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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: MabThera is indicated in adults for non-Hodgkin’s lymphoma (NHL): 2 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. MabThera maintenance therapy is indicated for the treatment…
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. Premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
Posology The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1400 mg irrespective of the patient’s body surface area. 4). If patients were not able to receive one full MabThera intravenous infusion dose prior to the switch, they should continue the subsequent cycles with MabThera intravenous formulation until a full intravenous dose is successfully administered.
Therefore, the switch to MabThera subcutaneous formulation can only occur at the second or subsequent cycles of treatment. It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and strength is being given to the patient, as prescribed.
3 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 MabThera subcutaneous formulation is not intended for intravenous administration and should be given via subcutaneous injection only. The 1400 mg strength is intended for subcutaneous use in non-Hodgkin’s lymphoma (NHL) only.
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: first cycle with MabThera intravenous formulation 375 mg/m2 body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle for up to 8 cycles.
MabThera should be administered on Day 1 of each chemotherapy cycle, after administration of the glucocorticoid component of the chemotherapy if applicable. Maintenance therapy • Previously untreated follicular lymphoma The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 1400 mg 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 administrations in total).
• Relapsed/refractory follicular lymphoma The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 1400 mg 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 administrations in total).
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 bronchodilators, and glucocorticoids if required.
Please see cytokine release syndrome above for severe reactions. Administration related reactions have been observed in up to 50% of patients treated with MabThera subcutaneous formulation in clinical trials. 8). Local cutaneous reactions were very common in patients receiving MabThera subcutaneous in clinical trials.
8). Some local cutaneous reactions occurred more than 24 hours after the MabThera subcutaneous administration. The majority of local cutaneous reactions seen following administration of MabThera subcutaneous formulation was mild or moderate and resolved without any specific treatment.
Before starting MabThera subcutaneous injections, all patients must always receive beforehand, a full dose of MabThera by intravenous infusion, using MabThera intravenous formulation. The highest risk of experiencing an administration related reaction is generally observed at cycle one.
Beginning the therapy with MabThera intravenous infusion would allow a better handling of the administration reactions by slowing or stopping the intravenous infusion. If patients were not able to receive one full MabThera intravenous infusion dose prior to the switch, they should continue the subsequent cycles with MabThera intravenous formulation until a full intravenous dose is successfully administered.
Therefore, the switch to MabThera subcutaneous formulation can only occur at the second or subsequent cycles of treatment. As with the intravenous formulation, MabThera subcutaneous formulation should be administered in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced healthcare professional.
Traceability In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded. 4 pertains to the use of MabThera subcutaneous formulation in the approved indications Treatment of non-Hodgkin’s lymphoma (strength 1400 mg) and Treatment of chronic lymphocytic leukaemia (strength 1600 mg).
For information related to the other indications, please refer to the SmPC of MabThera intravenous formulation. The use of MabThera subcutaneous formulation as monotherapy in patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy cannot be recommended as the safety of the once weekly subcutaneous administration has not been established.
Progressive multifocal leukoencephalopathy Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML). 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). 5 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 Patients in a severely immunocompromised state.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Diffuse large B-cell non-Hodgkin's lymphoma MabThera should be used in combination with CHOP chemotherapy. The recommended dose is: first cycle, MabThera intravenous formulation: 375 mg/m2 body surface area, followed by subsequent cycles with MabThera subcutaneous formulation injected at a fixed dose of 1400 mg per cycle.
In total: 8 cycles. MabThera is administered on Day 1 of each chemotherapy cycle after intravenous infusion of the glucocorticoid component of CHOP. Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B-cell non-Hodgkin’s lymphoma.
4 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 Dose adjustments during treatment No dose reductions of MabThera are recommended. 8). Special populations Paediatric population The safety and efficacy of MabThera in children aged below 18 years has not been established.
No data are available. Elderly No dose adjustment is required in patients aged 65 years and above.
Method of administration Subcutaneous injections:
MabThera 1400 mg subcutaneous formulation should be administered as subcutaneous injection only, over approximately 5 minutes. The hypodermic injection needle must only be attached to the syringe immediately prior to administration to avoid potential needle clogging.
MabThera subcutaneous formulation should be injected subcutaneously into the abdominal wall and never into areas where the skin is red, bruised, tender, hard or areas where there are moles or scars. No data are available on performing the injection in other sites of the body, therefore injections should be restricted to the abdominal wall.
During the treatment course with MabThera subcutaneous formulation, other medicinal products for subcutaneous administration should preferably be given at different sites. If an injection is interrupted it can be resumed at the same site or another location may be used, if appropriate.
Premedication consisting of an analgesic/antipyretic and an antihistamine should always be administered before each dose of MabThera subcutaneous formulation. Premedication with glucocorticoids should also be considered. 8 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions. Patients should be instructed to contact their treating physician immediately if symptoms that are suggestive of severe hypersensitivity or cytokine release syndrome occur at any time after medicinal product administration.
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.
5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited. The MabThera intravenous formulation 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. 8). g. 3). 8). Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
The majority of these patients were also exposed to cytotoxic chemotherapy. 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.
8). The majority of patients had received rituximab in combination with chemotherapy or as part of a haematopoietic stem cell transplant. Cases of enteroviral meningoencephalitis including fatalities have been reported following use of rituximab.
g. West Nile virus and neuroborreliosis. Immunisation The safety of immunisation with live viral vaccines, […]
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.
Infusion/Administration-related reactions 6 mabthera0001m1-3-1-uk-spc-clean-PLGB00031-0866 MabThera is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions. This set of reactions which includes syndrome of cytokine release, tumour lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
They are not specifically related to the route of administration of MabThera and can be observed with both formulations. Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the MabThera intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first MabThera intravenous infusion.
8). Severe cytokine release syndrome is characterised by severe dyspnea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphaetemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest X-ray. The syndrome frequently manifests itself within one or two hours of initiating the first infusion.
Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution. 2) and should receive aggressive symptomatic treatment.
Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out. Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Patients with a high tumour burden or with a high number (≥ 25 x 109/L) of circulating malignant cells, who may be at higher risk of especially severe cytokine release syndrome, should be treated with extreme caution. These patients should be very closely monitored throughout the first infusion.
Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still > 25 x 109/L.
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.
, 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 […]