6. If this is an URGENT request, please call (800) 882-4462 (800.88.CIGNA) Most Recent Soliris Dose Supplemental Soliris With Each Plasma Intervention Timing of Supplemental Plasmapheresis or plasma exchange (PE) 300 mg 300 mg per each Highly elevated biological markers of cellular processes observed in patients with aHUS reinforce the chronic nature of aHUS. There are several different dosing schedules – one requires a single dose, then a second dose two weeks later. h��=Aa����5 �E��f�I,��A��YوU��hT���� 1RF�yn��1��ruw=o����(H���&T!�`@��!��`��p�y�a:E^�Ǐx;� Symptom improvement was sustained through 26 weeks as measured by the primary efficacy endpoint, MG-ADL, in the REGAIN study. 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). See Important Safety Information, including Boxed Warning, and full Prescribing Information. The wholesale acquisition cost of Soliris is $6,522.90 for a 300mg vial as of September 2017, which translates to a HCPCS price of $217.43. Note: Add on, dose escalation of IST, or additional rescue therapy from baseline to treat myasthenia gravis or exacerbation of symptoms while on Soliris therapy will be considered as treatment failure. — Alexion’s Soliris® (eculizumab), another C5 inhibitor, is approved for the treatment of PNH, atypical hemolytic uremic syndrome, and generalized myasthenia gravis. *Note: Add on, dose escalation of IST, or additional rescue therapy from baseline to treat myasthenia gravis or exacerbation of symptoms while on Soliris therapy will be considered as treatment failure. SOLIRIS is a prescription medicine called a monoclonal antibody. Soliris is proven for the treatment of generalized myasthenia gravis.1,9,11 Generalized Myasthenia Gravis (gMG) SOLIRIS® (eculizumab) is indicated in adult patients with generalized Myasthenia Gravis ... supplemental dosing of SOLIRIS is required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or … ... You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated. Do you want to continue? In atypical Haemolytic Uremic Syndrome (aHUS) and refractory generalized Myasthenia Gravis (gMG): The aHUS and refractory gMG dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase: • Initial phase: 900 mg of Soliris administered via a 25 – 45 minute intravenous infusion every week for the first 4 weeks. NMOSD. 1,2 SOLIRIS is the first and only complement inhibitor approved for the treatment of adult patients with gMG who are AChR+. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. aHUS. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. SOLIRIS is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Use caution when administering Soliris to patients with any systemic infection. Reducing drug dosage in well-responding patients with relatively high drug levels cuts down cost. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. 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. Generally rituximab is considered safe and and well tolerated. Learn more about OneSource™: complimentary support for your patients. endstream endobj startxref Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. may be available based on patient’s insurance. adults with myasthenia gravis, in whom other medicines do not work and who are positive for AChR antibody. SOLIRIS is the first and only complement inhibitor approved for adults with anti-acetylcholine receptor antibody-positive (AChR+) generalized Myasthenia Gravis (gMG), a chronic and debilitating neuromuscular disorder. Limitation(s) of use: Soliris is not indicated for … Generalized Myasthenia Gravis ... Soliris Dose Plasmapheresis or plasma exchange (PE) each plasmapheresis or PE 300 mg 300 mg per each plasmapheresis or PE Within 60 minutes after ≥ 600 mg 600 mg per each plasmapheresis or PE. An alternative is a weekly dose for four weeks. Soliris is not prescribed concurrently with Ultomiris; 7. Median (IQR) age at diagnosis of MG and start of RTX were 41.5 (24.3; 65.8) and 47.5 (33; 71) years, respectively. A Myasthenia Gravis Activities of Daily Living (MG-ADL) assessment is a way to measure the severity of your gMG symptoms and their impact on your daily activities. • Initial phase: 600 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) intravenous infusion every week for the first 4 weeks. No, By checking this box and submitting this form, I give. Soliris® (eculizumab) Home | HCP Site. Pharmacology, adverse reactions, warnings and side effects. 