H���M�� ���s���1����J��V��b��M��8��w ��f[U+U�����1t�vY!Y#sg�lk��X��:��pTH�.��wzvT��Lp��#�&δ� ���cZ2=����M�GuZ�����+N;�q�Uimi�j��>u]�2�O�uČ����I�_�p�3)��5�b˥J�0��w�a��P�TCb:�x�Ҡ?k���d�sH� ��rq_/�;� Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Did the Wise Men Notice the Babinski Sign in the Christ Child? Compare formulary status to other drugs in the same class. Kc���#�� ���& An orphan disease by definition effects 200,000 people or less in the United States. "�% ��+O0��Q)2��y����fx�̫gP�4��mK� 1T��I��O3�G$���-Ѿ;g��֊D�%A�&�1��8�a�z� >�&��>n��1�9�8�PFtl�p�����ᴚ�V��a��.I�2�݄iW,+���ZV{���+�ܨ�^�I��y\����x�X-��Ҡ�-�R|��ɇ�Ԣ�@Ć�I+Q�ݭ���r���r�[�VK)漸w�h�cѶMsK�]b�b�c��Q}���/6�$���Q��7 Adding plans allows you to compare formulary status to other drugs in the same class. Inflammation Of The Tissue Lining The Sinuses 9. Most Cough 5. Adults: Infuse IV over at least 35 min; may slow/stop infusion if adverse effect occurs, but total infusion time should not exceed 2 hr. Together, these mean that Ultomiris is administered every eight weeks while Soliris is given every two weeks. Drugs, 2003 Quick MRI Scan for Routine Prostate Cancer Screening? Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of … If the medicinal product is not used immediately after dilution, storage times must not exceed 24 hours at 2 °C – 8 °C or 5 hours at room temperature taking into account the expected infusion time. endstream endobj 33 0 obj <>stream Efficacy endpoints included patient survival degree of hemolysis, Infuse over 35 minutes. Urinary Tract Infection 16. endstream endobj startxref ���4�*��:��GM"��(�ĝ��B����c��ΜH�emB�:���m���� ;���U��P+ ^2�q�oav;�-V8��Z�R1��e�Ee�� �;ؓF8\�7WZt���t-d�����Ls38�2֙v 900 mg of Soliris via a 25-45 minute intravenous infusion every week for the first 4 weeks. Eculizumab should be diluted to a final concentration of 5 mg/mL by adding appropriate amounts of 0.9% sodium chloride (NaCl), 0.45% NaCl, 5% dextrose in … endstream endobj 29 0 obj <> endobj 30 0 obj <> endobj 31 0 obj <>stream The above information is provided for general endstream endobj 34 0 obj <>stream Fever 7. Indicated for paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, Doses 1-4: 600 mg IV qWeek for first 4 weeks, followed by, Indicated for treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy; effectiveness based on the effects on thrombotic microangiopathy and renal function, Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by, Indicated for generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive, Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive, Supplemental dosing required for aHUS, gMG, or NMOSD in the setting of concomitant support with plasma exchange or plasma infusion (plasmapheresis or plasma exchange; fresh frozen plasma infusion), Dose 5 and thereafter: Wait 7 days following 4th dose, then administer 900 mg IV for 5th dose, then 900 mg IV q14days thereafter, This dosage regimen is for PNH, in cases of Degos disease the dosing can reach 1200 mg/dose, Idiopathic membranous glomerular nephropathy, Renal transplantation: prevention of delayed graft function, Shiga-Toxin producing Escherichia coli hemolytic uremic syndrome, Administer at recommended dosage regimen time points, or within two days of these time points, Supplemental dosing required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or fresh frozen plasma infusion), As with all proteins, there is a potential for immunogenicity, Fatal or serious infections: Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria sicca/subflava, Neisseria spp unspecified, Increases the risk of meningococcal infections, Vaccinate with a meningococcal vaccine at least 2 weeks prior to receiving the first dose; revaccinate according to current medical guidelines for