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Inform patients about the signs and symptoms of meningococcal infection, and strongly advise patients to seek immediate medical attention if these signs or symptoms occur. least 4 plasmapheresis or plasma exchange or fresh frozen plasma infusion (PE/PI) treatments the week prior to screening. History of at least 2 relapses in last 12 months or 3 relapses in the last 24 months, with at least 1 relapse in the 12 months prior to screening. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 0000011353 00000 n The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dosage Form: injection, solution, concentrate. Table 5 summarizes all adverse events reported in at least 10% of patients in Studies C08-002A/B, C08-003A/B and C10-004 combined. Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Soliris can cause serious side effects including: pyridostigmine, Mestinon, neostigmine, eculizumab, Ultomiris, satralizumab, ravulizumab, Enspryng, Prostigmin. Gently invert the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the product and diluent. Expanded Disability Status Scale (EDSS) score ≤ 7 (consistent with the presence of at least limited ambulation with aid). Study C10-003 included 22 pediatric and adolescent patients, of which 18 patients were less than 12 years of age. Soliris [package insert]. For patients 18 years of age and older, Soliris therapy consists of: Administer Soliris at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.4)]. <]>> 0000003665 00000 n 1805 95 1 These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units). Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV. Immediate and sustained access to treatment urgently needed References 1. The median patient age was 6.5 (range: 5 months to 17 years). 0000023701 00000 n Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-Soliris (1-888-765-4747) or at www.Solirisrems.com. In Study C08-002A/B, mean platelet count (± SD) increased from 109 ± 32 ×109/L at baseline to 169 ± 72 ×109/L by one week; this effect was maintained through 26 weeks (210 ± 68 ×109/L), and 2 years (205 ± 46 ×109/L). Revised: 10/2020 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS MENINGOCOCCAL INFECTIONS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Vaccination and Prophylaxis When treatment was continued for more than 26 weeks, two additional patients achieved Hematologic Normalization as well as Complete TMA response. Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks. The median patient age was 28 (range, 17 to 68 years). Patients enrolled in Study C08-002A/B were required to have ADAMTS13 activity level above 5%; observed range of values in the trial were 70%-121%. Genotoxicity studies have not been conducted with eculizumab. Before you receive Soliris, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take. If you are also receiving PE/PI, additional doses of Soliris are required based on the Prescribing Information. Patients were 19 to 75 years of age (mean 44 years of age), and 91% were female. Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. All had signs or symptoms of intravascular hemolysis. All patients enrolled in Study C10-004 were required to have ADAMTS13 activity level above 5%; observed range of values in the trial were 28%-116%. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica.In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Patients enrolled in Study C08-003A/B were required to have ADAMTS13 activity level above 5%; observed range of values in the trial were 37%-118%. Reduction in terminal complement activity was observed in all patients after commencement of Soliris. 0000016811 00000 n What is the most important information I should know about Soliris? Discard any unused portion left in a vial, as the product contains no preservatives. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. The data described below reflect exposure to Soliris in 196 adult patients with PNH, age 18-85, of whom 55% were female. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients. The proportion of clinical responders at Week 26 with no rescue therapy was statistically significantly higher for Soliris compared to placebo for both measures. 0000027910 00000 n 9,732,149 and US Patent No.9,718,880 in addition to others including patents pending. Soliris (eculizumab) injection is a sterile, clear, colorless, preservative-free 10 mg/mL solution for intravenous infusion and is supplied in 30-mL single-dose vials. A total of 10 patients received PE/PI prior to eculizumab. 0000038511 00000 n Injection: 300 mg/30 mL (10 mg/mL) as a clear, colorless solution in a single-dose vial. Hematologic Normalization and Complete TMA response were maintained by all responders. 