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. - Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease (see section 5.1). Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. MRN: Phone: 1‐800‐809‐1265 Fax: 1‐866‐872‐8920 DOB: STANDARD Soliris® (eculizumab) PLAN OF TREATMENT for Myasthenia Gravis NOTE: Patient may be ineligible to receive eculizumab if receiving antibiotics for active infectious process, antifungal therapy, active fever and/or suspected infection, presents with any symptoms of meningococcal infections, and/or surgery. Median (IQR) age at diagnosis of MG and start of RTX were 41.5 (24.3; 65.8) and 47.5 (33; 71) years, respectively. and . Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. �;1���jAr�"9����0���d�GL�%RLj�[��/�~�*� FG{ Dosing Limits A. Max Units (per dose and over time) [Medical Benefit]: Indication Loading Doses Maintenance Dose PNH 60 billable units Days 1, 8, 15, & 22; then 90 billable units Day 29 90 billable units every 14 days aHUS, gMG 90 billable units Days 1, 8, 15, & 22; then 120 billable units Day 29 120 billable units every 14 days III. endstream endobj 498 0 obj <. SOLIRIS [package insert]. SOLIRIS prescription and dosage sizes information for physicians and healthcare professionals. Dose does not exceed 900 mg per week for the first 4 weeks, followed by 1,200 mg for the fifth dose 1 week later, then 1,200 mg … SOLIRIS prescription and dosage sizes information for physicians and healthcare professionals. For patients with atypical HUS and less than 18 years of age, administer SOLIRIS based upon body weight, according to the following schedule (Table 1): Table 1: Dosing recommendations in patients less than 18 years of age Patient Body Weight Induction Maintenance 40 kg and over 900 mg weekly x 4 doses 1200 mg at week 5; then 1200 mg every 2 For re-authorization: • The individual is continuing to receive benefits from Soliris therapy (e.g., reductions in exacerbations of myasthenia gravis; improvement in speech, swallowing, mobility, and respiratory functions). SOLIRIS, ALEXION, the Alexion logo, and the OneSource logo are registered trademarks of Alexion Pharmaceuticals, Inc., and OneSource is a trademark of Alexion Pharmaceuticals, Inc. - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. • Soliris is prescribed by or in consultation with a neurologist. 650 0 obj <>stream G70.00 Myasthenia gravis without (acute) exacerbation G70.01 Myasthenia gravis with (acute) exacerbation Appendix 2 – Centers for Medicare and Medicaid Services (CMS) Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. Howard JFJ: Myasthenia gravis: The role of complement at the neuromuscular junction. 2.1 Important Dosing Considerations. Infusion-Related ReactionsAdministration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Soliris® (eculizumab) HCP | Dosing. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). By using our website, you agree to our use of cookies in accordance with our cookie policy. Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. It is not known if SOLIRIS is safe and effective in children with gMG. Patients are monitored for any reactions during the infusion and for at least one hour afterwards. 10 to 29 kg: 600 mg IV infusion/dose for aHUS; safety and efficacy have not been established for PNH, myasthenia gravis, or NMOSD. A personalized approach can improve therapy efficacy and quality of life. Results: 34 (60.7%) of a total of 56 patients were women. For adults with anti-AChR+ generalized Myasthenia Gravis. Soliris is given weekly initially and then every two or three weeks. For patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: ​ 900 mg weekly for the first 4 weeks, followed by ​ 1200 mg for the fifth dose 1 week later, then ​ 1200 mg every 2 weeks thereafter. Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. You are now leaving solirisgmgpro.com, a website provided by Alexion Pharmaceuticals, Inc. Copyright © 2021, Alexion Pharmaceuticals, Inc. All rights reserved. myasthenia gravis (MG) neuromyelitis optica spectrum disorder (NMOSD, Devic disease or neuromyelitis optica [NMO]) paroxysmal nocturnal hemoglobinuria (PNH) other (please specify): Fax completed form to: (855) 840-1678 . 594 0 obj <>/Filter/FlateDecode/ID[<2D086CB2A3DF9B4284B765959CF9EDD1>]/Index[497 154]/Info 496 0 R/Length 228/Prev 313264/Root 498 0 R/Size 651/Type/XRef/W[1 3 1]>>stream two (2) weeks prior to the administration of the first dose of Soliris 3. Soliris® (eculizumab) ... lowering of dose or intensify dosing. Please see additional Important Safety Information for Soliris, including Boxed WARNING regarding serious meningococcal infections, below. Soliris should be administered at the recommended dosage regime time points, or within 2 days of these time points. 100-2), Chapter 15, §50 Drugs and Biologicals. Risk of Discontinuation and Deviation from Recommended Dosing Schedule. • Adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive • Adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 (AQP4) antibody positive. 41 patients from Study C10-004 with aHUS and ≥18 years of age were evaluated prior to and during Soliris ® treatment 2. Download assessment Soliris is proven and/or medically necessary for the treatment of generalized myasthenia gravis … Prior to SOLIRIS , up to 35% of patients with available support did not survive beyond 5 years Generalized Myasthenia Gravis (gMG) Debilitating, chronic and progressive autoimmune neuromuscular disease that can lead to inability to walk, talk, eat or breathe Source: Caprioli J, Noris M, Brioschi S, et al. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Generalized Myasthenia Gravis (gMG) • Must be prescribed by or in consultation with a neurologist • Must have a diagnosis of Myasthenia Gravis • Must be anti-acetylcholine receptor (AChR) antibody positive Pharmacology, adverse reactions, warnings and side effects. Dosing information for Soliris® (eculizumab). Boston, MA: Alexion Pharmaceuticals, Inc; 2019. In addition, patients should be immunized with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection. o Soliris or Ultomiris are dosed according to the US FDA labeled dosing for PNH; and o Prescribed by, or in consultation with, a hematologist or oncologist; and o Reauthorization will be for no more than 12 months. o Soliris is dosed according to the US FDA labeled dosing for NMOSD: up to a maximum of 1200 mg every 2 weeks; and o Prescribed by, or in consultation with, a neurologist; and o Patient is not receiving Soliris in combination with any of the following: [45742] We use cookies to give you the best online experience. A booster dose is possible in six months. Myasthenia gravis is an autoimmune condition mediated by autoantibodies to components of the postsynaptic muscle endplate; the antibodies target the … • Maintenance phase: 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) SOLIRIS and gMG. Under the Soliris REMS, prescribers must enroll in the program. Usual Adult Dose of Soliris for Myasthenia Gravis: 900 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks Comments:-Administer this drug IV over 35 minutes in adults.-Administer this drug at the recommended time, or within 2 days of the recommended time. Do you want to continue? Yes o Soliris is dosed according to the US FDA labeled dosing for gMG: up to a maximum of 1200 mg every 2 weeks; and o Prescribed by, or in consultation with, a neurologist; and o Reauthorization will be for no more than 12 months. Neuromyelitis Optica Spectrum Disorder Reference: 1. For patients with generalized Myasthenia Gravis, Soliris therapy consists of: • 900 mg weekly for the first 4 weeks, followed by • 1200 mg for the fifth dose 1 week later, then Dilute Soliris dose with equal amount of sodium chloride 0.9% to a final concentration of 5mg/mL Heparin 10 u/mL OR Heparin 100 u/mL 3mL 5mL Flush the line after the infusion per physician orders Vaccination reduces, but does not eliminate, the risk of meningococcal infections. 1.3 Generalized Myasthenia Gravis (Gmg) Soliris is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. Myasthenia Gravis. Myasthenia gravis (MG) is a debilitating, ... Immunize patients with meningococcal vaccines at least two weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. 4.2 Posology and method of administration. starting Soliris. 30 to 39 kg: 900 mg IV infusion/dose for aHUS; safety and efficacy have not been established for PNH, myasthenia gravis, or NMOSD. For adults with anti-AQP4 antibody-positive Neuromyelitis Optica Spectrum Disorder. Yes News Dosing Begins in Phase 2 Trial Testing Batoclimab for Myasthenia Gravis News Both IVIG and SCIG Effective as Maintenance Therapy in MG, Study Finds News Possible Genetic Component to MG Found in Large-scale North American Analysis Myasthenia gravis is an autoimmune neuromuscular disease in which a person’s immune system attacks the nervous system, Orders: Soliris® (eculizumab) IV dosing as selected to infuse over 35 minutes diluted in Sodium Chloride 0.9% with final volume is equal drug … o Soliris is dosed according to the US FDA labeled dosing for gMG: up to a maximum of 1200 mg every 2 weeks; and Prescriber must be enrolled in the Soliris (REMS) program, available at 1‐888‐765‐4747 or at www.solirisrems.com. Sign up to stay informed about SOLIRIS® (eculizumab). Indicated for generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive. to starting Soliris*. 0 Soliris is dosed according to the US FDA labeled dosing for PNH: 900 mg every 2 weeks; and Prescribed by or in consultation with a hematologist; and Reauthorization will be for no more than 12 months. SOLIRIS is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. H;2l�܁p'���� 3�eX�TiF��@:����r��L�����Z�=?�.��б����}2��.�N{#�)mc��W"��&j��X�V���3�Yf+��pLR3�x���KL� �� �X9��@���A� n�*ˑf�Ō~ ��� Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV, 3. ... adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. MEDICATION STRENGTH DOSE & DIRECTIONS QUANTITY/REFILLS Soliris 300 mg/30 mL vial (10 mg/mL) For Treatment of PHN: Dose Titration – Month 1: Administer 600 mg via IV infusion every 7 days for 4 weeks For Treatment of aHUS: Dose Titration – Month 1: Administer 900 mg via IV infusion every 7 days for 4 weeks For Treatment of gMG: Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by. %%EOF Approval duration (initial): 6 months Dose 5: 1200 mg IV 1 week later, THEN. 900 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks Comments:-Administer this drug IV over 35 minutes in adults. The Myasthenia Gravis Foundation of America Postintervention Status scale was used to assess outcomes. 1200 mg IV q2Weeks thereafter. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. ��s������X�x7��I�H&%t�a�B�yo��ƟF���^�ual��0:[&����� Results: 34 (60.7%) of a total of 56 patients were women. The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase: • Initial phase: 600 mg of Soliris administered via … The presumed mechanism of action of eculizumab in generalized myasthenia gravis is the reduction of the terminal complement complex C5b-9 deposition at the neuromuscular junction. 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. Myasthenia gravis (MG) is a debilitating, chronic and progressive autoimmune neuromuscular disease that can … Dosing and Administration. Follow each infusion with a %PDF-1.6 %���� Use: For patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. h�b```c``~�������A���b�,���500,��@p��_LEQ���~k�*��3�41�|?liV����[{�*+:��:u�Hء@ twm:���R��FOY �b�b�͠�`̐ �yL1h�� T>��ޜ!��f�BiqY����2^f��Z��8�͊����U�՚��|(SC�����{��xp1̴��0ӫ�a3���I`�$�P Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. It is not known if SOLIRIS is safe and effective in children with gMG. For the starting 900 mg dose, the total WAC would be $19,569 and for the maintenance dose of 1,200 mg it would equal $26,092 (Table 2). Usual Adult Dose for Neuritis. About Generalized Myasthenia Gravis. The most frequently reported adverse reaction in gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain. The Myasthenia Gravis Foundation of America Postintervention Status scale was used to assess outcomes. No, IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING. Completing one with your doctor before starting Soliris can help you both track your symptoms. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Soliris (eculizumab), developed by Alexion Pharmaceuticals, is approved by the U.S. Food and Drug Administration (FDA) and the European Commission to treat certain adults with generalized myasthenia gravis.It is given as an intravenous (IV) infusion once a week for one month, followed by a fifth dose one week later and then ongoing infusions once every two weeks. SOLIRIS is used to treat: adults with a disease called generalized Myasthenia Gravis (gMG) who are … Orders: Soliris® (eculizumab) IV dosing as selected to infuse over 35 minutes diluted in Sodium Chloride 0.9% with final volume is equal drug volume to diluent volume. Positive serologic test for anti‐AChR antibodies, 2. Please enter your information below to receive updates: *Required field. Infusions last approximately 35 minutes, plus 1 hour to monitor for an infusion-related reaction. Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

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