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Briumvi is a brand name for Ublituximab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
4 for additional steps to reduce IRRs): • 100 mg methylprednisolone or 10-20 mg dexamethasone (or an equivalent) approximately 30-60 minutes prior to each infusion; • Antihistaminic (eg. g. paracetamol) may also be considered. Posology 3 First and second doses The first dose is administered as a 150 mg intravenous infusion (first infusion), followed by a 450 mg intravenous infusion (second infusion) 2 weeks later (see Table 1).
Subsequent doses Subsequent doses are administered as a single 450 mg intravenous infusion every 24 weeks (Table 1). The first subsequent dose of 450 mg should be administered 24 weeks after the first infusion. A minimal interval of 5 months should be maintained between each dose of ublituximab.
Infusion adjustments in case of IRRs Life-threatening IRRs If there are signs of a life-threatening or disabling IRR during an infusion, the infusion must be stopped immediately and the patient should receive appropriate treatment.
4). Severe IRRs If a patient experiences a severe IRR, the infusion should be interrupted immediately and the patient should receive symptomatic treatment. The infusion should be restarted only after all symptoms have resolved. When restarting, the infusion rate should be at half of the infusion rate at the time of onset of the IRR.
If the rate is tolerated, the rate should be increased as described in Table 1. Mild to moderate IRRs If a patient experiences a mild to moderate IRR, the infusion rate should be reduced to half the rate at the onset of the event. This reduced rate should be maintained for at least 30 minutes.
If the reduced rate is tolerated, the infusion rate may then be increased as described in Table 1. Dose modifications during treatment No dose reductions are recommended. In case of dose interruption or infusion rate reduction due to IRR, the total duration of the infusion would be increased, but not the total dose.
Delayed or missed doses If an infusion is missed, it should be administered as soon as possible; administration after a delayed or missed dose should not wait until the next planned dose. The treatment interval of 24 weeks (with a minimum of 5 months) should be maintained between doses (see Table 1).
8%). Tabulated list of adverse reactions Table 2 summarises the adverse reactions that have been reported in association with the use of ublituximab. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each System Organ Class and frequency grouping, adverse reactions are presented in order of decreasing frequency. 8 Table 2: Adverse reactions MedDRA System Organ Class (SOC) Very common Common Uncommon Infections and infestations Upper respiratory tract infections, Respiratory tract infections Herpes virus infections, Lower respiratory tract infections Encephalitis, Meningitis, Meningoencephalitis Blood and lymphatic system disorders Neutropenia Musculoskeletal and connective tissue disorders Pain in extremity Injury, poisoning and procedural complications Infusion-related reactions1 1 Symptoms reported as IRRs within 24 hours of the infusion are described below in ‘Infusion-related reactions’.
Description of selected adverse reactions Infusion-related reactions In active-controlled RMS trials, symptoms of IRR included pyrexia, chills, headache, tachycardia, nausea, abdominal pain, throat irritation, erythema, and anaphylactic reaction.
IRRs were primarily mild to moderate in severity. 4%). 6% with the second infusion and decreased thereafter. 7% of patients experienced IRRs that led to treatment interruption. 4% of patients experienced IRRs that were serious. There were no fatal IRRs.
9% in the teriflunomide group. 4%, respectively). The infections were predominantly mild to moderate in severity and consisted primarily of respiratory tract-related infections (mostly nasopharyngitis and bronchitis). 8% teriflunomide treated patients.
0% of teriflunomide treated patients. Laboratory abnormalities Immunoglobulins decrease In active-controlled RMS trials, treatment with ublituximab resulted in a decrease in total immunoglobulins over the controlled period of the studies, mainly driven by the reduction in IgM.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). 2). , paracetamol) may also be considered. Patients treated with ublituximab should be observed during infusions.
Patients should be monitored for at least one hour after the completion of the first two infusions. Subsequent infusions do not require monitoring post-infusion unless IRR and/or hypersensitivity has been observed. Physicians should inform patients that IRRs can occur up to 24 hours after the infusion.