187 Soliris-treated PNH patients were enrolled in a long term extension study. A statistically significant difference favoring Soliris was observed in the mean change from baseline to Week 26 in QMG total scores [-4.6 points in the Soliris-treated group compared with -1.6 points in the placebo-treated group (p=0.001)]. 0000007985 00000 n 0000020146 00000 n Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. The product is formulated at pH 7 and each 30 mL vial contains 300 mg of eculizumab, polysorbate 80 (6.6 mg) (vegetable origin), sodium chloride (263.1 mg), sodium phosphate dibasic (53.4 mg), sodium phosphate monobasic (13.8 mg), and Water for Injection, USP. The following adverse reactions have been identified during post-approval use of Soliris. Soliris was administered according to the recommended dosage regimen [see Dosage and Administration (2.4)]. Ensure that patients receive the Medication Guide. The MG-ADL is a categorical scale that assesses the impact on daily function of 8 signs or symptoms that are typically affected in gMG. 0000037570 00000 n 0000004683 00000 n Signs and Symptoms of Meningococcal Infection. Stopping treatment with Soliris may cause breakdown of your red blood cells due to PNH. adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. The most common adverse reactions (≥10%) that occurred in Soliris-treated patients in the long-term extension to gMG Study 1, Study ECU-MG-302, and that are not included in Table 8 were headache (26%), nasopharyngitis (24%), diarrhea (15%), arthralgia (12%), upper respiratory tract infection (11%), and nausea (10%). Patients treated with Soliris had significantly reduced (p< 0.001) hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see Table 11). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Drug interaction studies have not been conducted with eculizumab in patients treated with IVIg. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. 0000003855 00000 n Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. In order to qualify for enrollment, patients were required to have a platelet count < lower limit of normal range (LLN), evidence of hemolysis such as an elevation in serum LDH, and serum creatinine above the upper limits of normal, without the need for chronic dialysis. In addition, 3 out of 130 previously vaccinated patients with aHUS developed meningococcal infections while receiving treatment with Soliris [see Adverse Reactions (6.1)]. See 17 for PATIENT COUNSELING INFORMATION and FDA - approved patient labeling. Overall, the efficacy results for these pediatric patients appeared consistent with what was observed in patients enrolled in Studies C08-002A/B and C08-003A/B (Table 16). ... SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Limited data on outcomes of pregnancies that have occurred following Soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see Data). Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. patients- with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 0000008620 00000 n Hemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry. There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy (see Clinical Considerations). Four of the five patients who required dialysis at baseline were able to discontinue dialysis. Soliris may also increase the risk of other types of serious infections. See full prescribing information for ALDURAZYME. Table 14 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in Study C08-003A/B. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). In Study C10-004, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins or auto-antibodies to factor H. Table 18 summarizes the efficacy results for Study C10-004. Seventy percent of patients had an identified complement regulatory factor mutation or auto-antibody. Long-term animal carcinogenicity studies of eculizumab have not been conducted. Use caution when administering Soliris to patients with any systemic infection [see Warnings and Precautions (5.1)]. Resources for your patients on Soliris® (eculizumab). Patients in Study C08-002A/B received Soliris for a minimum of 26 weeks. Available for Android and iOS devices. Accessed July 2020. In Study C08-002A/B, the median duration of Soliris therapy was approximately 100 weeks (range: 2 weeks to 145 weeks). 1. 0000038674 00000 n Table 17 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in Study C10-004. 0000011945 00000 n Among the 20 patients with a CKD stage ≥2 at baseline, 17 (85%) achieved a CKD improvement of ≥1 stage. counsel you about the risk of meningococcal infection, give you information about the symptoms of meningococcal infection. Soliris works to help manage anti-acetylcholine receptor antibody-positive generalized Myasthenia Gravis (anti-AChR Ab+ gMG) by focusing on a … The safety and effectiveness of Soliris for the treatment of aHUS have been established in pediatric patients. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. The serious reactions included infections and progression of PNH. have all recommended vaccinations before you start Soliris. Soliris is only available through a program called the Soliris REMS. Background U.S. Food and Drug Administration (FDA)-Approved Indications. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Two of the 96 (2%) Soliris-treated patients with NMOSD had antibodies to Soliris detected during the entire treatment period. (defined as the number of plasma exchange or plasma infusion interventions and the number of new dialyses required per patient per day). The mean eGFR (± SD) was 31 ± 19 mL/min/1.73m2 at baseline, and was maintained through 26 weeks (37 ± 21 mL/min/1.73m2) and 2 years (40 ± 18 mL/min/1.73m2). The time to the first adjudicated on-trial relapse was significantly longer in Soliris-treated patients compared to placebo-treated patients (relative risk reduction 94%; hazard ratio 0.058; p < 0.0001) (Figure 1). The precise mechanism by which eculizumab exerts its therapeutic effect in gMG patients is unknown, but is presumed to involve reduction of terminal complement complex C5b-9 deposition at the neuromuscular junction. I am a Patient. 0000010594 00000 n Patients were excluded if they had been treated with rituximab or mitoxantrone within 3 months or with IVIg within 3 weeks prior to screening. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and … The QMG is a 13-item categorical scale assessing muscle weakness. 0000000016 00000 n See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. The first complement inhibitor approved by the FDA, Soliris has been studied in 51 clinical trials and is approved for 4 indications, with 50,000 patient-years of data, and 13 years of postmarket experience. The FDA approval of Soliris for atypical hemolytic uremic syndrome was based on three single-arm studies: two prospective (aHUS Studies 1 and 2) and one retrospective study (aHUS Study 3). 0000005463 00000 n 0000023439 00000 n The pharmacokinetics of eculizumab were not affected by age (2 months to 85 years), sex, or race. Analysis of retrospectively collected adverse event data from pediatric and adult patients enrolled in Study C09-001r (N=30) revealed a safety profile that was similar to that which was observed in the two prospective studies. “Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. 0000028120 00000 n Neuromyelitis Optica Spectrum Disorder (NMOSD). Table 8 displays the most common adverse reactions from gMG Study 1 that occurred in ≥5% of Soliris-treated patients and at a greater frequency than on placebo. Although limited published data does not report detectable levels of eculizumab in human milk, maternal IgG is known to be present in human milk. Do not use beyond the expiration date stamped on the carton. In the aHUS population, antibodies to Soliris were detected in 3/100 (3%) patients using the ECL assay. Soliris vials may be stored in the original carton at controlled room temperature (not more than 25° C/77° F) for only a single period up to 3 days. In Studies C08-002A/B, C08-003A/B and C10-004 combined, 60% (47/78) of patients experienced a serious adverse event (SAE). Timing of Supplemental Soliris Dose. ]. Paroxysmal nocturnal hemoglobinuria (PNH) is an ongoing, progressive disease that starts in … Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.1)]. Paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Baseline characteristics were similar between treatment groups, including age at diagnosis (38 years in each group), gender [66% female (eculizumab) versus 65% female (placebo)], and duration of gMG [9.9 (eculizumab) versus 9.2 (placebo) years]. 1.2 Atypical Hemolytic Uremic Syndrome (aHUS) Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. See ". Soliris is given through a vein (I.V. paroxysmal nocturnal hemoglobinuria (PNH). In the single arm clinical study (PNH Study 2), the effect was maintained through week 52 [see Clinical Studies (14)]. If you have an infusion-related reaction during your Soliris infusion, your doctor may decide to give Soliris more slowly or stop your infusion. See Important Safety Information, including Boxed Warning, and full Prescribing Information. However, the majority of patients received concomitant anticoagulants; the effects of anticoagulant withdrawal during Soliris therapy was not studied [see Warnings and Precautions (5.4)]. For more information, ask your doctor or pharmacist. Fifty-one percent of patients had an identified complement regulatory factor mutation or auto-antibody. 1899 0 obj <>stream 0000037895 00000 n They are required to be revaccinated according to current medical guidelines for meningococcal vaccines use while on Soliris therapy. trailer Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the hemoglobin concentration (the "set-point") which would define each patient's hemoglobin stabilization and transfusion outcomes. 