0 • Soliris [package insert]. References 1. 2. This site is intended for healthcare professionals. The clinical course of neuromyelitis optica (Devic’s syndrome). 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). Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. 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. Safety and efficacy of eculizumab in anti-acetycholine … Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. Atypical Hemolytic Uremic Syndrome (aHUS) Complement-Inhibitor Therapy Naïve* Administer the doses … 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. Neuromyelitis Optica Spectrum Disorder (NMOSD) All fields are required. 6. :��r� *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. • Transfer the recommended dose to an infusion bag. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… K��Dz��P�=C�4�#8 H���}��\� ~5VMZ�,�a��~*�1����8�E�c�oƊ���C+X��çbI��҈̼� FL���!,b �!0 Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Soliris [package insert]. Before you can receive SOLIRIS, your doctor must enroll in the SOLIRIS REMS program; counsel you about the risk of meningococcal … 2. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Complete prescribing information is available at www.soliris.com. 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. Soliris [package insert]. STUDY DESIGN1,2 %PDF-1.7 %���� Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. Eculizumab in aquaporin-4–positive neuromyelitis optica spectrum disorder. Alexion OneSource™ provides gMG patient support. Soliris-treated patients had a 96% relative … Soliris (eculizumab) [package insert]. References 1. Wingerchuk DM, Hogancamp WF, O’Brien PC, Weinshenker BG. 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�� Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. 7. 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. 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). !ۍ�=$�'"ٞ�j5iCjr!�F��ɋ�H��I��P We use cookies to give you the best online experience. Accessed August 2018. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Soliris [package insert]. Use caution when administering Soliris to patients with any systemic infection. ���DStr�Y�?��K|G��>Eχ�.zN�f<3o�~��G� kL��.�j�� H`��V�Y4*���9y5xw�3W�\����ɸ.�v(Y�KH�FZ���u���,&h�O����3�eB���qH��jP�����OT/m$��ʢ� ���EZ�P�@u� �Cq��v��2�a�X�pl%3,�Q�C�~�:����?�[��];� ��c�ѓc\��a�ɓ:W�M{Wn;������$�;�j��".�78T�m��(�^L��A��9�}�N��9>��P�����K4�Є���Zh��Z����;5���pv?� 9�'��)���|~ �o' h�b```��,�B ���� Get the … h�bbd```b``���� ����Z���Q ��D�[������`5s@$�0 �� $�@l ���1012�~ � �%����� @� �� 3508 0 obj <>stream Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. Neurology. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. 2. Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … 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 References 1. 5;��p�8{X�.2�\.6��˯�n��x��أ����� Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. Alexion Pharmaceuticals; 2009. ���,��� ��gB{,0aY΄�8�Lx�=` h>V1�%��檨�aR�L,�_i���4�4�z&���3�M�v��(��X�&�Q>P�3e���N�� $ ��{,IA�{�`$�k,�A�*�,3���3A�` �=�� 1,2 Ashley N. Lewis, PharmD, BCPS, is a drug information specialist at University of North Carolina Hospitals (UNCH). WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, Patients who are not currently vaccinated against. 7f*�@X�a�T�g�?���Vs���`���j�w'��NJ����k��p�m��`��`G��j��Y�����D��)!����n�U� g� Copyright © 2020, Alexion Pharmaceuticals, Inc. All rights reserved. Accessed July 2020. Soliris 300 mg concentrate for solution for infusion . • Dilute Soliris … The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion. Package leaflet: Information for the user . Eculizumab . 6�1���B� �e~�t�����*у�3 �`L��m^����|����@��6�����2�`N��5l�OD�*!9�yD2��5n)F2m$*@�*CW New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. 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. :�3�ʞ��~*b��a�^:4r���N���]���_������l1���y�^ߊi'�Ќ����J�40��. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). 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��. 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. Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. 9/2020 Updated to include Uplizna™ and to change the policy name. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … 2012;9:14. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 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. J Neuroinflammation. See full prescribing information for ALDURAZYME. 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. Resources for your patients on Soliris® (eculizumab). Under the Soliris REMS, prescribers must enroll in the program. 1/2021 Updated to include Enspryng™ and to change the policy name again. Boston, MA: Alexion Pharmaceuticals, Inc. 2. Alexion OneSource™ provides gMG patient support. See Important Safety Information, including Boxed Warning, and full Prescribing Information. 15. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. See Important Safety Information, including Boxed Warning, and full Prescribing Information. 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. … Accessed July 2020. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely and effectively. ��{�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*. {Γ���[Jo4y:):c��l+��ȯ=��o�߄�o98�(��H���w#Dj,(���I�Hc���U�I��53i�7�� Soliris ® [package insert… Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Accessed July 2020. … References 3. Soliris is a medicine that affects your immune system. Under the Soliris REMS, prescribers must enroll in the program. See full prescribing information for ORENCIA. ?p�?Mޑ�ۢ�}:Rc������ ��L| 2/2021 Updated vaccination requirements for Soliris ®. Soliris [package insert]. �*�H��M*��zl��L���Ǩ ���=!LO{b�:��Ŀ��G�_�~��;����[�'>�/"��O� X٩�"�`�v�5�9 �ܞ���`��b��'*2껜}�������1'�?