Arch Neurol. endstream endobj startxref Boston, MA: Alexion Pharmaceuticals, Inc; 2019. *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Accessed July 2020. h��Zko�6�+�آ���(����-&�M��>xm���l����ｗ�,Ɋ-ef[�(��!��\�VZkƙ��0� ,�B`�1%gVac#����H汃6�x���� Other Systemic Infections Due to its mechanism of action, Soliris … 7. • Dilute Soliris … 1/2021 Updated to include Enspryng™ and to change the policy name again. Y�n�*�J� References 1. ��{�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*. 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. Get the … endstream endobj 3430 0 obj <>stream Thrombotic microangiopathy complications were observed after Soliris … z�7�nVV�%��H�F�f���G|MKt��G��?��1.�]� 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. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … 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@�! Jarius S, Ruprecht K, Wildemann B, et al. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 7f*�@X�a�T�g�?���Vs���`���j�w'��NJ����k��p�m��`��`G��j��Y�����D��)!����n�U� g� 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). Read all of this leaflet carefully before you start using this medicine because it contains … • Loirat C, Fakhouri F, Ariceta G, et al. Mealy MA, Wingerchuk DM, Greenberg BM, Levy M. Epidemiology of neuromyelitis optica in the United States: a multicenter analysis. The Medical Letter On Drugs and Therapeutics, Eculizumab (Soliris) for Paroxysmal Nocturnal 5. An international consensus approach to the management of … Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … See Important Safety Information, including Boxed Warning, and full Prescribing Information. 6. [Package Insert]. 2012;9:14. Soliris 300 mg concentrate for solution for infusion . Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. 3508 0 obj <>stream US National Library of Medicine. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite … 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. 15. References 1. 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 … 2/2021 Updated vaccination requirements for Soliris ®. %PDF-1.7 %���� Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. :�3�ʞ��~*b��a�^:4r���N���]���_������l1���y�^ߊi'�Ќ����J�40��. See full prescribing information for ORENCIA. Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal … Guidelines for … _#��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)�$e+�BI��,�fe�V���������1������_�7�M��͘�8;a�Z���(Y�h{�����3D(��͞����+X References 1. • Soliris [package insert]. Neurology. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. New Haven, CT; Alexion Pharmaceuticals, Inc; July 2018. Soliris® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. iokwpd��w1���Xt���ǦJ�� kR��cBN��� �I�2�KI䡫n���):�|J�� �b�?a�^S���j$�$:��֬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�� 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 (5.2). References 1. 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 … Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. Prognostic factors and disease course in aquaporin-4 antibody-positive patients with neuromyelitis optica spectrum disorder from the United Kingdom and Japan. 1,2 Ashley N. Lewis, PharmD, BCPS, is a drug information specialist at University of North Carolina Hospitals (UNCH). Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble … J Neuroinflammation. SOLIRIS can cause serious side effects including serious infusion-related reactions. See full prescribing information for ALDURAZYME. 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. ��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 2012;135(pt 6):1834-1849. Soliris is a medicine that affects your immune system. Boston, MA: Alexion Pharmaceuticals, Inc; 2019. h�bbd```b``���� ����Z���Q ��D�[������`5s@$�0 �� $�@l ���1012�~ � �%����� @� �� We use cookies to give you the best online experience. References: Soliris [package insert]. Page 5 | SOLIRIS… Eculizumab . … 3. ���DStr�Y�?��K|G��>Eχ�.zN�f<3o�~��G� kL��.�j�� H`��V�Y4*���9y5xw�3W�\����ɸ.�v(Y�KH�FZ���u���,&h�O����3�eB���qH��jP�����OT/m$��ʢ� ���EZ�P�@u� Alexion Pharmaceuticals; 2009. Use caution when administering Soliris to patients with any systemic infection. 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. � 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). Soliris [package insert]. 4. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… 8. Loirat C, Fakhouri F, Ariceta G, et al. K��Dz��P�=C�4�#8 H���}��\� ~5VMZ�,�a��~*�1����8�E�c�oƊ���C+X��çbI��҈̼� FL���!,b �!0 Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. Soliris ® [package insert… Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. {Γ���[Jo4y:):c��l+��ȯ=��o�߄�o98�(��H���w#Dj,(���I�Hc���U�I��53i�7�� Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. endstream endobj 3429 0 obj <>stream N Engl J Med. Accessed July 2020. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … 1. 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. Eculizumab in aquaporin-4–positive neuromyelitis optica spectrum disorder. SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. References 1. Soliris treatment is recommended to continue for the patient’s lifetime, unless the discontinuation of Soliris is clinically indicated (see Warnings and Precautions). Under the Soliris REMS, prescribers must enroll in the program. An international consensus approach to the management of atypical hemolytic uremic … 2. 5;��p�8{X�.2�\.6��˯�n��x��أ����� 2. Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. Accessed July 2020. �*�H��M*��zl��L���Ǩ ���=!LO{b�:��Ŀ��G�_�~��;����[�'>�/"��O� X٩�"�`�v�5�9 �ܞ���`��b��'*2껜}�������1'�?