1.2 Atypical Hemolytic Uremic Syndrome (aHUS) Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. For both endpoints, and also at higher response thresholds (≥4-, 5-, 6-, 7-, or 8-point improvement on MG-ADL, and ≥6-, 7-, 8-, 9-, or 10-point improvement on QMG), the proportion of clinical responders was consistently greater for Soliris compared to placebo. In a placebo-controlled trial evaluating the effect of Soliris for the treatment of NMOSD (NMOSD Study 1), 96 patients received Soliris at the recommended dosage regimen and 47 patients received placebo [see Clinical Studies (14.4)]. No patient required new dialysis with Soliris. There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment. Major baseline characteristics were balanced (see Table 10). 0000041587 00000 n Eculizumab, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Soliris (eculizumab) injection is a sterile, preservative-free, clear, colorless solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton (NDC 25682-001-01). adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Alexion Pharmaceuticals, Inc. 0000010857 00000 n In Study C10-003, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins or auto-antibodies to factor H. Table 20 summarizes the efficacy results for Study C10-003. 0000038729 00000 n Prior to treatment, patients should fully understand the risks and benefits of Soliris, in particular the risk of meningococcal infection. 0000041750 00000 n See ". The use of Soliris increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis). HCPs should report all suspected adverse events, including reports of meningococcal infection by contacting Alexion Pharmaceuticals, Inc. at 1.888.Soliris (1.888.765.4747); or reporting the information to the FDA MedWatch Reporting System by phone at 1.800.FDA.1088 (1.800.332.1088) or by mail using Form 3500 at http://www.fda.gov/MedWatch In all studies, the dose of Soliris was 600 mg study drug every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration. aHUS Sensitive to PE/PI (Study C08-003A/B). Both patients had previously received a meningococcal vaccine. 0000019857 00000 n 煆_@w�&Lʦ� Ya��RP�QP,���Q44H10��)f�4�>�f��P ͖ �%���"n uL�f@�XH�II��,-��Dl H�< l.���&5%�!��h ��`u>�� �J���:@�2�;� �ʁT 0000050506 00000 n Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. 0000015406 00000 n 0000037950 00000 n Only administer as an intravenous infusion. In the placebo-controlled clinical study, serious adverse reactions occurred among 4 (9%) patients receiving Soliris and 9 (21%) patients receiving placebo. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. 0000017121 00000 n The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Administer vaccinations for the prevention of infection due to Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) according to ACIP guidelines [see Warnings and Precautions (5.1, 5.2)]. 0000038346 00000 n Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion-related reaction. Patients who are not currently vaccinated against, Monitoring Disease Manifestations after Soliris Discontinuation [. The mean eGFR (± SD) increased from 23 ± 15 mL/min/1.73m2 at baseline to 56 ± 40 mL/min/1.73m2 by 26 weeks; this effect was maintained through 2 years (56 ± 30 mL/min/1.73m2). Soliris FDA Approval History. During the treatment phase of the trial, 76% percent of patients received concomitant IST, including chronic corticosteroids; 24% of patients did not receive concomitant IST or chronic corticosteroids during the treatment phase of the trial. Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Table 15 summarizes the efficacy results for Study C08-003A/B. 0000016665 00000 n for additional guidance on the management of the risk of meningococcal infection]. Soliris was previously approved by the U.S. Food and Drug Administration (FDA) on September 23, 2011 for the treatment of patients with aHUS to inhibit complement-mediated TMA. The mean platelet count (± SD) increased from 88 ± 42 ×109/L at baseline to 281 ± 123 ×109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 293 ± 106 ×109/L). 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, without the need for chronic dialysis. 0000004839 00000 n The use of concurrent corticosteroids was limited to 20 mg per day or less. The admixture must not be heated in a microwave or with any heat source other than ambient air temperature. Study C08-003A/B enrolled patients undergoing chronic PE/PI who generally did not display hematologic signs of ongoing thrombotic microangiopathy (TMA). Inform patients that vaccination may not prevent meningococcal infection [see Warnings and Precautions (5.1)]. Available data suggest that clinical response is usually achieved by 12 weeks of Soliris treatment. Eculizumab, the active ingredient in Soliris, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.

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