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";s:4:"text";s:21254:"Please consult the Product Monograph 1 for further information about the vaccine. Available at: http://www.soliris.net/. Zurich (CH): Alexion Pharma GmbH; 2016. Suspension for Injection. Bexsero Product Monograph ca.gsk.com. Q�BV���(�1���ƀqZp��Pv�g���?���!_�4�O���fO���� � jc Administer the prepared solution immediately following preparation. © Copyright 2021, Selected Revisions May 27, 2019. Soliris (eculizumab) [Product Monograph]. The Canadian Product Monograph of SOLIRIS has been updated to include this new safety information. 2 0 obj
Nürnberger J, Philipp T, Witzke O et al. Ri�ջ4���`��ݮ�B����:]���쑌��!��E,xD&�����C��(/�H\�݊�x��K�a�}�]ā`�Q�i��1p�F1����v��v@�(y��e�3�U�g�x�Fd�����2�G,XXW� Pregnant women with conditions that are a risk for IPD should receive pneumococcal vaccine as indicated. AHFS DI Essentials™. 5. 2013; 62 (No. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. 8��%���5���) PROLIA Product Monograph Page 7 of 80 Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcemia (eg, history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, … Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Soliris 300 mg concentrate solution for injection summary of product characteristics. However, eculizumab has been associated with significant but rare harms in other populations, such as anemia, high blood pressure and infections, particularly meningococcal infections. Page 6 of 52. 9th ed. Noris M, Remuzzi G. Atypical hemolytic-uremic syndrome. Refer to the administration reference tables below for minimum infusion duration. Usual Adult Dose of Soliris for Paroxysmal Nocturnal Hemoglobinuria: 600 mg IV every week for 4 weeks, followed by 900 mg IV at week 5, then 900 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. Summary Safety Review - Soliris and Bexsero. 1995; 333:1253-8. http://www.ncbi.nlm.nih.gov/pubmed/7566002?dopt=AbstractPlus, 9. The pre-hearing conference will resume in Ottawa on . Licensed use : Individuals 2 years of age and older : Off-license use : None : Indications for use of provincially funded vaccine • All individuals 65 years of age and older. Winthrobe’s clinical hematology. Treatment of atypical hemolytic uremic syndrome and thrombotic microangiopathies: a focus on eculizumab. Accessed 2013 Sept 25. Search PI documents endobj
), May be prescribed only by clinicians enrolled in the program.1 24 Clinicians must agree to counsel patients regarding risk of meningococcal infection, provide educational materials, and ensure patient compliance with meningococcal vaccination requirements.1 24, Additional information about the Soliris REMS program available at 888-765-4747.1. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Do not freeze. 20. Sustained response and long-term safety of eculizumab in paroxysmal nocturnal hemoglobinuria. Cheshire, CT; 2007 Mar 16. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. �VP"��,�"%6J���O؋=clh�s�pL��;����IF�r���J��S2*�l�4 �ɴx��LOG�WN� ���'~8��2���)5d�1������mD��d�������ۋ���Z�%_.�$ �x\�e��Ӳ�����4U��� Please consult the Product Monograph. Am J Kidney Dis. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Protect from light. *P���U(F�Qmv�eu�,&�� ������i9"�*��iQXE�%:UM�}�H_a~W�6�o������}I�lnc|��]4�m4��|Y-�?㡎^���] ), Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1, Patients with PNH: Headache,1 3 4 21 nasopharyngitis,1 3 4 back pain,1 3 21 nausea,1 3 4 21 fatigue,1 cough,1 1 herpes simplex infections,1 sinusitis,1 respiratory tract infection,1 constipation,1 myalgia,1 pain in extremity,1 influenza-like illness.1, Patients with aHUS: Hypertension, upper respiratory tract infection,1 diarrhea,1 headache,1 anemia,1 vomiting,1 nausea,1 urinary tract infection,1 leukopenia,1 insomnia,1 cough,1 pharyngolaryngeal pain,1 abdominal pain,1 fatigue,1 peripheral edema,1 pyrexia,1 vertigo,1 extremity pain.1, No formal drug interaction studies to date.1, Plasma concentrations ≥35 mcg/mL required to block complement.16 17, Complement activity inhibited for ≤2 weeks following single dose.19, Reduction of hemolysis (as determined by reduction in LDH concentrations) maintained at least 52 weeks in open-label study.1 17, Human IgG crosses placenta and is distributed into milk.1 Potential exists for eculizumab to cross placenta and distribute into milk.1, Metabolic fate of immunoglobulins not well characterized; catabolized in various tissues via diffuse cellular processes.15, Minimal excretion in urine expected due to large molecular size.1 15 Small quantities of immunoglobulin found in bile.15, Patients with PNH: Approximately 272 hours.1, Patients with aHUS: Approximately 291 hours.1, In patients