Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see WARNINGS AND PRECAUTIONS]. Call your doctor for medical advice about side effects. Fifty percent of patients had an identified complement regulatory factor mutation or auto-antibody. Revised: June 2019. The efficacy of Soliris for the treatment of gMG was established in gMG Study 1 (NCT01997229), a 26-week randomized, double-blind, parallel-group, placebo-controlled, multi-center trial that enrolled patients who met the following criteria at screening: A total of 62 patients were randomized to receive Soliris treatment and 63 were randomized to receive placebo. Please enter your username and password to try again. In addition, 3 out of 130 previously vaccinated patients with aHUS developed meningococcal infections while receiving treatment with Soliris [see ADVERSE REACTIONS]. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Both patients had previously received a meningococcal vaccine. Among the 20 patients with a CKD stage ≥2 at baseline, 17 (85%) achieved a CKD improvement of ≥1 stage. The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established. 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)]. In the PNH population, antibodies to Soliris were detected in 3/196 (2%) patients using the ELISA assay and in 5/161 (3%) patients using the ECL assay. Median exposure was 67 weeks (range: 2-145 weeks). In clinical studies, 2 out of 196 PNH patients developed serious meningococcal infections while receiving treatment with Soliris; both had been vaccinated [see ADVERSE REACTIONS]. All patients received the recommended Soliris dose regimen. Vaccination reduces, but does not eliminate, the risk of meningococcal infections. How do I prepare my kid for a hematology consultation? US License Number 1743. or intravenous infusion) usually over 35 minutes in adults and 1 to 4 hours in pediatric patients. 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. Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Easy & secure access! Table 4: Adverse Reactions Reported in 5% or More of Soliris Treated Patients with PNH and Greater than Placebo in the Controlled are pregnant or plan to become pregnant. In patients with PNH, aHUS, gMG, and NMOSD, free C5 concentrations of < 0.5 mcg/mL was correlated with complete blockade of terminal complement activity. Fifty-one percent of patients had an identified complement regulatory factor mutation or auto-antibody. Use of Soliris in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of Soliris for the treatment of aHUS. Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks. Your dose of Soliris is determined by your doctor. 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%). Drug interaction studies have not been conducted with eculizumab in patients treated with IVIg. Table 15 summarizes the efficacy results for Study C08-003A/B. Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks. Anemia Symptoms and Signs, Types, Treatment and Causes, Mantle Cell Lymphoma Differs From Other Lymphomas, 1200 mg at week 5; then 1200 mg every 2 weeks, 900 mg at week 3; then 900 mg every 2 weeks, 600 mg at week 3; then 600 mg every 2 weeks, 300 mg at week 2; then 300 mg every 2 weeks, 300 mg at week 2; then 300 mg every 3 weeks, Supplemental Soliris Dose with Each Plasma Intervention, 300 mg per each plasmapheresis or plasma exchange session, Within 60 minutes after each plasmapheresis or plasma exchange, 600 mg per each plasmapheresis or plasma exchange session, 300 mg per infusion of fresh frozen plasma, 60 minutes prior to each infusion of fresh frozen plasma, History of aplastic anemia or myelodysplastic syndrome (%), Patients with history of thrombosis (events), Concomitant steroids/immunosuppressant treatments (%), Packed RBC units transfused per patient in previous 12 months (median (Q1,Q3)), Free hemoglobin at baseline (median, mg/dL), Percentage of patients with stabilized hemoglobin levels, Packed RBC units transfused per patient (median), Free hemoglobin at end of study (median, mg/dL), Time from aHUS diagnosis until screening in months, median (min, max), Time from current clinical TMA manifestation until screening in months, median (min, max), Complete TMA response, n (%) Median Duration of complete TMA response, weeks (range), Hematologic normalization, n (%) Median Duration of hematologic normalization, weeks (range), Daily TMA intervention rate, median (range), Complete TMA response, n (%) Median duration of complete TMA response, weeks (range), Patients with eGFR improvement ≥ 15 mL/min/1.73 m, Time from aHUS diagnosis until start of study drug in months, median (range), Time from current clinical TMA manifestation until first study dose in months, median (range), Patients with eGFR improvement ≥ 15 mL/min/1.73m, Hematologic Normalization, n (%) Median duration of hematologic normalization, weeks (range), Daily TMA Intervention Rate, median (range), Complete Hematologic Normalization, n (%) Median Duration of complete hematologic normalization, weeks (range), Daily TMA Intervention rate, median (range), Soliris change relative to placebo – LS Mean Difference, adults and children with a disease called, adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-, pain or swelling of your nose or throat (nasopharyngitis), swelling of legs or feet (peripheral edema ), common cold (upper respiratory infection), 600 mg weekly for the first 4 weeks, followed by, 900 mg for the fifth dose 1 week later, then, 900 mg weekly for the first 4 weeks, followed by, 1200 mg for the fifth dose 1 week later, then. stay up-to-date with all recommended vaccinations during treatment with SOLIRIS. All patients received the recommended dosage of Soliris. The most common side effects in people with PNH treated with SOLIRIS include: The most common side effects in people with aHUS treated with SOLIRIS include: The most common side effects in people with gMG treated with SOLIRIS include: The most common side effects in people with NMOSD treated with SOLIRIS include: Tell your doctor about any side effect that bothers you or that does not go away. 