chemotherapy should be given after RUXIENCE infusion. Prophylaxis with adequate hydration and administration of uricostatics (such as allopurinol) 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 x109/L it is recommended to administer methylprednisolone IV shortly before infusion with RUXIENCE to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
In study ML17102 an equivalent of 80mg of methylprednisolone (100 mg prednisone IV) was given prior to infusions with rituximab. Seventy-four percent (74%) of patients in the R-FC arms of study ML17102 received at least one dose of corticosteroids, with 27% receiving two or more doses.
Dosage Adjustments During Treatment No dose reductions of RUXIENCE are recommended but 47% of patients in the clinical trial ML17102 for CLL required a delayed and/or slowed infusion, and 17% required their first dose split over two days.
When RUXIENCE is given in combination with CHOP chemotherapy, standard dose reductions for the chemotherapeutic drugs should be applied. When RUXIENCE is given as maintenance treatment, treatment should be delayed in case of significant clinical toxicity according to standard practice.
RUXIENCE as a Component of ZEVALIN® (Ibritumomab Tiuxetan) Therapeutic Regimen As a required component of the ZEVALIN therapeutic regimen, RUXIENCE is administered twice. The first administration of RUXIENCE is a single infusion of 250 mg/m2 and should precede the second administration by 7-9 days.
At the second administration, RUXIENCE 250 mg/m2 should be infused within 4 hours prior to the administration of 90Y-ibritumomab tiuxetan. Refer to the ZEVALIN product monograph for full prescribing information. Rheumatoid Arthritis […]
• Progressive Multifocal Leukoencephalopathy (PML) Patients with RA, NHL and CLL who received treatment with RUXIENCE may have an increased risk of PML. PML can cause disability or death. Healthcare professionals should monitor patients on RUXIENCE for any new sign or symptom that may be suggestive of PML.
Further treatment with RUXIENCE should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy). • Tumour Lysis Syndrome (TLS) Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment of NHL patients with RUXIENCE (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
• Hepatitis B Virus (HBV) Reactivation HBV reactivation has occurred in patients treated with RUXIENCE, in some cases resulting in fulminant hepatitis, hepatic failure, and death. All patients should be screened for HBV infection before treatment initiation, and should be monitored during and after treatment with RUXIENCE.
In the event of HBV reactivation, RUXIENCE and concomitant medications should be discontinued. • Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions including Toxic Epidermal Necrolysis (TEN) and Stevens Johnson Syndrome (SJS) have occurred in patients treated with RUXIENCE.
Patients experiencing a severe mucocutaneous reaction should discontinue treatment with RUXIENCE and seek prompt medical evaluation (see 7 WARNINGS AND PRECAUTIONS, Skin). • Infections Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during or following the completion of RUXIENCE-based therapy.
RUXIENCE treatment should not be initiated in patients with severe active infections. Patients should be screened for infectious disease history (see 7 WARNINGS AND PRECAUTIONS, Infections). • Cardiovascular Serious and potentially fatal cardiovascular events have been reported rarely following administration of RUXIENCE (see 7 WARNINGS AND PRECAUTIONS).
1 Dosing Considerations • Hypersensitivity reactions and severe infusion-related reaction may occur with administration of RUXIENCE (see 7 WARNINGS AND PRECAUTIONS). Since transient hypotension may occur during RUXIENCE (rituximab for injection) Page 7 of 126 infusion with RUXIENCE, consideration should be given to withholding anti-hypertensive medications 12 hours prior to and throughout infusion with RUXIENCE.
• Patients who develop clinically significant arrhythmias should undergo cardiac monitoring during and after subsequent infusions of RUXIENCE. Patients with pre-existing cardiac conditions such as angina and arrhythmias should be monitored during and after the infusion of RUXIENCE.
g. g. diphenhydramine) should always be administered before each infusion of RUXIENCE. Premedication with glucocorticoids should also be considered, particularly if RUXIENCE is not given in combination with steroid-containing chemotherapy (See 7 WARNINGS AND PRECAUTIONS: Non- Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia-Infusion- Related Events).
Initial treatment The recommended dosage of RUXIENCE as a single agent is 375 mg/m2 given as an IV infusion once weekly for four doses (on days 1, 8, 15, and 22). The recommended dosage of RUXIENCE in combination with CVP chemotherapy is 375 mg/m2 for 8 cycles (21 days/cycle), administered as an IV infusion on day 1 of each chemotherapy cycle after IV administration of the corticosteroid component of CVP.
Maintenance treatment In previously untreated patients with advanced […]
• Hepatitis B Virus (HBV) Reactivation HBV reactivation has occurred in patients treated with RUXIENCE, in some cases resulting in fulminant hepatitis, hepatic failure, and death. All patients should be screened for HBV infection before treatment initiation, and should be monitored during and after treatment with RUXIENCE.
In the event of HBV reactivation, RUXIENCE and concomitant medications should be discontinued. • Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions including Toxic Epidermal Necrolysis (TEN) and Stevens Johnson Syndrome (SJS) have occurred in patients treated with RUXIENCE.
Patients experiencing a severe mucocutaneous reaction should discontinue treatment with RUXIENCE and seek prompt medical evaluation (see 7 WARNINGS AND PRECAUTIONS, Skin). • Infections Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during or following the completion of RUXIENCE-based therapy.
RUXIENCE treatment should not be initiated in patients with severe active infections. Patients should be screened for infectious disease history (see 7 WARNINGS AND PRECAUTIONS, Infections). • Cardiovascular Serious and potentially fatal cardiovascular events have been reported rarely following administration of RUXIENCE (see 7 WARNINGS AND PRECAUTIONS).
1 Dosing Considerations • Hypersensitivity reactions and severe infusion-related reaction may occur with administration of RUXIENCE (see 7 WARNINGS AND PRECAUTIONS). Since transient hypotension may occur during RUXIENCE (rituximab for injection) Page 7 of 126 infusion with RUXIENCE, consideration should be given to withholding anti-hypertensive medications 12 hours prior to and throughout infusion with RUXIENCE.
• Patients who develop clinically significant arrhythmias should undergo cardiac monitoring during and after subsequent infusions of RUXIENCE. Patients with pre-existing cardiac conditions such as angina and arrhythmias should be monitored during and after the infusion of RUXIENCE.
g. g. diphenhydramine) should always be administered before each infusion of RUXIENCE. Premedication with glucocorticoids should also be considered, particularly if RUXIENCE is not given in combination with steroid-containing chemotherapy (See 7 WARNINGS AND PRECAUTIONS: Non- Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia-Infusion- Related Events).
Initial treatment The recommended dosage of RUXIENCE as a single agent is 375 mg/m2 given as an IV infusion once weekly for four doses (on days 1, 8, 15, and 22). The recommended dosage of RUXIENCE in combination with CVP chemotherapy is 375 mg/m2 for 8 cycles (21 days/cycle), administered as an IV infusion on day 1 of each chemotherapy cycle after IV administration of the corticosteroid component of CVP.
Maintenance treatment In previously untreated patients with advanced high-tumour burden follicular lymphoma, after complete or partial response to induction treatment the recommended dose of RUXIENCE maintenance therapy is 375 mg/m2 body surface area.
RUXIENCE maintenance therapy should be initiated eight weeks following completion of RUXIENCE in combination with chemotherapy. RUXIENCE as a single agent should be administered every 8 weeks for a maximum of 12 doses (two years). The recommended dose of RUXIENCE for relapsed or refractory patients after response to induction treatment is 375 mg/m2 every 3 months until disease […]