TG Therapeutics Announces European Launch of BRIUMVI (ublituximab-xiiy) - Seite 2

BRIUMVI is indicated in the US for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in the European Union (EU) for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

Highlights from the EU Label for BRIUMVI
In the EU, BRIUMVI is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

CONTRAINDICATIONS:

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

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Traceability: The name and the batch number of the administered product should be clearly recorded.

Infusion-related reactions (IRRs): Symptoms of IRR may include pyrexia, chills, headache, tachycardia, nausea, abdominal pain, throat irritation, erythema, and anaphylactic reaction.

Patients should premedicate with a corticosteroid and an antihistamine to reduce the frequency and severity of IRRs. The addition of an antipyretic (e.g., paracetamol) may also be considered. Patients treated with ublituximab should be observed during infusions. Patients should be monitored for at least one hour after the completion of the first two infusions. Subsequent infusions do not require monitoring post-infusion unless IRR and/or hypersensitivity has been observed. Physicians should inform patients that IRRs can occur up to 24 hours after the infusion.

Infections: Administration must be delayed in patients with an active infection until the infection is resolved.

It is recommended to verify the patient’s immune status before dosing since severely immunocompromised patients (e.g., significant neutropenia or lymphopenia) should not be treated. Ublituximab has the potential for serious, sometimes life-threatening or fatal, infections. Most of the serious infections that occurred in controlled clinical trials in RMS resolved. 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.