soliris rems patient enrollment

Under the Soliris REMS, prescribers must enroll in the program (Alexion Pharmaceuticals, 2019a). Fax the form to Soliris REMS at 1 … Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0000036227 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. Under the Soliris REMS, prescribers must enroll in the program. Enroll in the ULTOMIRIS REMS Click here to complete the ULTOMIRIS REMS Prescriber Enrollment online Or Print and sign the Prescriber Enrollment Form. 0000025440 00000 n 3) Counsel patients and provide them with the Patient Safety Brochure and Patient Safety Card. <]/Prev 162575>> REMS Compliance (per reporting period and cumulatively) a. Contraindications Patients with unresolved serious Neisseria meningitidis infection ¨ 900 mg weekly x 4 doses, 1200 mg at week 5; then 1200 mg every 2 weeks thereafter. 0000020513 00000 n Under the eculizumab REMS prescribers must enroll in the program. 0000126288 00000 n SOLIRIS® (eculizumab) DIN: 02322285 (Refer to Product Monograph for complete prescribing information) ¨ Atypical Hemolytic Uremic Syndrome (aHUS) For patients ≥18 years of age ¨ 900 mg weekly x 4 doses, 1200 mg at week 5; then 1200 mg every 2 weeks thereafter for 12 months For patients … 0000074883 00000 n Primary ICD-10: D59.5 PNH D59.3 aHUS G70.00 anti-AchR+ gMG 0000036412 00000 n trailer Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0000014544 00000 n Before you can receive SOLIRIS, your doctor must: enroll in the SOLIRIS REMS program; counsel you about the risk of … 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. Remind their patients to show this card to any doctor involved in their treatment. 0000013953 00000 n 0000020686 00000 n Under the Soliris REMS, prescribers must enroll in the program. REMs Provider Enrollment Form Completed Documented meningococcal vaccine administration Date Administered: Current Medication List: Clinical/Progress Notes, H&P, Labs, Tests, supporting DX Attached H&P Labs/Tests Patients Demographics, including insurance infomation Please attach original prescription orders For Treatment of gMG & NMOSD: You may complete this form • online at www.solirisrems.com 0000024631 00000 n Need for immediate medical evaluation of signs and symptoms consistent with 0000016912 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. SOLIRIS is only available through a program called the SOLIRIS REMS. Enroll in the ULTOMIRIS REMS Click here to complete the ULTOMIRIS REMS Prescriber Enrollment online Or Print and sign the Prescriber Enrollment Form. SOLIRIS is only available through a program called the SOLIRIS REMS. The number of new patients treated with Soliris b. 0000066606 00000 n 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. 0000021025 00000 n 0000109166 00000 n At CVS Specialty®, our goal is to help streamline the onboarding process to get patients the medication they need as quickly as possible. 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 Even if a patient stops using Soliris, they should keep their Soliris Patient Safety Card with them. enrollment by phone with Alexion at 1-888-765-4747 or obtain enrollment documents via the Soliris REMS website at www.SolirisREMS.com. 0000036387 00000 n �ilex���3na��(�*�h��~��9�_Y^FΦN��L��/����2J�1��ͬdPGv�3��LPDz20UZ��� �#| Certification in the SOLIRIS REMS includes the following steps: The Spanish versions of the Patient education material can be downloaded from below: Soliris is a trademark of Alexion Pharmaceuticals, Inc, Increased risk of meningococcal infections with Soliris, Early signs of invasive meningococcal infections, and. 0000014945 00000 n %%EOF X��c�jh��30�10�2�eLc|�������1�����M�!�ɒ��a[C6[ ['C4�s L`�e�g�d�a�g��Ndx�����( Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com. To order a Soliris Patient Safety Card, contact Soliris REMS at 1.888.SOLIRIS Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Risk Evaluation and Mitigation Strategies (REMS) Understanding REMS with this updated listingwill help your facility service your residents . (Refer to Product Monograph for complete prescribing information) ¨ Atypical Hemolytic Uremic Syndrome (aHUS) For patients≥18 years of age. Under the ULTOMIRIS REMS, prescribers must enroll in the program. possible meningococcal infections. SOLIRIS is only available through a program called the SOLIRIS REMS. 0000008736 00000 n Mail the form to Soliris REMS, Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210. 0000020289 00000 n a. 0 0000035967 00000 n 0000148275 00000 n See Important Safety Information, including Boxed Warning, and full Prescribing Information. 0000037447 00000 n 3) Counsel patients and provide them with the Patient Safety Brochure and Patient Safety Card. 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. 0000138603 00000 n Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). ... (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). SOLIRIS is only available through a program called the SOLIRIS REMS. 0000001756 00000 n xref Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. Enrollment information will be submitted to the SPRAVATO® REMS. Alexion OneSource™ provides gMG patient support. (1.888.765.4747). Deliver product to: Office Patient’s home Clinic Is prescriber enrolled with One Source: Yes No If no, call 888.765.4747. Enrollment in the eculizumab REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at solirisrems.com . Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 78 0 obj <>stream 0000020612 00000 n startxref more effectively and quickly . 0000148164 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. Certification in the XIAFLEX REMS Program by completing training and enrollment in the program. 