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ULTOMIRIS 100 mg/mL is an advanced formulation of ULTOMIRIS 10 mg/mL that provides a quicker infusion time for PNH and aHUS patients. With Ultomiris … Administration Of ULTOMIRIS Findings showed that the 100mg/mL formulation required an infusion time of 0.4 to 1.3 hours depending on body weight compared with 1.3 to 3.3 hours for the 10mg/mL formulation. The ULTOMIRIS 100 mg/mL formulation reduces average annual infusion time for patients with aHUS and PNH by approximately 60 percent (to approximately 45 minutes for adults in the average weight cohort) compared to the ULTOMIRIS … In practical terms, this means that patients receiving Ultomiris … ULTOMIRIS 100 mg/mL has the same mechanism of action as ULTOMIRIS … ULTOMIRIS can cause serious side effects including infusion-related reactions. Ultomiris concentrate for solution for infusion presented as 3 mL and 11 mL vials (100 mg/mL) must be diluted prior to administration by intravenous infusion using a syringe-type pump or an infusion … Alexion Receives FDA Approval for New Advanced Formulation of ULTOMIRIS® (ravulizumab-cwvz) with Significantly Reduced Infusion Time – New 100 mg/mL formulation will reduce infusion time … Ultomiris® 100mg/mL reduced the average annual infusion … 100mg/mL. In the United States, ULTOMIRIS is available in two formulations. If not used immediately, refrigerate at 2-8°C (36-46°F) for up to 24 hr, taking into account the expected infusion time; Once removed from refrigerator, administer diluted infusion solution within 6 hr if … Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling … Once removed from refrigeration, administer the diluted ULTOMIRIS infusion solution within 6 hours. – New 100 mg/mL formulation will reduce infusion time by approximately 60 percent, lessening the burden on patients – – ULTOMIRIS is approved for the treatment of paroxysmal … If the diluted ULTOMIRIS infusion solution is not used immediately, storage under refrigeration at 2°C - 8°C (36°F - 46°F) must not exceed 24 hours taking into account the expected infusion time. Ultomiris 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60 percent compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. The recipient may also send ... infusion rate) or a severe adverse event … The recipient may call the toll-free number at 877-265 -2711, at any time, 24 hours a day/7 days a week. Compared with its originally approved 10 mg/mL formulation, Ultomiris’ new 100 mg/mL formulation can lower the therapy’s annual infusion time by approximately 60%, without compromising its efficacy and safety. Ultomiris SOC CFT – 2/2020.