There is no experience with administration of supplemental doses of ULTOMIRIS. Now, the … This will help them diagnose and treat you quickly. Seventeen of the 29 patients (59%) who required dialysis at study entry discontinued dialysis by the end of the available follow-up and 6 of 27 (22%) patients were off dialysis at baseline were on dialysis at last available follow-up. No serious adverse reaction was reported in more than 1 patient treated with ULTOMIRIS. The mean eGFR (+/- SD) increased from 15.86 (14.82) at baseline to 51.83 (39.16) by 26 weeks. Call your doctor right away if you have any new signs or symptoms of infection. It is a humanized monoclonal antibody that binds to the human C5 complement protein; thus, inhibiting terminal complement-mediated intravascular For more information, ask your doctor or pharmacist. See. No clinically significant differences in the pharmacokinetics of ravulizumab-cwvz were observed based on sex, age (10 months to 83 years), race, hepatic impairment, or any degree of renal impairment, including patients with proteinuria or receiving dialysis. The mean (%CV) volume of distribution at steady state was 5.34 (17.2) L and 5.22 (35.4) L in patients with PNH and aHUS, respectively. ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. The most frequent serious adverse reactions reported in more than 2 patients (2.7%) treated with ULTOMIRIS were hypertension, pneumonia and abdominal pain. TMA complications post-discontinuation can be identified if any of the following is observed: If TMA complications occur after ULTOMIRIS discontinuation, consider reinitiation of ULTOMIRIS treatment or appropriate organspecific supportive measures. For patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab infusion, and then administer maintenance doses once every 8 weeks or every 4 weeks (depending on body weight), starting 2 weeks after loading dose administration. ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). In order to qualify for enrollment, patients were required to have a platelet count ≤150 × 109 /L, evidence of hemolysis such as an elevation in serum LDH, and serum creatinine above the upper limits of normal or required dialysis. What Are Side Effects of Ultomiris? The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. 833-551-2539, INFORMATION FOR HEALTHCARE PROFESSIONALS ONLY. RxList does not provide medical advice, diagnosis or treatment. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. The immunogenicity of ravulizumab-cwvz has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding anti-ravulizumab-cwvz antibodies. Life-threatening meningococcal infections have occurred in patients treated with ULTOMIRIS. If ULTOMIRIS therapy is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Merck KGaA, primarily known as the Merck Group’s CDMO arm, is playing with giants in oncology and looking at novel mechanisms of action to compete. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Call your doctor for medical advice about side effects. Table 2: ULTOMIRIS Weight-Based Dosing Regimen – aHUS. One additional patient had a Complete TMA Response that was confirmed after the 26-week Initial Evaluation Period. Find patient medical information for Ultomiris intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Refer to the administration reference tables below. The use of ULTOMIRIS increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). Patients were vaccinated against meningococcal infection prior to or at the time of initiating treatment with ULTOMIRIS or eculizumab, or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination. NDC 25682-022-01. Ninety-three percent of patients had extra-renal signs (cardiovascular, pulmonary, central nervous system, gastrointestinal, skin, skeletal muscle) or symptoms of aHUS at baseline. ULTOMIRIS is given through a vein by intravenous (I.V.) After each infusion, you should be monitored for at least 1 hour for infusion reactions. The majority of patients (71%) had pretreatment extra-renal signs (cardiovascular, pulmonary, central nervous system, gastrointestinal, skin, skeletal muscle) or symptoms of aHUS at baseline. What are the possible side effects of ULTOMIRIS? Tables 6, 7 and 8 describes adverse reactions that occurred at a rate of 10% or more among patients treated with ULTOMIRIS in aHUS studies. As with all therapeutic proteins, there is potential for immunogenicity. ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation. Eight patients entered the study with evidence of TMA for > 3 days after childbirth (ie, postpartum). Discover ULTOMIRIS mechanism of action. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS. In clinical trials, 5 out of 296 patients treated with ULTOMIRIS experienced infusion-related reactions (lower back pain, drop in blood pressure, infusion-related pain, elevation in blood pressure and limbs discomfort) during ULTOMIRIS administration which did not require discontinuation. PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages, and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. In clinical studies, clinically relevant adverse reactions in <10% of patients include viral tonsillitis in adults and viral infection in pediatric patients. Levosimendan, a small molecule that acts by increasing calcium sensitivity in both heart and skeletal muscle fibers, was originally developed by Orion to treat acute heart failure. At baseline, 71.4% (n = 40) of patients had Stage 5 chronic kidney disease (CKD). One fatal case of sepsis was identified in a patient treated with ULTOMIRIS. Trade Name: Ultomiris® Ravulizumab is the generic name for the trade name drug Ultomiris. Patients who demonstrated clinically stable disease after being treated with eculizumab for at least the prior 6 months were randomized 1:1 to either continue eculizumab or to switch to ULTOMIRIS. Dilute ULTOMIRIS to a final concentration of 5 mg/mL. Non-inferiority of ULTOMIRIS to eculizumab was demonstrated across endpoints in the complement inhibitor naïve treatment population described in the table below. Under the ULTOMIRIS REMS, prescribers must enroll in the program. The heavy chain CH1 domain, hinge region, and the first 5 amino acids of the CH2 domain match the human IgG2 amino acid sequence, residues 6 to 36 in the CH2 region (common to both human IgG2 and IgG4 amino acid sequences), while the remainder of the CH2 domain and the CH3 domain match the human IgG4 amino acid sequence. Advise patients of the need for vaccination against meningococcal infections according to current medical guidelines. As with plasmapheresis, the effect of IVIG is seen typically in less than … If ULTOMIRIS must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. infusion usually over about 2 hours in adults and up to 4 hours in children. What is the most important information I should know about ULTOMIRIS? Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. A total of 56 patients with aHUS were evaluated for efficacy. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-844-259-6783 or at www.ultomirisrems.com. Do not shake. Ultomiris can cause serious side effects including: Your doctor will treat your symptoms as needed. Serious adverse reactions were reported in 42 (57%) patients with aHUS receiving ULTOMIRIS. See. Other Infections ULTOMIRIS provides immediate, complete, and sustained complement inhibition in adult and pediatric patients.1. The safety and effectiveness of ULTOMIRIS for the treatment of aHUS have been established in pediatric patients aged one month and older. This website is intended for residents of the United States. Table 7: Adverse Reactions Reported in ≥10% of ULTOMIRIS-Treated Patients with aHUS in Study ALXN1210-aHUS-312. Know the medicines you take and the vaccines you receive. Patients with confirmed diagnosis of STEC-HUS after enrollment were excluded from the efficacy evaluation. It is a terminal complement inhibitor that specifically binds to the C5 protein of the terminal complement cascade and inhibits its breakdown. Do not shake. Before you can receive ULTOMIRIS, your doctor must: ULTOMIRIS may also increase the risk of other types of serious infections. The effect of withdrawal of anticoagulant therapy during ULTOMIRIS treatment has not been established. Treatment should not alter anticoagulant management. The study consisted of a 26-week Initial Evaluation Period and patients were allowed to enter an extension period for up to 4.5 years. The mechanism of action for IVIG in MG is uncertain. Do not freeze. The heavy and light chain variable regions that form the human C5 binding site consist of human framework regions grafted to murine complementarity-determining regions. Last reviewed on RxList: 10/22/2020 Table 15 presents the demographics and baseline characteristics of the 56 adult patients enrolled in Study ALXN1210-aHUS-311 that constituted the Full Analysis Set. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies. Ultomiris is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Store ULTOMIRIS vials refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect from light. have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. Patients who are not currently vaccinated against. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Inform patients with PNH or aHUS that they may develop hemolysis or TMA, respectively, when ULTOMIRIS is discontinued and that they will be monitored by their healthcare professional for at least 16 weeks for PNH or at least 12 months for aHUS following ULTOMIRIS discontinuation. After discontinuing treatment with ULTOMIRIS, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction. Please see accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis. Major baseline characteristics were balanced between treatment groups. Life-threatening meningococcal infections/sepsis have occurred in patients treated with ULTOMIRIS. The recommended dosing regimen in adult and pediatric patients one month of age and older with aHUS weighing 5 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Advise patients to report any new signs and symptoms of infection. a starting dose of ULTOMIRIS as an infusion by your doctor, and then. The mean total PNH granulocyte clone size was 83%, the mean total PNH monocyte clone size was 86%, and the mean total PNH RBC clone size was 60%. Long-term animal carcinogenicity studies of ravulizumab-cwvz have not been conducted. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The most common side effects of Ultomiris in people treated for PNH are upper respiratory infection and headache. The constant regions of ravulizumabcwvz include the human kappa light chain constant region, and the protein engineered “IgG2/4” heavy chain constant region. Due to heterogeneous nature of aHUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized. Prophylactic treatment with appropriate antibiotics beyond 2 weeks after vaccination was at the discretion of the provider. adults and children 1 month of age and older with a disease called atypical hemolytic uremic syndrome (aHUS). Included as part of the PRECAUTIONS section. ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to encapsulated bacteria infections, especially infections … An increase in mean platelet count was observed after commencement of ULTOMIRIS, increasing from 118.52 × 109/L at baseline to 240.34 ×109/L at Day 8 and remaining above 227 × 109/L at all subsequent visits in the Initial Evaluation Period (26 weeks). Counsel patients of the increased risk of infections, particularly those due to encapsulated bacteria, especially Neisseria species. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. Ultomiris is a slightly bigger protein than Soliris and has a tweak that lets the body recycle and reuse it. All responses were maintained through all available follow-up. In clinical studies, treatment-emergent antibodies to ravulizumab-cwvz were detected in 1 of 206 (0.5%) patients with PNH and 1 of 71 (1.4%) patients with aHUS. Manufactured by: Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boston, MA 02210 USA, US License Number 1743. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. The safety and efficacy of ULTOMIRIS for the treatment of PNH in pediatric patients have not been established. When animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. Four patients died during the ALXN1210-aHUS-311 study. When maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group). Clinical symptoms of TMA include changes in mental status, seizures, In addition, at least two of the following laboratory signs observed concurrently and results should be confirmed by a second measurement 28 days apart with no interruption, an increase in serum creatinine of 25% or more as compared to baseline or to. The mean (%CV) clearance of ravulizumab-cwvz in patients with PNH and aHUS are 0.08 (29.5) L/day and 0.08 (53.3) L/day, respectively. an increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment. Table 13: Baseline Characteristics in Eculizumab-Experienced Patients with PNH. Half-life of Soliris is 11.25 to 17.25 days.1,2, bTargeted engineering to incorporate 4 amino acid substitutions designed to reduce TMDD and enhance FcRn-mediated recycling into Soliris has led to the generation of ULTOMIRIS, which exhibited an extended duration of action in preclinical models relative to Soliris.3, cIn the majority (93%) of adult and pediatric patients with atypical-HUS throughout the entire 26-week treatment period.1. Certain people may also have an increased risk of gonorrhea infection. The extent and duration of the pharmacodynamic response in patients with PNH and aHUS were exposure-dependent for ULTOMIRIS. There are risks to the mother and fetus associated with untreated PNH and aHUS in pregnancy (see Clinical Considerations). are breastfeeding or plan to breastfeed. The product should be mixed gently. Inform patients that vaccination may not prevent meningococcal infection. ULTOMIRIS is the first and only long-acting C5 inhibitor that provides immediate and complete inhibition for 8 weeks. Knowledge about drug, mechanism of action, and briefing of clinical evidences Detailed information and insights on the drug Upadacitinib which is manufactured by AbbVie Inc. , Ultomiris (ravulizumab-cwvz) a humanized monoclonal antibody manufactured by Alexion Pharmaceuticals Inc. and many more Initial Therapy: Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Refer to the administration reference tables below for minimum infusion duration. Study ALXN1210-aHUS-312 enrolled pediatric patients who displayed signs of TMA. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you have not already had this vaccine. Ravulizumab-cwvz consists of 2 identical 448 amino acid heavy chains and 2 identical 214 amino acid light chains and has a molecular weight of approximately 148 kDa. If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS. Ultomiris is used to treat: It is not known if Ultomiris is safe and effective in children with PNH. Genotoxicity studies have not been conducted with ravulizumab-cwvz. 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. INDICATION The study in eculizumab-experienced patients [ALXN1210-PNH-302; NCT03056040] was a 26-week, multicenter, open-label, randomized, active-controlled, non-inferiority Phase 3 study conducted in 195 patients with PNH who were clinically stable after having been treated with eculizumab for at least the past 6 months. Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. The safety and efficacy of ULTOMIRIS in patients with PNH was assessed in two open-label, randomized, active-controlled, noninferiority Phase 3 studies: PNH Study 301 and PNH Study 302. It is not known if ULTOMIRIS passes into your breast milk. 6. may occur. Infusion must be administered through a 0.2 or 0.22 micron filter. In clinical studies, 59 patients with PNH were treated with ULTOMIRIS less than 2 weeks after meningococcal vaccination. adults and children 1 month of age and older with a disease called, the treatment of adult patients with paroxysmal nocturnal, the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to, The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose [see. Inform patients who discontinue ULTOMIRIS to keep the ULTOMIRIS Patient Safety Card with them for eight months after the last ULTOMIRIS dose, because the increased risk of meningococcal infection persists for several weeks following discontinuation of ULTOMIRIS. Serious Meningococcal Infections. No apparent correlation of antibody development to altered pharmacokinetic profile, clinical response, or adverse events was observed. Do not use if there is evidence of particulate matter or precipitation. In PNH clinical studies, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ULTOMIRIS; all 3 had been vaccinated. Prescribers must counsel patients about the risk of meningococcal infection/sepsis, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines. General information about the safe and effective use of ULTOMIRIS. - Knowledge about drug, mechanism of action, and briefing of clinical evidences - Detailed information and insights on the drug Upadacitinib which is manufactured by AbbVie Inc. , Ultomiris (ravulizumab-cwvz) a humanized monoclonal antibody manufactured by Alexion Pharmaceuticals Inc. and many more Other endpoints included platelet count change from baseline, dialysis requirement, and renal function as evaluated by eGFR. Advise patients that administration of ULTOMIRIS may result in infusion reactions. Mechanism and efficacy — IVIG is pooled immunoglobulin from thousands of donors. Prior to administration, allow the admixture to adjust to room temperature (18°C-25°C, 64°F-77°F). Patients had to meet each Complete TMA Response criteria at 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between. The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving ULTOMIRIS have not been established. Due to the risk of meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
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