0000010673 00000 n 2) Enroll in the ULTOMIRIS REMS by completing this form. Under the Soliris REMS, prescribers must enroll in the program. 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. 0000148201 00000 n OneSource is a complimentary, personalized patient support program offered by Alexion and tailored to the specific needs of people living with aHUS, gMG, HPP, LAL-D, NMOSD and PNH. 0000148393 00000 n Alexion OneSource™ provides gMG patient support. Enrollment Form Local Events. 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. SOLIRIS is only available through a program called the SOLIRIS REMS. See Important Safety Information, including Boxed Warning, and full Prescribing Information. 6 73 0000036713 00000 n 0000002168 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. 0000006366 00000 n Under the Soliris REMS, prescribers must enroll in the program. 0000148536 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. 0000025072 00000 n Eculizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Deliver product to: Office Patient’s home Clinic Is prescriber enrolled with One Source: Yes No If no, call 888.765.4747. 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. 0000018594 00000 n 0000021612 00000 n See Important Safety Information, including Boxed Warning, and full Prescribing Information. ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 0000004296 00000 n 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 Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1888-765-4747) or at www.solirisrems.com. Certification consists of review of. Remind patients to carry the Patient Safety Card with them at all times. 0000015127 00000 n 0000020760 00000 n SOLIRIS is only available through a program called the SOLIRIS REMS. endstream endobj 7 0 obj <>>> endobj 8 0 obj <. 0000067137 00000 n Fax the form to Soliris REMS at 1-877-580-2596 (ALXN); or. 0000021696 00000 n Counsel patients using both the Patient Safety Brochure and Patient Safety Card. Prescriber must be certified by the Soliris REMS program before prescribing. 0000039076 00000 n 0000016783 00000 n Primary ICD-10: D59.5 PNH D59.3 aHUS G70.00 anti-AchR+ gMG OR: Print and sign the Prescriber Enrollment Form: Mail the form to Soliris REMS, Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210. SOLIRIS®(eculizumab) DIN: 02322285. 0000074596 00000 n Prescriber must be certified by the Soliris REMS program before prescribing. 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 0000021543 00000 n 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. 0000125887 00000 n Eliza Dollard, PharmD August 2015 Eculizumab (Soliris®) Procedure for Use in Patients Age ≥ 18 Years Jackson Memorial Hospital Eculizumab Prescribing Procedure: All prescribers must be enrolled in the Soliris REMS (Risk Evaluation and Mitigation Strategy) Program o Additional REMS information and enrollment instructions can be found at www.solirisrems.com 0000037743 00000 n Primary ICD-10: D59.5 PNH D59.3 aHUS G70.00 anti-AchR+ gMG 0000025047 00000 n For patients<18 years of age. 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 %PDF-1.4 %���� 0000021366 00000 n 0000037171 00000 n The OneSource process following enrollment: Contact you and your healthcare team. 1) Review the SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card. 0000039405 00000 n 0000108569 00000 n 0000020535 00000 n 0000003246 00000 n Patients may have increased susceptibility to infections, especially with encapsulated bacteria. 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. Risk Evaluation and Mitigation Strategies (REMS) Understanding REMS with this updated listingwill help your facility service your residents . 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. 0000013825 00000 n Under the Soliris REMS, prescribers must enroll in the program. Download Enrollment Forms Send your specialty Rx and enrollment form to us electronically, or by phone or fax. 0000000016 00000 n 6 0 obj <> endobj 0000008362 00000 n 0000003626 00000 n 2) Enroll in the SOLIRIS REMS by completing this form. Prescriber must be certified by the Soliris REMS program before prescribing. 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. 0000020878 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. 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. Certification in the XIAFLEX REMS Program by completing training and enrollment in the program. Under the Soliris REMS, prescribers must enroll in the program. 0000039770 00000 n Explain to their patients that if they cannot reach their doctor, they should go to the emergency room immediately and show the emergency room staff the Soliris Patient Safety Card. more effectively and quickly . 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 . 0000020402 00000 n 0000024889 00000 n Contraindications Patients with unresolved serious Neisseria meningitidis infection 0000003067 00000 n 0000125633 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. 0000021429 00000 n 0000025371 00000 n 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 SOLIRIS is only available through a program called the SOLIRIS REMS. 0000025524 00000 n Provide these materials to your patients. h�b``pc``�d```��ˀ 0000138344 00000 n Deliver product to: Office Patient’s home Clinic Is prescriber enrolled with One Source: Yes No If no, call 888.765.4747. SOLIRIS is only available through a program called the SOLIRIS REMS. 0000066353 00000 n for 12 months. 0000108322 00000 n 0000002043 00000 n 0000138908 00000 n 0000012239 00000 n 0000004133 00000 n

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