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RITUXAN SC 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) RITUXAN (rituximab injection) is indicated for: • the treatment of patients with CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy. • the treatment of patients with…
Verbatim from this product's HC label. Tap a section to expand.
). • Infusion Reactions: Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
• Progressive Multifocal Leukoencephalopathy (PML): Patients with NHL and CLL who received treatment with Rituxan may have an increased risk of PML. PML can cause disability or death. Healthcare professionals should monitor patients on Rituxan for any new sign or symptom that may be suggestive of PML.
Further treatment with Rituxan should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Progressive Multifocal Leukoencephalopathy). • Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis has been reported in the setting of TLS following treatment of NHL and CLL patients with Rituxan.
Fatal instances of TLS have been observed in NHL patients (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events). • Hepatitis B Virus (HBV) Reactivation: HBV reactivation has occurred in patients treated with Rituxan, 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 Rituxan. In the event of HBV reactivation, Rituxan 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 Rituxan. Patients experiencing a severe mucocutaneous reaction should discontinue treatment with Rituxan 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 Rituxan-based therapy. Rituxan treatment should not be initiated in patients with severe active infections.
Patients should be screened for infectious disease history (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
for details. 2 CONTRAINDICATIONS • Rituxan is contraindicated in patients with known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or to its excipients (see 7 WARNINGS AND PRECAUTIONS).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Rituxan is also contraindicated in patients who have or have had progressive multifocal PrRITUXAN® (rituximab injection) Page 5 of 91 leukoencephalopathy (PML).
• Rituxan is not recommended for use in patients with severe, active infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • General: Rituxan is a potent drug. Several adverse reactions are associated with Rituxan, 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) and Chronic Lymphocytic Leukemia (CLL). , 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 Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
• Progressive Multifocal Leukoencephalopathy (PML): Patients with NHL and CLL who received treatment with Rituxan may have an increased risk of PML. PML can cause disability or death. Healthcare professionals should monitor patients on Rituxan for any new sign or symptom that may be suggestive of PML.
). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Rituxan is also contraindicated in patients who have or have had progressive multifocal PrRITUXAN® (rituximab injection) Page 5 of 91 leukoencephalopathy (PML).
• Rituxan is not recommended for use in patients with severe, active infections. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • General: Rituxan is a potent drug. Several adverse reactions are associated with Rituxan, 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) and Chronic Lymphocytic Leukemia (CLL). , 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 Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
• Progressive Multifocal Leukoencephalopathy (PML): Patients with NHL and CLL who received treatment with Rituxan may have an increased risk of PML. PML can cause disability or death. Healthcare professionals should monitor patients on Rituxan for any new sign or symptom that may be suggestive of PML.
Further treatment with Rituxan should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Progressive Multifocal Leukoencephalopathy). • Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis has been reported in the setting of TLS following treatment of NHL and CLL patients with Rituxan.
• Rituxan is contraindicated in patients with known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or to its excipients (see 7 WARNINGS AND PRECAUTIONS). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Rituxan is also contraindicated in patients who have or have had progressive multifocal PrRITUXAN® (rituximab injection) Page 5 of 91 leukoencephalopathy (PML). • Rituxan 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.
PrRITUXAN® (rituximab injection) Page 6 of 91 • Cardiovascular:
Serious and potentially fatal cardiovascular events have been reported rarely following administration of Rituxan (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations It is important to check the product labels to ensure that the appropriate formulation (IV or SC) and strength is being given to the patient, as prescribed.
• Rituxan SC formulation is not intended for intravenous administration. • Rituxan SC is not intended for self-administration. 4 Administration). • Rituxan SC 1400 mg is intended for use in non-Hodgkin’s lymphoma (NHL) only. • Rituxan SC 1600 mg is intended for use in chronic lymphocytic leukemia (CLL) only.
g. g. diphenhydramine) should always be given before each administration of Rituxan SC. Premedication with glucocorticoids should also be considered, particularly if Rituxan SC is not given in combination with steroid-containing chemotherapy (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
Dosage adjustments during treatment No dose reductions of Rituxan are recommended. When Rituxan is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic drugs should be applied. Initial treatment All patients must always receive their first dose of Rituxan by intravenous administration, using the Rituxan IV formulation.
The subcutaneous formulation should only be given at the second or subsequent cycles. Patients, unable to receive the full Rituxan IV infusion dose should continue to receive subsequent cycles with Rituxan IV until a full IV dose is successfully administered.
In patients who are able to receive the full Rituxan IV infusion dose, the second or subsequent Rituxan dose can be given subcutaneously using the Rituxan SC formulation (see 7 WARNINGS AND PRECAUTIONS). Please refer to the separate Rituxan IV Product Monograph for full instructions on dosing and administration of the intravenous formulation.
2 Recommended Dose and Dosage Adjustment Follicular Non-Hodgkin’s Lymphoma (FL) Induction PrRITUXAN® (rituximab injection) Page 7 of 91 Rituxan should be administered on day 1 of each chemotherapy cycle, after the administration of the glucocorticoid component of the chemotherapy, for up to 8 cycles.
