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Ritemvia is a brand name for Rituximab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ritemvia is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Ritemvia maintenance therapy is indicated for the treatment of adult…
Verbatim from this product's EMA label. Tap a section to expand.
4). g. paracetamol and diphenhydramine, should always be given before each administration of Ritemvia. In adult patients with non-Hodgkin’s lymphoma, premedication with glucocorticoids should be considered if Ritemvia 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 Ritemvia. In addition, prednisone should be given as indicated in Table 1.
In patients with GPA or MPA in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to each infusion of Ritemvia 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 Ritemvia (the last dose of methylprednisolone may be given on the same day as the first infusion of Ritemvia).
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 Ritemvia treatment. Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for adult patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Paediatric population In paediatric patients with GPA or MPA, prior to the first Ritemvia 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.
1). Pneumocystis jirovecii pneumonia (PJP) prophylaxis is recommended for paediatric patients with GPA or MPA during and following Ritemvia treatment, as appropriate. Posology Non-Hodgkin’s lymphoma Follicular non-Hodgkin's lymphoma Combination therapy The recommended dose of Ritemvia 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.
Ritemvia 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 Ritemvia 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).
8. These symptoms are usually reversible with interruption of rituximab 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. 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 rituximab. 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 rituximab administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the rituximab infusion. Cardiac disorders Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with rituximab.
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. Rituximab 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.
Traceability In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file. Progressive multifocal leukoencephalopathy (PML) All patients treated with rituximab for rheumatoid arthritis, GPA, MPA or pemphigus vulgaris must be given the patient alert card with each infusion.
The alert card contains important safety informationMedicinal product no longer authorised 9 for patients regarding potential increased risk of infections, including PML. Very rare cases of fatal PML have been reported following the use of rituximab.
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 rituximab must be permanently discontinued.
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 rituximab therapy may lead to similar stabilisation or improved outcome.
1. 4). Patients in a severely immunocompromised state. 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.
Other brands of Rituximab in European Union.
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• Relapsed/refractory follicular lymphoma The recommended dose of Ritemvia 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 Ritemvia 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 Ritemvia 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 CHOP.
Safety and efficacy of Ritemvia have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin’s lymphoma. Dose adjustments during treatmentMedicinal product no longer authorised 5 No dose reductions of Ritemvia are recommended.
When Ritemvia is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied. Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) Patients treated with Ritemvia must be given the patient alert card with each infusion.
Adult induction of remission The recommended dosage of Ritemvia for induction of remission therapy in adult patients with GPA and MPA is 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (four infusions in total).
Adult maintenance treatment Following induction of remission with Ritemvia, maintenance treatment in adult patients with GPA and MPA should be initiated no sooner than 16 weeks after the last Ritemvia infusion. Following […]
Regular full blood counts, including neutrophil and platelet counts, should be performed during rituximab therapy. 8). g. 3). 8). Cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
The majority of these subjects were also exposed to cytotoxic chemotherapy. Limited information from one study in relapsed/refractory CLL patients suggests that rituximab 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 rituximab. At minimum this should include HBsAg-status and HBcAb-status. These can be complemented withMedicinal product no longer authorised 11 other appropriate markers as per local guidelines.
Patients with active hepatitis B disease should not be treated with rituximab. 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. Immunisations The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Patients treated with rituximab may receive non-live vaccinations; however, with non-live vaccines response rates may be reduced. In a non-randomised study, adult patients with relapsed low-grade NHL who received rituximab 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 titer). 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 rituximab. 8). In case of such an event, with a suspected relationship to rituximab, treatment should be permanently discontinued.
Paediatric population Only limited data are available for patients under 3 years of age. 1 for further information. Rheumatoid arthritis, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and pemphigus vulgaris Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Infusion-related reactions Rituximab is associated with infusion related reactions (IRRs), which may be related to release of cytokines […]
Non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia Infusion-related reactions Rituximab 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 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. Severe infusion-related reactions with fatal outcome have been reported during post-marketing use of the rituximab intravenous formulation, with an onset ranging within 30 minutes to 2 hours after starting the first rituximab intravenous infusion.
8). Severe cytokine release syndrome is characterised by severe dyspnoea, 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, hyperphosphataemia, 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 such as patients with CLL, who may be at higher risk of especially severe cytokine releaseMedicinal product no longer authorised 10 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.
8. These symptoms are usually reversible with interruption of rituximab 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. 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 […]