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Mabthera10 mg/ml
IV Infusion
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Medicine overview
Indications of Mabthera 10 mg/ml
Non-Hodgkin's Lymphoma (NHL): Mabthera 10 mg/ml is indicated for the treatment of patients with- Relapsed or refractorylow-grade or follicularCD20-positiveB-cell NHL as a single agent Previously untreated follicularCD20-positiveB-cell NHL in combination with first line chemotherapy andin patients achieving a complete or partial response to Rituxan in combination with chemotherapylow-grade or follicularCD20-positiveB-cell NHL as a single agent Previously untreated follicularCD20-positiveB-cell NHL in combination with first line chemotherapy andin patients achieving a complete or partial response to Rituxan in combination with chemotherapyas single-agent maintenance therapy. Non-progressing (including stable disease)low-gradeCD20-positiveB-cell NHL as a single agent after first-line CVP chemotherapy Previously untreated diffuse large B-cellin combination with fludarabine and cyclophosphamide (FC)in combination with glucocorticoids
Theropeutic Class
Cytotoxic immunosuppressants
Pharmacology
Mabthera 10 mg/ml is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation.
Absorption
It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.
Distribution
Duration: Detectable in serum 3-6 mth after completion of therapy; B-cell recovery 6-12 mth following completion of therapy.
Dosage & Administration of Mabthera 10 mg/ml
Notes:Intravenous (Adult)-Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min
Max rate
Dosage:400 mg/hr
Notes:When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m2 given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m2 may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses
Maintenance
Dosage:375 mg/m2 given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr
Chronic lymphocytic leukaemia
Dosage:375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6
Rheumatoid arthritis
Dosage:Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate
Notes:Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions
| Condition | Dosage | Notes |
|---|---|---|
| Intravenous (Adult)-Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min | ||
| Max rate | 400 mg/hr | When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m2 given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m2 may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses |
| Maintenance | 375 mg/m2 given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr | |
| Chronic lymphocytic leukaemia | 375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6 | |
| Rheumatoid arthritis | Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate | Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions |
Dosage of Mabthera 10 mg/ml
Notes:Intravenous (Adult)-Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min
Max rate
Dosage:400 mg/hr
Notes:When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m2 given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m2 may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses
Maintenance
Dosage:375 mg/m2 given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr
Chronic lymphocytic leukaemia
Dosage:375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6
Rheumatoid arthritis
Dosage:Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate
Notes:Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions
| Condition | Dosage | Notes |
|---|---|---|
| Intravenous (Adult)-Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min | ||
| Max rate | 400 mg/hr | When used with CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m2 given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated with 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m2 may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses |
| Maintenance | 375 mg/m2 given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr | |
| Chronic lymphocytic leukaemia | 375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6 | |
| Rheumatoid arthritis | Given as two 1 g IV infusion doses, separated by 2 wk and in combination with methotrexate | Corticosteroids may be given before each infusion to minimise the risk and severity of infusion reactions |
Interaction of Mabthera 10 mg/ml
Increased risk of renal toxicity with cisplatin.
Contraindications
Hypersensitivity to murine proteins. Patients with active, severe infections. Severely immunocompromised state. Concomitant use with live viral vaccines. Lactation.
Side Effects of Mabthera 10 mg/ml
Reactivation of hepatitis B virus. Fever and rigors. Pruritus, skin rashes, dyspnoea, bronchospasm, angioedema, transient hypotension, and flushing, asthenia, headache, rhinitis, thrombocytopenia, neutropenia, anaemia, abdominal pain, bowel obstruction, and perforation. Exacerbation of heart failure and angina pectoris. Reversible interstitial pneumonia and interstitial fibrosis. Depletion of immunoglobulin concentrations.
Pregnancy & Lactation
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Precautions & Warnings
Extensive tumour burden, pulmonary insufficiency or pulmonary tumour infiltration; history of cardiac disease. Pregnancy.
Storage Conditions
Store between 2-8° C.
Reconstitution
Dilute the appropriate dose with sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL.
Drug Classes
Cytotoxic immunosuppressants
Mode Of Action
Mabthera 10 mg/ml is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.Duration: Detectable in serum 3-6 mth after completion of therapy; B-cell recovery 6-12 mth following completion of therapy.
Pregnancy
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Frequently Asked Questions
What is Mabthera 10 mg/ml used for?
Non-Hodgkin's Lymphoma (NHL): Rituximab is indicated for the treatment of patients with- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-ag…
What is the dosage of Mabthera 10 mg/ml?
Intravenous (Adult)-Non-Hodgkin's lymphoma, Refractory or relapsed follicular lymphoma: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min. Max rate: 400 mg/hr. When used with CVP (cyclophosphamide, vincristine and p…
What are the side effects of Mabthera 10 mg/ml?
Reactivation of hepatitis B virus. Fever and rigors. Pruritus, skin rashes, dyspnoea, bronchospasm, angioedema, transient hypotension, and flushing, asthenia, headache, rhinitis, thrombocytopenia, neutropenia, anaemia, abdominal pain, bowel obstruction, and perforation. Exacerbation of heart failure and angina pectoris. Reversible interstitial pneumonia and interstitial fibrosis. Depletion of immu…
Who should not take Mabthera 10 mg/ml?
Hypersensitivity to murine proteins. Patients with active, severe infections. Severely immunocompromised state. Concomitant use with live viral vaccines. Lactation.
What precautions should be taken with Mabthera 10 mg/ml?
Extensive tumour burden, pulmonary insufficiency or pulmonary tumour infiltration; history of cardiac disease. Pregnancy.
Is Mabthera 10 mg/ml safe during pregnancy and breastfeeding?
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.