• Dilute Soliris … Soliris-treated patients had a 96% relative … Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble … This site is intended for healthcare professionals. An international consensus approach to the management of atypical hemolytic uremic … z�7�nVV�%��H�F�f���G|MKt��G��?��1.�]� 2. 8. Soliris [package insert]. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 3508 0 obj <>stream Soliris® (eculizumab) is the FIRST AND ONLY FDA-approved complement inhibitor indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).1, In the Soliris PREVENT study of patients with anti-AQP4 antibody-positive NMOSD, Soliris was superior to placebo based on time to first adjudicated on-trial relapse (primary endpoint).1, reduction in risk of relapse in adult patients treated with Soliris compared to placebo (Hazard Ratio=0.058; P<0.0001).1, of patients treated with Soliris who were relapse-free at 48 weeks vs 63% with placebo.1,2. h�b```��,�B ���� References: Soliris [package insert]. _#��F����F-��W�_���QS�$�C늌��ʤf,3"n(5��#gia��},3K1�Y��y��̈���}Eނ\5��}�����eà�C�A��f�"rkL&��Pb3���#r+L�2J aEJ�ܼJɖO�R�P5)�$e+�BI��,�fe�V���������1������_�7�M��͘�8;a�׌Z���(Y�h{�����3D(��͞����+X !ۍ�=$�'"ٞ�j5iCjr!�F��ɋ�H��I��P Package leaflet: Information for the user . Accessed March 13, 2020. �uu�q� ����YC�qZ+����q���^X��q�$Ϝ#��\@�Ρ�:2�/E�h����w��i(*惐X�,����X�0���O��������Zo Soliris treatment is recommended to continue for the patient’s lifetime, unless the discontinuation of Soliris is clinically indicated (see Warnings and Precautions). Use caution when administering Soliris to patients with any systemic infection. SOLIRIS patent expiration date, news, international patents, biosimilar launch March 2021 - When will the patents on SOLIRIS expire, and when will biosimilar SOLIRIS be available? H��W�r�6}����d�� �N&3�;�$��Ӈ8�$_�Hr%%��Q���.��Ʊ�dƎ ����=g�����hŞ}X���|��,�>eϞ��ww2��JH��~�J��dw珟�lw�������`B�L�����2&X��Lg�,����v��O�+z*����λD������;/�����Z;�{��&���!c���ׇ��,���HVv�,�Q%Wj;�8��e�×��T'/_ �_��$��J�R���� .1\;}��,y�^�E�~�p��M*Er�����MM�6������� �w�"e�M�N���H��]�R@�! ClinicalTrials.gov. Kitley J, Leite MI, Nakashima I, et al. Complete prescribing information is available at www.soliris.com. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Alexion OneSource™ provides gMG patient support. 1/2021 Updated to include Enspryng™ and to change the policy name again. • Transfer the recommended dose to an infusion bag. Get the … Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. �Cq��v��2�a�X�pl%3,�Q�C�~�:����?�[��];� ��c�ѓc\��a�ɓ:W�M{Wn;������$�;�j��".�78T�m��(�^L��A��9�}�N��9>��P�����K4�Є���Zh��Z����;5���pv?� 9�'��)���|~ �o' Under the Soliris REMS, prescribers must enroll in the program. An international consensus approach to the management of … ?p�?Mޑ�ۢ�}:Rc������ ��L| Patients may have increased susceptibility to infections, especially with encapsulated bacteria. 3. Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description). Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early. She is currently the … Read all of this leaflet carefully before you start using this medicine because it contains … Accessed July 2020. h��Zko�6�+�آ���(����-&�M��>xm���l����ｗ�,Ɋ-ef[�(��!��\�VZkƙ��0� ,�B`�1%gVac#����H汃6�x���� Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. • Soliris [package insert]. 6. Read all of this leaflet carefully before you start using this medicine because it contains … • Loirat C, Fakhouri F, Ariceta G, et al. • Dilute Soliris … Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. Safety and efficacy of eculizumab in anti-acetycholine … Data on file, Alexion Pharmaceuticals. d�]�X�P�B����㬍G^f���y��k�EG�D�qG��G�FK ��0�����A�����A5���"�*X:�� @#8hV@����/� bIpXi20��hf`d7dWe`�����{1k>ˆ����b�?�2�h�x�P�w��+�Gl������ 2�\�t��< ����}2(�����2p}���c�` �\�� Accessed July 2020. Soliris [package insert]. Prognostic factors and disease course in aquaporin-4 antibody-positive patients with neuromyelitis optica spectrum disorder from the United Kingdom and Japan. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Dilute Soliris to a final admixture concentration of 5 mg/mL using the following steps: • Withdraw the required amount of Soliris from the vial into a sterile syringe. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Eculizumab . Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … Soliris [package insert]. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. � … :��r� Soliris is a medicine that affects your immune system. Resources for your patients on Soliris® (eculizumab). Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS is only available through a program called the SOLIRIS REMS. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. All fields are required. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Eculizumab in aquaporin-4–positive neuromyelitis optica spectrum disorder. Thrombotic microangiopathy complications were observed after Soliris … See full prescribing information for ALDURAZYME. N Engl J Med. Soliris [package insert]. 2012;9:14. 7f*�@X�a�T�g�?���Vs���`���j�w'��NJ����k��p�m��`��`G��j��Y�����D��)!����n�U� g� References 1. Alexion Pharmaceuticals; 2009. Page 5 | SOLIRIS… New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. By checking this box and providing my information above, I am giving Alexion permission to contact me for marketing purposes or otherwise provide me with information about Alexion’s products, services, and programs or other topics of interest, and to conduct market research or surveys. ���DStr�Y�޵?��K|G��>Eχ�.zN�f<3o�~��G� kL��.�j�� H`��V�Y4*���9y5xw�3W�\����ɸ.�v(Y�KH�FZ���u���,&h�O����3�eB���qH��jP�����OT/m$��ʢ� ���EZ�P�@u� 1999;53(5):1107-1114. 2012;135(pt 6):1834-1849. Wingerchuk DM, Hogancamp WF, O’Brien PC, Weinshenker BG. Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. ��{�¹v0��M��i�s�z�����-��>l{�l���xLЪ"df#=�֟�i���۸�b��r.��53�������>{��Í��+bSU�KG5)B��Ɔ���ɦ)a7�H�9'D U��q��N�g/Kx��s܆+��9��~�)][x��d0�%���xm�[�U\���dp��K�{���t��V*. 1,2 Ashley N. Lewis, PharmD, BCPS, is a drug information specialist at University of North Carolina Hospitals (UNCH). Atypical Hemolytic Uremic Syndrome (aHUS) Complement-Inhibitor Therapy Naïve* Administer the doses … Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. 9/2020 Updated to include Uplizna™ and to change the policy name. 2. %PDF-1.7 %���� The Medical Letter On Drugs and Therapeutics, Eculizumab (Soliris) for Paroxysmal Nocturnal SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… Neuromyelitis Optica Spectrum Disorder (NMOSD) Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 7. Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Arch Neurol. Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal … Neurology. Eculizumab . 4. Soliris. 2019;381(7):614‑625. %%EOF 5;��p�8{X�.2�\.6��˯�n��x��أ����� Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). Alexion OneSource™ provides gMG patient support. Get the … WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, Patients who are not currently vaccinated against. SOLIRIS patent expiration date, news, international patents, biosimilar launch March 2021 - When will the patents on SOLIRIS expire, and when will biosimilar SOLIRIS be available? Over time, relapses have been shown to be inevitable for the majority of patients with NMOSD.5,6,8, Learn more about the 3+ year PREVENT study.1,2. K��Dz��P�=C�4�#8 H���}��\� ~5VMZ�,�a��~*�1����8�E�c�oƊ���C+X��çbI��҈̼� FL���!,b �!0 Soliris ® [package insert… Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum … See Important Safety Information, including Boxed Warning, and full Prescribing Information. hemolytic uremic syndrome (STEC-HUS). Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. 2. Soliris [package insert]. Pittock SJ, Berthele A, Fujihara K, et al. Soliris 300 mg concentrate for solution for infusion . By using our website, you agree to our use of cookies in accordance with our. :�3�ʞ��~*b��a�^:4r���N���]���_������l1���y�^ߊi'�Ќ����J�40��. Package Insert - SHINGRIX; Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX) Refer to Section 1.1 of the Clinical Review Memo for information … Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. �x R�P�}� �%l+�k�O`����t�����"�̳�lL8��J�f��r���Є�SW���{D�3�l�.���r��!�qC&����k֕0�1��_�j��蒧����,e�;Ԅe>t�q3 Ԓ�~�Tx8 ȝ��'!�r�"B��/��x˙ Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely and effectively. Soliris [package insert]. 67 5.3 Monitoring After Soliris Discontinuation 68 Since Soliris therapy increases the number of PNH cells [in study 1, the proportion of PNH RBCs increased 69 among Soliris … The clinical course of neuromyelitis optica (Devic’s syndrome). 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. endstream endobj 3426 0 obj <>/Metadata 139 0 R/Outlines 210 0 R/Pages 3416 0 R/StructTreeRoot 215 0 R/Type/Catalog>> endobj 3427 0 obj <>/MediaBox[0 0 612 792]/Parent 3417 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 3428 0 obj <>stream … ���,��� ��gB{,0aY΄�8�Lx�=` h>V1�%��檨�aR�L,�_i���4�4�z&���3�M�v��(��X�&�Q>P�3e���N�� $ ��{,IA�{�`$�k,�A�*�,3���3A�` �=�� Safety and efficacy of eculizumab in anti-acetycholine … The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). … Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. 0 Loirat C, Fakhouri F, Ariceta G, et al. ��S�X�-�狇�v�8Y�����|�ޜ}������pȻY���s����՗�٬4'9������;֭��t-�Y�\n�'����w�ap�Qn�u3����~\>��]�.��ߴ��v�����0?n�' Fҟ�?�Ք�i�}/C����.���1y=^��׬utOey�s�.�ш��o�ֱ%>�V�l�Eڣ���C��9���f�{Z >��.����7}�T���&S/7���������kB�k "�n#G����݆�Þ ����m m���M�c�8��B'��=FsO��de�o��[\�R{����6������'\�Ǔ�T��`?rt��]�\;>C�CO��{�1��e7�J�̦-���c��x�C�>J�}L��>O|�z�uB)L�j���N(�T��. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. NULOJIX ® (belatacept) (in combination with basiliximab induction, mycophenolate mofetil [MMF], and corticosteroids) is indicated for prophylaxis of organ rejection in adults receiving a kidney transplant; … The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called … Under the Soliris REMS, prescribers must enroll in the program. Soliris must be diluted to a final admixture concentration of 5 mg/mL using the following steps: • Withdraw the required amount of Soliris from the vial into a sterile syringe. 2.2 Recommended Weight-Based Dosage Regimen The recommended dosing regimen for adult patients (≥ 18 years of age) with PNH consists of a loading dose followed by maintenance dosing, … The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion. [Package Insert]. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. iokwpd��w1���Xt���ǦJ�� kR��cBN��� �I�2�KI䡫n���):�|J�� �b�?a�^S���j$�$:��֬x�d+T5a�cGIo�?A�㏬��>�}v�/�ć�w�h�2�{�o���x��JLODy+ ݟ���v�Ι���S�v�QRb��햱w�>�g��q�����vҘ��T�N"�d�M��8#��[�������k���������j5�)����x�R���KS�.