with aHUS undergoing plasma exchange interventions, clearance was increased and half-life reduced (to 1.26 hours).1, 2–8°C.1 Do not freeze or shake.1 Store in manufacturer’s carton and protect from light.1, Following dilution, stable for 24 hours at 2–8°C or at room temperature.1, Single-use vials do not contain preservative.1 Discard unused portions.1. Alexion Pharmaceuticals, Inc. Paper presented at American Society of Hematology Annual Meeting. REVIEW TYPE . … For instructions on dilution of the medicinal product before administration, see section 6.6. For more information, please visit the . ), Gently invert diluted solution to mix completely.1, Vials are for single use only.1 Discard any unused portion after preparing dose.1, Administer by IV infusion over 35 minutes; if infusion must be slowed due to adverse effects, do not exceed 2 hours total infusion time.1, Adhere to recommended time points of administration, or within 2 days of each time point, to achieve maximum benefit.1 31, Pediatric patients ≥2 months of age weighing ≥40 kg: 900 mg once a week for 4 weeks, followed by a dose of 1200 mg at week 5, then 1200 mg every 2 weeks thereafter.1, Pediatric patients ≥2 months of age weighing 30 to <40 kg: 600 mg once a week for 2 weeks, followed by a dose of 900 mg at week 3, then 900 mg every 2 weeks thereafter.1, Pediatric patients ≥2 months of age weighing 20 to <30 kg: 600 mg once a week for 2 weeks, followed by a dose of 600 mg at week 3, then 600 mg every 2 weeks thereafter.1, Pediatric patients ≥2 months of age weighing 10 to <20 kg: Initial dose of 600 mg, followed by a dose of 300 mg at week 2, then 300 mg every 2 weeks thereafter.1, Pediatric patients ≥2 months of age weighing 5 to <10 kg: Initial dose of 300 mg, followed by a dose of 300 mg at week 2, then 300 mg every 3 weeks thereafter.1, In patients receiving plasmapheresis or plasma exchange, administer supplemental dose of 300 mg (if most recent dose was 300 mg) or 600 mg (if most recent dose was ≥600 mg) within 60 minutes after each plasmapheresis or plasma exchange.1 (See Special Populations under Pharmacokinetics. 2013; 28:675-7. http://www.ncbi.nlm.nih.gov/pubmed/23389238?dopt=AbstractPlus, 34. Alexion Pharmaceuticals, Inc. Soliris (eculizumab) medication guide. 2012; 59:707-10. http://www.ncbi.nlm.nih.gov/pubmed/22196848?dopt=AbstractPlus, 31. The Canadian Product Monograph of SOLIRIS has been … Antibody pharmacokinetics and pharmacodynamics. Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). 2009; 360:544-6. http://www.ncbi.nlm.nih.gov/pubmed/19179329?dopt=AbstractPlus, 27. PROLIA Product Monograph Page 6 of 80 Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Subcutaneous Solution for injection / 60 mg denosumab in 1 mL solution in a single use prefilled syringe Single use prefilled syringe: sorbitol, acetate, polysorbate 20, water for injection (USP) and sodium hydroxide. Eculizumab . PrSoliris ® (eculizumab). Distribution of eculizumab is restricted.1 (See Restricted Distribution Program under Dosage and Administration. Lancet. Parker C, Omine M, Richards S et al. Bouts A, Monnens L, Davin JC et al. <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Pediatr Nephrol. Eculizumab for congenital atypical hemolytic-uremic syndrome. inhibitor eculizumab (Soliris®). DATE OF APPROVAL . October 23, 2017 . Rockville, MD: US Food and Drug Administration; 2007 Mar 16. ), Unvaccinated patients must receive an appropriate polyvalent meningococcal vaccine series at least 2 weeks prior to first dose of eculizumab and receive revaccination of booster doses thereafter according to current vaccination guidelines.1 5 6 (See Vaccinations under Dosage and Administration.) Diagnosis and management of paroxysmal nocturnal hemoglobinuria. 97 414). 2012; 27:2323-6. http://www.ncbi.nlm.nih.gov/pubmed/22890512?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3491201&blobtype=pdf, 29. Accessed 2007 Jul 5. Safety and efficacy of the terminal complement inhibitor eculizumab in patients with paroxysmal nocturnal hemoglobinuria: SHEPHERD phase III clincial study results. ), Use caution in patients with any systemic infection.1, Possible risk of serious hemolysis following discontinuance of therapy in patients with PNH.1 6 10 Monitor patients for ≥8 weeks after discontinuing therapy for manifestations of hemolysis.1, Possible return of thrombotic microangiopathic symptoms following discontinuance of therapy in patients with aHUS; monitor patients for ≥12 weeks after discontinuing therapy for manifestations of thrombotic microangiopathy (e.g., mental status changes, seizures, angina, dyspnea, thrombosis).1 22 28 32 In addition, the occurrence of 2 of the following laboratory changes or a repeat occurrence of any one of the changes may indicate the development of thrombotic microangiopathy: a decrease in platelet count by ≥25% compared with baseline or the peak platelet count during eculizumab treatment; an increase in Scr by ≥25% compared with baseline or the nadir value during eculizumab treatment; or an increase in serum LDH concentration by ≥25% from baseline or the nadir value during eculizumab treatment.1 Consider reinitiation of drug, plasma therapy, and/or supportive measures if manifestations of thrombotic microangiopathy recur after discontinuance of therapy.1, High risk of venous thrombosis (potentially life-threatening or fatal) in patients with PNH.4 8 18 20 Effects of withdrawing anticoagulant therapy in patients receiving eculizumab not established.1 Treatment with eculizumab should not affect concomitant anticoagulant management.1, As with all therapeutic proteins, there is a risk of immunogenicity with eculizumab.1 3 6 Antibodies to eculizumab, including some that were neutralizing, have been detected; no apparent relationship between the development of antibodies and clinical response.1, In patients with PNH, serum LDH concentrations may be used to monitor response to therapy (e.g., hemolysis, PNH erythrocytes).1 10 Following withdrawal of therapy, monitor serum LDH concentrations and other parameters to detect serious hemolysis.1 6 (See Complications Following Treatment Discontinuance under Cautions. Soliris (eculizumab) BLA #125166: Risk evaluation mitigation strategy. 3 0 obj
N Engl J Med. Tschumi S, Gugger M, Bucher BS et al. Lobo ED, Hansen RJ, Balthasar JP. 18. Pharmacology, adverse reactions, warnings and side effects. Am J Kidney Dis. x��X�N�H�G�;̥-5���qUU 10 0 obj
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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 the ‘complement system’.. Gently invert the infusion bag containing the diluted Soliris solution to ensure thorough mixing of the product and diluent. PI documents can be found by searching this website or by using the PI search database in eBusiness Services. 7. Anon. ), Not known whether eculizumab is distributed into human milk.1 (See Extent under Pharmacokinetics.) The generic name of Soliris is eculizumab. Administer the prepared solution immediately following preparation. Compendium of Monographs - Guidance Document This document outlines and describes what a monograph is and how it can be used in a product application for natural health products sold in Canada. Individuals prescribed eculizumab (Soliris®) are at increased risk of serious infections, especially with encapsulated bacteria, such as : ... See Product Monograph : Pregnancy . FDA Approved Drug Products: Eculizumab Intravenous Infusion ; Alexion Pharma: Soliris Product Monograph ; External Links PubChem Substance 46505429 RxNav 591781 ChEMBL CHEMBL1201828 Therapeutic Targets Database DAP000967 PharmGKB PA164776637 RxList RxList Drug Page Drugs.com Drugs.com Drug Page Wikipedia Eculizumab AHFS Codes CAS Number: 219685-50-4 2009; 361:1676-87. http://www.ncbi.nlm.nih.gov/pubmed/19846853?dopt=AbstractPlus, 24. FDA News. What the medication is used for. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747). Gruppo RA, Rother RP. SOLIRIS can cause serious side effects including serious infusion-related reactions. MANUFACTURER . Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. BEXSERO. Eculizumab in atypical hemolytic uremic syndrome: long-term clinical course and histological findings. Alexion Pharmaceuticals, Inc. Soliris (eculizumab) concentrated solution for intravenous infusion prescribing information. N Engl J Med. Note: Individuals prescribed eculizumab (Soliris®) ... August 20). Soliris with NDC 25682-001 is a a human prescription drug product labeled by Alexion Pharmaceuticals Inc.. GlaxoSmithKline Inc. (2019, February 25) Bexsero® Multicomponent meningococcal B vaccine (recombinant, adsorbed). The purpose of the pre-hearing conference was to allow parties to identify or circumscribe the issues related to the hearing and resolve any other issues that may facilitate the conduct of the hearing. Köse O, Zimmerhackl LB, Jungraithmayr T et al. SOLIRIS net product sales were $976.7 million, compared to $791.9 million in the fourth quarter of 2017, representing a 23 percent increase. Product Monograph, originally provided to the Board in early February 2009, described the "usual dose" of Soliris for a PNH patient as "600 mg of Soliris every 7 days for the first 4 weeks", followed by "900 mg of Soliris for the fifth dose 7 days later", and then "900 mg of Soliris every 14 days thereafter. Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Prior to administration, the admixture should be allowed to adjust to … Product Monograph. 2009; 360:542-4. http://www.ncbi.nlm.nih.gov/pubmed/19179328?dopt=AbstractPlus, 26. The Canadian Product Monograph for Soliris includes a boxed warning: “Soliris increases the risk of meningococcal infections. "33 The in 1. endobj
1. for further information about the product. 2011; 26:2085-8. http://www.ncbi.nlm.nih.gov/pubmed/21877169?dopt=AbstractPlus, 28. Paris, France; 2013 Apr 29. pyridostigmine, Mestinon, neostigmine, Soliris, Ultomiris, satralizumab, ravulizumab, Enspryng, Prostigmin. ), In patients receiving fresh frozen plasma infusion in whom most recent eculizumab dose was ≥300 mg, administer supplemental dose of 300 mg 60 minutes prior to each unit of fresh frozen plasma infused.1, Optimal duration of therapy not known.29 32 33 Because of chronic nature of aHUS and some evidence suggesting that treatment discontinuance may result in a return of disease manifestations, long-term (e.g., at least 1 year) therapy may be beneficial; some experts recommend lifelong therapy.1 22 28 29 32 33 37 (See Complications Following Treatment Discontinuance under Cautions. Where availablelinks to product information (PI) pdf documents are provided. 2.2 I keep seeing different years associated with the product monograph guidance and … 4. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. a The mean (SD) terminal elimination half-life and clearance of ravulizumab-cwvz in patients with PNH are 49.7 (8.9) days and 0.08 (0.022) L/day, respectively. 2004; 93:2645-68. http://www.ncbi.nlm.nih.gov/pubmed/15389672?dopt=AbstractPlus, 16. 8. Half-life of eculizumab is 11.25-17.25 days. Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica.In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Alberta Immunization Policy - Biological Products Pneumococcal PolysaccharidePNEUMOVAX® 23 August 10, 2015 Pneumococcal Vaccine, 23-valent Polysaccharide: PNEUMOVAX 23 Revision Date: August10, 2015 Please consult the Product Monograph 1 … The terminal complement protein (C5) inhibitor eculizumab (Soliris®) is the first agent to be specifically approved in the EU, USA, Canada and Japan for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 water channel autoantibody (AQP4-IgG) seropositive and (in the EU only) for those with a relapsing course of disease. Total net product sales were $1,128.5 million in the fourth quarter of 2018, compared to $909.4 million in the fourth quarter of 2017. endobj
Alexion Pharmaceuticals, Cheshire, CT: Personal communication. �E4�94V PI documents can be found by searching this website or by using the PI search database in eBusiness Services. N Engl J Med. Sorbitol (E 420) This medicinal product contains 100 mg sorbitol in each vial which is equivalent to 40 mg/kg. 4 0 obj
Insights From the Use in Clinical Practice of Eculizumab in Adult Patients With Atypical Hemolytic Uremic Syndrome Affecting the Native Kidneys: An Analysis of 19 Cases. Hill A, Richards SJ, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal hemoglobinuria. Refer to the administration reference tables below for minimum infusion duration. 5. 2013; 368:2169-81. http://www.ncbi.nlm.nih.gov/pubmed/23738544?dopt=AbstractPlus, 23. Do not shake. Am J Kidney Dis. Terminal complement inhibitor; a recombinant humanized immunoglobulin IgG2/4 kappa monoclonal antibody.1 3 4 10 16 17 19, Treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; designated an orphan drug by FDA for this use.1 2 3 4 10 16 17, Improves symptoms of PNH by reducing hemolysis, stabilizing hemoglobin concentrations, and reducing transfusion requirements.1 3 4 6 10 16 17 Reduced fatigue and improved quality of life also reported.1 3 6 Only curative treatment of PNH to date is stem cell transplantation.8 10 20, Treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy; designated an orphan drug by FDA for this use.1 2 22 31, Improves outcomes related to thrombotic microangiopathy (e.g., increased platelet counts, normalization of hematologic parameters) and improves renal function.1 22 25 26 27 29 30 31 32, Assess vaccination status prior to initiating therapy.1 (See Serious Meningococcal Infections and see Other Infections under Cautions. Product Monograph, originally provided to the Board in early February 2009, described the "usual dose" of Soliris for a PNH patient as "600 mg of Soliris every 7 days for the first 4 weeks", followed by "900 mg of Soliris for the fifth dose 7 days later", and then "900 mg of Soliris every 14 days thereafter. ";s:7:"keyword";s:25:"soliris product monograph";s:5:"links";s:1191:"Ramesh Thiyagarajah Größe,
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