soliris injection uses

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. 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. A pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to Soliris have not suggested safety concerns. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations. Table 7: Adverse Reactions Occurring in at Least 15% of Patients Less than 18 Years of Age Enrolled in Study C09-001r. The most common serious adverse reactions were: viral infection (2%), headache (2%), anemia (2%), and pyrexia (2%). It is not known if SOLIRIS is safe and effective in children with gMG. No pediatric patient required new dialysis during treatment with Soliris. Your health providers will prepare and administer Soliris, and will have to do monitoring for at least an hour after infusion. Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks. Table 18: Efficacy Results for Study C10-004. It is used for the management of a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). Although limited published data does not report detectable levels of eculizumab in human milk, maternal IgG is known to be present in human milk. All patients sustained a reduction in intravascular hemolysis over a total Soliris exposure time ranging from 10 to 54 months. Dose 5: 1200 mg IV 1 week later, THEN. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Table 12: Baseline Characteristics of Patients Enrolled in Study C08-002A/B. Table 2: Supplemental Dose of Soliris after PE/PI. Do not give SOLIRIS to other people, even if they have the same symptoms that you have. (eculizumab) 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%. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients. Clinical Study. For these reasons, comparison of the incidence of antibodies to eculizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. If you are an adult, you will usually receive a SOLIRIS infusion by your doctor: After each infusion, you should be monitored for one hour for allergic reactions. The mean eGFR (± SD) increased from 33 ± 30 mL/min/1.73m2 at baseline to 98 ± 44 mL/min/1.73m2 by 26 weeks. Table 4: Adverse Reactions Reported in 5% or More of Soliris Treated Patients with PNH and Greater than Placebo in the Controlled This disorder can cause a decrease in red blood cells ( anemia ). Table 22: Adjudicated On-trial Annualized Relapse Rate – Full Analysis Set. Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. The use of concurrent corticosteroids was limited to 20 mg per day or less. Complete TMA Response and Hematologic Normalization were maintained by all responders. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. injection, for intravenous use. Hematologic Normalization and Complete TMA response were maintained by all responders. Make sure to follow the doctor’s instructions in taking Soliris. For a full description of this disclaimer, please see our Terms of Use. These are not all the possible side effects of SOLIRIS. have all recommended vaccinations before you start SOLIRIS. 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. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. The most commonly reported SAEs were hypertension (9%), viral gastroenteritis (9%), pyrexia (9%), and upper respiratory infection (9%). In Study C08-003A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins. Serious adverse reactions occurred among 16% of the patients in these studies. See “How will I receive SOLIRIS?”. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Table 13 summarizes the efficacy results for Study C08-002A/B. Inactive ingredients: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, and Water for Injection, This Medication Guide has been approved by the U.S. Food and Drug Administration. See “How will I receive SOLIRIS?”. Patients were 19 to 79 years of age, and 66% were female. The data described below were derived from 78 adult and adolescent patients with aHUS in Studies C08-002A/B, C08-003A/B and C10-004. The efficacy of Soliris for the treatment of NMOSD was established in NMOSD Study 1 (NCT01892345), a randomized, double-blind, placebo-controlled trial that enrolled 143 patients with NMOSD who were anti-AQP4 antibody positive and met the following criteria at screening: A total of 96 patients were randomized to receive Soliris treatment and 47 were randomized to receive placebo. 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. 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. 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. Note that Soliris can greatly increase your risk of having meningitis, a condition caused by inflammation of membranes surrounding the brain. Soliris 300 MG in 30 ML Injectionis used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia. Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. (so-leer-is) SOLIRIS® Intravenous immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as eculizumab and thereby decrease serum eculizumab concentrations. Under the Soliris REMS, prescribers must enroll in the program [see WARNINGS AND PRECAUTIONS]. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion reaction. Table 19 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in Study C10-003. Advise The Patient To Read FDA-Approved Patient Labeling (Medication Guide). Treatment with Soliris requires certain precautions because it makes the patient more vulnerable to infections.Â. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Hemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry. The safety and effectiveness of Soliris for the treatment of aHUS have been established in pediatric patients. Patients were excluded if they had been treated with rituximab or mitoxantrone within 3 months or with IVIg within 3 weeks prior to screening. Soliris Solution for injection drug summary. The median patient age was 28 years (range: 13 to 63 years). 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]. How do I prepare my kid for a hematology consultation? Visit the FDA MedWatch website or call 1-800-FDA-1088. Responses were observed across all ages from 5 months to 17 years of age. Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if an infection is suspected. Inform patients with aHUS that there is a potential for TMA complications due to aHUS when Soliris is discontinued and that they will be monitored by their healthcare professional for at least 12 weeks following Soliris discontinuation. drugs a-z list Table 19: Baseline Characteristics of Patients Enrolled in Study C10-003. In clinical studies among patients without PNH, meningococcal meningitis occurred in one unvaccinated patient. Soliris is associated with an approximate 2,000-fold increased risk of meningococcal disease in comparison to the general U.S. population annual rate (0.14 per 100,000 population in 2015). For more information, ask your doctor or pharmacist. Patients in Study C08-002A/B received Soliris for a minimum of 26 weeks. 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. This medicine is available only under a restricted distribution program called Soliris® REMS (Risk Evaluation and Mitigation Strategy) Program. the upper limits of normal, serum creatinine level ≥97 percentile for age without the need When treatment was continued for more than 26 weeks, six additional patients achieved Complete TMA response. Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. Table 20: Efficacy Results for Study C10-003. Table 16: Efficacy Results in Pediatric Patients Enrolled in Study C09-001r. Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection [see WARNINGS AND PRECAUTIONS]. Dilute Soliris to a final concentration of 5 mg/mL by adding the appropriate amount (equal volume of diluent to drug volume) of 0.9% Sodium Chloride Injection, USP; 0.45% Sodium Chloride Injection, USP; 5% Dextrose in Water Injection, USP; or Ringer’s Injection, USP to the infusion bag. The use of Soliris increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis). The mean eGFR (± SD) increased from 17 ± 12 mL/min/1.73m2 at baseline to 47 ± 24 mL/min/1.73m2 by 26 weeks. Soliris was studied in a placebo-controlled clinical study (PNH Study 1, in which 43 patients received Soliris and 44, placebo); a single arm clinical study (PNH Study 2); and a long term extension study (E05-001). Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy. You must tell the doctor if you are pregnant or breastfeeding before taking Soliris. 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]. Mean platelet count (± SD) increased from 171 ± 83 x109/L at baseline to 233 ±109 x109/L after one week of therapy; this effect was maintained through 26 weeks (mean platelet count (± SD) at week 26: 254 ± 79 x109/L). Table 5: Per Patient Incidence of Adverse Events in 10% or More Adult and Patients in Study C10-004 received Soliris for a minimum of 26 weeks. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis. The baseline demographic and disease characteristics were balanced between treatment groups. Inform patients that vaccination may not prevent meningococcal infection [see WARNINGS AND PRECAUTIONS]. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Following intravenous maintenance doses of 900 mg once every 2 weeks in patients with PNH, the week 26 observed mean ± SD serum eculizumab maximum concentration (Cmax) was 194 ± 76 mcg/mL and the trough concentration (Ctrough) was 97 ± 60 mcg/mL. However, children need to be vaccinated against influenza and pneumonia before starting treatment. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STECHUS). The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established. Reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris. Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 4-8 times the equivalent of the clinical dose of Soliris had no adverse effects on mating or fertility. What's the clotting-role of basopenia and elevated neutrophils? Elderly patients need to be closely monitored when treated with Soliris. Get best price and read about company. 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. Click here, Need to login as a patient? Certain fungal infections (aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count. Table 21: Analysis of Change from Baseline to Week 26 in MG-ADL and QMG Total Scores in gMG Study 1. If on immunosuppressive therapy (IST), on a stable dose regimen. 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]. Two of 161 patients with PNH (1.2%) and 1 of 100 patients with aHUS (1%), and none of the 96 patients with NMOSD had low positive values for neutralizing antibodies. All patients received the recommended dosage of Soliris. Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks. It is possible that Soliris may be passed into breast milk, so do not nurse while using the drug.Â. Common Brand(s): Soliris This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s). Revised: June 2019. Limitation of Use Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Admixed solutions of Soliris are stable for 24 h at 2°-8° C (36°-46° F) and at room temperature. Your FindaTopDoc account is completely free. Patients receiving anticoagulants and systemic corticosteroids at baseline continued these medications. In the placebo-controlled clinical study (PNH Study 1), Soliris when administered as recommended reduced serum LDH levels from 2200 ± 1034 U/L (mean ± SD) at baseline to 700 ± 388 U/L by week one and maintained the effect through the end of the study at week 26 (327 ± 433 U/L) in patients with PNH. 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. For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: For adult and pediatric patients with aHUS, and adult patients with gMG or NMOSD, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2). Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. 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. Soliris is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms). 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]. Each vial of Soliris is single-use only, so it must be thrown away after extracting the medicine, even if there is still some liquid left. None of the 62 patients with gMG had antibodies to Soliris detected following the 26-week active treatment. SOLIRIS is used to treat: It is not known if SOLIRIS is safe and effective in children with PNH, gMG, or NMOSD. Because Soliris can make you more vulnerable to infections, you have to make the doctor know if you have symptoms of infection such as fever, sore throat, or a cough before treatment. Your Login details are incorrect. 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.

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