The recommended dose of Rituxan in combination with chemotherapy for induction treatment in previously untreated Stage III/IV follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma is: • First cycle - Rituxan intravenous formulation - 375 mg/m2 administered as an IV infusion on day 1 of cycle 1 after IV administration of the corticosteroid component of chemotherapy.
During their first cycle the patient is at the highest risk of experiencing an infusion/administration related reaction. Beginning therapy with Rituxan IV infusion allows management of infusion/administration related reactions by slowing or stopping the intravenous infusion (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
• Patients unable to receive the full Rituxan intravenous dose should continue to receive subsequent cycles with Rituxan IV until a full IV dose is successfully administered. If the full intravenous infusion is tolerated, then: • […]
Further treatment with Rituxan should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Progressive Multifocal Leukoencephalopathy). • Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis has been reported in the setting of TLS following treatment of NHL and CLL patients with Rituxan.
Fatal instances of TLS have been observed in NHL patients (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events). • Hepatitis B Virus (HBV) Reactivation: HBV reactivation has occurred in patients treated with Rituxan, 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 Rituxan. In the event of HBV reactivation, Rituxan 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 Rituxan. Patients experiencing a severe mucocutaneous reaction should discontinue treatment with Rituxan 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 Rituxan-based therapy. Rituxan treatment should not be initiated in patients with severe active infections.
Patients should be screened for infectious disease history (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
PrRITUXAN® (rituximab injection) Page 6 of 91 • Cardiovascular:
Serious and potentially fatal cardiovascular events have been reported rarely following administration of Rituxan (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations It is important to check the product labels to ensure that the appropriate formulation (IV or SC) and strength is being given to the patient, as prescribed.
• Rituxan SC formulation is not intended for intravenous administration. • Rituxan SC is not intended for self-administration. 4 Administration). • Rituxan SC 1400 mg is intended for use in non-Hodgkin’s lymphoma (NHL) only. • Rituxan SC 1600 mg is intended for use in chronic lymphocytic leukemia (CLL) only.
g. g. diphenhydramine) should always be given before each administration of Rituxan SC. Premedication with glucocorticoids should also be considered, particularly if Rituxan SC is not given in combination with steroid-containing chemotherapy (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
Dosage adjustments during treatment No dose reductions of Rituxan are recommended. When Rituxan is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic drugs should be applied. Initial treatment All patients must always receive their first dose of Rituxan by intravenous administration, using the Rituxan IV formulation.
The subcutaneous formulation should only be given at the second or subsequent cycles. Patients, unable to receive the full Rituxan IV infusion dose should continue to receive subsequent cycles with Rituxan IV until a full IV dose is successfully administered.
In patients who are able to receive the full Rituxan IV infusion dose, the second or subsequent Rituxan dose can be given subcutaneously using the Rituxan SC formulation (see 7 WARNINGS AND PRECAUTIONS). Please refer to the separate Rituxan IV Product Monograph for full […]
Fatal instances of TLS have been observed in NHL patients (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events). • Hepatitis B Virus (HBV) Reactivation: HBV reactivation has occurred in patients treated with Rituxan, 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 Rituxan. In the event of HBV reactivation, Rituxan 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 Rituxan. Patients experiencing a severe mucocutaneous reaction should discontinue treatment with Rituxan 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 Rituxan-based therapy. Rituxan treatment should not be initiated in patients with severe active infections.
Patients should be screened for infectious disease history (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
PrRITUXAN® (rituximab injection) Page 6 of 91 • Cardiovascular:
Serious and potentially fatal cardiovascular events have been reported rarely following administration of Rituxan (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations It is important to check the product labels to ensure that the appropriate formulation (IV or SC) and strength is being given to the patient, as prescribed.
• Rituxan SC formulation is not intended for intravenous administration. • Rituxan SC is not intended for self-administration. 4 Administration). • Rituxan SC 1400 mg is intended for use in non-Hodgkin’s lymphoma (NHL) only. • Rituxan SC 1600 mg is intended for use in chronic lymphocytic leukemia (CLL) only.
g. g. diphenhydramine) should always be given before each administration of Rituxan SC. Premedication with glucocorticoids should also be considered, particularly if Rituxan SC is not given in combination with steroid-containing chemotherapy (see 7 WARNINGS AND PRECAUTIONS, Immune, Infusion/Administration Related Events).
Dosage adjustments during treatment No dose reductions of Rituxan are recommended. When Rituxan is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic drugs should be applied. Initial treatment All patients must always receive their first dose of Rituxan by intravenous administration, using the Rituxan IV formulation.
The subcutaneous formulation should only be given at the second or subsequent cycles. Patients, unable to receive the full Rituxan IV infusion dose should continue to receive subsequent cycles with Rituxan IV until a full IV dose is successfully administered.
In patients who are able to receive the full Rituxan IV infusion dose, the second or subsequent Rituxan dose can be given subcutaneously using the Rituxan SC formulation (see 7 WARNINGS AND PRECAUTIONS). Please refer to the separate Rituxan IV Product Monograph for full instructions on dosing and administration of the intravenous formulation.
2 Recommended Dose and Dosage Adjustment Follicular Non-Hodgkin’s Lymphoma (FL) Induction PrRITUXAN® (rituximab injection) Page 7 of 91 Rituxan should be administered on day 1 […]