Let’s schedule time
to talk about Elfabrio®
(pegunigalsidase alfa-iwxj) |
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\Hi \##accFname##,
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I'm {{userName}}, your Elfabrio {{User.Title}} from Chiesi Global Rare Diseases. I wanted to introduce myself and let you know I will be available as an ongoing resource for you and your team.
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Elfabrio is the first and only PEGylated ERT for Fabry disease—with treatment exposure that increased over time.1,2,a I’d like to share more information with you about the clinical efficacy and safety profile of Elfabrio and how it may help your patients with Fabry disease.
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Let me know if you have time for \a call in the next few weeks to discuss a novel treatment option for your patients with Fabry disease. Please don’t hesitate to call me at or email me at if you have any questions about Elfabrio.
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In the meantime, if you’d like more information about Elfabrio, please visit hcp.elfabrio.com.
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\Sincerely,
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{{userName}}
{{User.Title}}
{{userEmailAddress}}
{{User.Phone}}
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Elfabrio® (pegunigalsidase alfa-iwxj) is indicated for the treatment of adults with confirmed Fabry disease. This indication is approved under accelerated approval based on reduction of globotriaosylceramide (Gb3) inclusion bodies in renal peritubular capillary cells. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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Hypersensitivity reactions including anaphylaxis: Because of the potential for severe allergic reactions including anaphylaxis, appropriate medical support measures should be readily available during Elfabrio administration. If severe reactions occur, immediately discontinue Elfabrio and provide necessary emergency treatment. The risks and benefits of re-administering Elfabrio following a severe hypersensitivity reaction (including anaphylaxis) should be considered.
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Infusion-related reactions: In clinical trials, 21% (11/53) of Elfabrio-treated patients experienced one or more infusion-related reactions, defined as any adverse reaction with onset after start of the infusion and up to 2 hours after the end of infusion. In patients who experienced infusion-related reactions, recommend pre-treatment with an antihistamine prior to subsequent infusions. If an infusion-related reaction occurs, consider decreasing the infusion rate, temporarily stopping the infusion, and/or administering additional antihistamines and/or corticosteroids. If severe infusion-related reactions occur, consider immediate discontinuation and initiation of appropriate medical treatment.
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Compromised cardiac function: Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion-related reactions.
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Immunogenicity: It is unknown if the presence or induction of immunoglobulin G (IgG) antibodies to Elfabrio is associated with a higher risk of adverse events and/or infusion-related reactions during treatment. Patients who demonstrate hypersensitivity reactions during Elfabrio treatment should be monitored for the presence of IgG antibodies to Elfabrio. Physicians should consider testing for immunoglobulin E (IgE) antibodies in patients who experience suspected allergic reactions and consider the risks and benefits of continued treatment in patients with anti-Elfabrio IgE antibodies.
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Common adverse reactions: The most common adverse reactions reported in ≥5% of patients are nausea, dizziness, diarrhea, pruritus, and infusion-related reaction.
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Please see Full Prescribing Information for Elfabrio.
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Reference: 1. Elfabrio. Prescribing information. Chiesi Farmaceutici S.p.A.; 2021. 2. Fabrazyme. Prescribing information. Genzyme Corporation; 2018.
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