TG Therapeutics Announces European Launch of BRIUMVI (ublituximab-xiiy) - Seite 3

Progressive Multifocal Leukoencephalopathy (PML): John Cunningham virus (JCV) infection resulting in PML has been observed very rarely in patients treated with anti-CD20 antibodies and mostly associated with risk factors (e.g., patient population, lymphopenia, advanced age, polytherapy with immunosuppressants). Physicians should be vigilant for the early signs and symptoms of PML, which can include any new onset, or worsening of neurological signs or symptoms, as these can be similar to MS disease.

If PML is suspected, dosing with ublituximab must be withheld. Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for JCV Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered. If PML is confirmed, treatment must be discontinued permanently.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been observed in patients treated with anti-CD20 antibodies.

HBV screening should be performed in all patients before initiation of treatment as per local guidelines. Patients with active HBV (i.e., an active infection confirmed by positive results for HBsAg and anti HB testing) should not be treated with ublituximab. Patients with positive serology (i.e., negative for HBsAg and positive for HB core antibody (HBcAb +) or who are carriers of HBV (positive for surface antigen, HBsAg+) should consult liver disease experts before starting the treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.

Vaccinations: The safety of immunisation with live or live-attenuated vaccines, during or following therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion. All immunisations should be administered according to immunisation guidelines at least 4 weeks prior to treatment initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to treatment initiation for inactivated vaccines.

Vaccination of infants born to mothers treated with ublituximab during pregnancy: In infants of mothers treated with ublituximab during pregnancy, live or live-attenuated vaccines should not be administered before the recovery of B-cell counts has been confirmed. Depletion of B cells in these infants may increase the risks associated with live or live-attenuated vaccines. Measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended.