Facilitate prescriber certification in the REMS document and the REMS materials. 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. Provide a copy of the materials to the patient. in the Soliris (eculizumab) REMS Program. Receive counseling from the prescriber using the Patient Safety Card and Patient Safety Brochure. 2) Enrollin the SOLIRIS REMS by completing this form. 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. Discontinue Soliris in patients who are being treated for serious meningococcal infections. 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. Get meningococcal vaccines as directed by your dotor. SOLIRIS is only available through a program called the SOLIRIS REMS. CONTRAINDICATIONS. 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. meningococcal infections by informing healthcare providers and patients about the: Increased risk of meningococcal infections with Soliris. 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 sponsor’s proposed REMS consists of ETASU (prescriber training) and a timetable for submission of assessments. 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 (1-888-765-4747) or at www.solirisrems.com. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1 Modified the REMS Program supporting document, Soliris REMS document, Prescriber SOLIRIS is only available through a program called the SOLIRIS REMS. The purpose of the SOLIRIS REMS is to mitigate the occurrence and morbidity associated with. Assess the patient's meningococcal vaccine status and immunize patients. 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. 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. Counsel the patient using the Patient Safety Card, and Patient Safety Brochure. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Take antibiotics as directed by your doctor for two weeks after you get your vaccine if you have to start Soliris right away. Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of … Under the ULTOMIRIS REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. 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. Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. 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. The goals of the REMS are: To mitigate the occurrence and morbidity associated with meningococcal infections. Soliris REMS program. Under the Soliris REMS, prescribers must enroll in the program. See the application holder(s) REMS Website or the approved REMS materials for more information. Alexion OneSource™ provides gMG patient support. :¶3ÇÊ~*bçßaá^:4rÔµNÔÍ]êüù_°Ñl1« äyà^ßi'¦ÐÊûÊ®J¦40. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris REMS. Soliris can lower the ability of your immune system to fight infections, especially meningococcal infection, which requires immediate medical attention. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, U.S. Department of Health and Human Services. Modified to reflect revisions to the Prescriber Enrollment Form to include prescriber specialty. SOLIRIS is only available through a program called the SOLIRIS REMS. View Soliris's Regulatory Information at Drugs@FDA, Instructions for Downloading Viewers and Players, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Patient Safety_Brochure.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Patient_Safety_Card.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Prescriber_Enrollment_Form.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_Prescriber_Safety_Brochure.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Program_Website_Screenshots.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Document.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/rems/Soliris_2020_04_07_REMS_Full.pdf. including any appended REMS materials. Provide the patient with a prescription for a two-week course of antibiotic prophylaxis if Soliris must be started less than 2 weeks after the patient was immunized. To educate Healthcare Professionals (HCPs) and Patients regarding: the increased risk of meningococcal infections with Soliris. Patients with unresolved Neisseria meningitidis infection. Safety Brochure, REMS Dosing and Administration guide, and Prescriber Introductory Letter and Enrollment Form, and removal of the Medication Guide from the REMS. Disclaimer: This webpage provides general information about REMS programs Review the drug's Prescribing Information. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1888-765-4747) or at www.solirisrems.com. Healthcare Provider Enrollment (per reporting period and cumulatively): a. 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 You may complete this form Under the Soliris REMS, prescribers must enroll in the program. constitute a replacement, modification, or revision of the approved REMS document, The summary information provided herein is not comprehensive and may not include Under the Soliris REMS, prescribers must enroll in the program. Review the following: Patient Safety Card, Prescriber Safety Brochure, and Patient Safety Brochure. Under the Soliris REMS, prescribers must enroll in the program. To mitigate the occurrence and morbidity associated with meningococcal infections. SOLIRIS is a prescription medicine used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Modified to make editorial changes to the REMS document and changes to the REMS appended materials to align with labeling changes related to the new indication. Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection Under the Soliris REMS, prescribers must enroll in the program. Refer to the approved REMS document Early signs of invasive meningococcal infections, and. Visit www.solirisREMS.com or call 1-888-SOLIRIS (765-4747) to learn more about the Soliris REMS. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com. View the Soliris Prescribing Information and Medication Guide at DailyMed. all of the information relevant to REMS participants. 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 [see Warnings and Precautions (5.2)]. 3) Counselpatients and provide them with the Patient Safety Brochure and Patient Safety Card. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). 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. Initial authorization is for six months . 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. 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 … 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. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program. 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 … 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. to various REMS participants (e.g., patients, pharmacies, and healthcare providers). the early signs of … Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program counsel you about the risk of meningococcal infection Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. 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). Modified to align with the changes to the prescribing information related to vaccination in patients receiving Soliris (eculizumab) in the Medication Guide, and REMS appended materials, including 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. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 1) Reviewthe SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card. SOLIRIS is only available through a program called the SOLIRIS REMS. Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.2)]. To educate Healthcare Professionals (HCPs) and Patients regarding: the increased risk of meningococcal infections with Soliris, the early signs of invasive meningococcal infections, and, the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections. Revaccinate patients according to the Advisory Committee on Immunization Practices recommendations. Numbers enrolled: total, newly enrolled, and active (ordered Soliris at least once during the reporting period) stratified by medical specialty 2. Assess the patient for early signs of meningococcal infection and evaluate immediately, if infection is suspected. 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 … SOLIRIS is only available through a program called the SOLIRIS 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 only available through a program called the SOLIRIS REMS. dpÏäKê{â¢Ó×t¾V*. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (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 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. Report cases of meningococcal infection, including the patient's clinical outcomes to Alexion Pharmaceuticals, Inc. Get meningococcal vaccines as directed by your doctor. Provide consistency with the revised package insert in the REMS document, Medication Guide, and appended REMS materials. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. The Soliris REMS assessment plan must include, but is not limited to, the following: Program Implementation and Operations: 1. 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. Prescriber . Update the sponsor’s address on the REMS document. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. for complete information on the REMS requirements for each approved application. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). This webpage does not SOLIRIS is only available through a program called the SOLIRIS REMS. 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 … 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. Add additional language regarding storage instructions in the REMS appended material, Dosing and Administration Guide, as reflected in the January 11, 2016 labeling. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers).
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