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Soliris is a breakthrough, potentially lifesaving treatment for two rare blood diseases, affecting about 180 patients in Canada. Infuse over 35 minutes. To view formulary information first create a list of plans. 49 0 obj
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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. Please confirm that you would like to log out of Medscape. Most �vC}X�f��#O�Ș �F���B�E�/�iKx�g�SH�^/D���4a�8�I�%CglIUa�W���~r0�V�
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A healthcare provider will give you this injection. 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 Share cases and questions with Physicians on Medscape consult. How much to take / use. Contact the applicable plan Most In November 2014, we announced positive data using OMS721 to inhibit thrombus formation in an ex vivo pathophysiologic system of aHUS. The above information is provided for general The patient does not have any FDA labeled contraindications to therapy with the requested agent AND 2. The infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children. commonly, these are "non-preferred" brand drugs. Most endstream
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Children may receive eculizumab injection on a different schedule, depending on their age and body weight. Access your plan list on any device – mobile or desktop. Refer to Oxford’s Home Health Care policy. Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of … A: Generally acceptable. Anemia 2. If you log out, you will be required to enter your username and password the next time you visit. High Blood Pressure If experienced, these tend to have a Less Severe expression 1. 2010
commonly, these are "preferred" (on formulary) brand drugs. 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. 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. 6. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Headache 8. 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. Established Efficacy US/SOL-N/0046 The most common side effects in people with NMOSD treated … endstream
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B#�{�����>%�(�@%�jE�BS�B�� 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 … It is usually given to adults once a week for 5 weeks and then once every other week. restrictions. 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 provider for the most current information. h�bbd``b`� �@�q�`�
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Requests for home infusion of Soliris require additional pre-certification for the home care services. Constipation 4. 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. "�% ��+O0��Q)2��y����fx�̫gP�4��mK� 1T��I��O3�G$���-Ѿ;g��֊D�%A�&�1��8�a�z�
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Together, these mean that Ultomiris is administered every eight weeks while Soliris is given every two weeks. H��T�n�0��+�H+�ZクP �%(r�%�f+��D���w��W$F/Z����-���"������(IZP�X�8� Kc���#�� ���&
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Soliris® (Eculizumab) Page 2 of 7 ... eculizumab infusion in the parent studies. Plasma exchange or infusion may transiently maintain normal levels of hematologic measures but does not treat the underlying systemic disease. Each vial contains 30 mL of 10 mg/mL sterile, preservative‐free solution. 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. �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
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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 • SOLIRIS is given through a vein (I.V. 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 … 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. BLA 125166/S409 Page 8 MEDICATION GUIDE Soliris ® (so-leer-is) (eculizumab) Read the Medication Guide before you start Soliris and before each infusion. �v
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or intravenous infusion) usually over 35 minutes in adults and 1 to 4 hours in pediatric patients. �&����1 ��d�Q�YKg�b�����9]�������#�$ ��w��o;�ٞ��h��kR(Z�� �:C��{���A7�/���"ar���)�s�" ^�E��O� m3�=
Fever 7. This drug is available at a higher level co-pay. To be sure, reducing how often a … Intense Abdominal Pain 10. 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. 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 . Efficacy assessments were performed at least every 2 weeks from the time of initiation of eculizumab therapy in the parent study. Inflammation Of The Tissue Lining The Sinuses 9. 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. Individual plans may vary The recipient will receive more details and instructions to access this offer. Maintenance phase. Extra doses of eculizumab injection are also given before or after certain other treatments for PNH , aHUS, MG, or NMOSD. 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. Admixed solutions of Soliris are stable for 24 h at 2°-8° C (36°-46° F) and at room temperature. Diarrhea 6. Storage Unused vials b- ��ģH&F�� ������~ A> https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvc29saXJpcy1lY3VsaXp1bWFiLTM0Mjg3NQ==, View explanations for tiers and endstream
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Soliris is a pharmaceutical used to treat an orphan disease, atypical hemolytic-uremic syndrome (aHUS).
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and formulary information changes. 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. informational and educational purposes only. ���4�*��:��GM"��(�ĝ��B����c��ΜH�emB�:���m���� ;���U��P+
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4/21/2015 2 7 73% Reduction in Mean Units Transfused Eculizumab (Soliris ®) is an anti-C5 monoclonal antibody that is approved by the FDA and the EMA to treat patients with aHUS. "�% ��+O0��Q)2��y����fx�̫gP�4��mK� 1T��I��O3�G$���-Ѿ;g��֊D�%A�&�1��8�a�z�
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It is usually given every 7 days for 5 weeks, then every 14 days. Backache 3. Efficacy endpoints included patient survival degree of hemolysis, ;���6����l�0�8ch��H���Ɨ�(T�]+D��%��L��q��QJ��[��< commonly, these are "non-preferred" brand drugs or specialty 1200 mg of Soliris administered via a 25-45 minute intravenous infusion on the fifth week, followed by 1200 mg of Soliris administered via a 25-45 minute intravenous infusion every 14 ± … Patient treatment preference was evaluated at one time point using an 11 ... Tell the doctor or nurse right away if one gets any of these symptoms during the SOLIRIS infusion… Children: Infuse IV over 1-4 hr via gravity feed, a syringe-type pump, or an infusion. endstream
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Cough 5. A Common Cold 2. If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. Soliris is given weekly initially and then every two or three weeks. This drug is available at the lowest co-pay. VI. Urinary Tract Infection 16. Journal Article, You are being redirected to
Rare disease drugmaker Alexion has wasted no time converting patients to Ultomiris, the successor to its rare disease blockbuster Soliris. Your doctor will perform a blood test to make sure Soliris is the right … Initial phase. Soliris (eculizumab) will be approved when ALL of the following are met: 1. commonly, these are generic drugs. Vomiting This website also contains material copyrighted by 3rd parties. H��T�n�0��+�H+�ZクP �%(r�%�f+��D���w��W$F/Z����-���"������(IZP�X�8� Kc���#�� ���&
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