���V)x�ڄ���qV*[�؂��n��]Xie��Xo���6a�PD I�2�� 5. References 1. PREVENT (Prevention of Relapses in Neuromyelitis Optica): Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Soliris in patients with anti-AQP4 antibody-positive NMOSD who received Soliris (N=96) or placebo (N=47). References 1. US National Library of Medicine. Soliris (eculizumab) [package insert]. SOLIRIS can cause serious side effects including serious infusion-related reactions. :� �]���3ؑ���It�bb"�u),=��o���ұL�X�}�{��}&��w��[��9�C���������gz�_����8ó���mu_� �{�����GH�����凓���G����zB��mcB7[k�`7�(�צ*`W��EJ�����/O�����ck�0hm�v]��� �]�_��a��ſ��g�T�,�:? We use cookies to give you the best online experience. Guidelines for … References: Soliris [package insert]. Accessed July 2020. x�]��j�0��~ Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite … 3425 0 obj <> endobj Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Brain. 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. New Haven, CT; Alexion Pharmaceuticals, Inc; July 2018. See full prescribing information for ORENCIA. 1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris … �*�H��M*��zl��L���Ǩ ���=!LO{b�:��Ŀ��G�_�~��;����[�'>�/"��O� X٩�"�`�v�5�9 �ܞ���`��b��'*2껜}�������1'�?|Y:ڗ��p���w��M��X��\�@= Package leaflet: Information for the user . ��sD����0� I���J�2��4UO>�`1�����G��u�4��}�Ig �4BM�kz �s���F�&�@r"��CZr� ��T�R��@��% >`�V�萘�o}�ۇ�S��� H���-}�������m8�����F X Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. 6�1���B� �e~�t�����*у�3 �`L��m^����|����@��6�����2�`N��5l�OD�*!9�yD2��5n)F2m$*@�*CW Mealy MA, Wingerchuk DM, Greenberg BM, Levy M. Epidemiology of neuromyelitis optica in the United States: a multicenter analysis. Although no specific agents are recommended, the eculizumab package insert notes that most patients in this situation received prophylactic antibiotics until at least 2 weeks after vaccination. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. Soliris [package insert]. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). References 1. Soliris … 2/2021 Updated vaccination requirements for Soliris ®. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Soliris is not indicated for the treatment of patients with Shiga toxin E. Coli related hemolytic uremic syndrome (STEC-HUS) Speak with your doctor about how Soliris can help in the treatment of aHUS. J Neuroinflammation. package also contains an oxygen absorber and oxygen indicator to minimize oxidation. References Under the Soliris REMS, prescribers must enroll in the program. endstream endobj startxref Copyright © 2020, Alexion Pharmaceuticals, Inc. All rights reserved. endstream endobj 3430 0 obj <>stream 3443 0 obj <>/Filter/FlateDecode/ID[<7FAEC3263EDC5246A9994F89F7F28BA1>]/Index[3425 84]/Info 3424 0 R/Length 100/Prev 718362/Root 3426 0 R/Size 3509/Type/XRef/W[1 3 1]>>stream Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Soliris [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. h�bbd```b``���� ����Z���Q ��D�[������`5s@$�0 �� $�@l ���׺1012�~ � �%����� @� �� Other Systemic Infections Due to its mechanism of action, Soliris … With Soliris, A future with fewer relapses is possible. 1. Jarius S, Ruprecht K, Wildemann B, et al. *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Alexion Pharmaceuticals; 2009. {Γ���[Jo4y:):c��l+��ȯ=��o�߄�o98�(��H���w#Dj,(���׭I�Hc���U�I��53i�7�� endstream endobj 3429 0 obj <>stream Boston, MA: Alexion Pharmaceuticals, Inc. 2. Accessed August 2018. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Use caution when administering Soliris to patients with any systemic infection. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). • Transfer the recommended dose to an infusion bag. Y�n�*�J� See Important Safety Information, including Boxed Warning, and full Prescribing Information. STUDY DESIGN1,2 15. References 1. Under the Soliris REMS, prescribers must enroll in the program (5.2). 2012;69(9):1176-1180. Soliris 300 mg concentrate for solution for infusion . Soliris® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant treatment. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).
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