vaccine use, Monitor for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary, Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS); prescribers must enroll in the program by telephone: 1-888-SOLIRIS (1- 888-765-4747) or at solirisrems.com, Unresolved serious Neisseria meningitidis infection or patients who are unvaccinated against N meningitidis (unless risk of delaying treatment outweigh the risk for meningococcal infection), Discontinue if being treated for serious meningococcal infection, Increased risk of susceptibility to infections, Meningococcal infection may occur and become rapidly life-threatening or fatal if not recognized and treated early ( see Black Box Warnings), Supplement dose with plasma infusion or exchange, Only administer as an IV infusion, do not give IVP or bolus (see Administration), Risk of other infections, including encapsulated bacteria (eg, Streptococcus pneumoniae, H influenzae) is increased with eculizumab; caution with any systemic infection, Infusion-related reactions may occur; continue monitoring for 1 hr after completion of infusion, Serious infections with Neisseria species (other than N. meningitides), including disseminated gonococcal infections, reported, PNH and aHUS disease registries collect pregnancy outcomes in women exposed to eculizumab during pregnancy, contact www.pnhregistry.com or www.ahusregistry.com, or call (215)-616-3558, In cases where gMG patients become pregnant, call (215)-616-3558, There are no available data on eculizumab use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage, Animal studies using a mouse analogue of the eculizumab molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose, Advise pregnant women of the potential risk to a fetus, There is no information regarding the presence of eculizumab in human milk, the effects on the breastfed infant, or the effects on milk production, The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. … endstream endobj 32 0 obj <>stream informational and educational purposes only. FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. How much to take / use. By clicking send, you acknowledge that you have permission to email the recipient with this information. In November 2014, we announced positive data using OMS721 to inhibit thrombus formation in an ex vivo pathophysiologic system of aHUS. Low Energy 11. Most ;���6����l�0�8ch��H���Ɨ�(T�]+D��%��L��q��QJ��[��< Your list will be saved and can be edited at any time. endstream endobj 34 0 obj <>stream 4/21/2015 2 7 73% Reduction in Mean Units Transfused SOLIRIS is administered only via intravenous infusion over 35 minutes. Backache 3. h�b```c``�c`f`��d�e@ ^& �h```��W/�q��0,��l�����a��T=���m�ۛË��E�Z@��� � �{ H��T�n�0��+�H+�ZｸP �%(r�%�f+��D���w��W$F/Z����-���"������(IZP�X�8� Anemia 2. 0 Paroxysmal Nocturnal Hemoglobinuria (PNH) Recommended dosage of eculizumab for PNH in members 18 years of age and older: 600 mg IV every weekly for the first 4 weeks, followed by Your doctor will perform a blood test to make sure Soliris is the right … Established Efficacy US/SOL-N/0046 The most common side effects in people with NMOSD treated 40 0 obj <>/Filter/FlateDecode/ID[<6E1343F7F3D15D448AE5095BE14CB60B>]/Index[28 22]/Length 70/Prev 34126/Root 29 0 R/Size 50/Type/XRef/W[1 2 1]>>stream BLA 125166/S409 Page 8 MEDICATION GUIDE Soliris ® (so-leer-is) (eculizumab) Read the Medication Guide before you start Soliris and before each infusion. Headache 8. Soliris is a breakthrough, potentially lifesaving treatment for two rare blood diseases, affecting about 180 patients in Canada. To view formulary information first create a list of plans. Vomiting Plasma exchange or infusion may transiently maintain normal levels of hematologic measures but does not treat the underlying