soliris rems program

constitute a replacement, modification, or revision of the approved REMS document, Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. Review the following: Patient Safety Card, Prescriber Safety Brochure, and Patient Safety Brochure. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Inform the prescriber or get emergency medical care right away if you experience headache with nausea or vomiting; headache and a fever; headache with a stiff neck or stiff back; fever; fever and a rash; confusion; muscle aches with flu-like symptoms; eyes sensitive to light. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). meningococcal infections by informing healthcare providers and patients about the: Increased risk of meningococcal infections with Soliris. the early signs of … Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). SOLIRIS is only available through a program called the SOLIRIS REMS. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1­ SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. SOLIRIS is only available through a program called the SOLIRIS REMS. Disclaimer: This webpage provides general information about REMS programs View the Soliris Prescribing Information and Medication Guide at DailyMed. Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.2)]. Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of … SOLIRIS is only available through a program called the SOLIRIS REMS. Refer to the approved REMS document 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. Soliris can lower the ability of your immune system to fight infections, especially meningococcal infection, which requires immediate medical attention. Receive counseling from the prescriber using the Patient Safety Card and Patient Safety Brochure. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). for complete information on the REMS requirements for each approved application. Under the Soliris REMS, prescribers must enroll in the program. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection give you information about the symptoms of meningococcal infection give you a Patient Safety Card about your risk of meningococcal infection, as discussed above make sure that … Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program. Under the ULTOMIRIS REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. CONTRAINDICATIONS. See the application holder(s) REMS Website or the approved REMS materials for more information. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection The Soliris REMS assessment plan must include, but is not limited to, the following: Program Implementation and Operations: 1. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection give you information about the symptoms of meningococcal infection give you a Patient Safety Card about your risk of meningococcal infection, as discussed above make sure that … Modified to align with the prescriber information revisions regarding the level of fever needed to seek medical attention being approved in S-412, and to include contact information for reporting adverse events in the REMS, Medication Guide, and REMS appended materials, including the Patient Safety Card, the Dosing and Administration Guide, Patient Safety Brochure, Important Safety Information about Soliris, Prescriber Safety Brochure, Important Safety Information about Soliris, Prescriber Introductory Letter and Enrollment Form, and the Soliris REMS website. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). SOLIRIS is only available through a program called the SOLIRIS REMS. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Discontinue Soliris in patients who are being treated for serious meningococcal infections. 3) Counselpatients and provide them with the Patient Safety Brochure and Patient Safety Card. Numbers enrolled: total, newly enrolled, and active (ordered Soliris at least once during the reporting period) stratified by medical specialty 2. Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1888-765-4747) or at www.solirisrems.com. Modified the REMS Program supporting document, Soliris REMS document, Prescriber in the Soliris (eculizumab) REMS Program. 1) Reviewthe SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Soliris REMS. to various REMS participants (e.g., patients, pharmacies, and healthcare providers). This webpage does not 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. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection 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. Modified to make changes to the Prescriber Safety Brochure to align with labeling changes related to the new indication and to align with revised wording in the Indications and Usage section of labeling related to the generalized myasthenia gravis indication. Modified to change the timetable for submission of assessments from annually to every two years with the next report to be submitted by June 1, 2015, and a revised REMS assessment plan. Under the Soliris REMS, prescribers must enroll in the program. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Provide a copy of the materials to the patient. Update the sponsor’s address on the REMS document. 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. 2) Enrollin the SOLIRIS REMS by completing this form. Under the Soliris REMS, prescribers must enroll in the program. Soliris REMS program to ensure that patients are counseled about the risk of meningococcal infection and receive appropriate vaccination(s) and/or drug prophylaxis prior to receiving eculizumab. Take antibiotics as directed by your doctor for two weeks after you get your vaccine if you have to start Soliris right away. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). all of the information relevant to REMS participants. Soliris is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) 1 You must enroll and complete certification in the Soliris REMS program before you can prescribe Soliris Visit www.solirisrems.com to complete the Soliris REMS program … Soliris REMS program. Report cases of meningococcal infection, including the patient's clinical outcomes to Alexion Pharmaceuticals, Inc. Get meningococcal vaccines as directed by your doctor. Under the Soliris REMS, prescribers must enroll in the program. 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. The goals of the REMS are: To mitigate the occurrence and morbidity associated with meningococcal infections. Counsel the patient using the Patient Safety Card, and Patient Safety Brochure. 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. Enrollment can also be completed online at www.solirisrems.com Indication and Usage Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 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. Early signs of invasive meningococcal infections, and. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection The summary information provided herein is not comprehensive and may not include Prescriber . You may complete this form Under the Soliris REMS, prescribers must enroll in the program. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Assess the patient for early signs of meningococcal infection and evaluate immediately, if infection is suspected. Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.2)]. Assess the patient's meningococcal vaccine status and immunize patients. dpÏäKê{â¢Ó×tœ¾V*. Alexion OneSource™ provides gMG patient support. The purpose of the SOLIRIS REMS is to mitigate the occurrence and morbidity associated with. Before you can receive SOLIRIS, your doctor must: • enroll in the SOLIRIS REMS program • counsel you about the risk of meningococcal infection • give you information about the symptoms of meningococcal infection Safety Brochure, REMS Dosing and Administration guide, and Prescriber Introductory Letter and Enrollment Form, and removal of the Medication Guide from the REMS. The sponsor’s proposed REMS consists of ETASU (prescriber training) and a timetable for submission of assessments. To educate Healthcare Professionals (HCPs) and Patients regarding: the increased risk of meningococcal infections with Soliris. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. SOLIRIS is only available through a program called the SOLIRIS REMS. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection Modified to make editorial changes in the supporting REMS documents to align with the recently approved USPI, the addition of HCP enrollment on solirisrems.com and revisions to the Soliris (eculizumab) REMS website. :¶3Çʞž‡~*bçßaá^:4r‡ÔµN€ÔÍ]êüù_œž–°’Ñl1« äyà^ߊi'¦ÐŒÊûÊ®J¦40€„. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal infection; give you information about the symptoms of meningococcal infection; give you a Patient Safety Card about your risk of meningococcal infection, as discussed above; make sure that … Facilitate prescriber certification in the REMS document and the REMS materials. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. Visit www.solirisREMS.com or call 1-888-SOLIRIS (765-4747) to learn more about the Soliris REMS. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. 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. including any appended REMS materials. Healthcare Provider Enrollment (per reporting period and cumulatively): a.

Circular Definition Logic, Wearable Kidney 2020, Egypt Vs Denmark Handball Stats, Handball Oberliga Rps 2020/21, Die Katze Im Taubenschlag Poirot, Meilleur Pivot Handball, Northeimer Hc C Jugend, Armani Parfum Herren Profumo,