Loading…
RIXIMYO 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) RIXIMYO (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.
). • Infusion Reactions: Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RIXIMYO 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 RIXIMYO (rituximab for in jection) Page 6 of 115 who received treatment with RIXIMYO may have an increased risk of PML. PML can cause disability or death.
Healthcare professionals should monitor patients on RIXIMYO for any new sign or symptom that may be suggestive of PML. Further treatment with RIXIMYO should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy).
• Tumor 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 rituximab (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
• Hepatitis B Virus (HBV) Reactivation: HBV reactivation has occurred in patients treated with rituximab, 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 RIXIMYO.
In the event of HBV reactivation, RIXIMYO 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 rituximab.
Patients experiencing a severe mucocutaneous reaction should discontinue treatment with RIXIMYO 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 RIXIMYO-based therapy.
RIXIMYO 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 RIXIMYO (see 7 WARNINGS AND PRECAUTIONS).
for details. 2 CONTRAINDICATIONS • RIXIMYO is contraindicated in patients with known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins ( see 7 WARNINGS AND PRECAUTIONS), or to any component of this product.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • RIXIMYO is also contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). • RIXIMYO is not recommended for use in patients with severe, active infections.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • General: RIXIMYO is a potent drug. Several adverse reactions are associated with rituximab, 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 AND ADMINISTRATION). • Infusion Reactions: Deaths within 24 hours of rituximab infusion have occurred.
Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RIXIMYO 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 RIXIMYO (rituximab for in jection) Page 6 of 115 who received treatment with RIXIMYO may have an increased risk of PML. PML can cause disability or death.
), or to any component of this product. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • RIXIMYO is also contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML).
• RIXIMYO is not recommended for use in patients with severe, active infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • General: RIXIMYO is a potent drug. Several adverse reactions are associated with rituximab, 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 AND ADMINISTRATION). • Infusion Reactions: Deaths within 24 hours of rituximab infusion have occurred.
Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RIXIMYO 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 RIXIMYO (rituximab for in jection) Page 6 of 115 who received treatment with RIXIMYO may have an increased risk of PML. PML can cause disability or death.
Healthcare professionals should monitor patients on RIXIMYO for any new sign or symptom that may be suggestive of PML. Further treatment with RIXIMYO should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy).
• RIXIMYO is contraindicated in patients with known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins ( see 7 WARNINGS AND PRECAUTIONS), or to any component of this product.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • RIXIMYO is also contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML). • RIXIMYO 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.
Know a brand we are missing in Canada? Suggest a brand →
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.
1 Dosing Considerations • Hypersensitivity reactions and severe infusion-related reaction may occur with administration of RIXIMYO (see 7 WARNINGS AND PRECAUTIONS). Since transient hypotension may occur during infusion with RIXIMYO, consideration should be given to withholding anti-hypertensive medications 12 hours prior to and throughout infusion with RIXIMYO.
• Patients who develop clinically significant arrhythmias should undergo cardiac monitoring during and after subsequent infusions of RIXIMYO. Patients with pre -existing cardiac conditions such as angina and arrhythmias should be monitored during and after th e infusion of RIXIMYO.
g. g. diphenhydramine) should always be administered before each infusion of RIXIMYO. Premedication with glucocorticoids should also be considered, particularly if RIXIMYO 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 adult Low Grade or Follicular Non-Hodgkin’s Lymphoma (NHL) patients administered RIXIMYO according to the 90-minute infusion rate, premedication with glucocorticoids should be considered if RIXIMYO is not given in combination with glucocorticoid-containing chemotherapy.
Initial treatment The recommended dosage of RIXIMYO 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 RIXIMYO 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 RIXIMYO maintenance therapy is 375 mg/m2 body surface area.
