6 73 Deliver product to: Office Patient’s home Clinic Is prescriber enrolled with One Source: Yes No If no, call 888.765.4747. X��c�jh��30�10�2�eLc|�������1�����M�!�ɒ��a[C6[ ['C4�s L`�e�g�d�a�g��Ndx�����( 0000025524 00000 n for 12 months. 0000039076 00000 n 78 0 obj <>stream 0000013825 00000 n 0000016912 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. 0000125633 00000 n 0000020513 00000 n (Refer to Product Monograph for complete prescribing information) ¨ Atypical Hemolytic Uremic Syndrome (aHUS) For patients≥18 years of age. Fax the form to Soliris REMS at 1 … 0000126288 00000 n 0000016783 00000 n REMS Compliance (per reporting period and cumulatively) a. SOLIRIS is only available through a program called the SOLIRIS REMS. 0000020760 00000 n 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. 0000108569 00000 n Enrollment Form Local Events. Primary ICD-10: D59.5 PNH D59.3 aHUS G70.00 anti-AchR+ gMG HCPs should report all suspected adverse events, including reports of meningococcal infection by contacting Alexion Pharmaceuticals, Inc. at 1.888.Soliris (1.888.765.4747); or reporting the information to the FDA MedWatch Reporting System by phone at 1.800.FDA.1088 (1.800.332.1088) or by mail using Form 3500 at http://www.fda.gov/MedWatch, The purpose of the SOLIRIS REMS is to mitigate the occurrence and morbidity associated with, Soliris is available only through a restricted program under a Risk Evaluation and Mitigation, HCPs who prescribe Soliris must be specifically certified. 0000148393 00000 n Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1888-765-4747) or at www.solirisrems.com. 0000003626 00000 n Provide these materials to your patients. 0000138344 00000 n 0000021612 00000 n Prescriber must be certified by the Soliris REMS program before prescribing. Primary ICD-10: D59.5 PNH D59.3 aHUS G70.00 anti-AchR+ gMG 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. 0000008736 00000 n more effectively and quickly . Patient Counseling about the risks of corporal rupture and other serious injuries to the penis and the importance of patient adherence to post-injection instructions. Counsel patients using both the Patient Safety Brochure and Patient Safety Card. Need for immediate medical evaluation of signs and symptoms consistent with 0000037171 00000 n Contraindications Patients with unresolved serious Neisseria meningitidis infection Even if a patient stops using Soliris, they should keep their Soliris Patient Safety Card with them. SOLIRIS is only available through a program called the SOLIRIS REMS. 0000024889 00000 n Prescriber must be certified by the Soliris REMS program before prescribing. 0000148201 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. 0000014945 00000 n Advise their patients that this safety card contains important safety information about the risk of meningococcal infection that they need to be aware of before they are given Soliris and during their treatment with Soliris. Patient Agreement By signing this form, I understand and acknowledge that: Before my treatment begins, I will: • Enroll in the SPRAVATO® REMS by completing this Patient Enrollment Form with my healthcare provider. See Important Safety Information, including Boxed Warning, and full Prescribing Information. You may complete this form • online at www.ultomirisrems.com • by fax at 1-877-580-2596 (ALXN) • by scanning and emailing to REMS@alexion.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 Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program; counsel you about the risk of … 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 Alexion OneSource™ provides gMG patient support. 0000066606 00000 n 0000074883 00000 n 0000148275 00000 n %%EOF 3) Counsel patients and provide them with the Patient Safety Brochure and Patient Safety Card. 0000148164 00000 n Under the Soliris REMS, prescribers must enroll in the program. 0000008362 00000 n 0000021366 00000 n startxref xref 1) Review the SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card. %PDF-1.4 %���� Eculizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). h�b``pc``�d```��ˀ Certification in the XIAFLEX REMS Program by completing training and enrollment 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 . Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0 Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0000025440 00000 n Contraindications Patients with unresolved serious Neisseria meningitidis infection 0000010673 00000 n Patients Taking Soliris~ Soliris can lower the ability of your immune system to fight infections, especially meningococcal infection, ... Soliris REMS: Patient Safety Card Author: fda Under the ULTOMIRIS REMS, prescribers must enroll in the program. 0000039405 00000 n 0000021429 00000 n Demographics of patients treated with Soliris (gender, pediatric age group, diagnosis) c. A comparison of the number of patients who received Soliris to the number of patients enrolled in the voluntary patient support program 3. trailer 0000015127 00000 n <]/Prev 162575>> 0000014544 00000 n Mail the form to Alexion Pharmaceutical, Inc. ATTN: REMS Program, 121 Seaport Boulevard, Boston, MA 02210 ; Fax the form to ULTOMIRIS REMS at 1-877-580-2596 ; Scan and email the form to rems@alexion.com 0000035967 00000 n 0000036713 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. See Important Safety Information, including Boxed Warning, and full Prescribing 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. 0000025047 00000 n 0000020402 00000 n 0000021025 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. more effectively and quickly . SOLIRIS is only available through a program called the SOLIRIS REMS. For patients<18 years of age. 1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 0000067137 00000 n Risk Evaluation and Mitigation Strategies (REMS) Understanding REMS with this updated listingwill help your facility service your residents . Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. �ilex���3na��(�*�h��~��9�_Y^FΦN��L��/����2J�1��ͬdPGv�3��LPDz20UZ��� �#| Certification consists of review of. Enroll in the ULTOMIRIS REMS Click here to complete the ULTOMIRIS REMS Prescriber Enrollment online Or Print and sign the Prescriber Enrollment Form. 0000138603 00000 n The OneSource process following enrollment: Contact you and your healthcare team. 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. OR: Print and sign the Prescriber Enrollment Form: Mail the form to Soliris REMS, Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210. 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. Remind their patients to show this card to any doctor involved in their treatment. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com. 0000109166 00000 n 0000036227 00000 n Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0000108322 00000 n Under the Soliris REMS, prescribers must enroll in the program. Risk Evaluation and Mitigation Strategies (REMS) Understanding REMS with this updated listingwill help your facility service your residents . 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. See Important Safety Information, including Boxed Warning, and full Prescribing Information. 3) Counsel patients and provide them with the Patient Safety Brochure and Patient Safety Card. Under the Soliris REMS, prescribers must enroll in the program. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. 0000004133 00000 n 0000001756 00000 n Mix Soliris 900 mg/90 mL in NS 90 mL Infuse 900 mg/180 mL IV via gravity/pump once a week x 4 infusions Initial: Prescriber must be enrolled in REMS program. 0000003246 00000 n 0000138908 00000 n 0000012239 00000 n Download Enrollment Forms Send your specialty Rx and enrollment form to us electronically, or by phone or fax. Under the Soliris REMS, prescribers must enroll in the program (Alexion Pharmaceuticals, 2019a). ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0000002168 00000 n a. 0000036412 00000 n 2) Enroll in the ULTOMIRIS REMS by completing this form. 0000020535 00000 n 0000036387 00000 n Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. 2) Enroll in the SOLIRIS REMS by completing this form. Primary ICD-10: D59.5 PNH D59.3 aHUS G70.00 anti-AchR+ gMG 0000006366 00000 n SOLIRIS®(eculizumab) DIN: 02322285. 0000003067 00000 n endstream endobj 7 0 obj <>>> endobj 8 0 obj <. ¨ 900 mg weekly x 4 doses, 1200 mg at week 5; then 1200 mg every 2 weeks thereafter. ... (AEGIS) evaluated the effectiveness of eculizumab in reducing hemolysis (primary endpoint) in 29 Japanese patients with PNH, with enrollment criteria similar to previously published pivotal studies (Kanakura et al, 2011).
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