A recently FDA-approved treatment
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Elfabrio pegunigalsidase alfa-iwxj Now FDA Approved
Dear Healthcare Professional,
As you may have heard Elfabrio® (pegunigalsidase alfa-iwxj) was recently FDA approved for the treatment of adults with Fabry disease.1 Review the full indication here:

Indication
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.
Please see Important Safety Information below and Full Prescribing Information for Elfabrio.
Learn more about Elfabrio, a novel PEGylated enzyme replacement therapy (ERT) for your patients with Fabry1:
  • Pharmacology: Long-lasting treatment exposure that increases over time1,a
    The Elfabrio half-life increases from ~80 hours (78.9±10.3 hours) on Day 1 to ~120 hours (121±22 hours) by Year 1.1
  • Proven pharmacology both in ERT-naive and ERT-experienced patients1
    In clinical studies where patients received the approved dose of 1 mg/kg every other week, treatment with Elfabrio reduced plasma lyso-Gb3 levels in both ERT-naive and ERT-experienced patients with Fabry.1
  • Dosing designed with the patient in mind Elfabrio is infused at a dose of 1 mg/kg every other week.1
    Once patient tolerance is established, subsequent infusions may be decreased in 30-minute decrements, until a minimum maintenance infusion of 90 minutes.1 Patients may also receive infusions at home.1
  • Common adverse reactions
    The most common adverse reactions reported in ≥5% of patients are nausea, dizziness, diarrhea, pruritus, and infusion-related reaction.
aClinical studies have not established that pharmacological characteristics, including half-life, result in superior efficacy or safety based on clinically relevant endpoints.
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Elfabrio ordering information
Eversana is the exclusive distributor of Elfabrio. When ordering Elfabrio, use the following NDC codes1:
Product description NDC # Strength Package size
Elfabrio® (pegunigalsidase alfa-iwxj) 10122-160-02 20 mg One carton containing 1 single-use vial
Elfabrio® (pegunigalsidase alfa-iwxj) 10122-160-05 20 mg One carton containing 5 single-use vials
Elfabrio® (pegunigalsidase alfa-iwxj) 10122-160-10 20 mg One carton containing 10 single-use vials
Thank you for considering Elfabrio for your patients with Fabry.
For more information on Elfabrio, visit hcp.elfabrio.com.

Important Safety Information
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.
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.
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.
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.
Common adverse reactions: The most common adverse reactions reported in ≥5% of patients are nausea, dizziness, diarrhea, pruritus, and infusion-related reaction.
Please see Full Prescribing Information for Elfabrio.
Reference: 1. Elfabrio. Prescribing information. Chiesi Farmaceutici S.p.A.; 2021.
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