2. Infection Administration must be delayed in patients with an active infection until the infection is resolved. g. 8). 8). Most of the serious infections that occurred in controlled clinical trials in relapsing forms of multiple sclerosis (RMS) resolved.
There were 3 infection-related deaths that occurred, all in patients treated with ublituximab; the infections leading to death were post-measles encephalitis, pneumonia, and post- operative salpingitis following an ectopic pregnancy.
, patient population, lymphopenia, advanced age, polytherapy with immunosuppressants). Physicians should be vigilant for the early signs and symptoms of PML, which can include any new onset, or worsening of neurological signs or symptoms, as these can be similar to MS disease.
If PML is suspected, dosing with ublituximab must be withheld. Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for JCV Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered.
If PML is confirmed, treatment must be discontinued permanently. Hepatitis B virus (HBV) reactivation HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been observed in patients treated with anti-CD20 antibodies.
1. 4). 4). • Known active malignancies. 5
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2), no dose adjustment is considered necessary in patients over 55 years of age. 2). 2). Paediatric population The safety and efficacy of Briumvi in children and adolescents aged 0 to 18 years have not yet been established. No data are available.
Method of administration After dilution, Briumvi is administered as an intravenous infusion through a dedicated line. Infusions should not be administered as an intravenous push or bolus.
Table 1:
Dose and schedule Amount and volume Infusion rate Duration1 First Infusion 150 mg in 250 ml • Start at 10 ml per hour for the first 30 minutes • Increase to 20 ml per hour for the next 30 minutes • Increase to 35 ml per hour for the next hour • Increase to 100 ml per hour for the remaining 2 hours 4 hours Second Infusion (2 weeks later) 450 mg in 250 ml • Start at 100 ml per hour for the first 30 minutes • Increase to 400 ml per hour for the remaining 30 minutes 1 hour Subsequent Infusions (once every 24 weeks)2 450 mg in 250 ml • Start at 100 ml per hour for the first 30 minutes • Increase to 400 ml per hour for the remaining 30 minutes 1 hour 1Infusion duration may take longer if the infusion is interrupted or slowed.
2The first subsequent infusion should be administered 24 weeks after the first infusion. 8 mg/ml for the second infusion and all subsequent infusions. 6.
1%, respectively. 9%, respectively. Lymphocytes 9 In active controlled RMS trials, a transient decrease in lymphocytes was observed in 91% of ublituximab patients at Week 1. 8% of the patients reported a decrease in lymphocytes. All decreases in lymphocytes were Grade 1 (<LLN-800 cells/mm3) and 2 (between 500 and 800 cells/mm3) in severity.
Neutrophils counts In active-controlled RMS trials, a decrease in neutrophils counts < LLN was observed in 15% of ublituximab patients compared with 22% of patients treated with teriflunomide. The majority of the neutrophil decreases were transient (only observed once for a given patient treated with ublituximab) and were Grade 1 (between <LLN and 1500 cells/mm3) and 2 (between 1000 and 1500 cells/mm3) in severity.
Approximately 1% of the patients in the ublituximab group had Grade 4 neutropenia vs. 0% in the teriflunomide group. One ublituximab treated patient with Grade 4 (< 500 cells/mm3) neutropenia required specific treatment with granulocyte-colony stimulating factor.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
6 HBV screening should be performed in all patients before initiation of treatment as per local guidelines. e. an active infection confirmed by positive results for HBsAg and anti HB testing) should not be treated with ublituximab. e.
negative for HBsAg and positive for HB core antibody (HBcAb +) or who are carriers of HBV (positive for surface antigen, HBsAg+) should consult liver disease experts before starting the treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
1). All immunisations should be administered according to immunisation guidelines at least 4 weeks prior to treatment initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to treatment initiation for inactivated vaccines.
Vaccination of infants born to mothers treated with ublituximab during pregnancy In infants of mothers treated with ublituximab during pregnancy, live or live-attenuated vaccines should not be administered before the recovery of B-cell counts has been confirmed.
Depletion of B cells in these infants may increase the risks associated with live or live-attenuated vaccines. Measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended. Inactivated vaccines may be administered as indicated prior to recovery from B-cell depletion.
However, assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. 6). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.