Active Ingredient: Ublituximab
Ublituximab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 150 milligrams ublituximab, one dose, over the duration of 2 weeks. Afterwards, intravenous, 450 milligrams ublituximab, once every 24 weeks.
Treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
The following two premedications must be administered (orally, intravenously, intramuscular, or subcutaneously) prior to each infusion to reduce the frequency and severity of IRRs:
In addition, premedication with an antipyretic (e.g. paracetamol) may also be considered.
The first dose is administered as a 150 mg intravenous infusion (first infusion), followed by a 450 mg intravenous infusion (second infusion) 2 weeks later.
Subsequent doses are administered as a single 450 mg intravenous infusion every 24 weeks. The first subsequent dose of 450 mg should be administered 24 weeks after the first infusion.
A minimal interval of 5 months should be maintained between each dose of ublituximab.
If there are signs of a life-threatening or disabling IRR during an infusion, the infusion must be stopped immediately and the patient should receive appropriate treatment. Treatment must be permanently discontinued in these patients.
If a patient experiences a severe IRR, the infusion should be interrupted immediately and the patient should receive symptomatic treatment. The infusion should be restarted only after all symptoms have resolved. When restarting, the infusion rate should be at half of the infusion rate at the time of onset of the IRR. If the rate is tolerated, the rate should be increased.
If a patient experiences a mild to moderate IRR, the infusion rate should be reduced to half the rate at the onset of the event. This reduced rate should be maintained for at least 30 minutes. If the reduced rate is tolerated, the infusion rate may then be increased.
No dose reductions are recommended. In case of dose interruption or infusion rate reduction due to IRR, the total duration of the infusion would be increased, but not the total dose.
If an infusion is missed, it should be administered as soon as possible; administration after a delayed or missed dose should not wait until the next planned dose. The treatment interval of 24 weeks (with a minimum of 5 months) should be maintained between doses.
Ublituximab is administered as an intravenous infusion through a dedicated line. Infusions should not be administered as an intravenous push or bolus.
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