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

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