BRIUMVI

What it is

Briumvi is a concentrate for solution for infusion containing ublituximab 150 mg in 6 mL at a concentration of 25 mg/mL. Ublituximab is a chimeric monoclonal antibody produced in a clone of the rat myeloma cell line YB2/0 by recombinant DNA technology. Ublituximab is a chimeric monoclonal antibody that selectively targets CD20-expressing cells. The precise mechanism by which ublituximab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20 inducing lysis of CD20+ B cells primarily through antibody-dependent cell-mediated cytotoxicity (ADCC) and, to a lesser extent through complement-dependent cytotoxicity (CDC).

Approved indications

— Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Dosing overview

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. Subsequent doses are administered as a single 450 mg intravenous infusion every 24 weeks. A minimal interval of 5 months should be maintained between each dose of ublituximab. Methylprednisolone 100 mg or dexamethasone 10–20 mg (or an equivalent) must be administered orally, intravenously, intramuscularly, or subcutaneously approximately 30–60 minutes prior to each infusion. An antihistamine (for example diphenhydramine) must also be administered approximately 30–60 minutes prior to each infusion. Premedication with an antipyretic (for example paracetamol) may also be considered.

Key safety warnings

Symptoms of infusion-related reactions may include pyrexia, chills, headache, tachycardia, nausea, abdominal pain, throat irritation, erythema, and anaphylactic reaction. The incidence of infusion-related reactions in patients treated with ublituximab was 45.3%, with the highest incidence with the first infusion (40.4%), 8.6% with the second infusion and decreasing thereafter, with 1.7% of patients experiencing infusion-related reactions that led to treatment interruption. Ublituximab has the potential for serious, sometimes life-threatening or fatal, infections; most of the serious infections that occurred in controlled clinical trials in relapsing forms of multiple sclerosis resolved, though 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 postoperative salpingitis following an ectopic pregnancy. John Cunningham virus (JCV) infection resulting in progressive multifocal leukoencephalopathy (PML) has been observed very rarely in patients treated with anti-CD20 antibodies; 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; if PML is suspected, dosing with ublituximab must be withheld, and if PML is confirmed, treatment must be discontinued permanently. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been observed in patients treated with anti-CD20 antibodies; HBV screening should be performed in all patients before initiation of treatment as per local guidelines, and patients with active HBV should not be treated with ublituximab. Clinically significant liver injury, without findings of viral hepatitis, has been reported in the post-marketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of multiple sclerosis, including Briumvi; signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred weeks to months after administration.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Severe active infection. Patients in a severely immunocompromised state. Known active malignancies.

PBS listing

Solution concentrate for intravenous infusion 150 mg in 6 mL is listed on 4 PBS items with streamlined restriction, at an ex-manufacturer price of A$3861.00.

Regulatory history

Briumvi was approved for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features on 4 June 2025, leading to its registration in the ARTG on 11 June 2025. The PBAC recommended Briumvi in May 2025 for the treatment of relapsing-remitting multiple sclerosis (RRMS). Briumvi is subject to additional monitoring in Australia, which will allow quick identification of new safety information.