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. Inform patients with PNH that they may develop hemolysis due to PNH when Soliris is discontinued and that they will be monitored by their healthcare professional for at least 8 weeks following Soliris discontinuation. Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. This medicine is available only under a restricted distribution program called Soliris® REMS (Risk Evaluation and Mitigation Strategy) Program. Patients. In clinical studies among patients without PNH, meningococcal meningitis occurred in one unvaccinated patient. It can be used for treating serious kidney disorder called atypical hemolytic uremic syndrome (aHUS). The dosage regimen for pediatric patients weighing less than 40 kg enrolled in Study C09-001r and Study C10-003 was based on body weight [see DOSAGE AND ADMINISTRATION]. Advise The Patient To Read FDA-Approved Patient Labeling (Medication Guide). Soliris Solution for injection drug summary. Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. In Study C08-002A/B, the median duration of Soliris therapy was approximately 100 weeks (range: 2 weeks to 145 weeks). Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see WARNINGS AND PRECAUTIONS]. 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). However, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. Serious adverse reactions occurred among 16% of the patients in these studies. Soliris-treated patients had a 96% relative reduction in the adjudicated on-trial annualized relapse rate (ARR) compared to patients on placebo, as shown in Table 22. Patients enrolled in Study C10-003 were required to have ADAMTS13 activity level above 5%; observed range of values in the trial were 38%-121%. Table 6: Per Patient Incidence of Adverse Reactions in 10% or More Patients Enrolled in Study C10-003. The median patient age was 35 (range: 18 to 80 years). One patient had no PE/PI the week prior to screening because of PE/PI intolerance. Soliris was administered according to the recommended dosage regimen [see DOSAGE AND ADMINISTRATION]. Refer to DOSAGE AND ADMINISTRATION for information on the stability and storage of diluted solutions of Soliris. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Visit cvs.com for more details. 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%. Drug Information on Soliris (eculizumab) includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, ... Eculizumab is given as an infusion into a vein. This disorder can cause a decrease in red blood cells ( anemia ). You are encouraged to report negative side effects of prescription drugs to the FDA. Efficacy evaluations were based on thrombotic microangiopathy (TMA) endpoints. Compared to placebo-treated patients, Soliris-treated patients had reduced annualized rates of hospitalizations (0.04 for Soliris versus 0.31 for placebo), of corticosteroid administrations to treat acute relapses (0.07 for Soliris versus 0.42 for placebo), and of plasma exchange treatments (0.02 for Soliris versus 0.19 for placebo). To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection. Table 17 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in Study C10-004. SOLIRIS can cause serious side effects including: If you have an infusion-relatedreaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. How do you know when you need a blood transfusion? Severe allergic reaction symptoms such as hives, Symptoms of possible kidney problems such as passing too little or no urine, swelling of the feet or ankles, tiredness or. (so-leer-is) At this time, make sure to contact your health providers right away for any untoward symptoms. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. These signs and symptoms are as follows: Inform patients that they will be given a Soliris Patient Safety Information Card that they should carry with them at all times. 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. The results of the analysis of the MG-ADL and QMG from gMG Study 1 are shown in Table 21. FindATopDoc is a trusted resource for patients to find the top doctors in their area. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). SOLIRIS is used to treat: It is not known if SOLIRIS is safe and effective in children with PNH, gMG, or NMOSD. What are the possible side effects of SOLIRIS? Patients were 19 to 79 years of age, and 66% were female. Table 13 summarizes the efficacy results for Study C08-002A/B. Adolescent Patients Enrolled in Studies C08-002A/B, C08-003A/B and In Studies C08-002A/B, C08-003A/B and C10-004 combined, 60% (47/78) of patients experienced a serious adverse event (SAE). In all studies, the dose of Soliris in adult and adolescent patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg 7 ± 2 days later, then 1200 mg every 14 ± 2 days thereafter. The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 12 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in Study C08-002A/B. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation. Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. SOLIRIS is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The safety and effectiveness of Soliris for the treatment of aHUS have been established in pediatric patients. Five single-arm studies [four prospective: C08-002A/B (NCT00844545 and NCT00844844), C08-003A/B (NCT00838513 and NCT00844428), C10-003 (NCT01193348), and C10-004 (NCT01194973); and one retrospective: C09-001r (NCT01770951)] evaluated the safety and efficacy of Soliris for the treatment of aHUS. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Table 20: Efficacy Results for Study C10-003. The following adverse reactions have been identified during post-approval use of Soliris. For patients less than 18 years of age, administer Soliris based upon body weight, according to the following schedule (Table 1): Table 1: Dosing Recommendations in aHUS Patients Less Than 18 Years of Age. Table 8: Adverse Reactions Reported in 5% or More of Soliris-Treated Patients in gMG Study 1 and at a Greater Frequency than in Placebo-Treated Patients. In Study C08-003A/B, the median duration of Soliris therapy was approximately 114 weeks (range: 26 to 129 weeks). In Study C08-003A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins. PM150_CCC_Soliris_(eculizumab_injection_for_intravenous_use_Alexion) 2 of 7 DATA CONTAINED IN THIS DOCUMENT IS CONSIDERED CONFIDENTIAL AND PROPRIETARY INFORMATION AND ITS DUPLICATION USE OR DISCLOSURE IS PROHIBITED WITHOUT PRIOR APPROVAL OF COMMUNITY HEALTH PLAN OF WASHINGTON. The studies included a total of 47 pediatric patients (ages 2 months to 17 years). See “What is the most important information I should know about SOLIRIS?”. The serious reactions included infections and progression of PNH. General information about the safe and effective use of SOLIRIS. Study C10-003 enrolled patients who were required to have a platelet count < lower limit of normal range (LLN), evidence of hemolysis such as an elevation in serum LDH above 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. Certain fungal infections (aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and My son has thalassemia minor. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Clinical Study. Inform parents or caregivers of children receiving Soliris for the treatment of aHUS that their child should be vaccinated against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) according to current medical guidelines. Participate in Health Journeys in over 100 specialty communities. Table 22: Adjudicated On-trial Annualized Relapse Rate – Full Analysis Set. The primary efficacy endpoint for gMG Study 1 was a comparison of the change from baseline between treatment groups in the Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL) total score at Week 26. Table 2: Supplemental Dose of Soliris after PE/PI. Effects of eculizumab upon fertility have not been studied in animals. Study C08-003A/B enrolled patients undergoing chronic PE/PI who generally did not display hematologic signs of ongoing thrombotic microangiopathy (TMA). If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. Patients in Study C08-003A/B received Soliris for a minimum of 26 weeks. Renal function, as measured by eGFR, was improved during Soliris therapy. Table 12: Baseline Characteristics of Patients Enrolled in Study C08-002A/B. However, the majority of patients received concomitant anticoagulants; the effects of anticoagulant withdrawal during Soliris therapy was not studied [see WARNINGS AND PRECAUTIONS]. Find doctors & request online appointments. Among the 16 patients ages 1 month to <12 years with a CKD stage ≥2 at baseline, 14 (88%) achieved a CKD improvement by ≥1 stage. Dose 5: 1200 mg IV 1 week later, THEN. PNH patients with at least four transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44). Study C10-004 enrolled patients who displayed signs of thrombotic microangiopathy (TMA). Your doctor will decide if you need additional meningococcal vaccination. In a 26-week placebo-controlled trial evaluating the effect of Soliris for the treatment of gMG (gMG Study 1), 62 patients received Soliris at the recommended dosage regimen and 63 patients received placebo [see Clinical Studies]. Patients in Study C10-003 received Soliris for a minimum of 26 weeks. It is very important not to miss doses of Soliris, which can result in sudden serious side effects. A statistically significant difference favoring Soliris was observed in the mean change from baseline to Week 26 in MG-ADL total scores [-4.2 points in the Soliristreated group compared with -2.3 points in the placebo-treated group (p=0.006)]. Under the Soliris REMS, prescribers must enroll in the program. Simple Facebook login. 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. Nine of the 11 patients who required dialysis at study baseline were able to discontinue dialysis during Soliris treatment. Make sure to follow the doctorâs instructions in taking Soliris. The median patient age was 6.5 (range: 5 months to 17 years). Table 4 summarizes the adverse reactions that occurred at a numerically higher rate in the Soliris group than the placebo group and at a rate of 5% or more among patients treated with Soliris. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. A total of 10 patients received PE/PI prior to eculizumab. Inform patients that they are required to receive meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris, if they have not previously been vaccinated. Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients. An ECL based neutralizing assay with a low sensitivity of 2 mcg/mL was performed to detect neutralizing antibodies for the 5 patients with PNH, the 3 patients with aHUS, and the 2 patients with NMOSD with anti-eculizumab antibody positive samples using the ECL assay.
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