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