Ublituximab Application Scope

Ublituximab, marketed under the brand name Briumvi, is a glycoengineered anti-CD20 monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

Characteristics

Ingredients:
- Active Ingredient: Ublituximab-xiiy (a recombinant chimeric monoclonal IgG1 antibody targeting CD20)
- Inactive Ingredients: Hydrochloric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection, USP
Properties: Binds to CD20-expressing B-cells, leading to cell lysis through antibody-dependent cellular cytolysis and complement-dependent cytolysis
Packaging Specification: Single-dose vials containing 150 mg/6 mL of solution
Storage:
- Unopened Vials: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze or shake
- Diluted Solution: If not used immediately, store refrigerated at 2°C to 8°C for up to 24 hours. May be stored at room temperature (up to 25°C or 77°F) for an additional 8 hours, including infusion time
Expiry Date: Refer to the specific vial’s labeling for the expiration date.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) in December 2022 for the treatment of relapsing forms of MS
Approval Number: FDA approval granted in December 2022
Date of Revision: Refer to the prescribing information or manufacturer’s website for the most recent revision date.
Manufacturer: TG Therapeutics, Inc.

Guidelines for the Use of Ublituximab

Dosage and Administration:
- First Infusion: 150 mg IV over at least 4 hours
- Second Infusion: 450 mg IV over at least 1 hour, administered two weeks after the first infusion
- Subsequent Infusions: 450 mg IV every 24 weeks over at least 1 hour
Adverse Reactions:
- - Common (>10%): Infusion reactions (48%), upper respiratory tract infections (45%), decreased IgM levels
  - Less Common (1–10%): Lower respiratory tract infections, herpes-virus-associated infections, extremity pain, insomnia, fatigue, decreased IgG and IgA levels
Contraindications:
- Active hepatitis B virus (HBV) infection
- History of life-threatening infusion reaction to ublituximab
Precautions:
- Infections: Increased risk of serious and fatal bacterial, fungal, and new or reactivated viral infections. Delay administration in patients with active infections until resolved .
- Progressive Multifocal Leukoencephalopathy (PML): Monitor for signs and symptoms; discontinue treatment if PML is confirmed .
- Immunoglobulin Levels: Monitor serum immunoglobulin levels during treatment, especially in patients with opportunistic or recurrent infections .
- Vaccinations: Administer all immunizations according to guidelines at least 4 weeks prior to initiating therapy for live or live-attenuated vaccines and at least 2 weeks prior for non-live vaccines. Live vaccines are not recommended during treatment and until B-cell repletion

Ublituximab Interactions

Drug Interactions:
- Contraindicated: Talimogene laherparepvec (increased immunosuppressive effects; risk of infection)
- Serious Interactions: Other immunosuppressive agents such as axicabtagene ciloleucel, brexucabtagene autoleucel, ciltacabtagene autoleucel (increased risk of infection)

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.