Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. Atypical Hemolytic Uremic Syndrome (aHUS) Complement-Inhibitor Therapy Naïve* Administer the doses … !ۍ�=$�'"ٞ�j5iCjr!�F��ɋ�H��I��P ���,��� ��gB{,0aY΄�8�Lx�=` h>V1�%��檨�aR�L,�_i���4�4�z&���3�M�v��(��X�&�Q>P�3e���N�� $ ��{,IA�{�`$�k,�A�*�,3���3A�` �=�� �x R�P�}� �%l+�k�O`����t�����"�̳�lL8��J�f��r���Є�SW���{D�3�l�.���r��!�qC&����k֕0�1��_�j��蒧����,e�;Ԅe>t�q3 Ԓ�~�Tx8 ȝ��'!�r�"B��/��x˙ Soliris [package insert]. Safety and efficacy of eculizumab in anti-acetycholine … References: Soliris [package insert]. Alexion Pharmaceuticals; 2009. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Neuromyelitis Optica Spectrum Disorder (NMOSD) Kitley J, Leite MI, Nakashima I, et al. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 3. … Soliris [package insert]. Soliris-treated patients had a 96% relative … With Soliris, A future with fewer relapses is possible. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 6. Read all of this leaflet carefully before you start using this medicine because it contains … The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called … �uu�q� ����YC�qZ+����q���^X��q�$Ϝ#��\@�Ρ�:2�/E�h����w��i(*惐X�,����X�0���O��������Zo Complete prescribing information is available at www.soliris.com. Under the Soliris REMS, prescribers must enroll in the program. 7. 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�` �\�� endstream endobj startxref She is currently the … SOLIRIS is only available through a program called the SOLIRIS REMS. %%EOF Use caution when administering Soliris to patients with any systemic infection. Under the Soliris REMS, prescribers must enroll in the program. References 1. Loirat C, Fakhouri F, Ariceta G, et al. This site is intended for healthcare professionals. 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). Accessed March 13, 2020. Wingerchuk DM, Hogancamp WF, O’Brien PC, Weinshenker BG. 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. 2/2021 Updated vaccination requirements for Soliris ®. 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. 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 We use cookies to give you the best online experience. � See full prescribing information for ALDURAZYME. 3508 0 obj <>stream 9/2020 Updated to include Uplizna™ and to change the policy name. SOLIRIS can cause serious side effects including serious infusion-related reactions. 7f*�@X�a�T�g�?���Vs���`���j�w'��NJ����k��p�m��`��`G��j��Y�����D��)!����n�U� g� References 1. References 1. 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 … 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. 5. Soliris [package insert]. h�b```��,�B ���� 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 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. package also contains an oxygen absorber and oxygen indicator to minimize oxidation. 0 Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. See Important Safety Information, including Boxed Warning, and full Prescribing Information. 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. :��r� ClinicalTrials.gov. Eculizumab . Brain. Soliris ® [package insert… Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. An international consensus approach to the management of … 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 … Soliris. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Soliris treatment is recommended to continue for the patient’s lifetime, unless the discontinuation of Soliris is clinically indicated (see Warnings and Precautions). Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Eculizumab in aquaporin-4–positive neuromyelitis optica spectrum disorder. 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, … z�7�nVV�%��H�F�f���G|MKt��G��?��1.�]� References: Soliris [package insert]. 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. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. … _#��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 hemolytic uremic syndrome (STEC-HUS). 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. Guidelines for … endstream endobj 3430 0 obj <>stream • Dilute Soliris … ��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��. Get the … Soliris 300 mg concentrate for solution for infusion . • Dilute Soliris … Accessed August 2018. Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. Package leaflet: Information for the user . 8. 2. References 1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris … K��Dz��P�=C�4�#8 H���}��\� ~5VMZ�,�a��~*�1����8�E�c�oƊ���C+X��çbI��҈̼� FL���!,b �!0 Mealy MA, Wingerchuk DM, Greenberg BM, Levy M. Epidemiology of neuromyelitis optica in the United States: a multicenter analysis. Neurology. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Package leaflet: Information for the user . Arch Neurol. 1/2021 Updated to include Enspryng™ and to change the policy name again. Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. Y�n�*�J� 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'/_ �_��$��J�R���� .1\;}��,y�^�E�~�p��M*Er�����MM�6������� �w�"e�M�N���H��]�R@�! 1. Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant treatment. Soliris [package insert]. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Soliris [package insert]. Accessed July 2020. Alexion OneSource™ provides gMG patient support. Jarius S, Ruprecht K, Wildemann B, et al. Package Insert - SHINGRIX; Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX) Refer to Section 1.1 of the Clinical Review Memo for information … {Γ���[Jo4y:):c��l+��ȯ=��o�߄�o98�(��H���w#Dj,(���׭I�Hc���U�I��53i�7�� Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … �Cq��v��2�a�X�pl%3,�Q�C�~�:����?