|Y:ڗ��p���w��M��X��\�@= 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, … See Important Safety Information, including Boxed Warning, and full Prescribing Information. ���,��� ��gB{,0aY΄�8�Lx�=` h>V1�%��檨�aR�L,�_i���4�4�z&���3�M�v��(��X�&�Q>P�3e���N�� $ ��{,IA�{�`$�k,�A�*�,3���3A�` �=�� :��r� Data on file, Alexion Pharmaceuticals. Accessed March 13, 2020. ?p�?Mޑ�ۢ�}:Rc������ ��L| The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). d�]�X�P�B����㬍G^f���y��k�EG�D�qG��G�FK ��0�����A�����A5���"�*X:�� @#8hV@����/� bIpXi20��hf`d7dWe`�����{1k>ˆ����b�?�2�h�x�P�w��+�Gl������ 2�\�t��< ����}2(�����2p}���c�` �\�� 1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris … Boston, MA: Alexion Pharmaceuticals, Inc. 2. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. Soliris [package insert]. Under the Soliris REMS, prescribers must enroll in the program. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Soliris [package insert]. Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum … Complete prescribing information is available at www.soliris.com. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely and effectively. References Soliris [package insert]. Get the … 6�1���B� �e~�t�����*у�3 �`L��m^����|����@��6�����2�`N��5l�OD�*!9�yD2��5n)F2m$*@�*CW Atypical Hemolytic Uremic Syndrome (aHUS) Complement-Inhibitor Therapy Naïve* Administer the doses … Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). Soliris [package insert]. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. 2. 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 She is currently the … %%EOF All fields are required. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Soliris 300 mg concentrate for solution for infusion . Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. hemolytic uremic syndrome (STEC-HUS). • Transfer the recommended dose to an infusion bag. STUDY DESIGN1,2 Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Soliris … �uu�q� ����YC�qZ+����q���^X��q�$Ϝ#��\@�Ρ�:2�/E�h����w��i(*惐X�,����X�0���O��������Zo Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. 2012;69(9):1176-1180. Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. The clinical course of neuromyelitis optica (Devic’s syndrome). ClinicalTrials.gov. References: Soliris [package insert]. Safety and efficacy of eculizumab in anti-acetycholine … With Soliris, A future with fewer relapses is possible. 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. Soliris-treated patients had a 96% relative … SOLIRIS is only available through a program called the SOLIRIS REMS. 9/2020 Updated to include Uplizna™ and to change the policy name. 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. Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant treatment. 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; … Accessed August 2018. Soliris [package insert]. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Wingerchuk DM, Hogancamp WF, O’Brien PC, Weinshenker BG. Soliris (eculizumab) [package insert]. 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). Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Use caution when administering Soliris to patients with any systemic infection. Alexion OneSource™ provides gMG patient support. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. • Transfer the recommended dose to an infusion bag. This site is intended for healthcare professionals. 1999;53(5):1107-1114. 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? 3425 0 obj <> endobj Read all of this leaflet carefully before you start using this medicine because it contains … Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Package leaflet: Information for the user . !ۍ�=$�'"ٞ�j5iCjr!�F��ɋ�H��I��P SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… Neuromyelitis Optica Spectrum Disorder (NMOSD) �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' Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. Resources for your patients on Soliris® (eculizumab). Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. 0 Safety and efficacy of eculizumab in anti-acetycholine … h�b```��,�B ���� Under the Soliris REMS, prescribers must enroll in the program. … Copyright © 2020, Alexion Pharmaceuticals, Inc. All rights reserved. Package leaflet: Information for the user . 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 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? Soliris. Soliris [package insert]. ��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��. See Important Safety Information, including Boxed Warning, and full Prescribing Information. x�]��j�0��~ Soliris [package insert]. Alexion Pharmaceuticals; 2009. Pittock SJ, Berthele A, Fujihara K, et al. 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. Package Insert - SHINGRIX; Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX) Refer to Section 1.1 of the Clinical Review Memo for information … WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, Patients who are not currently vaccinated against. �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˙ Brain. :� �]���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�,�:? HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. 2019;381(7):614‑625. Kitley J, Leite MI, Nakashima I, et al. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 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 is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. Eculizumab . • Dilute Soliris … Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 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. By using our website, you agree to our use of cookies in accordance with our.
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