BRIUMVI dosing and convenient administration
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DOSING & ADMINISTRATION
BRIUMVI is a 1-hour, 450 mg intravenous (IV) infusion given every 24 weeks following the starting dose1
95%
of all BRIUMVI infusions were completed in 1 hour without interruption in clinical trials*2
*± 5 minutes
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BRIUMVI offers flexible premedication and post-infusion monitoring options1
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. 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. - An antipyretic (e.g., acetaminophen)
may also be considered for use prior to administration
Treatment
- 1-hour infusion following the starting dose
- Day 1 infusion is 150 mg over 4 hours; Day 15 infusion is 450 mg over 1 hour; subsequent infusions are 450 mg over
1 hour, every 24 weeks
Flexible post-infusion monitoring
- 1-hour post-infusion monitoring required on Day 1 and Day 15
After the third infusion and beyond, post-infusion monitoring is at physician discretion unless infusion reactions and/or hypersensitivity have been observed in association with the current or any prior infusion
DMT=Disease-modifying therapy
Prior to the administration of BRIUMVI, ensure that the appropriate assessments have been completed1
Assessments prior to the first dose of BRIUMVI1
HBV Screening
- Prior to initiating BRIUMVI, perform 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
Serum Immunoglobulins
- Prior to initiating BRIUMVI, perform testing for quantitative serum immunoglobulins. 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
Assessment before every infusion1
Infection Assessment
- Prior to every infusion of BRIUMVI, determine whether there is an active infection. In case of an active infection, delay infusion of BRIUMVI until the infection resolves
Pregnancy Testing (Recommended)
- Pregnancy testing is recommended for females of reproductive potential prior to each infusion with BRIUMVI
Understanding the correct dosage and infusion rates for your patients1
aWithdraw and discard the required volume of 0.9% sodium chloride injection, USP from the infusion bag following the preparation instructions
bInfusion duration may take longer if the infusion is interrupted or slowed.
cAdminister the first subsequent infusion 24 weeks after the first infusion.
Dose modifications in response to infusion reactions depend on severity. Any change in rate will increase the total duration of the infusion but not the total dose1
Life-threatening infusion reactions
Stop infusion immediately and permanently discontinue BRIUMVI. Provide appropriate supportive treatment.
Severe infusion reactions
Immediately interrupt the infusion and administer appropriate supportive treatment, as necessary. Restart the infusion only after all symptoms have resolved. When restarting, begin at half of the infusion rate at the time of onset of the infusion reaction. If this rate is tolerated, increase the rate as described in the infusion rate table.
Mild to moderate infusion reactions
Reduce the infusion rate to half the rate at the onset of the infusion reaction and maintain the reduced rate for at least 30 minutes. If the reduced rate is tolerated, increase the rate as described in the infusion rate table.
Preparing BRIUMVI for infusion
BRIUMVI must be prepared by a healthcare professional using aseptic technique.1 Prepare the solution for infusion as follows:
BRIUMVI should be a clear to opalescent, colorless to slightly yellow solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if discolored or if the solution contains discrete foreign particulate matter.
Preparation of solution for the first infusion
1
Prepare infusion bag for the first infusion (150 mg) using 1 vial (150 mg/6 mL) of BRIUMVI.
2
Withdraw 6 mL 0.9% NaCl injection, USP from the 250 mL infusion bag and discard.
3
Withdraw 6 mL BRIUMVI solution from the vial.
4
Add 6 mL (150 mg) BRIUMVI into the infusion bag containing 0.9% NaCl injection, USP.
Preparation of solution for the second and subsequent infusions
5
Prepare infusion bag for second infusion (450 mg) and subsequent infusions (450 mg) using 3 vials (150 mg/6 mL) of BRIUMVI.
6
Withdraw 18 mL 0.9% NaCl injection, USP from the 250 mL infusion bag and discard.
7
Withdraw 18 mL BRIUMVI solution from the vials
(6 mL/vial).
8
Add 18 mL (450 mg) BRIUMVI into the infusion bag containing 0.9% NaCl injection, USP.
Mix diluted solution by gentle inversion. Do not shake.
NaCl=Sodium chloride
USP=United States Pharmacopeia
Prior to the start of the IV
infusion, the contents of the
infusion bag should be at
room temperature.
Administer the diluted infusion solution through a dedicated line.
Use the prepared infusion
solution immediately. If
the diluted solution is not
administered immediately,
store for up to:
24 hours in the refrigerator at
2°C to 8°C (36°F to 46°F)
If the diluted solution is stored refrigerated, allow it to equilibrate to room temperature prior to administration (~ 2 hours).
The diluted solution can be stored for an additional 8 hours at room temperature up to 25°C (77°F), which includes the equilibration time and infusion time.
Do not freeze.
No incompatibilities between
BRIUMVI and PVC or PO bags
and IV administration sets
have been observed.
IV=intravenous
PVC=polyvinyl chloride
PO=polyolefin
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References: 1. BRIUMVI. Prescribing information. TG Therapeutics Inc; 2022. 2. Fox EJ, Steinman L, Hartung H-P, et al. Infusion-related reactions (IRRs) with ublituximab in patients with relapsing multiple sclerosis (RMS): post hoc analyses from the phase 3 ULTIMATE I and II studies. Presented at: 2022 American Academy of Neurology (AAN) Annual Meeting; April 2-7, 24-26, 2022; Seattle, WA.