�[��];� ��c�ѓc\��a�ɓ:W�M{Wn;������$�;�j��".�78T�m��(�^L��A��9�}�N��9>��P�����K4�Є���Zh��Z����;5���pv?� 9�'��)���|~ �o' Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Soliris 300 mg concentrate for solution for infusion . Under the Soliris REMS, prescribers must enroll in the program. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum … US National Library of Medicine. Soliris [package insert]. 2. 1,2 Ashley N. Lewis, PharmD, BCPS, is a drug information specialist at University of North Carolina Hospitals (UNCH). 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; … Soliris [package insert]. ��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 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). Boston, MA: Alexion Pharmaceuticals, Inc. 2. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal … See Important Safety Information, including Boxed Warning, and full Prescribing Information. 4. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. • Loirat C, Fakhouri F, Ariceta G, et al. • Transfer the recommended dose to an infusion bag. ���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$��ʢ� ���EZ�P�@u� HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely and effectively. endstream endobj 3429 0 obj <>stream Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s). Soliris … SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, Patients who are not currently vaccinated against. 6�1���B� �e~�t�����*у�3 �`L��m^����|����@��6�����2�`N��5l�OD�*!9�yD2��5n)F2m$*@�*CW ��{�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*. 2012;69(9):1176-1180. 1999;53(5):1107-1114. Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Eculizumab . SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. Soliris® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. Copyright © 2020, Alexion Pharmaceuticals, Inc. All rights reserved. :� �]���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�,�:? :�3�ʞ��~*b��a�^:4r���N���]���_������l1���y�^ߊi'�Ќ����J�40��. 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�� J Neuroinflammation. References 1. Under the Soliris REMS, prescribers must enroll in the program (5.2). *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. 2012;9:14. 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. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). New Haven, CT; Alexion Pharmaceuticals, Inc; July 2018. Thrombotic microangiopathy complications were observed after Soliris … See full prescribing information for ORENCIA. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. 15. %PDF-1.7 %���� • Soliris [package insert]. Soliris (eculizumab) [package insert]. Prognostic factors and disease course in aquaporin-4 antibody-positive patients with neuromyelitis optica spectrum disorder from the United Kingdom and Japan. h��Zko�6�+�آ���(����-&�M��>xm���l����ｗ�,Ɋ-ef[�(��!��\�VZkƙ��0� ,�B`�1%gVac#����H汃6�x���� Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. All fields are required. Pittock SJ, Berthele A, Fujihara K, et al. Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. N Engl J Med. 2. Read all of this leaflet carefully before you start using this medicine because it contains … [Package Insert]. Other Systemic Infections Due to its mechanism of action, Soliris … 2012;135(pt 6):1834-1849. Accessed July 2020. STUDY DESIGN1,2 … Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. Alexion Pharmaceuticals; 2009. • Transfer the recommended dose to an infusion bag. Use caution when administering Soliris to patients with any systemic infection. Page 5 | SOLIRIS… 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. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 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. Alexion OneSource™ provides gMG patient support. Data on file, Alexion Pharmaceuticals. The Medical Letter On Drugs and Therapeutics, Eculizumab (Soliris) for Paroxysmal Nocturnal 3425 0 obj <> endobj Soliris [package insert]. 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? New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. x�]��j�0��~ Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. 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. 5;��p�8{X�.2�\.6��˯�n��x��أ����� Under the Soliris REMS, prescribers must enroll in the program. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. h�bbd```b``���� ����Z���Q ��D�[������`5s@$�0 �� $�@l ���׺1012�~ � �%����� @� �� Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … Safety and efficacy of eculizumab in anti-acetycholine … Get the … An international consensus approach to the management of atypical hemolytic uremic … The clinical course of neuromyelitis optica (Devic’s syndrome). Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Resources for your patients on Soliris® (eculizumab). Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite … The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). 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. Soliris is a medicine that affects your immune system. By using our website, you agree to our use of cookies in accordance with our. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble … �*�H��M*��zl��L���Ǩ ���=!LO{b�:��Ŀ��G�_�~��;����[�'>�/"��O� X٩�"�`�v�5�9 �ܞ���`��b��'*2껜}�������1'�?|Y:ڗ��p���w��M��X��\�@= Accessed July 2020. ?p�?Mޑ�ۢ�}:Rc������ ��L| Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). 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? 2019;381(7):614‑625. 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. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… References 1. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII.