BRIUMVI

BRIUMVI- ublituximab injection, solution, concentrate
TG Therapeutics, Inc.

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.

2 DOSAGE AND ADMINISTRATION

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 with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with BRIUMVI [see Warnings and Precautions ( 5.2)] .

Serum Immunoglobulins

Prior to initiating BRIUMVI, perform testing for quantitative serum immunoglobulins [see Warnings and Precautions ( 5.4)]. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with BRIUMVI.

Vaccinations

Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of BRIUMVI for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines [see Warnings and Precautions ( 5.2) and Clinical Pharmacology ( 12.2)] .

2.2 Assessment and Premedication Before Every Infusion

Infection Assessment

Prior to every infusion of BRIUMVI, determine whether there is an active infection. In case of active infection, delay infusion of BRIUMVI until the infection resolves [see Warnings and Precautions ( 5.2)] .

Recommended Premedication

Pre-medicate with 100 mg of methylprednisolone administered intravenously (or an equivalent oral dosage or equivalent corticosteroid) approximately 30 minutes prior to each BRIUMVI infusion to reduce the frequency and severity of infusion reactions [see Warnings and Precautions ( 5.1)] . Pre-medicate with an antihistamine (e.g., diphenhydramine) administered orally or intravenously approximately 30-60 minutes prior to each BRIUMVI infusion to further reduce the frequency and severity of infusion reactions.

The addition of an antipyretic (e.g., acetaminophen) may also be considered.

Pregnancy Testing

Pregnancy testing is recommended for females of reproductive potential prior to each infusion with BRIUMVI [see Warnings and Precautions ( 5.3) and Use in Specific Populations ( 8.1, 8.3)].

2.3 Recommended Dosage and Dose Administration

Administer BRIUMVI under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions, such as serious infusion reactions.

  • First Infusion: 150 mg intravenous infusion
  • Second Infusion: 450 mg intravenous infusion administered two weeks after the first infusion
  • Subsequent Infusions: 450 mg intravenous infusion administered 24 weeks after the first infusion and every 24 weeks thereafter
  • Observe the patient 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 in association with the current or any prior infusion [see Warnings and Precautions ( 5.1)].
Table 1: Recommended Dose, Infusion Rate, and Infusion Duration for MS

1 Withdraw and discard the required volume of 0.9% Sodium Chloride Injection, USP from the infusion bag following the preparation instructions in Preparation and Administration ( 2.6).

2 Infusion duration may take longer if the infusion is interrupted or slowed.

3 Administer the first subsequent infusion 24 weeks after the first infusion.

Dose (mg) and Volume (mL) of BRIUMVI Volume (mL) of 0.9% Sodium Chloride Injection, USP 1 Infusion Rate (mL/hour) Duration 2
First Infusion 150 mg (6 mL) 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 (18 mL) 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) 3 450 mg (18 mL) 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

2.4 Delayed or Missed Doses

If a planned infusion of BRIUMVI is missed, administer BRIUMVI as soon as possible; do not wait until the next scheduled infusion. Reset the infusion schedule to administer the next sequential infusion 24 weeks after the missed infusion is administered. Infusions of BRIUMVI must be separated by at least 5 months.

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