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Have you heard about Elfabrio: the PEGylated enzyme replacement therapy (ERT) for Fabry disease? With an overall mean half-life of ~80 hours* (from 53 to 121 hours) and blood levels that increase with repeat administration, Elfabrio is a long-lasting treatment for your patients living with Fabry.1,2
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The efficacy and safety of Elfabrio were validated by a robust, broad-ranging clinical trial program in Fabry disease including adult male and female switch and treatment-naïve patients with classic or nonclassic Fabry.1,3-6 I’d like to share more information with you about the clinical profile and the important features of Elfabrio.
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Elfabrio has an initial half-life of 78.9 ± 10.3 hours. Clinical studies have not established that pharmacological characteristics, including half-life, result in superior efficacy or safety based on clinically relevant endpoints. Infusions are every 2 weeks.1 |
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What can Elfabrio mean for your patients?
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Efficacy
Comparable mean change in eGFR observed vs agalsidase beta over 2 years1,7
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Tolerability
Safety profile was assessed through long-term clinical trials including a head-to-head trial with an agalsidase beta control group1,3,4
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Immunogenicity
Low rates of ADA formation with Elfabrio for naïve and treatment-experienced patients1,7†‡
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Let me know if you have time for {{customText[falsea calltruea video chattruean in-person meeting]}}in the next few weeks to discuss how Elfabrio can be a viable treatment option for your patients. Please don’t hesitate to get in touch if you have any questions.
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The effect of IgG ADAs on the effectiveness of Elfabrio has not been fully characterized. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. |
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In Trial 1 (NAÏVE), 4 out of 14 (28.5%) treatment-naïve patients had treatment-emergent ADAs. In Trial 2 (BALANCE), 6 out of 52 (11.5%) treatment-experienced patients had treatment-emergent ADAs.1,7 |
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| Indication |
| Elfabrio® (pegunigalsidase alfa-iwxj) is indicated for the treatment of adults with confirmed Fabry disease. |
| Important Safety Information |
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WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
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Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during Elfabrio administration. If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, discontinue Elfabrio immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to Elfabrio may be considered.
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Prior to Elfabrio administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. Inform patients and caregivers of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions (IARs), and instruct them to seek medical care immediately if such symptoms occur.
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If a severe hypersensitivity reaction (including anaphylaxis) or severe IAR occurs, immediately discontinue Elfabrio administration and initiate appropriate medical treatment. |
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If a mild to moderate hypersensitivity reaction or IAR occurs, consider slowing the infusion rate or temporarily withholding the dose. |
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In clinical trials, 20 (14%) Elfabrio-treated patients experienced hypersensitivity reactions. Four Elfabrio-treated patients (3%) experienced anaphylaxis reactions that occurred within 5 to 40 minutes of the start of the initial infusion. The signs and symptoms of hypersensitivity reactions and anaphylaxis included headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema.
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In clinical trials, 41 (29%) Elfabrio-treated patients experienced one or more infusion-associated reactions, including hypersensitivity, nausea, chills, pruritus, rash, chest pain, dizziness, vomiting, asthenia, pain, sneezing, dyspnea, nasal congestion, throat irritation, abdominal pain, erythema, diarrhea, burning sensation, neuralgia, headache, paresthesia, tremor, agitation, increased body temperature, flushing, bradycardia, myalgia, hypertension, and hypotension.
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A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitor serum creatinine and urinary protein-to-creatinine ratio. If glomerulonephritis is suspected, discontinue treatment until a diagnostic evaluation can be conducted.
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When switching to Elfabrio from a prior enzyme replacement therapy, the risk of hypersensitivity reactions and infusion-associated reactions may be increased in certain patients with pre-existing anti-drug antibodies (ADAs). Consider monitoring IgG and IgE ADAs and clinical or pharmacodynamic response (eg, plasma lyso-Gb3 levels).
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The most common adverse reactions (≥15%) were infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.
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Please see Full Prescribing Information for Elfabrio.
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References: 1. Elfabrio. Prescribing Information. Chiesi Farmaceutici S.p.A.; 2023. 2. Schiffmann R, Goker-Alpan O, Holida M, et al. Pegunigalsidase alfa, a novel PEGylated enzyme replacement therapy for Fabry disease, provides sustained plasma concentrations and favorable pharmacodynamics: a 1-year phase 1/2 clinical trial. J Inherit Metab Dis. 2019;42(3):534-544. doi:10.1002/jimd.12080. 3. Wallace EL, Goker-Alpan O, Wilcox WR, et al. First results of a head-to-head trial of pegunigalsidase alfa vs agalsidase beta in Fabry disease: 2-year results of the phase 3 randomized, double-blind, BALANCE study. Poster presented at: WORLDSymposium: 19th Annual Research Meeting; February 22-26, 2023; Orlando, FL. https://protalixbiotherapeutics.gcs-web.com/static-files/58f1efe6-de3c-455d-b814-3e9e96373a8c. 4. Atta M, Hughes D, Gonzalez D, et al. Long-term safety and efficacy of pegunigalsidase alfa: a multicenter extension study in adult patients with Fabry disease. Poster presented at: 7th Update on Fabry Disease: Biomarkers, Progression and Treatment Opportunities in 2022; May 29-31, 2022; Würzburg, Germany. https://protalixbiotherapeutics.gcs-web.com/static-files/465d2891-4135-42e5-8581-f24e175cb07f. 5. Bernat J, Holida M, Longo N, et al. Long-term safety and efficacy of pegunigalsidase alfa administered every 4 weeks in patients with Fabry disease: 2-year interim results from the ongoing phase 3 BRIGHT51 open-label extension study. Poster presented at: WORLDSymposium: 19th Annual Research Meeting; February 22-26, 2023; Orlando, FL. https://protalixbiotherapeutics.gcs-web.com/static-files/d2dae305-1926-4418-9c62-3da527a62395. 6. West M, Linhart A, Dostalova G, et al. Switching from agalsidase alfa to pegunigalsidase alfa to treat patients with Fabry disease: 1 year of treatment data from BRIDGE, a phase 3 open-label study. Poster presented at: 7th Update on Fabry Disease: Biomarkers, Progression and Treatment Opportunities in 2022; May 29-31, 2022; Würzburg, Germany. https://protalixbiotherapeutics.gcs-web.com/static-files/e7e1cbc9-4858-42a2-b03f-1854e3e7a143. 7. US Food and Drug Administration. Drug approval package: Elfabrio; Multi-discipline Review. May 8, 2023. Accessed July 17, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761161Orig1s000MultidisciplineR.pdf.
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