|Y:ڗ��p���w��M��X��\�@= endstream endobj 3430 0 obj <>stream 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. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). New Haven, CT; Alexion Pharmaceuticals, Inc; July 2018. Pittock SJ, Berthele A, Fujihara K, et al. Mealy MA, Wingerchuk DM, Greenberg BM, Levy M. Epidemiology of neuromyelitis optica in the United States: a multicenter analysis. 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@�! Y�n�*�J� Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. References: Soliris [package insert]. 1. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. An international consensus approach to the management of atypical hemolytic uremic … 8. Alexion Pharmaceuticals; 2009. package also contains an oxygen absorber and oxygen indicator to minimize oxidation. 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. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for … 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, … An international consensus approach to the management of … See Important Safety Information, including Boxed Warning, and full Prescribing Information. 4. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS… Read all of this leaflet carefully before you start using this medicine because it contains … ClinicalTrials.gov. • Transfer the recommended dose to an infusion bag. 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. Data on file, Alexion Pharmaceuticals. 2012;69(9):1176-1180. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … • Dilute Soliris … 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? Arch Neurol. US National Library of Medicine. N Engl J Med. 2019;381(7):614‑625. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). �uu�q� ����YC�qZ+����q���^X��q�$Ϝ#��\@�Ρ�:2�/E�h����w��i(*惐X�,����X�0���O��������Zo endstream endobj 3429 0 obj <>stream 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�` �\�� Get the … �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-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant treatment. 1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris … :� �]���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�,�:? Soliris. Guidelines for … %%EOF 2012;135(pt 6):1834-1849. • Loirat C, Fakhouri F, Ariceta G, et al. 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; … Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Soliris [package insert]. Read all of this leaflet carefully before you start using this medicine because it contains … Soliris® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. Package leaflet: Information for the user . x�]��j�0��~ She is currently the … ��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 Brain. 1999;53(5):1107-1114. 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 Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble … Eculizumab . Under the Soliris REMS, prescribers must enroll in the program (5.2). 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? Package Insert - SHINGRIX; Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX) Refer to Section 1.1 of the Clinical Review Memo for information … References 1. SOLIRIS is only available through a program called the SOLIRIS REMS. [Package Insert]. Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. Page 5 | SOLIRIS… Soliris [package insert]. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. Other Systemic Infections Due to its mechanism of action, Soliris … With Soliris, A future with fewer relapses is possible. The Medical Letter On Drugs and Therapeutics, Eculizumab (Soliris) for Paroxysmal Nocturnal Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. By using our website, you agree to our use of cookies in accordance with our. 5. Use caution when administering Soliris to patients with any systemic infection. Soliris [package insert]. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Kitley J, Leite MI, Nakashima I, et al. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris 300 mg concentrate for solution for infusion . Under the Soliris REMS, prescribers must enroll in the program. Safety and efficacy of eculizumab in anti-acetycholine … 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 … References: Soliris [package insert]. � Soliris … SOLIRIS® (eculizumab) SOLIRIS® is a Complement Inhibitor Indicated for the Treatment of Patients With PNH to Reduce Hemolysis SOLIRIS® (eculizumab) [package insert]. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. … Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum … Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite … Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 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. Soliris treatment is recommended to continue for the patient’s lifetime, unless the discontinuation of Soliris is clinically indicated (see Warnings and Precautions). _#��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 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���� SOLIRIS can cause serious side effects including serious infusion-related reactions. Thrombotic microangiopathy complications were observed after Soliris … References 1. 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). 3425 0 obj <> endobj z�7�nVV�%��H�F�f���G|MKt��G��?��1.�]� Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS … Soliris [package insert]. endstream endobj startxref hemolytic uremic syndrome (STEC-HUS). Jarius S, Ruprecht K, Wildemann B, et al.
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