BRIUMVI 150 mg/6mL
ublituximab · INJECTION, SOLUTION, CONCENTRATE · TG Therapeutics, Inc.
BRIUMVI is a injection, solution, concentrate containing ublituximab at 150 mg/6mL, taken intravenous. Manufactured by TG Therapeutics, Inc..
Key Facts
- Brand Name
- BRIUMVI
- Generic Name
- ublituximab
- NDC Code (Product)
73150-150- Manufacturer
- TG Therapeutics, Inc.
- Strength
- 150 mg/6mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761238
- Drug Class
- CD20-directed Cytolytic Antibody [EPC]
- Marketing Start
- 12/28/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 , 14 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Before initiating BRIUMVI, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin ( 2.1 ). Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion ( 2.2 ). Administer BRIUMVI by intravenous infusion. First Infusion: 150 mg intravenous infusion ( 2.3 ) Second Infusion: 450 mg intravenous infusion two weeks after the first infusion ( 2.3 ) Subsequent Infusions: 450 mg intravenous infusion 24 weeks after the first infusion and every 24 weeks thereafter ( 2.3 ) Must be diluted in 0.9% Sodium Chloride Injection, USP prior to administration ( 2.3 , 2.6 ). Monitor patients closely during and for at least one hour after the completion of the first two infusions. Post-infusion monitoring of subsequent infusions is at physician discretion unless infusion reaction and/or hypersensitivity has been observed ( 2.3 , 5.1 ). 2.1 Assessments Prior to First Dose of BRIUMVI Hepatitis B Virus Screening Prior to initiating BRIUMVI, perform Hepatitis B virus (HBV) screening. BRIUMVI is contraindicated in patients …
Contraindications
4 CONTRAINDICATIONS BRIUMVI is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] A history of life-threatening infusion reaction to BRIUMVI [see Warnings and Precautions (5.1) ] Active hepatitis B virus infection ( 4 ) History of life-threatening infusion reaction to BRIUMVI ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Immunosuppressive or Immune-Modulating Therapies The concomitant usage of BRIUMVI with other immune-modulating or immunosuppressant drugs, including immunosuppressant doses of corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when co-administering immunosuppressive therapies with BRIUMVI. When switching from therapies with immune effects, the duration and mechanism of action of these therapies should be taken into account because of potential additive immunosuppressive effects when initiating BRIUMVI.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Liver Injury [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥10%) were infusion reactions and upper respiratory tract infections ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact TG Therapeutics at 1-877-848-9462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In active-controlled clinical trials (Study 1 and Study 2), 545 patients with RMS received BRIUMVI [see Clinical Studies (14) ]. The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Table 2 summarizes the adverse r…
Frequently Asked Questions
What is BRIUMVI used for?
BRIUMVI contains ublituximab. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is BRIUMVI a controlled substance?
BRIUMVI is not classified as a controlled substance by the DEA.
What is the generic name for BRIUMVI?
The generic name for BRIUMVI is ublituximab. There are no other listed brand versions of ublituximab.
What is the NDC code for BRIUMVI 150 mg/6mL?
The NDC (National Drug Code) for BRIUMVI 150 mg/6mL is 73150-150, listed by TG Therapeutics, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)