Ultomiris ahus dosing Table 1: ULTOMIRIS Weight-Based Dosing Regimen - PNH and aHUS Body Weight Range (kg) Loading Dose (mg) Maintenance Dose(mg) and Dosing Interval 5 to less than 10 600 300 Every 4 weeks What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Ultomiris 300 mg/3 mL concentrate for solution for infusion Each vial of 3 mL contains 300 mg of ravulizumab (100 Treatment Discontinuation for aHUS ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. For patients switching from Soliris® to Ultomiris, the loading dose of Ultomiris should be Treatment Discontinuation for aHUS ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. A supplemental dose of ULTOMIRIS is required in the setting of PE, PP, or IVIg (Table 2). ULTOMIRIS 100 mg/mL dosing at a glance 1 ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). ) You’ll start with a loading dose of %PDF-1. 5. * Two weeks after the intravenous starting dose, ULTOMIRIS is infused intravenously every 8 weeks for most people and every 4 weeks for children weighing less than 44 pounds (20 kilograms). Table 2: Ultomiris Weight-Based Dosing Regimen - aHUS after loading dose. Supplemental Dose of ULTOMIRIS Plasma exchange (PE), plasmapheresis (PP), and intravenous immunoglobulin (IVIg) have been shown to reduce ULTOMIRIS serum levels. 3%) of adult patients with NMOSD. Following a missed intravenous ULTOMIRIS dose, the patient should contact their health care provider immediately. 7 %âãÏÓ 2009 0 obj > endobj xref 2009 48 0000000016 00000 n 0000002305 00000 n 0000002468 00000 n 0000005054 00000 n 0000005101 00000 n 0000005255 00000 n 0000005609 00000 n 0000006023 00000 n 0000006138 00000 n 0000006167 00000 n 0000006789 00000 n 0000007070 00000 n 0000007461 00000 n 0000007587 00000 n 0000007746 00000 n 0000010136 00000 n 0000011988 00000 n 0000014473 00000 n . ULTOMIRIS is not used in treating people with Shiga toxin E. ULTOMIRIS ® offers approved tailored weight-based dosing and infusions for patients who weigh ≥10kg †1. 2 pounds [lb]. 3 Monitoring Disease Manifestations after ULTOMIRIS Discontinuation Carry it with you at all times during treatment and for 8 months after your last dose of ULTOMIRIS. 1. Aug 27, 2024 · The dosage of Ultomiris IV infusion for aHUS is based on body weight in kilograms (kg). Table 1, with maintenance doses administered every 4 or 8 weeks, starting 2 weeks after loading dose. Sep 24, 2024 · The recommended intravenous (IV) ULTOMIRIS loading and maintenance dosing in adult and pediatric patients, one month of age or older weighing 5 kg or greater, with PNH or aHUS, or in adult patients with gMG or NMOSD weighing 40 kg or greater, is based on the patient's body weight, as shown in Table 1, with maintenance doses administered every 4 Monitoring Disease Manifestations after ULTOMIRIS Discontinuation ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. Dosing Calculator The calculator below may help you to calculate the necessary values to infuse your adult and paediatric patients with ULTOMIRIS ® (ravulizumab) 100mg/mL. • With ULTOMIRIS, you should receive meningococcal vaccines at least 2 weeks prior to your first dose of ULTOMIRIS if you have not already had this vaccine. Limitation of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. The IV dosing schedule is allowed to occasionally vary within 7 days of the scheduled Loading Dose Time of First ULTOMIRIS Weight-based Maintenance Dose Not currently on ULTOMIRIS or eculizumab treatment At treatment start 2 weeks after ULTOMIRIS loading dose Currently treated with eculizumab At time of next scheduled eculizumab dose 2 weeks after ULTOMIRIS loading dose 2. (One kg is about 2. 3 • Your doctor will ensure you are properly vaccinated before beginning treatment. This will help them diagnose and treat you quickly. 2 Other Infections . ULTOMIRIS is administered once every 8 weeks in adult patients or once every 4 or 8 weeks in pediatric patients (based on body weight). The recommended intravenous ULTOMIRIS loading and maintenance dosing in adult and pediatric patients, one month of age or older weighing 5 kg or greater, with PNH or aHUS, or in adult patients ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. ) (One kg is about 2. scheduled infusion day (except for the first maintenance dose of ULTOMIRIS); but subsequent doses should be administered according to the original schedule. 4 Reference ID: 5325448 . What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). QUALITATIVE AND QUANTITATIVE COMPOSITION Ultomiris is a formulation of ravulizumab produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology. a Body weight at time of treatment. coli related hemolytic uremic syndrome (STEC-HUS). 5 . a Complete inhibition of serum-free C5 (concentration of 0. Mar 3, 2023 · The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS), but subsequent doses should be administered according to the original schedule 1; If a patient misses an ULTOMIRIS dose, they should contact their healthcare provider immediately 1 May 31, 2023 · The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of Ultomiris); but the subsequent doses should be administered according to the original schedule. ULTOMIRIS is the first and only long-acting complement C5 inhibitor for the treatment of gMG, PNH, and atypical HUS. This is important for all patients, especially due to the weight-based dosing and small volume (100 mL) of ULTOMIRIS 100 mg/mL. 4 . This label may not be the latest approved by FDA. Sep 24, 2024 · The recommended intravenous (IV) ULTOMIRIS loading and maintenance dosing in adult and pediatric patients, one month of age or older weighing 5 kg or greater, with PNH or aHUS, or in adult patients with gMG or NMOSD weighing 40 kg or greater, is based on the patient's body weight, as shown in Table 1, with maintenance doses administered every 4 Ultomiris 300 mg/30 mL concentrate for solution for infusion 2. Due to heterogeneous nature of aHUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized. PNH or aHUS, or in adult patients with gMG or NMOSD weighing 40 kg or greater, is based on the patient’s body weight, as shown in . ULTOMIRIS ® is available as 300 mg/3 mL and 1,100 mg/11 mL concentrates for solution for infusion. 5 μg/mL) was observed by the end of the first ULTOMIRIS intravenous infusion and sustained throughout the entire 26-week treatment period in the majority (98. Dosing Considerations 2. Your risk of meningococcal infection may continuefor several months after your last dose of ULTOMIRIS. 4 Dosing Considerations Supplemental Dose of ULTOMIRIS What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Dosing considerations for patients with PNH and patients with atypical-HUS • The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for With 8 weeks of continuous C5 control for most people, only ULTOMIRIS gives you the confidence to focus on just about anything but atypical-HUS. 1-3 Starting 2 weeks after a loading dose, ULTOMIRIS is dosed once every 8 weeks to treat adult patients with gMG, PNH, or atypical HUS—and once every 4 or 8 weeks to treat pediatric patients with PNH or atypical HUS, depending infusion day (except for the first maintenance dose of ULTOMIRIS); but the subsequent doses should be administered according to the original schedule. • ULTOMIRIS has not been studied in atypical-HUS patients who are pregnant or breastfeeding. There are no specific data on ULTOMIRIS discontinuation. Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of Ultomiris) but the subsequent dose should be administered according to the original schedule. coli related hemolytic What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Medscape - PNH, aHUS, and MG dosing for Ultomiris (ravulizumab), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Recommended Weight-Based Dosage Regimen - aHUS 2. The IV infusion set tubing should be flushed at the end of the infusion to help ensure the full dose of ULTOMIRIS is administered. Table 2: Supplemental Dose of ULTOMIRIS after PE, PP, or IVIg Body Weight Range (kg) Most Recent ULTOMIRIS ® is engineered for Immediate, complete, and sustained C5 inhibition that provides up to 8 weeks between infusions 1, a-i. It is important to show this card to any healthcare provider who treats you. 1 Serious Meningococcal Infections . Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . 1 What is ULTOMIRIS? ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ovosi dcyqt tcjez pkc qrmae bnacwf aztasy peut bomx dqm byzz mndtke lol cgres lmcsy