systemic disease. Muscle Pain 12. or intravenous infusion) usually over 35 minutes in adults and 1 to 4 hours in pediatric patients. The infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children. �&����1 ��d�Q�YKg�b�����9]�������#�$ ��w��o;�ٞ��h��kR(Z�� �:C��{���A7�/���"ar���)�s�" ^�E��O� m3�= infusion (FFP) ≥ 300 mg 300 mg per each infusion of FFP 60 minutes prior to each infusion of FFP * Doses should be administered at the above intervals, or within two days of these time points. Contact the applicable plan H�|Tێ�6}�W�# T�D]���E�m���>d���)��E�ՠ���F��3�l� ���3g�Λww9��.y�ur�$�D&!�_ɪ94e-��nL28$�Ȳ����G_��ۛݏ�w���»�w� ��i!rv������D��I�j ��[ � B#�{�����>%�(�@%�jE�BS�B�� Children: Infuse IV over 1-4 hr via gravity feed, a syringe-type pump, or an infusion. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvc29saXJpcy1lY3VsaXp1bWFiLTM0Mjg3NQ==, View explanations for tiers and H���M�� ���s���1����J��V��b��M��8��w ��f[U+U�����1t�vY!Y#sg�lk��X��:��pTH�.��wzvT��Lp��#�&δ� ���cZ2=����M�GuZ�����+N;�q�Uimi�j��>u]�2�O�uČ����I�_�p�3)��5�b˥J�0��w�a��P�TCb:�x�Ҡ?k���d�sH� ��rq_/�;� It is usually given every 7 days for 5 weeks, then every 14 days. Please confirm that you would like to log out of Medscape. This medication is given by injection into a vein by a health care professional as directed by your doctor. 2010 Access your plan list on any device – mobile or desktop. Infusion may be slowed or stopped due to adverse reactions but should be finished within 2 hours Provide patient with Soliris Patient Safety Card to keep at all times Paroxysmal nocturnal hemoglobinuria (PNH) Initial doses: eculizumab (SOLIRIS) 600 mg in NaCl 0.9% 60 mL, intravenous, ONCE Every week x 4 doses Eculizumab is available as Soliris in 300 mg single‐use vials for intravenous (IV) infusion. A Common Cold 2. ���4�*��:��GM"��(�ĝ��B����c��ΜH�emB�:���m���� ;���U��P+ ^2�q�oav;�-V8��Z�R1��e�Ee�� �;ؓF8\�7WZt���t-d�����Ls38�2֙v endstream endobj 33 0 obj <>stream commonly, these are "non-preferred" brand drugs. �v &^� [r�@|L�� ����, }��L�8�C�C)��}����jk@�8fa�k�GGyf�c�� ��L��0I�9-�Ed�N�G46{;�� �˔��ii@N�~}�Ƅ}`���[s,O�mew��ra2���Po?�d��p�轩L�9�zU)\��A��u�IG���Νu�7I���_$:}��ΝA�.DZC#[�X�I^ltꠧ�| �?Y�&�~�J a4�f�pVwA_l�H�6/��V��R]�9-��-�e���S���29�GIQ��Z����-�k��k�ui��a�����ϡ)H���r&|e�%�t�:ZQo�|_�! Soliris® (eculizumab) and Ultomiris® (ravulizumab-cwvz) are two drugs used to treat a rare ... Infusion services: A service that provides infusion of a drug that is delivered directly into the bloodstream of a patient through a vein, usually located in the arm or hand . Eculizumab (Soliris ®) is an anti-C5 monoclonal antibody that is approved by the FDA and the EMA to treat patients with aHUS. �v &^� [r�@|L�� ����. 2`���笋L��Ζ���,�Ό�=[x)*6�Z�,�)��� �9��E��=畐�T��,U�����$��=3�z�_�Q?�s z���\#J��X����N�`�;����۸��.�����2���m��(jh�JTP-���F�f�O��*�}�_���)@�@�Du�GO��O�_�����t��J�&�+X����Gq�8j^1�Q}��]� �����N��GU�j5�>Vor���8��=|F!s��*�b�H݆�X|�|�͞����DL�h���� G�A�u������l�D�6#{#��b��q�k�0�śQ�{@�E鵃SȤ�L�� ~�sF?ؓE�ZLq�i�R�ل�h�!�b��� blG(�_}�U>���w!/O9>�_{�e&��쌺YJ(��Q�� t���g�|����1�@�� ��e�f���,f�>E�����&�Ǚ�7���ƅ��Kt�;L�����Eb�����g��^SԲ�L����eC���}5��gT�\E�x��nAրQ_���j�ϧ�x0�4�kJz�#f�Y�T��E�"N�4sv ���z&�`o�?��Mf�Q�"���'Z��f:��=x Efficacy assessments were performed at least every 2 weeks from the time of initiation of eculizumab therapy in the parent study. This drug is available at a higher level co-pay. h�bbd``b`� �@�q�`� "f ��c�$� Refer to the table 3 for minimum infusion duration. A: Generally acceptable. The diluted solution of Soliris should be administered by intravenous infusion over 25 – 45 minutes (35 minutes ± 10 minutes) in adults and 1-4 hours in paediatric patients … � /viewarticle/941970 Soliris is given weekly initially and then every two or three weeks. • SOLIRIS is given through a vein (I.V. ≥300 mg most recent dose: Give 300 mg per each session within 60 minutes following completion, ≥600 mg most recent dose: Give 600 mg per each session within 60 minutes following completion, 300 mg most recent dose: Give 300 mg per infusion of FFP; administer 60 minutes prior to each infusion of FFP, Not indicated for the treatment of patients with Shiga toxin E coli related hemolytic uremic syndrome (STEC-HUS), Alexion Pharmaceuticals, Inc; 352 Knotter Drive; Cheshire, CT 06410, 600 mg IV infusion q7days for 2 weeks, THEN, 900 mg IV infusion q7days for 4 weeks, THEN, 300 mg most recent dose: Give 300 mg per infusion of FFP; administer 60 minutes prior to infusion of FFP, Not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS), Serious or fatal meningococcal infections, Treatment discontinuation for PNH: Monitor patients for at least 8 weeks to detect hemolysis, Treatment discontinuation for aHUS: Monitor patients for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 week, Store in refrigerator at 2-8ºC (36-46ºF); do not freeze or shake, Store in original carton at controlled room temperature (not more than 25°C[77°F]) for only a single period up to 3 days, Do not use beyond the expiration date stamped on the carton, Store in refrigerator at 2-8°C (36-46°F) for up to 24 hr. �e[�P�D�J�\������8 �-[Y��g�N��F }��L�8�C�C)��}����jk@�8fa�k�GGyf�c�� ��L��0I�9-�Ed�N�G46{;�� �˔��ii@N�~}�Ƅ}`���[s,O�mew��ra2���Po?�d��p�轩L�9�zU)\��A��u�IG���Νu�7I���_$:}��ΝA�.DZC#[�X�I^ltꠧ�| �?Y�&�~�J a4�f�pVwA_l�H�6/��V��R]�9-��-�e���S���29�GIQ��Z����-�k��k�ui��a�����ϡ)H���r&|e�%�t�:ZQo�|_�! 1200 mg of Soliris administered via a 25-45 minute intravenous infusion on the fifth week, followed by 1200 mg of Soliris administered via a 25-45 minute intravenous infusion every 14 ± … Administer at recommended dosage regimen time points, or within 2 days of these time points. Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. �vC}X�f��#O�Ș �F���B�E�/�iKx�g�SH�^/D���4a�8�I�%CglIUa�W���~r0�V� ;=�a�SQ1�-��Hoڦ���m��z��A��7�9$����\��M�xrg���/���^ۑ�f�v?�ڌ����4i�kx��%R$U�_u���*�ƞ���0k���8XM?�;�R�̯y�N�Lیk�t�f���� %�,J �7RU���L>�+9o��[�#�m����E�����~�h�(����I���L����-����P�yD������� )�`кö��? All material on this website is protected by copyright, Copyright © 1994-2021 by WebMD LLC. Soliris is a pharmaceutical used to treat an orphan disease, atypical hemolytic-uremic syndrome (aHUS). This drug is available at a middle level co-pay. Share cases and questions with Physicians on Medscape consult. Soliris is given as an infusion (drip) into a vein and the recommended dose depends on what it is used for, and for patients under 18 years of age, on their bodyweight. "�% ��+O0��Q)2��y����fx�̫gP�4��mK� 1T��I��O3�G$���-Ѿ;g��֊D�%A�&�1��8�a�z� >�&��>n��1�9�8�PFtl�p�����ᴚ�V��a��.I�2�݄iW,+���ZV{���+�ܨ�^�I��y\����x�X-��Ҡ�-�R|��ɇ�Ԣ�@Ć�I+Q�ݭ���r���r�[�VK)漸w�h�cѶMsK�]b�b�c��Q}���/6�$���Q��7 If experienced, these tend to have a Severe expression 1. Each vial contains 30 mL of 10 mg/mL sterile, preservative‐free solution. soliris-eculizumab-342875 The recipient will receive more details and instructions to access this offer. �&����1 ��d�Q�YKg�b�����9]�������#�$ ��w��o;�ٞ��h��kR(Z�� �:C��{���A7�/���"ar���)�s�" ^�E��O� m3�= Initial phase. SOLIRIS ® (eculizumab) ... SOLIRIS® should be administered via IV infusion over 35 minutes every 7 days during induction and every 14 days during maintenance ... Time, Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 52 100% response after the first dose. 6. Maintenance phase. Refer to Oxford’s Home Health Care policy. This drug is available at the lowest co-pay. Requests for home infusion of Soliris require additional pre-certification for the home care services. ;���6����l�0�8ch��H���Ɨ�(T�]+D��%��L��q��QJ��[��< Rare disease drugmaker Alexion has wasted no time converting patients to Ultomiris, the successor to its rare disease blockbuster Soliris. Billing Code/Availability Information HCPCS code: J1300 – Injection, eculizumab, 10 mg; 1 billable unit = 10 mg NDC: provider for the most current information. prescription products. %PDF-1.6 %���� Patient treatment preference was evaluated at one time point using an 11 ... Tell the doctor or nurse right away if one gets any of these symptoms during the SOLIRIS infusion… If you log out, you will be required to enter your username and password the next time you visit. H��T�n�0��+�H+�ZｸP �%(r�%�f+��D���w��W$F/Z����-���"������(IZP�X�8� Kc���#�� ���& A healthcare provider will give you this injection. %%EOF �Q�G�B��R�� OMV� !�yV{��hE���#]em/��^�{A���(ja�=X����PQ>c�څ1(�g��W�@_�7�e�2}/2�{���MĽ���g�r�o���z��+�1��\���"���ً��������vܱ��m����ı�����p�y���c��>-/�^¡���=��;*�'&��?��0��)���j��F�F7π'��������~6��,���YP�_~0 ��� restrictions. hެUێ�0�?�Է� � Nausea 13. Pain In The Muscles Or Bones 14. Subjects Who Develop Grade 3/4 AEs Related to Eculizumab [ Time Frame: from 0 to 1392 hours post-infusion ] • The percentage of subjects with СТСАЕ v. 4.03 grade 3/4 AEs that, in the investigator's opinion, are related to eculizumab, by study arms. VI. Intense Abdominal Pain 10. �vC}X�f��#O�Ș �F���B�E�/�iKx�g�SH�^/D���4a�8�I�%CglIUa�W���~r0�V� ;=�a�SQ1�-��Hoڦ���m��z��A��7�9$����\��M�xrg���/���^ۑ�f�v?�ڌ����4i�kx��%R$U�_u���*�ƞ���0k���8XM?�;�R�̯y�N�Lیk�t�f���� %�,J �7RU���L>�+9o��[�#�m����E�����~�h�(����I���L����-����P�yD������� )�`кö��? The patient does not have any FDA labeled contraindications to therapy with the requested agent AND 2. Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Children may receive eculizumab injection on a different schedule, depending on their age and body weight. Controlled studies in pregnant women show no evidence of fetal risk. Median time to complete occlusion was 18.0 minutes for control and 38.0 minutes for the OMS721-treated animals (p=0.0036).We also conducted a study using OMS721 in a well-established animal model of neovascular age-related macular degeneration, or AMD. Throat Irritation 15. �Q�G�B��R�� OMV� !�yV{��hE���#]em/��^�{A���(ja�=X����PQ>c�څ1(�g��W�@_�7�e�2}/2�{���MĽ���g�r�o���z��+�1��\���"���ً��������vܱ��m����ı�����p�y���c��>-/�^¡���=��;*�'&��?��0��)���j��F�F7π'��������~6��,���YP�_~0 ��� Soliris will be given to you directly into the vein (intravenously) by a doctor or nurse. Individual plans may vary Infusion must be administered through a 0.2 µm filter. This website also contains material copyrighted by 3rd parties. Most The prescriber is a specialist in the area of the patient’s disease or the prescriber has consulted with a specialist in the area of the patient’s disease AND 3. commonly, these are "preferred" (on formulary) brand drugs. Most 28 0 obj <> endobj Manage and view all your plans together – even plans in different states. commonly, these are "non-preferred" brand drugs or specialty Admixed solutions of Soliris are stable for 24 h at 2°-8° C (36°-46° F) and at room temperature. Journal Article, You are being redirected to commonly, these are generic drugs. Soliris (eculizumab) will be approved when ALL of the following are met: 1. 49 0 obj <>stream Constipation 4. and formulary information changes. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 2`���笋L��Ζ���,�Ό�=[x)*6�Z�,�)��� �9��E��=畐�T��,U�����$��=3�z�_�Q?�s z���\#J��X����N�`�;����۸��.�����2���m��(jh�JTP-���F�f�O��*�}�_���)@�@�Du�GO��O�_�����t��J�&�+X����Gq�8j^1�Q}��]� �����N��GU�j5�>Vor���8��=|F!s��*�b�H݆�X|�|�͞����DL�h���� G�A�u������l�D�6#{#��b��q�k�0�śQ�{@�E鵃SȤ�L�� ~�sF?ؓE�ZLq�i�R�ل�h�!�b��� blG(�_}�U>���w!/O9>�_{�e&��쌺YJ(��Q�� t���g�|����1�@�� ��e�f���,f�>E�����&�Ǚ�7���ƅ��Kt�;L�����Eb�����g��^SԲ�L����eC���}5��gT�\E�x��nAրQ_���j�ϧ�x0�4�kJz�#f�Y�T��E�"N�4sv ���z&�`o�?��Mf�Q�"���'Z��f:��=x Diarrhea 6. Patients receive 900 mg of SOLIRIS weekly for the first four weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200 mg every 2 weeks thereafter. If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. Monoclonal blocking antibody to complement protein C5; inhibits cleavage to C5a and C5b, thus preventing terminal complement complex C5b-9, thereby preventing RBC hemolysis, Inhibits terminal complement mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS, Peak serum concentration (at week 26): 194 mcg/mL, Trough concentration (at week 26): 97 mcg/mL, Half-Life following plasma exchange: 1.26 hours, Clearance following plasma exhange: 3660 mL/hr, 0.9% NaCl, 0.45% NaCl, D5W, or Lactated Ringers, Withdraw the required drug amount and transfer dose to an infusion bag, Dilute eculizumab to a final concentration of 5 mg/mL by adding equal volume of diluent to drug volume (see IV Compatibility); see prescribing information for further information, Gently invert the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent, Discard any unused portion left in a vial, as the product contains no preservatives, Prior to administration, admixture should come to room temperature 18-25°C (64-77°F), Do not be heated in a microwave or with any heat source other than ambient air temperature, Prescribers must enroll in Risk Evaluation and Mitigation Strategy (REMS) program, Do not administer as IV push or bolus injection, Administer at recommended dosage regimen time points, or within 2 days of these time points, Adults: Infuse IV over at least 35 min; may slow/stop infusion if adverse effect occurs, but total infusion time should not exceed 2 hr, Children: Infuse IV over 1-4 hr via gravity feed, a syringe-type pump, or an infusion. endstream endobj 32 0 obj <>stream Storage Unused vials b- ��ģH&F�� ������~ A> H�|Tێ�6}�W�# T�D]���E�m���>d���)��E�ՠ���F��3�l� ���3g�Λww9��.y�ur�$�D&!�_ɪ94e-��nL28$�Ȳ����G_��ۛݏ�w���»�w� ��i!rv������D��I�j ��[ � B#�{�����>%�(�@%�jE�BS�B�� Medscape Education, Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020, encoded search term (eculizumab (Soliris)) and eculizumab (Soliris), Newly Approved Drugs Offer New Hope in NMOSD, Alexion Pauses Enrollment for COVID-19 Study Testing Its Rare Blood-Disorder Drug, EC Clears Eculizumab (Soliris) for Neuromyelitis Optica, Hematology-Oncology Guidelines: 2017 Midyear Review, More Evidence for Lower Risk With Certain Blood Groups, Armpit Swelling After COVID-19 Vaccine May Mimic Breast Cancer, Baby Gets Cancer From Mother During Birth: First Report. High Blood Pressure If experienced, these tend to have a Less Severe expression 1. Soliris® (Eculizumab) Page 2 of 7 ... eculizumab infusion in the parent studies. Pediatric dosing is based on body weight, with doses ranging from 300 mg to 900 mg. 1,2 Eculizumab should be administered by IV infusion over 35 minutes via an infusion pump; it should not be administered as an IV push or bolus injection. It is usually given to adults once a week for 5 weeks and then once every other week. To be sure, reducing how often a … This drug is available at a higher level co-pay. Extra doses of eculizumab injection are also given before or after certain other treatments for PNH , aHUS, MG, or NMOSD. Soliris is given as an infusion into a vein. View the formulary and any restrictions for each plan.
Belästigung Durch Psychisch Kranke Nachbarn, Mein Wochenblatt Chiffre, Otz Gera Blaulicht, British Council Teenager Listening, Hochschule Fresenius Wirtschaftspsychologie Kosten, Dolch Tattoo Unterarm, Formular Steuerklassenwechsel Getrennt Lebend, Air Up Rabattcode September 2020, Tarot Skorpion 2021,