RIXIMYO maintenance therapy should be initiated eight weeks following completion of RIXIMYO in combination with chemotherapy. RIXIMYO as a single agent should be administered every 8 weeks for a maximum of 12 doses (two years). The recommended dose of RIXIMYO 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 RIXIMYO. Premedication with glucocorticoids should also be considered, particularly if RIXIMYO 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 adult Diffuse Large B Non-Hodgkin’s Lymphoma (NHL) patients administered RIXIMYO according to the 90-minute infusion rate, premedication with glucocorticoids should be considered if RIXIMYO is not given in combination with glucocorticoid-containing chemotherapy.
RIXIMYO should be used in combination with […]
Healthcare professionals should monitor patients on RIXIMYO for any new sign or symptom that may be suggestive of PML. Further treatment with RIXIMYO should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Progressive Multifocal Leukoencephalopathy).
• Tumor 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 rituximab (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
• Hepatitis B Virus (HBV) Reactivation: HBV reactivation has occurred in patients treated with rituximab, 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 RIXIMYO.
In the event of HBV reactivation, RIXIMYO 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 rituximab.
Patients experiencing a severe mucocutaneous reaction should discontinue treatment with RIXIMYO 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 RIXIMYO-based therapy.
RIXIMYO 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 RIXIMYO (see 7 WARNINGS AND PRECAUTIONS).
1 Dosing Considerations • Hypersensitivity reactions and severe infusion-related reaction may occur with administration of RIXIMYO (see 7 WARNINGS AND PRECAUTIONS). Since transient hypotension may occur during infusion with RIXIMYO, consideration should be given to withholding anti-hypertensive medications 12 hours prior to and throughout infusion with RIXIMYO.
• Patients who develop clinically significant arrhythmias should undergo cardiac monitoring during and after subsequent infusions of RIXIMYO. Patients with pre -existing cardiac conditions such as angina and arrhythmias should be monitored during and after th e infusion of RIXIMYO.
g. g. diphenhydramine) should always be administered before each infusion of RIXIMYO. Premedication with glucocorticoids should also be considered, particularly if RIXIMYO 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 adult Low Grade or Follicular Non-Hodgkin’s Lymphoma (NHL) patients administered RIXIMYO according to the 90-minute infusion rate, premedication with glucocorticoids should be considered if RIXIMYO is not given in combination with glucocorticoid-containing chemotherapy.
Initial treatment The recommended dosage of RIXIMYO 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 RIXIMYO 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 […]
• Tumor 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 rituximab (see 7 WARNINGS AND PRECAUTIONS, Infusion-Related Events).
• Hepatitis B Virus (HBV) Reactivation: HBV reactivation has occurred in patients treated with rituximab, 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 RIXIMYO.
In the event of HBV reactivation, RIXIMYO 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 rituximab.
Patients experiencing a severe mucocutaneous reaction should discontinue treatment with RIXIMYO 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 RIXIMYO-based therapy.
RIXIMYO 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 RIXIMYO (see 7 WARNINGS AND PRECAUTIONS).
1 Dosing Considerations • Hypersensitivity reactions and severe infusion-related reaction may occur with administration of RIXIMYO (see 7 WARNINGS AND PRECAUTIONS). Since transient hypotension may occur during infusion with RIXIMYO, consideration should be given to withholding anti-hypertensive medications 12 hours prior to and throughout infusion with RIXIMYO.
• Patients who develop clinically significant arrhythmias should undergo cardiac monitoring during and after subsequent infusions of RIXIMYO. Patients with pre -existing cardiac conditions such as angina and arrhythmias should be monitored during and after th e infusion of RIXIMYO.
g. g. diphenhydramine) should always be administered before each infusion of RIXIMYO. Premedication with glucocorticoids should also be considered, particularly if RIXIMYO 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 adult Low Grade or Follicular Non-Hodgkin’s Lymphoma (NHL) patients administered RIXIMYO according to the 90-minute infusion rate, premedication with glucocorticoids should be considered if RIXIMYO is not given in combination with glucocorticoid-containing chemotherapy.
Initial treatment The recommended dosage of RIXIMYO 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 RIXIMYO 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 RIXIMYO maintenance therapy is 375 mg/m2 body surface area.
RIXIMYO maintenance […]