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MABTHERA is a brand name for Rituximab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Non-Hodgkin’s lymphoma (NHL) MabThera is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. 2 Mabthera-0001-m1-3-1-uk-spc-clean- PLGB00031-0864-0865 MabThera maintenance therapy is indicated for the treatment of adult follicular…
Verbatim from this product's MHRA label. Tap a section to expand.
4). g. paracetamol and diphenhydramine, should always be given before each administration of MabThera. Non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia In adult patients with non-Hodgkin’s lymphoma and CLL, premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
In paediatric 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 MabThera. In addition, prednisone should be given as indicated in Table 1.
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 intravenous shortly before infusion with MabThera to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Rheumatoid arthritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris 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 MabThera 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 MabThera (the last dose of methylprednisolone may be given on the same day as the first infusion of MabThera).
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 MabThera treatment. Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for adult and paediatric patients with GPA/MPA and adult patients with PV during and following MabThera treatment, as appropriate according to local clinical practice guidelines.
In paediatric patients with GPA or MPA, prior to the first MabThera IV 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 MabThera infusion.
8. These symptoms are usually reversible with interruption of MabThera infusion and administration of an anti-pyretic, an antihistaminic and occasionally oxygen, intravenous saline or 13 Mabthera-0001-m1-3-1-uk-spc-clean- PLGB00031-0864-0865 bronchodilators, and glucocorticoids if required.
Please see cytokine release syndrome above for severe reactions. Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins to patients. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera. Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Reactions attributed to hypersensitivity have been reported less frequently than those attributed to cytokine release. Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the MabThera infusion. 5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
MabThera has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity. Regular full blood counts, including neutrophil and platelet counts, should be performed during MabThera therapy.
Immunisations The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended. Patients treated with MabThera may receive non-live vaccinations; however, with non-live vaccines response rates may be reduced.
Traceability In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded. Progressive multifocal leukoencephalopathy All patients treated with MabThera for rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must be given the patient alert card with each infusion.
The alert card contains important safety information for patients regarding potential increased risk of infections, including progressive multifocal leukoencephalopathy (PML). Very rare cases of fatal PML have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases [including Systemic Lupus Erythematosus (SLE) and vasculitis] and during post-marketing use of MabThera in NHL and CLL (where the majority of patients had received MabThera in combination with chemotherapy or as part of haematopoietic stem cell transplant).
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Consultation with a Neurologist should be considered as clinically indicated. If any doubt exists, further evaluation, including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments, should be considered.
g. cognitive, neurological or psychiatric symptoms). Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of. If a patient develops PML, the dosing of MabThera must be permanently discontinued.
1. 4). Patients in a severely immunocompromised state. 4 regarding other cardiovascular diseases).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1). Posology It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) is being given to the patient, as prescribed. Dose adjustments during treatment No dose reductions of MabThera are recommended.
When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied. Non-Hodgkin’s lymphoma Follicular non-Hodgkin's lymphoma Combination therapy The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
MabThera should be administered on Day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable. Maintenance therapy • Previously untreated follicular lymphoma The recommended dose of MabThera used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 infusions in total).
• Relapsed/refractory follicular lymphoma The recommended dose of MabThera used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
Monotherapy Relapsed/refractory follicular lymphoma The recommended dose of MabThera monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
1). Adult diffuse large B-cell non-Hodgkin's lymphoma MabThera should be used in combination with CHOP chemotherapy. The recommended dosage is 375 mg/m2 body surface area, administered on Day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of […]
In a non-randomised study, adult patients with relapsed low-grade NHL who received MabThera monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs.
76% when assessed for > 2-fold increase in antibody titre). For CLL patients, similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials. Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Paediatric population Only limited data are available for patients under 3 years of age. 1 for further information. Rheumatoid arthritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris 14 Mabthera-0001-m1-3-1-uk-spc-clean- PLGB00031-0864-0865 Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of MabThera is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Infusion-related reactions MabThera is associated with infusion-related reactions (IRRs), which may be related to release of cytokines and/or other chemical mediators. Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the post-marketing setting.
In rheumatoid arthritis most infusion-related events reported in clinical trials were mild to moderate in severity. The most common symptoms were allergic reactions like headache, pruritus, throat irritation, flushing, rash, urticaria, hypertension and pyrexia.
In general, the proportion of patients experiencing any infusion reaction was higher following the first infusion than following the second infusion of any treatment course. 8). The reactions reported were usually reversible with a reduction in rate, or interruption, of MabThera infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions. Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue MabThera.
g. from 100 mg/h to 50 mg/h) when symptoms have completely resolved. g. epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
There are no data on the safety of MabThera in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease. In patients treated with MabThera, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Since hypotension may occur during MabThera infusion, consideration should be given to […]
Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen. It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
11 Mabthera-0001-m1-3-1-uk-spc-clean- PLGB00031-0864-0865 Cardiac disorders Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with MabThera.
Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely (see infusion-related reactions, below). 1). 8). g. g. where levels of CD4 or CD8 are very low). g. 8). It is recommended that immunoglobulin levels are determined prior to initiating treatment with MabThera.
Patients reporting signs and symptoms of infection following MabThera therapy should be promptly evaluated and treated appropriately. Before giving a subsequent course of MabThera treatment, patients should be re-evaluated for any potential risk for infections.
For information on progressive multifocal leukoencephalopathy (PML) please see PML section above. Cases of enteroviral meningoencephalitis including fatalities have been reported following use of rituximab. Hepatitis B Infections Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in patients receiving MabThera.
The majority of these patients were also exposed to cytotoxic chemotherapy. Limited information from one study in relapsed/refractory CLL patients suggests that MabThera treatment may also worsen the outcome of primary hepatitis B infections.
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with MabThera. At minimum this should include HBsAg-status and HBcAb-status. These can be complemented with other appropriate markers as per local guidelines.
Patients with active hepatitis B disease should not be treated with MabThera. Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
g. West Nile virus and neuroborreliosis. 8). In case of such an event with a suspected relationship to MabThera, treatment should be permanently discontinued. Non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia Infusion-related reactions MabThera is associated with infusion-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Cytokine release syndrome may be clinically […]